Sagent Pharmaceuticals, Inc.
Adenosine Injection, USP Safety Data Sheet (SDS)
SDS Issue Date: Sep 29, 2014
SDS No.: SDS 001
SDS Version No.: 7.0
Form No.: R-SOP-009-F001
Page: 1 of 10
Section 1 - Identification
(a) Product Identifier: Adenosine Injection, USP (b) Product Code: 25021-301
25021-307 Common/Trade Name: Adenosine Injection Chemical Name: 6-amino-9-beta-D-ribofuranosyl-9H-purine Chemical Family: Antiarrhythmic (c) Product Use: Pharmaceutical Product Type: Regulated Prescription Drug Container Information: Pre-filled syringe and single-dose vial (d) Distributor: Sagent Pharmaceuticals, Inc., 1901 N. Roselle Rd, Suite 700,
Schaumburg, IL 60195, 847-908-1600 (e) Emergency Telephone: 866-625-1618
Section 2 - Hazards Identification (a) Classification: Not a hazardous substance or mixture.
HMIS Rating Health Hazard 0 Flammability 0 Physical Hazard 0 NFPA Rating Health Hazard 0 Fire Hazard 0 Reactivity Hazard 0
(b) Signal Word, Hazard statement(s), Symbol(s), and/or Precautionary statement(s):
(c) Description of Hazards:
- Not a hazardous substance or mixture
Sagent Pharmaceuticals, Inc.
Adenosine Injection, USP Safety Data Sheet (SDS)
SDS Issue Date: Sep 29, 2014
SDS No.: SDS 001
SDS Version No.: 7.0
Form No.: R-SOP-009-F001
Page: 2 of 10
(b) Signal Word, Hazard statement(s), Symbol(s), and/or Precautionary statement(s):
(c) Description of Hazards:
Precautionary Statements: P264 P305 + P351 + P338 P337 + P313 P314
- Wash hands thoroughly after handling - IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
- If eye irritation persists, get medical attention - Get medical attention if you feel unwell
(d) Unknown Acute Toxicity: N/A
Section 3 – Composition / Information on Ingredients
(a) Chemical Name (b) Common Name / Synonym
% Composition or other measure
(c) CAS No.
(d) Impurities / Stabilizing Additives
6-amino-9-beta-D-ribofuranosyl-9H-
purine Adenosine 0.3% (w/v) 58-61-7 N/A
Sodium Chloride Sodium Chloride 0.9% (w/v) 7647-14-5 N/A Water for Injection Water for Injection 98.8% (w/v) 7732-18-5 N/A
Section 4 - First Aid Measures
Eye Exposure: Flush eyes with large volumes of water for 15 minutes or more. Seek medical attention if irritation or signs of exposure are noted.
Skin Exposure: Remove contaminated clothing, wash skin with water and soap for 15 minutes. Get medical attention if irritation or signs of exposure are noted.
Ingestion: If ingestion occurs, flush mouth with water and seek medical attention immediately. Never give anything by mouth to an unconscious person.
Injection: In cases of accidental injection, wash and disinfect area, get medical attention.
Sagent Pharmaceuticals, Inc.
Adenosine Injection, USP Safety Data Sheet (SDS)
SDS Issue Date: Sep 29, 2014
SDS No.: SDS 001
SDS Version No.: 7.0
Form No.: R-SOP-009-F001
Page: 3 of 10
Inhalation: If difficulty with breathing, remove from exposure, administer oxygen. Seek attention of a physician immediately. When appropriate and trained in CPR, provide artificial respiration.
Notes to Physician: See patient package insert in shipping carton for complete information.
Section 5 –Fire-fighting Measures
(a) Extinguishing Media Use water or an ABC multi-purpose extinguisher.
(b) Hazardous Combustion Products:
Not determined
(c) Special Protective Equipment / Precautions:
As with all fires, evacuate personnel to a safe area. Fire fighters should wear self-contained breathing apparatus to avoid inhalation of smoke. Product is aqueous-based and is not expected to present a fire hazard concern. Heat of the fire could cause vials or syringes to burst.
Section 6 - Accidental Release Measures
Spill: Use the appropriate personal protective equipment, see Section 8. Absorb Adenosine Injection with absorbent materials and dispose according to local, state, and federal guidelines.
Release to Air: If aerosolized, reduce exposures by ventilating area.
Release to Water: Refer to local water authority. Drain disposal is not recommended; refer to local, state, and federal disposal guidelines.
Section 7 - Handling and Storage
General Handling: When handling pharmaceutical products, avoid all contact with skin, eyes, nostrils and mouth. Avoid inhalation of dust, fumes, mist, and/or vapors associated with the product.
Storage Conditions: Store at controlled room temperature 20°-25°C (68°-77°F). Follow instructions provided in packaging.
Sagent Pharmaceuticals, Inc.
Adenosine Injection, USP Safety Data Sheet (SDS)
SDS Issue Date: Sep 29, 2014
SDS No.: SDS 001
SDS Version No.: 7.0
Form No.: R-SOP-009-F001
Page: 4 of 10
Section 8 - Exposure Controls / Personal Protection (a) Exposure Limits
Compound Issuer Type Exposure Limit Adenosine OSHA
ACGIH -----
TLV TLV STEL
NE NE NE
Sodium Chloride OSHA ACGIH -----
PEL TLV STEL
NE NE NE
(b) Engineering Controls
Ventilation: Good general ventilation should be sufficient to control airborne levels.
(c) Individual Protection Measures
Respiratory Protection:
Under normal use, respirators are not required. If aerosols are generated, a disposable dust/mist respirator (N95) may be used. Personnel wearing respirators should be fit tested and approved for respirator use under the OSHA Respiratory Protection Standard 29 CFR 1910.134.
Eye Protection: Safety glasses
Skin Protection: Work uniform or laboratory coat.
Other Protective Equipment:
Protective Latex or Nitrile gloves
Additional Exposure Precautions:
Wash hands following use. No eating, drinking, or smoking while handling this product.
Sagent Pharmaceuticals, Inc.
Adenosine Injection, USP Safety Data Sheet (SDS)
SDS Issue Date: Sep 29, 2014
SDS No.: SDS 001
SDS Version No.: 7.0
Form No.: R-SOP-009-F001
Page: 5 of 10
Section 9 - Physical and Chemical Properties (a) Appearance Clear Liquid (b) Odor No Odor (c) Odor Threshold None (d) pH 4.5 – 7.5 (e) Melting Point: Not applicable (f) Initial Boiling Point: Not available (g) Flash Point Not determined (h) Evaporation Rate: Approx to water (i) Flammability Not determined (j) Upper Lower Flammability or Explosion Limits Not determined (k) Vapor Pressure: Not available (l) Vapor Density: Not available (m) Relative Density Approx to water (n) Solubility(ies) Soluble in Water (o) Partition Coefficient: n-octanol/water Not available (p) Auto-ignition Temperature Not available (q) Decomposition Temperature Not available (r) Viscosity Not available
Section 10 - Stability and Reactivity
(a) Reactivity Not Reactive (b) Chemical Stability Stable under normal conditions (c) Possibility of Hazardous Reactions None (d) Conditions to Avoid None identified (e) Incompatible Materials None identified
(f) Hazardous Decomposition Products Decomposition products of this compound may include potentially hazardous byproducts such as oxides of carbon and nitrogen.
Sagent Pharmaceuticals, Inc.
Adenosine Injection, USP Safety Data Sheet (SDS)
SDS Issue Date: Sep 29, 2014
SDS No.: SDS 001
SDS Version No.: 7.0
Form No.: R-SOP-009-F001
Page: 6 of 10
Section 11 - Toxicological Information
(a) Likely Routes of Exposure Via contact with skin or eyes, or accidentally ingested.
(b) Symptoms related to the physical, chemical and toxicological characteristics
Exposure can cause dilation of the blood vessels and an increase in contraction of some smooth muscles. Minimal adverse effect should occur from routine use with this product. Acute signs and symptoms of exposure may include dizziness, nausea, vomiting, flushing of skin, irregular heartbeat, pain in chest, fluctuation in blood pressure and numbness or tingling in arms. May cause irritation to eyes, skin, and respiratory tract. Product may cause allergic reaction if inhaled or absorbed through the skin.
(c) Delayed and immediate effects and also chronic effects from short and long term exposure
Adenosine has low chronic toxicity.
(d) Acute Toxicity Component Type Route Species Dosage Adenosine LD50 Oral Mouse 20g/Kg Sodium Chloride LD50 Inhalation Rat 42 g/m3/1H Water LD50 Oral Rat 50000 mg/Kg (e) Hazardous Chemical Listings
NTP: No IARC: No OSHA: No
Sagent Pharmaceuticals, Inc.
Adenosine Injection, USP Safety Data Sheet (SDS)
SDS Issue Date: Sep 29, 2014
SDS No.: SDS 001
SDS Version No.: 7.0
Form No.: R-SOP-009-F001
Page: 7 of 10
Section 12 - Ecological Information
(a) Ecotoxicity
Sodium Chloride Water Flea – 340.7 – 469.2 mg/L, EC50, 48 h 1000 mg/L, EC50, 48 h Fish Oncorhynchus mykiss: 4747 – 7824 mg/L, LC50, 96 hrs Lepomis macrochirus: 5560 – 6080 mg/L, LC50, 96 hrs Pimephales promelas: 6020 – 7070 mg/L, LC50, 96 hrs Lepomis macrochirus: 12946 mg/L, LC50, 96 hrs Pimephales promelas: 7050 mg/L, LC50, 96 hrs
(b) Persistence and degradability No applicable ecological information found. (c) Bioaccumulative potential No applicable ecological information found. (d) Mobility in soil No applicable ecological information found. (e) Other Adverse Effects No applicable ecological information found.
Section 13 - Disposal Considerations
Waste Disposal: Dispose of any cleanup materials and waste residue according to all applicable laws and regulations.
Section 14 - Transport Information (a) UN Number Not available (b) UN Proper Shipping Name Not available (c) Transport Hazard Class(es) Not available (d) Packing Group Not available (e) Environmental Hazards Not available
Sagent Pharmaceuticals, Inc.
Adenosine Injection, USP Safety Data Sheet (SDS)
SDS Issue Date: Sep 29, 2014
SDS No.: SDS 001
SDS Version No.: 7.0
Form No.: R-SOP-009-F001
Page: 8 of 10
(f) Transport in bulk (according to Annex II of MARPOL 73/78 and the IBC Code)
Not available
(g) Special Precautions Not available DOT: Not dangerous goods ICAO/IATA: Not dangerous goods IMO: Not dangerous goods
Section 15 - Regulatory Information Below is selected regulatory information chosen primarily for possible Sagent usage. This section is not a complete analysis or reference to all applicable regulatory information. Please consider all applicable laws and regulations for your country/state. U.S. Regulations: TSCA – Exempt from this list; it is FDA regulated. CERCLA – Not listed SARA 302 - Not listed SARA 313 - Not listed OSHA Substance Specific – Not available California Prop. 65 – Not listed
Section 16 - Other Information As of the date of issuance, we are providing available information relevant to the handling of this material in the workplace. All information contained herein is offered with the good faith belief that it is accurate. THIS SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE ANY WARRANTY OF ANY KIND (INCLUDING WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). In the event of an adverse incident associated with this material, this safety data sheet is not intended to be a substitute for consultation with appropriately trained personnel. Nor is this safety data sheet intended to be a substitute for product literature which may accompany the finished product. For additional information contact: Sagent Pharmaceuticals, Inc. 1901 N. Roselle Rd, Suite 700 Schaumburg, IL 60195 847-908-1600
Sagent Pharmaceuticals, Inc.
Adenosine Injection, USP Safety Data Sheet (SDS)
SDS Issue Date: Sep 29, 2014
SDS No.: SDS 001
SDS Version No.: 7.0
Form No.: R-SOP-009-F001
Page: 9 of 10
Glossary: This glossary contains definitions of general terms used in SDSs. Not all of these Glossary Terms will apply to this SDS. ACGIH American Conference of Governmental Industrial Hygienists AIHA American Industrial Hygiene Association ANSI American National Standards Institute CAS Number Chemical Abstract Service Registry Number CERCLA Comprehensive Environmental Response Compensation and Liability Act (of 1980) CHAN Chemical Hazard Alert Notice CHEMTREC Chemical Transportation Emergency Center DOT Department of Transportation DSL Domestic Substances List EPA Environmental Protection Agency GHS Globally Harmonized System of Classification and Labelling of Chemicals HEPA High Efficiency Particulate Air (Filter) HMIS Hazardous Materials Identification System IARC International Agency for Research on Cancer ICAO/IATA International Civil Aviation Organization/International Air Transport Association IMO International Maritime Organization KOW Octanol/Water Partition Coefficient LEL Lower Explosive Limit MSDS Material Safety Data Sheet MSHA Mine Safety and Health Administration NA Not Applicable, except in Section 14 where NA = North America NE Not Established NADA New Animal Drug Application NAIF No Applicable Information Found NCI National Cancer Institute NDSL Non-Domestic Substances List NFPA National Fire Protection Association NIOSH National Institute for Occupational Safety and Health NOS Not Otherwise Specified NTP National Toxicology Program OSHA Occupational Safety and Health Administration OEL Occupational Exposure Limit PEL Permissible Exposure Limit (OSHA) RCRA Resource Conservation and Recovery Act RQ Reportable Quantity RTECS Registry of Toxic Effects of Chemical Substances SARA Superfund Amendments and Reauthorization Act SDS Safety Data Sheet STEL Short Term Exposure Limit TLV Threshold Limit Value (ACGIH) TPQ Threshold Planning Quantity
Sagent Pharmaceuticals, Inc.
Adenosine Injection, USP Safety Data Sheet (SDS)
SDS Issue Date: Sep 29, 2014
SDS No.: SDS 001
SDS Version No.: 7.0
Form No.: R-SOP-009-F001
Page: 10 of 10
TSCA Toxic Substances Control Act TWA Time Weighted Average/8 Hours Unless Otherwise Noted UEL Upper Explosive Limit UN United Nations USP United States Pharmacopeia WEEL Workplace Environmental Exposure Level (AIHA)
Amiodarone Hydrochloride for InjectionGHS product identifier
Section 1. Identification:
Amiodarone Hydrochloride for Injection
SAFETY DATA SHEETConforms to HazCom 2012/United States
Identified uses
Emergency telephone number (with hours of operation)
:
Antiarrhythmic.
Supplier's details :
:
Not available.
Not available.
Synonyms
Product type
:
:
Product code : NDC 0143-9875-10 NDC 0143-9875-01
Chemical family : Not available.
Container information : Not available.
CHEMTREC, U.S. : 1-800-424-9300 International: +1-703-527-388724/7
West-Ward Pharmaceuticals401 Industrial Way Eatontown NJ 07724Phone (732 542 1191)Fax (732 720 6220)
Section 2. Hazards identification
SERIOUS EYE DAMAGE/ EYE IRRITATION - Category 2AClassification of the substance or mixture
:
Signal word : Warning
Hazard statements :
Hazard pictograms :
Precautionary statements
Prevention :
Response :
Storage :
Disposal :
GHS label elements
OSHA/HCS status : This material is considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200).
Hazards not otherwise classified
: None known.
Hazards not otherwise classified (HNOC)
: None known.
P280 - Wear eye or face protection.P264 - Wash hands thoroughly after handling.
P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.P337 + P313 - If eye irritation persists: Get medical attention.
Not applicable.
Not applicable.
H319 - Causes serious eye irritation.
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Amiodarone Hydrochloride for Injection
Section 3. Composition/information on ingredients
Other means of identification
: Not available.
CAS number : Not applicable.
Substance/mixture
Product code : NDC 0143-9875-10 NDC 0143-9875-01
CAS number/other identifiers
: Mixture
Water 60 - 100 7732-18-5Polysorbate 80 5 - 10 9005-65-6Amiodarone Hydrochloride 1 - 5 19774-82-4Benzyl Alcohol 1 - 5 100-51-6
Ingredient name CAS number%
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
Occupational exposure limits, if available, are listed in Section 8.
Any concentration shown as a range is to protect confidentiality or is due to batch variation.
Wash out mouth with water. Remove dentures if any. Remove victim to fresh air and keep at rest in a position comfortable for breathing. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Stop if the exposed person feels sick as vomiting may be dangerous. Do not induce vomiting unless directed to do so by medical personnel. If vomiting occurs, the head should be kept low so that vomit does not enter the lungs. Get medical attention if adverse health effects persist or are severe. Never give anything by mouth to an unconscious person.If unconscious, place in recovery position and get medical attention immediately.Maintain an open airway. Loosen tight clothing such as a collar, tie, belt or waistband.
Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Continue to rinse for at least 20 minutes. Get medical attention.
Flush contaminated skin with plenty of water. Get medical attention if symptoms occur.Wash clothing before reuse. Clean shoes thoroughly before reuse.
Remove victim to fresh air and keep at rest in a position comfortable for breathing. If not breathing, if breathing is irregular or if respiratory arrest occurs, provide artificial respiration or oxygen by trained personnel. It may be dangerous to the person providing aid to give mouth-to-mouth resuscitation. Get medical attention if adverse health effects persist or are severe. If unconscious, place in recovery position and get medical attention immediately. Maintain an open airway. Loosen tight clothing such as a collar,tie, belt or waistband. In case of inhalation of decomposition products in a fire,symptoms may be delayed. The exposed person may need to be kept under medical surveillance for 48 hours.
Section 4. First aid measures
Eye contact
Skin contact
Inhalation
Ingestion :
:
:
:
Description of necessary first aid measures
Most important symptoms/effects, acute and delayed
Inhalation : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Ingestion
Skin contact : No known significant effects or critical hazards.
Causes serious eye irritation.:Eye contact
Over-exposure signs/symptoms
Potential acute health effects
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Amiodarone Hydrochloride for Injection
Section 4. First aid measures
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training. It may be dangerous to the person providing aid to give mouth-to-mouth resuscitation.
Notes to physician : In case of inhalation of decomposition products in a fire, symptoms may be delayed.The exposed person may need to be kept under medical surveillance for 48 hours.
Specific treatments : No specific treatment.
Skin contact
Ingestion
Inhalation No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.
:
:
:
Eye contact : Adverse symptoms may include the following:pain or irritationwateringredness
See toxicological information (Section 11)
Indication of immediate medical attention and special treatment needed, if necessary
Section 5. Fire-fighting measures
No special measures are required.
Hazardous thermal decomposition products
Specific hazards arising from the chemical
Decomposition products may include the following materials:carbon dioxidecarbon monoxidenitrogen oxideshalogenated compounds
No specific fire or explosion hazard.
Fire-fighters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA) with a full face-piece operated in positive pressure mode.
Special protective equipment for fire-fighters
Use an extinguishing agent suitable for the surrounding fire.
Extinguishing media
:
:
:
None known.
Suitable extinguishing media
:
Unsuitable extinguishing media
:
Special protective actions for fire-fighters
:
Section 6. Accidental release measuresPersonal precautions, protective equipment and emergency procedures
: No action shall be taken involving any personal risk or without suitable training. Keep unnecessary and unprotected personnel from entering. Do not touch or walk through spilled material. Avoid breathing vapor or mist. Provide adequate ventilation. Wear appropriate respirator when ventilation is inadequate. Put on appropriate personal protective equipment.
For non-emergency personnel
For emergency responders : If specialized clothing is required to deal with the spillage, take note of any information in Section 8 on suitable and unsuitable materials. See also the information in "For non-emergency personnel".
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Amiodarone Hydrochloride for Injection
Section 6. Accidental release measuresEnvironmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air).
Methods and materials for containment and cleaning up
Small spill
Stop leak if without risk. Move containers from spill area. Approach release from upwind. Prevent entry into sewers, water courses, basements or confined areas. Wash spillages into an effluent treatment plant or proceed as follows. Contain and collect spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth and place in container for disposal according to local regulations (see Section 13). Dispose of via a licensed waste disposal contractor. Contaminated absorbent material may pose the same hazard as the spilled product. Note: see Section 1 for emergency contact information and Section 13 for waste disposal.
Large spill :
Stop leak if without risk. Move containers from spill area. Dilute with water and mop up if water-soluble. Alternatively, or if water-insoluble, absorb with an inert dry material and place in an appropriate waste disposal container. Dispose of via a licensed waste disposal contractor.
:
Section 7. Handling and storage
Advice on general occupational hygiene
Conditions for safe storage,including any incompatibilities
Eating, drinking and smoking should be prohibited in areas where this material is handled, stored and processed. Workers should wash hands and face before eating,drinking and smoking. See also Section 8 for additional information on hygiene measures.
Store in accordance with local regulations. Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials (see Section 10) and food and drink. Keep container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed and kept upright to prevent leakage. Do not store in unlabeled containers. Use appropriate containment to avoid environmental contamination.
:
:
Protective measures Put on appropriate personal protective equipment (see Section 8). Do not ingest. Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist. Keep in the original container or an approved alternative made from a compatible material, kept tightly closed when not in use. Empty containers retain product residue and can be hazardous.Do not reuse container.
:
Precautions for safe handling
Section 8. Exposure controls/personal protection
Environmental exposure controls
: Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation.
Appropriate engineering controls
: Good general ventilation should be sufficient to control worker exposure to airborne contaminants.
Control parameters
Individual protection measures
Occupational exposure limits
Ingredient name
Benzyl Alcohol AIHA WEEL (United States, 10/2011). TWA: 10 ppm 8 hours.
Exposure limits
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Amiodarone Hydrochloride for Injection
Section 8. Exposure controls/personal protection
Hand protection
Use a properly fitted, air-purifying or supplied air respirator complying with an approved standard if a risk assessment indicates this is necessary. Respirator selection must be based on known or anticipated exposure levels, the hazards of the product and the safe working limits of the selected respirator.
Chemical-resistant, impervious gloves complying with an approved standard should be worn at all times when handling chemical products if a risk assessment indicates this is necessary. Considering the parameters specified by the glove manufacturer, check during use that the gloves are still retaining their protective properties. It should be noted that the time to breakthrough for any glove material may be different for different glove manufacturers. In the case of mixtures, consisting of several substances, the protection time of the gloves cannot be accurately estimated.
Safety eyewear complying with an approved standard should be used when a risk assessment indicates this is necessary to avoid exposure to liquid splashes, mists,gases or dusts. If contact is possible, the following protection should be worn, unless the assessment indicates a higher degree of protection: chemical splash goggles.
Eye/face protection
Respiratory protection :
:
:
Body protection Personal protective equipment for the body should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.
:
Wash hands, forearms and face thoroughly after handling chemical products, before eating, smoking and using the lavatory and at the end of the working period.Appropriate techniques should be used to remove potentially contaminated clothing.Wash contaminated clothing before reusing. Ensure that eyewash stations and safety showers are close to the workstation location.
Hygiene measures :
Skin protection
Other skin protection : Appropriate footwear and any additional skin protection measures should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.
Section 9. Physical and chemical properties
Physical state
Melting point
Vapor pressure
Relative density
Vapor density
Solubility in water
Liquid.
0°C (32°F)
Not available.
Not available.
Not available.
Very slightly soluble in water.
Not available.Odor
pH
Clear to pale yellow.Color
Evaporation rate Not available.
Auto-ignition temperature
Flash point
Not available.
Not available.
Not available.
Not available.
Not available.Odor threshold
Partition coefficient: n-octanol/water
:
:
:
:
:
:
:
:
:
:
:
:
:
:
Appearance
Boiling point : 100°C (212°F)
Flammability (solid, gas) : Not available.
Lower and upper explosive (flammable) limits
: Not available.
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Amiodarone Hydrochloride for Injection
Section 9. Physical and chemical properties
Viscosity Not available.:
Decomposition temperature : Not available.
Section 10. Stability and reactivity
Hazardous decomposition products
Conditions to avoid No specific data.
Under normal conditions of storage and use, hazardous decomposition products should not be produced.
The product is stable.Chemical stability
Reactive or incompatible with the following materials: oxidizing materials and acids.
:
:
:
Incompatible materials :
Possibility of hazardous reactions
: Under normal conditions of storage and use, hazardous reactions will not occur.
Reactivity : No specific test data related to reactivity available for this product or its ingredients.
Section 11. Toxicological information
Carcinogenicity
Mutagenicity
Teratogenicity
Reproductive toxicity
Information on toxicological effects
Acute toxicity
Product/ingredient name Result Species Dose Exposure
Irritation/Corrosion
Product/ingredient name Result Score Exposure ObservationSpecies
Benzyl Alcohol LD50 Dermal Rabbit 2000 mg/kg -LD50 Oral Rat 1230 mg/kg -
Sorbitan monooleate, ethoxylated Eyes - Mild irritant Rabbit - 150 mg -Benzyl Alcohol Skin - Moderate irritant Rabbit - 24 hours 100 mg -
Skin - Mild irritant Man - 48 hours 16 mg -Skin - Moderate irritant Pig - 100 % -
Sensitization
There is no data available.
There is no data available.
There is no data available.
There is no data available.
Specific target organ toxicity (single exposure)
Specific target organ toxicity (repeated exposure)
Aspiration hazard
There is no data available.
There is no data available.
There is no data available.
There is no data available.
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Amiodarone Hydrochloride for Injection
Section 11. Toxicological information
Information on the likely routes of exposure
Inhalation : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Ingestion
Skin contact : No known significant effects or critical hazards.
Causes serious eye irritation.:Eye contact
No known significant effects or critical hazards.General :
No known significant effects or critical hazards.Carcinogenicity :
No known significant effects or critical hazards.Mutagenicity :
No known significant effects or critical hazards.Teratogenicity :
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Symptoms related to the physical, chemical and toxicological characteristics
Skin contact
Ingestion
Inhalation No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.
:
:
:
Eye contact : Adverse symptoms may include the following:pain or irritationwateringredness
Potential chronic health effects
Delayed and immediate effects and also chronic effects from short and long term exposure
Numerical measures of toxicity
Oral 60891.1 mg/kgDermal 18000.3 mg/kgInhalation (vapors) 156.7 mg/L
Route ATE value
Acute toxicity estimates
: Dermal contact. Eye contact. Inhalation. Ingestion.
Potential acute health effects
Potential immediate effects
: No known significant effects or critical hazards.
Short term exposure
Potential delayed effects : No known significant effects or critical hazards.
Potential immediate effects
: No known significant effects or critical hazards.
Long term exposure
Potential delayed effects : No known significant effects or critical hazards.
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Amiodarone Hydrochloride for Injection
Section 12. Ecological information
LogPow BCF Potential
Bioaccumulative potential
Other adverse effects : No known significant effects or critical hazards.
Product/ingredient name
Product/ingredient name Aquatic half-life Photolysis Biodegradability
Toxicity
Product/ingredient name SpeciesResult Exposure
Persistence and degradability
Product/ingredient name Test DoseResult Inoculum
Soil/water partition coefficient (KOC)
: Not available.
Mobility in soil
Benzyl Alcohol Acute EC50 640 mg/L Algae - Scenedesmus subspicatus 96 hoursAcute IC50 700 mg/L Algae 72 hoursAcute LC50 10000 µg/L Fresh water Fish - Lepomis macrochirus 96 hours
Benzyl Alcohol OECD 301C 301C Ready Biodegradability -Modified MITI Test (I)
92 to 96 % - 28 days - -
Sorbitan monooleate, ethoxylated - 61%; 28 to 100 day(s) ReadilyBenzyl Alcohol - - Readily
Benzyl Alcohol 0.87 - low
Section 13. Disposal considerationsThe generation of waste should be avoided or minimized wherever possible. Disposal of this product, solutions and any by-products should comply with the requirements of environmental protection and waste disposal legislation and any regional local authority requirements. Dispose of surplus and non-recyclable products via a licensed waste disposal contractor. Waste should not be disposed of untreated to the sewer unless fully compliant with the requirements of all authorities with jurisdiction. Waste packaging should be recycled. Incineration or landfill should only be considered when recycling is not feasible. This material and its container must be disposed of in a safe way. Care should be taken when handling empty containers that have not been cleaned or rinsed out. Empty containers or liners may retain some product residues. Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers.
:Disposal methods
Section 14. Transport information
- - -
Not regulated.Not regulated. Not regulated.
DOT IMDG IATA
UN number
UN proper shipping name
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Amiodarone Hydrochloride for Injection
Section 14. Transport information-
-
-
-
-
-
- - -
Transport hazard class(es)
Packing group
Additional information
Environmental hazards
No. No. No.
AERG : Not applicable.
Special precautions for user
Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Transport within user’s premises: always transport in closed containers that are upright and secure. Ensure that persons transporting the product know what to do in the event of an accident or spillage.
: Not available.
:
Section 15. Regulatory informationU.S. Federal regulations :
Clean Air Act Section 112(b) Hazardous Air Pollutants (HAPs)
: Not listed
Clean Air Act Section 602 Class I Substances
: Not listed
Clean Air Act Section 602 Class II Substances
: Not listed
DEA List I Chemicals (Precursor Chemicals)
: Not listed
DEA List II Chemicals (Essential Chemicals)
: Not listed
TSCA 8(a) CDR Exempt/Partial exemption: Not determined
United States inventory (TSCA 8b): Not determined.
SARA 302/304
SARA 304 RQ : Not applicable.
Composition/information on ingredients
SARA 311/312
Classification : Immediate (acute) health hazard
Composition/information on ingredients
No products were found.
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Amiodarone Hydrochloride for Injection
Section 15. Regulatory information
The following components are listed: Benzyl Alcohol
WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.
Massachusetts :
SARA 313
Amiodarone Hydrochloride No. Yes. No. No.
Ingredient name Cancer Reproductive No significant risk level
Maximum acceptable dosage level
California Prop. 65
New York : None of the components are listed.
New Jersey : None of the components are listed.
Pennsylvania : The following components are listed: Benzyl Alcohol
State regulations
Polysorbate 80 ≥10 - <25 No. No. No. Yes. No.Amiodarone Hydrochloride ≥5 - <10 No. No. No. Yes. No.Benzyl Alcohol ≥1.7 - <2.5 No. No. No. Yes. No.
Name % Fire hazard
Sudden release of pressure
Reactive Immediate (acute)health hazard
Delayed (chronic)health hazard
No products were found.
Section 16. Other informationHistory
Prepared by :
Key to abbreviations : ATE = Acute Toxicity EstimateBCF = Bioconcentration FactorGHS = Globally Harmonized System of Classification and Labelling of ChemicalsIATA = International Air Transport AssociationIBC = Intermediate Bulk ContainerIMDG = International Maritime Dangerous GoodsLogPow = logarithm of the octanol/water partition coefficientMARPOL 73/78 = International Convention for the Prevention of Pollution From Ships,1973 as modified by the Protocol of 1978. ("Marpol" = marine pollution)UN = United Nations
Date of issue mm/dd/yyyy
Version :
:
1
08/15/2015
KMK Regulatory Services Inc.
Notice to readerTo the best of our knowledge, the information contained herein is accurate. However, neither the above-named supplier, nor any of its subsidiaries, assumes any liability whatsoever for the accuracy or completeness of the information contained herein.Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist.
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Ammonia Inhalant Solution Safety Data Sheet according to the federal final rule of hazard communication revised on 2012 (HazCom 2012) Date of issue: 06/02/2014 Version: 1.0
06/06/2014 EN (English) Page 1
SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1. Product identifier Product form : Mixture Trade name : Ammonia Inhalant Solution
1.2. Relevant identified uses of the substance or mixture and uses advised against Use of the substance/mixture : OTC drug used to treat or prevent fainting Use of the substance/mixture : For professional use only
1.3. Details of the supplier of the safety data sheet James Alexander Corporation 845 Route 94 Blairstown NJ 07825 Tel: (908) 362-9266 Note: The CHEMTREC emergency number is to be used only in the event of chemical emergencies involving a spill, leak, fire, exposure, or accident involving chemicals. All non-emergency questions should be directed to JAC at (908) 362-9266.
1.4. Emergency telephone number Emergency number : Chemtrec (800) 424-9300
SECTION 2: Hazards identification
2.1. Classification of the substance or mixture
GHS-US classification Flam. Liq. 2 H225 Skin Corr. 1B H314 Eye Dam. 1 H318 Carc. 1A H350
2.2. Label elements
GHS-US labelling Hazard pictograms (GHS-US) :
GHS02
GHS05
GHS08
Signal word (GHS-US) : Danger Hazard statements (GHS-US) : H225 - Highly flammable liquid and vapour
H314 - Causes severe skin burns and eye damage H318 - Causes serious eye damage H350 - May cause cancer
Precautionary statements (GHS-US) : P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P210 - Keep away from heat, hot surfaces, open flames, sparks. - No smoking P233 - Keep container tightly closed P240 - Ground/bond container and receiving equipment P241 - Use explosion-proof electrical, lighting, ventilating equipment P242 - Use only non-sparking tools P243 - Take precautionary measures against static discharge P260 - Do not breathe dust, fume, gas, mist, spray, vapours P264 - Wash hands thoroughly after handling P280 - Wear eye protection, protective clothing, protective gloves P301+P330+P331 - IF SWALLOWED: rinse mouth. Do NOT induce vomiting P303+P361+P353 - IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower P304+P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing P305+P351+P338 - If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing
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P308+P313 - IF exposed or concerned: Get medical advice/attention P310 - Immediately call a POISON CENTER or doctor/physician P321 - Specific treatment (see on this label) P363 - Wash contaminated clothing before reuse P370+P378 - In case of fire: Use dry chemical powder, alcohol-resistant foam, carbon dioxide (CO2), water spray, sand, earth for extinction P403+P235 - Store in a well-ventilated place. Keep cool P405 - Store locked up P501 - Dispose of contents/container to comply with applicable local, national and international regulation.
2.3. Other hazards No additional information available 2.4. Unknown acute toxicity (GHS-US) No data available
SECTION 3: Composition/information on ingredients
3.1. Substance Not applicable Full text of H-phrases: see section 16
3.2. Mixture
Name Product identifier % GHS-US classification Ethyl alcohol (CAS No) 64-17-5 30 - 40 Flam. Liq. 2, H225
Carc. 1A, H350 Ammonia (CAS No) 7664-41-7 15 - 20 Flam. Gas 2, H221
Compressed gas, H280 Acute Tox. 3 (Inhalation:gas), H331 Skin Corr. 1B, H314
SECTION 4: First aid measures
4.1. Description of first aid measures First-aid measures general : Never give anything by mouth to an unconscious person. If you feel unwell, seek medical advice
(show the label where possible). First-aid measures after inhalation : Remove to fresh air and keep at rest in a position comfortable for breathing. If breathing stops,
give artificial respiration. In case of breathing difficulties administer oxygen. by trained personnel. Seek medical attention immediately.
First-aid measures after skin contact : Immediately flush skin with plenty of water for at least 15 minutes. Remove/Take off immediately all contaminated clothing. Do not rub the skin and eyes after direct contact with the product. Seek medical attention immediately. Wash contaminated clothing before reuse.
First-aid measures after eye contact : In case of contact with eyes flush immediately with plenty of flowing water for 10 to 15 minutes holding eyelids apart and consult an ophthalmologist. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately get medical attention.
First-aid measures after ingestion : If the person is fully conscious, make him/her drink water. Never give an unconscious person anything to drink. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician. If swallowed, rinse mouth with water (only if the person is conscious).
4.2. Most important symptoms and effects, both acute and delayed Symptoms/injuries : Causes severe skin burns and eye damage. This material or its emissions may affect the central
nervous system and/or aggravate pre-existing disorders. Symptoms/injuries after inhalation : May cause cancer by inhalation. Prolonged and repeated inhalation of decomposition products
may cause a pulmonary oedema. Depression of the central nervous system, headaches, dizziness, drowsiness, loss of coordination. Irritating to the respiratory system, may cause throat pain and cough. Difficulty in breathing.
Symptoms/injuries after skin contact : May cause severe burns. Symptoms/injuries after eye contact : Causes serious eye damage. Can cause blindness. Symptoms/injuries after ingestion : May cause burns or irritation of the linings of the mouth, throat, and gastrointestinal tract.
Ingestion may cause nausea, vomiting and diarrhea.
4.3. Indication of any immediate medical attention and special treatment needed No additional information available
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SECTION 5: Firefighting measures
5.1. Extinguishing media Suitable extinguishing media : Alcohol resistant foam. Dry powder. Carbon dioxide. Sand. Unsuitable extinguishing media : Do not use a heavy water stream.
5.2. Special hazards arising from the substance or mixture Fire hazard : Highly flammable liquid and vapour. Explosion hazard : May form flammable/explosive vapour-air mixture. Reactivity : Thermal decomposition generates : Corrosive vapours. Reacts violently with acids. An
exothermic reaction may occur.
5.3. Advice for firefighters Firefighting instructions : Use water spray or fog for cooling exposed containers. Exercise caution when fighting any
chemical fire. Prevent fire-fighting water from entering environment. Protective equipment for firefighters : Do not enter fire area without proper protective equipment, including respiratory protection. Other information : Containers may swell and Burst during a fire due to internal pressure caused by heat. Vapours
are heavier than air and may travel considerable distance to an ignition source and flash back to source of vapours. Alcohols burn with a pale blue flame which may be extremely hard to see under normal lighting conditions. Personnel may be able to feel the heat of the fire without seeing flames. Extreme caution must be exercised in fighting alcohol fires.
SECTION 6: Accidental release measures
6.1. Personal precautions, protective equipment and emergency procedures General measures : Eliminate all ignition sources if safe to do so. Use special care to avoid static electric charges. No
naked lights. No smoking. Stop leak if safe to do so. No action shall be taken involving any personal risk or without suitable training. Wear protective clothing. For further information refer to section 8 : Exposure-controls/personal protection.
6.1.1. For non-emergency personnel Emergency procedures : Evacuate unnecessary personnel.
6.1.2. For emergency responders Protective equipment : Equip cleanup crew with proper protection. Emergency procedures : Ventilate area.
6.2. Environmental precautions Prevent entry to sewers and public waters. Notify authorities if liquid enters sewers or public waters.
6.3. Methods and material for containment and cleaning up Methods for cleaning up : Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Collect
spillage. Store away from other materials. Contain any spills with dikes or absorbents to prevent migration and entry into sewers or streams. Consult the appropriate authorities about waste disposal. Ensure all national/local regulations are observed.
6.4. Reference to other sections See Heading 8. Exposure controls and personal protection.
SECTION 7: Handling and storage
7.1. Precautions for safe handling Additional hazards when processed : Handle empty containers with care because residual vapours are flammable. Precautions for safe handling : Obtain special instructions before use. Do not handle until all safety precautions have been read
and understood. Personal protective equipment should be selected based upon the conditions under which this product is handled or used. Use personal protective equipment as required. Provide good ventilation in process area to prevent formation of vapour. Do not breathe gas, fumes, vapour or spray. No naked lights. No smoking. Use only non-sparking tools. Never use pressure to empty container. Ground/bond container and receiving equipment. Take care to allow internal pressure to escape from container before releasing closures. Remove closure carefully; internal pressure may be present. Keep closure up to prevent leakage. Wash hands and other exposed areas with mild soap and water before eating, drinking or smoking and when leaving work.
Hygiene measures : Wash hands and other exposed areas with mild soap and water before eating, drinking or smoking and when leaving work. Wash contaminated clothing before reuse. Do not eat, drink or smoke when using this product.
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7.2. Conditions for safe storage, including any incompatibilities Technical measures : Use explosion-proof machinery, apparatus, ventilation facilities, tools etc. Ensure the ventilation
system is regularly maintained and tested. Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of mists and/or vapors below the recommended exposure limits. Proper grounding procedures to avoid static electricity should be followed. Ground/bond container and receiving equipment. A washing facility/water for eye and skin cleaning purposes should be present. Comply with applicable regulations.
Storage conditions : Keep only in the original container in a cool well ventilated place. Keep in fireproof place. Keep container tightly closed. Protect containers against physical damage. Detached outside storage is preferable. Inside storage should be in an NFPA approved flammable liquids storage room or cabinet. Store in corrosion-proof area at temperatures below 77 degrees F (25oC). Store away from direct sunlight or other heat sources.
Incompatible materials : Avoid mixing with acids, most common metals, strong oxidizing agents, brass, zinc, chlorine, aluminum, copper, bronze, mercury, dimethyl sulfate and acetyl chloride.
7.3. Specific end use(s) No additional information available
SECTION 8: Exposure controls/personal protection
8.1. Control parameters
Ammonia (7664-41-7) USA ACGIH ACGIH TWA (ppm) 25 ppm
USA ACGIH ACGIH STEL (ppm) 35 ppm
USA OSHA OSHA PEL (TWA) (mg/m³) 35 mg/m³
USA OSHA OSHA PEL (TWA) (ppm) 50 ppm
Ethyl alcohol (64-17-5) USA ACGIH ACGIH STEL (ppm) 1000 ppm
USA OSHA OSHA PEL (TWA) (mg/m³) 1900 mg/m³
USA OSHA OSHA PEL (TWA) (ppm) 1000 ppm
8.2. Exposure controls Appropriate engineering controls : Emergency eye wash fountains and safety showers should be available in the immediate vicinity
of any potential exposure. Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of mists and/or vapors below the recommended exposure limits. Use explosion-proof ventilating equipment.
Personal protective equipment : Avoid all unnecessary exposure. A hazard assessment of the work area for PPE requirements should be conducted by a qualified professional pursuant to OSHA regulations. For certain operations, additional Personal Protection Equipment (PPE) may be required. Protective goggles. Gloves. Protective clothing.
Hand protection : Wear protective gloves. rubber gloves. For special purposes, it is recommended to check the
resistance to chemicals of the protective gloves mentioned above together with the supplier of these gloves.
Eye protection : Chemical goggles or face shield. Skin and body protection : Wear suitable protective clothing. Chemical resistant safety shoes. Respiratory protection : Wear a self-contained breathing apparatus and appropriate personal protective equipment
(PPE). Suggestions provided in this section for exposure control and specific types of protective equipment are based on readily available information. Users should consult with the specific manufacturer to confirm the performance of their protective equipment. Specific situations may require consultation with industrial hygiene, safety, or engineering professionals. Care must be taken to assure that any respirator chosen is capable of protecting the user from both ammonia and ethyl alcohol vapors.
Other information : Do not eat, drink or smoke during use.
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SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties Physical state : Liquid
Appearance : Clear. Colour : Red.
Odour : Pungent ammonia odour.
Odour threshold : No data available
pH : No data available
Relative evaporation rate (butyl acetate=1) : No data available
Melting point : No data available
Freezing point : No data available
Boiling point : > 35 °C (> 95 °F)
Flash point : < 10 °C (< 50 °F - Pensky Martens Closed Cup)
Auto-ignition temperature : No data available
Decomposition temperature : No data available
Flammability (solid, gas) : No data available
Vapour pressure : No data available
Relative vapour density at 20 °C : No data available
Relative density : No data available
Density : 0.891 (Specific Gravity @ 25 °C ) Solubility : Soluble in water.
Log Pow : No data available
Log Kow : No data available
Viscosity, kinematic : No data available
Viscosity, dynamic : No data available
Explosive properties : No data available
Oxidising properties : No data available
Explosive limits : No data available
9.2. Other information No additional information available
SECTION 10: Stability and reactivity
10.1. Reactivity Thermal decomposition generates : Corrosive vapours. Reacts violently with acids. An exothermic reaction may occur.
10.2. Chemical stability Not established.
10.3. Possibility of hazardous reactions Not established.
10.4. Conditions to avoid Direct sunlight. Extremely high or low temperatures. Open flame.
10.5. Incompatible materials Avoid mixing with acids, most common metals, strong oxidizing agents, brass, zinc, chlorine, aluminum, copper, bronze, mercury, dimethyl sulfate and acetyl chloride.
10.6. Hazardous decomposition products Thermal decomposition generates : Fume. Carbon monoxide. Carbon dioxide. May release flammable gases. Corrosive vapours. Ammonia. Nitrogen oxides. release of highly flammable gases/vapours hydrogen.
SECTION 11: Toxicological information
11.1. Information on toxicological effects Acute toxicity : Not classified
(Based on available data, the classification criteria are not met)
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Ammonia (7664-41-7) LD50 oral rat 350 mg/kg LC50 inhalation rat (ppm) 2000 ppm/4h
Ethyl alcohol (64-17-5) LC50 inhalation rat (mg/l) 124.7 mg/l (Exposure time: 4 h)
Skin corrosion/irritation : Causes severe skin burns and eye damage. Serious eye damage/irritation : Causes serious eye damage. Respiratory or skin sensitisation : Not classified
(Based on available data, the classification criteria are not met) Germ cell mutagenicity : Not classified
(Based on available data, the classification criteria are not met) Carcinogenicity : May cause cancer.
Ethyl alcohol (64-17-5) IARC group 1 - Carcinogenic to humans
Reproductive toxicity : Not classified (Based on available data, the classification criteria are not met)
Specific target organ toxicity (single exposure) : Not classified (Based on available data, the classification criteria are not met)
Specific target organ toxicity (repeated exposure)
: Not classified (Based on available data, the classification criteria are not met)
Aspiration hazard : Not classified (Based on available data, the classification criteria are not met)
Potential Adverse human health effects and symptoms
: Based on available data, the classification criteria are not met.
Symptoms/injuries after inhalation : May cause cancer by inhalation. Prolonged and repeated inhalation of decomposition products may cause a pulmonary oedema. Depression of the central nervous system, headaches, dizziness, drowsiness, loss of coordination. Irritating to the respiratory system, may cause throat pain and cough. Difficulty in breathing.
Symptoms/injuries after skin contact : May cause severe burns. Symptoms/injuries after eye contact : Causes serious eye damage. Can cause blindness. Symptoms/injuries after ingestion : May cause burns or irritation of the linings of the mouth, throat, and gastrointestinal tract.
Ingestion may cause nausea, vomiting and diarrhea.
SECTION 12: Ecological information
12.1. Toxicity
Ammonia (7664-41-7) LC50 fishes 1 0.44 mg/l (Exposure time: 96 h - Species: Cyprinus carpio) EC50 Daphnia 1 25.4 mg/l (Exposure time: 48 h - Species: Daphnia magna) LC50 fish 2 0.26 - 4.6 mg/l (Exposure time: 96 h - Species: Lepomis macrochirus)
Ethyl alcohol (64-17-5) LC50 fishes 1 12.0 - 16.0 ml/l (Exposure time: 96 h - Species: Oncorhynchus mykiss) EC50 Daphnia 1 9268 - 14221 mg/l (Exposure time: 48 h - Species: Daphnia magna) LC50 fish 2 > 100 mg/l (Exposure time: 96 h - Species: Pimephales promelas) EC50 Daphnia 2 10800 mg/l (Exposure time: 24 h - Species: Daphnia magna)
12.2. Persistence and degradability Ammonia Inhalant Solution Persistence and degradability Not established.
12.3. Bioaccumulative potential Ammonia Inhalant Solution Bioaccumulative potential Not established.
Ammonia (7664-41-7) Log Pow -1.14 (at 25 °C)
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Ethyl alcohol (64-17-5) Log Pow -0.32
12.4. Mobility in soil No additional information available
12.5. Other adverse effects Other information : Avoid release to the environment.
SECTION 13: Disposal considerations
13.1. Waste treatment methods Waste disposal recommendations : Dispose in a safe manner in accordance with local/national regulations. Do not re-use empty
containers. Ensure all national/local regulations are observed. Consult the appropriate authorities about waste disposal.
Additional information : Handle empty containers with care because residual vapours are flammable. Ecology - waste materials : Avoid release to the environment.
SECTION 14: Transport information
In accordance with DOT Transport document description : UN2924 Flammable liquids, corrosive, n.o.s. (Ammonia, Ethanol), 3, II UN-No.(DOT) : 2924 DOT NA no. : UN2924 DOT Proper Shipping Name : Flammable liquids, corrosive, n.o.s.
(Ammonia, Ethanol) Department of Transportation (DOT) Hazard Classes
: 3 - Class 3 - Flammable and combustible liquid 49 CFR 173.120
Hazard labels (DOT) : 3 - Flammable liquid 8 - Corrosive
DOT Symbols : G - Identifies PSN requiring a technical name Packing group (DOT) : II - Medium Danger DOT Special Provisions (49 CFR 172.102) : IB2 - Authorized IBCs: Metal (31A, 31B and 31N); Rigid plastics (31H1 and 31H2); Composite
(31HZ1). Additional Requirement: Only liquids with a vapor pressure less than or equal to 110 kPa at 50 C (1.1 bar at 122 F), or 130 kPa at 55 C (1.3 bar at 131 F) are authorized. T11 - 6 178.274(d)(2) Normal............. 178.275(d)(3) TP2 - a. The maximum degree of filling must not exceed the degree of filling determined by the following: (image) Where: tr is the maximum mean bulk temperature during transport, tf is the temperature in degrees celsius of the liquid during filling, and a is the mean coefficient of cubical expansion of the liquid between the mean temperature of the liquid during filling (tf) and the maximum mean bulk temperature during transportation (tr) both in degrees celsius. b. For liquids transported under ambient conditions may be calculated using the formula: (image) Where: d15 and d50 are the densities (in units of mass per unit volume) of the liquid at 15 C (59 F) and 50 C (122 F), respectively. TP27 - A portable tank having a minimum test pressure of 4 bar (400 kPa) may be used provided the calculated test pressure is 4 bar or less based on the MAWP of the hazardous material, as defined in 178.275 of this subchapter, where the test pressure is 1.5 times the MAWP.
DOT Packaging Exceptions (49 CFR 173.xxx) : 150 DOT Packaging Non Bulk (49 CFR 173.xxx) : 202 DOT Packaging Bulk (49 CFR 173.xxx) : 243 DOT Quantity Limitations Passenger aircraft/rail (49 CFR 173.27)
: 1 L
DOT Quantity Limitations Cargo aircraft only (49 CFR 175.75)
: 5 L
DOT Vessel Stowage Location : B - (i) The material may be stowed ‘‘on deck’’ or ‘‘under deck’’ on a cargo vessel and on a passenger vessel carrying a number of passengers limited to not more than the larger of 25 passengers, or one passenger per each 3 m of overall vessel length; and (ii) ‘‘On deck only’’ on passenger vessels in which the number of passengers specified in paragraph (k)(2)(i) of this section is exceeded.
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DOT Vessel Stowage Other : 40 - Stow ‘‘clear of living quarters’’
Additional information Other information : No supplementary information available.
ADR Transport document description : No additional information available
Transport by sea No additional information available
Air transport No additional information available
SECTION 15: Regulatory information
15.1. US Federal regulations Ammonia Inhalant Solution RQ (Reportable quantity, section 304 of EPA's List of Lists) :
588 lb
Ammonia (7664-41-7) Listed on the United States TSCA (Toxic Substances Control Act) inventory Listed on SARA Section 302 (Specific toxic chemical listings) Listed on SARA Section 313 (Specific toxic chemical listings) RQ (Reportable quantity, section 304 of EPA's List of Lists) :
100 lb
SARA Section 302 Threshold Planning Quantity (TPQ)
500
SARA Section 313 - Emission Reporting 1.0 % (includes anhydrous Ammonia and aqueous Ammonia from water dissociable Ammonium salts and other sources, 10% of total aqueous Ammonia is reportable under this listing)
Ethyl alcohol (64-17-5) Listed on the United States TSCA (Toxic Substances Control Act) inventory
15.2. International regulations
CANADA
Ammonia (7664-41-7) Listed on the Canadian DSL (Domestic Sustances List) inventory. WHMIS Classification Class A - Compressed Gas
Class B Division 1 - Flammable Gas Class D Division 1 Subdivision A - Very toxic material causing immediate and serious toxic effects Class E - Corrosive Material
Ethyl alcohol (64-17-5) Listed on the Canadian DSL (Domestic Sustances List) inventory. WHMIS Classification Class B Division 2 - Flammable Liquid
Class D Division 2 Subdivision B - Toxic material causing other toxic effects
EU-Regulations
Ammonia (7664-41-7) Listed on the EEC inventory EINECS (European Inventory of Existing Commercial Chemical Substances) substances.
Ethyl alcohol (64-17-5) Listed on the EEC inventory EINECS (European Inventory of Existing Commercial Chemical Substances) substances.
Classification according to Regulation (EC) No. 1272/2008 [CLP] Not classified
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Classification according to Directive 67/548/EEC or 1999/45/EC Not classified
15.2.2. National regulations
Ammonia (7664-41-7) Listed on the AICS (the Australian Inventory of Chemical Substances) Listed on Inventory of Existing Chemical Substances (IECSC) Listed on the Japanese ENCS (Existing & New Chemicals Substances) inventory. Listed on the Korean ECL (Existing Chemical List) inventory. Listed on New Zealand - Inventory of Chemicals (NZIoC) Listed on Inventory of Chemicals and Chemical Substances (PICCS) Poisonous and Deleterious Substances Control Law Listed on the Canadian Ingredient Disclosure List
Ethyl alcohol (64-17-5) Listed on IARC (International Agency for Research on Cancer) Listed on the AICS (the Australian Inventory of Chemical Substances) Listed on Inventory of Existing Chemical Substances (IECSC) Listed on the Japanese ENCS (Existing & New Chemicals Substances) inventory. Listed on the Korean ECL (Existing Chemical List) inventory. Listed on New Zealand - Inventory of Chemicals (NZIoC) Listed on Inventory of Chemicals and Chemical Substances (PICCS) Listed on the Canadian Ingredient Disclosure List
15.3. US State regulations
Ethyl alcohol (64-17-5) U.S. - California - Proposition 65 - Carcinogens List
U.S. - California - Proposition 65 - Developmental Toxicity
U.S. - California - Proposition 65 - Reproductive Toxicity - Female
U.S. - California - Proposition 65 - Reproductive Toxicity - Male
No significance risk level (NSRL)
Yes Yes
SECTION 16: Other information
Other information : None. Full text of H-phrases: see section 16: ------ Acute Tox. 3 (Inhalation:gas) Acute toxicity (inhalation:gas) Category 3 ------ Carc. 1A Carcinogenicity, Category 1A ------ Compressed gas Gases under pressure : Compressed gas ------ Eye Dam. 1 Serious eye damage/eye irritation, Category 1 ------ Flam. Gas 2 Flammable gases, Category 2 ------ Flam. Liq. 2 Flammable liquids Category 2 ------ Skin Corr. 1B Skin corrosion/irritation Category 1B ------ H221 Flammable gas ------ H225 Highly flammable liquid and vapour ------ H280 Contains gas under pressure; may explode if heated ------ H314 Causes severe skin burns and eye damage ------ H318 Causes serious eye damage ------ H331 Toxic if inhaled ------ H350 May cause cancer NFPA health hazard : 3 - Short exposure could cause serious temporary or
residual injury even though prompt medical attention was given.
NFPA fire hazard : 3 - Liquids and solids that can be ignited under almost all ambient conditions.
NFPA reactivity : 1 - Normally stable, but can become unstable at elevated temperatures and pressures or may react with water with some release of energy, but not violently.
Ammonia Inhalant Solution Safety Data Sheet according to the federal final rule of hazard communication revised on 2012 (HazCom 2012)
06/06/2014 EN (English) 10/10
SDS US (GHS HazCom 2012) This Material Safety Data Sheet is intended only as a guide to the appropriate precautionary handling of the material by a person trained in, or supervised by a person trained in, the safe handling of chemical materials. James Alexander Corporation (JAC), expressly disclaims all express or implied warranties of merchantability and fitness for a particular purpose with respect to the product or information provided herein. All information appearing herein is based upon data obtained from the manufacturer(s) and/or recognized technical sources. While the information is believed to be accurate, JAC makes no representations as to its accuracy or sufficiency. Conditions of use are beyond JAC’s control and therefore, users are responsible to verify this data under their own operating conditions to determine whether the product is suitable for their particular purposes and they assume all risks of their use, handling, and disposal of the product, or from the publication or use of, or reliance upon, information contained herein. This information relates only to the product designated herein and does not relate to its use in combination with any other material or in any other process.
1
SAFETY DATA SHEET
Product Name: Atropine Sulfate Injection
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Manufacturer Name And
Address
Hospira, Inc.
275 North Field Drive
Lake Forest, Illinois 60045
USA
Emergency Telephone
Hospira, Inc., Non-Emergency
CHEMTREC: North America: 800-424-9300;
International 1-703-527-3887; Australia - 61-290372994; UK - 44-870-8200418
224 212-2000
Product Name Atropine Sulfate Injection
Synonyms 1H, 5H-Tropan-3--ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate.
2. HAZARD(S) IDENTIFICATION
Emergency Overview Atropine Sulfate Injection is a solution containing atropine sulfate, an anticholinergic
drug that blocks the effects of acetylcholine in the body resulting is effects on many
organ systems including the eyes, gastrointestinal tract, heart, lung and central nervous
system. Clinically, atropine sulfate is used to treat a variety of GI disorders, to reduce
salivation and secretions during surgery, and to dilate pupils. In the workplace, this
material should be considered potentially irritating to the eyes and respiratory tract.
Based on clinical use, possible target organs include the eyes, skin, gastrointestinal
system, respiratory system, central nervous system, and cardiovascular system.
U.S. OSHA GHS Classification
Physical Hazards Hazard Class Hazard Category
Not Classified Not Classified
Health Hazards Hazard Class Hazard Category
Not Classified Not Classified
Label Element(s)
Pictogram NA
Signal Word NA
Hazard Statement(s) NA
Precautionary Statement(s)
Prevention Do not breathe vapor or spray.
Wash hands thoroughly after handling.
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
2
Product Name: Atropine Sulfate Injection
3. COMPOSITION/INFORMATION ON INGREDIENTS
Active Ingredient Name Atropine Sulfate Monohydrate
Chemical Formula (C17H23NO3)2• H2SO4• H2O
Component Approximate Percent by Weight CAS Number RTECS Number
Atropine Sulfate Monohydrate 0.01 73791-47-6 CK2455000 Non-hazardous ingredients include Water for Injection. Hazardous ingredients present at less than 1% include sodium chloride.
Hydrochloric acid and/or sodium hydroxide are added to adjust the pH.
4. FIRST AID MEASURES
Eye Contact Remove from source of exposure. Flush with copious amounts of water. If irritation
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Skin Contact Remove from source of exposure. Flush with copious amounts of water. If irritation
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Inhalation Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
Ingestion Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
5. FIRE FIGHTING MEASURES
Flammability
None anticipated for this aqueous product.
Fire & Explosion Hazard
None anticipated for this aqueous product.
Extinguishing Media
As with any fire, use extinguishing media appropriate for primary cause of fire such as
carbon dioxide, dry chemical extinguishing powder or foam.
Special Fire Fighting
Procedures
No special provisions required beyond normal firefighting equipment such as flame
and chemical resistant clothing and self contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES
Spill Cleanup and Disposal Isolate area around spill. Put on suitable protective clothing and equipment as
specified by site spill control procedures. Absorb the liquid with suitable material and
clean affected area with soap and water. Dispose of spill materials according to the
applicable federal, state, or local regulations.
7. HANDLING AND STORAGE
Handling
No special handling required under conditions of normal product use.
Storage No special storage required for hazard control. For product protection, follow storage
recommendations noted on the product case label, the primary container label, or the
product insert.
Special Precautions No special precautions required for hazard control.
3
Product Name: Atropine Sulfate Injection
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure Guidelines Exposure Limits
Component OSHA-PEL ACGIH-TLV AIHA WEEL Hospira EEL
Atropine Sulfate Monohydrate 8-hr TWA: Not
Established
8-hr TWA: Not
Established
8-hr TWA: Not
Established
8-hr TWA: Not
Established
Notes: OSHA PEL: US Occupational Safety and Health Administration – Permissible Exposure Limit
ACGIH TLV: American Conference of Governmental Industrial Hygienists – Threshold Limit Value. AIHA WEEL: Workplace Environmental Exposure Level
EEL: Employee Exposure Limit.
TWA: 8-hour Time Weighted Average.
Respiratory Protection
Respiratory protection is normally not needed during intended product use. However,
if the generation of aerosols is likely, and engineering controls are not considered
adequate to control potential airborne exposures, the use of an approved air-purifying
respirator with a HEPA cartridge (N95 or equivalent) is recommended under
conditions where airborne aerosol concentrations are not expected to be excessive. For
uncontrolled release events, or if exposure levels are not known, provide respirators
that offer a high protection factor such as a powered air purifying respirator or
supplied air. A respiratory protection program that meets OSHA's 29 CFR 1910.134
and ANSI Z88.2 requirements must be followed whenever workplace conditions
require respirator use. Personnel who wear respirators should be fit tested and
approved for respirator use as required.
Skin Protection
If skin contact with the product formulation is likely, the use of latex or nitrile gloves
is recommended.
Eye Protection
Eye protection is normally not required during intended product use. However, if eye
contact is likely to occur, the use of chemical safety goggles (as a minimum) is
recommended.
Engineering Controls Engineering controls are normally not needed during the normal use of this product.
9. PHYSICAL/CHEMICAL PROPERTIES
Appearance/Physical State Clear liquid
Odor NA
Odor Threshold NA
pH pH 4.2 (3.0 to 6.5)
Melting point/Freezing Point NA
Initial Boiling Point/Boiling Point Range NA
Flash Point NA
Evaporation Rate NA
Flammability (solid, gas) NA
Upper/Lower Flammability or Explosive Limits NA
Vapor Pressure NA
Vapor Density (Air =1) NA
Relative Density NA
Solubility NA
Partition Coefficient: n-octanol/water NA
Auto-ignition Temperature NA
Decomposition Temperature NA
Viscosity NA
4
Product Name: Atropine Sulfate Injection
10. STABILITY AND REACTIVITY
Reactivity
Not determined.
Chemical Stability
Stable under standard use and storage conditions.
Hazardous Reactions
Not determined
Conditions to Avoid
Not determined
Incompatibilities
Not determined
Hazardous Decomposition
Products
Not determined. During thermal decomposition, it may be possible to generate
irritating vapors and/or toxic fumes of carbon oxides (COx), nitrogen oxides (NOx),
and sulfur oxides (SOx).
Hazardous Polymerization Not anticipated to occur with this product.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity - Not determined for the product formulation. Information for the ingredients is as follows:
Ingredient(s) Percent Test Type Route of
Administration Value Units Species
Atropine Sulfate Monohydrate 100 LD50 Intravenous 56 mg/kg Mouse
Atropine Sulfate 100 LD50 Intravenous
37,73
31
70
60
mg/k
mg/kg
mg/kg
mg/kg
Rat
Mouse
Rabbit
Dog
Atropine Sulfate 100 LD50 Oral 500
468
mg/kg
mg/kg
Rat
Mouse
LD 50: Dosage that produces 50% mortality.
Occupational Exposure
Potential
Information on the absorption of this product via inhalation or skin contact is not
available. Avoid liquid aerosol generation and skin contact.
Signs and Symptoms
None anticipated from normal handling of this product. In clinical use, atropine can
cause suppressed salivation, dilated pupils, blurred vision, hot/dry sensation,
disorientation, increased heart rate, constipation, nausea, urinary retention and
hesitancy, palpitation, dizziness, drowsiness, decreased bronchi secretion,
photophobia, dry mouth, fever, glaucoma, difficulty breathing, flushing, rashes and
vomiting..
Aspiration Hazard None anticipated from normal handling of this product.
Dermal Irritation/ Corrosion None anticipated from normal handling of this product.
Ocular Irritation/ Corrosion None anticipated from normal handling of this product. However, inadvertent contact
of this product with eyes may produce stinging followed by blurred vision and
sensitivity to light.
Dermal or Respiratory
Sensitization
None anticipated from normal handling of this product.
Reproductive Effects None anticipated from normal handling of this product. Animal reproduction or
fertility studies have not been conducted with atropine.
Mutagenicity Studies have not been performed to evaluate the mutagenic potential of atropine.
Carcinogenicity Studies have not been performed to evaluate the carcinogenic potential of atropine.
5
Product Name: Atropine Sulfate Injection
11. TOXICOLOGICAL INFORMATION: continued
Carcinogen Lists
IARC: Not listed NTP: Not listed OSHA: Not listed
Specific Target Organ Toxicity
– Single Exposure
NA
Specific Target Organ Toxicity
– Repeat Exposure
Based on clinical use, possible target organs include the eyes, skin, gastrointestinal
system, respiratory system, central nervous system, and cardiovascular system.
12. ECOLOGICAL INFORMATION
Aquatic Toxicity Not determined for product.
Persistence/Biodegradability Not determined for product.
Bioaccumulation Not determined for product.
Mobility in Soil Not determined for product.
Notes:
13. DISPOSAL CONSIDERATIONS
Waste Disposal
All waste materials must be properly characterized. Further, disposal should be
performed in accordance with the federal, state or local regulatory requirements.
Container Handling and
Disposal
Dispose of container and unused contents in accordance with federal, state and local
regulations.
14. TRANSPORTATION INFORMATION
ADR/ADG/ DOT STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
ICAO/IATA STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
IMDG STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity NA
Notes: DOT - US Department of Transportation Regulations
6
Product Name: Atropine Sulfate Injection
15. REGULATORY INFORMATION
US TSCA Status Exempt. However, atropine sulfate is listed on the TSCA inventory.
US CERCLA Status Not listed
US SARA 302 Status
US SARA 313 Status
Not listed
Not listed
US RCRA Status Not listed
US PROP 65 (Calif.)
Not listed
Notes: TSCA, Toxic Substance Control Act; CERCLA, US EPA law, Comprehensive Environmental Response, Compensation, and
Liability Act; SARA, Superfund Amendments and Reauthorization Act; RCRA, US EPA, Resource Conservation and Recovery Act; Prop
65, California Proposition 65
GHS/CLP Classification* *In the EU, classification under GHS/CLP does not apply to certain substances and
mixtures, such as medicinal products as defined in Directive 2001/83/EC, which are in
the finished state, intended for the final user.
Hazard Class
NA
Hazard Category
NA
Pictogram
NA
Signal Word
NA
Hazard Statement
NA
Prevention Do not breathe vapor or spray.
Wash hands thoroughly after handling.
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
EU Classification* *Medicinal products are exempt from the requirements of the EU Dangerous
Preparations Directive.
Classification(s) NA
Symbol NA
Indication of Danger NA
Risk Phrases NA
Safety Phrases S23: Do not breathe vapor/spray
S24: Avoid contact with the skin
S25: Avoid contact with eyes
S37/39 Wear suitable gloves and eye/face protection.
7
Product Name: Atropine Sulfate Injection
16. OTHER INFORMATION Notes:
ACGIH TLV American Conference of Governmental Industrial Hygienists – Threshold Limit Value
CAS Chemical Abstracts Service Number
CERCLA US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act
DOT US Department of Transportation Regulations
EEL Employee Exposure Limit
IATA International Air Transport Association
LD50 Dosage producing 50% mortality
NA Not applicable/Not available
NE Not established
NIOSH National Institute for Occupational Safety and Health
OSHA PEL US Occupational Safety and Health Administration – Permissible Exposure Limit
Prop 65 California Proposition 65
RCRA US EPA, Resource Conservation and Recovery Act
RTECS Registry of Toxic Effects of Chemical Substances
SARA Superfund Amendments and Reauthorization Act
STEL 15-minute Short Term Exposure Limit
STOT - SE Specific Target Organ Toxicity – Single Exposure
STOT - RE Specific Target Organ Toxicity – Repeated Exposure
TSCA Toxic Substance Control Act
TWA 8-hour Time Weighted Average
MSDS Coordinator: Hospira GEHS
Date Prepared: October 17, 2012
Date Revised: June 02, 2014
Disclaimer: The information and recommendations contained herein are based upon tests believed to be reliable. However, Hospira
does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A
WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE
MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE.
Adjustment to conform to actual conditions of usage may be required. Hospira assumes no responsibility for results
obtained or for incidental or consequential damages, including lost profits, arising from the use of these data. No
warranty against infringement of any patent, copyright or trademark is made or implied.
EN-2304 Page 1 of 3
INFANT 25% DEXTROSE Injection, USP CONCENTRATED DEXTROSE FOR INTRAVENOUS ADMINISTRATION TO INFANTS. NOTE: This solution is hypertonic— see Warnings and Precautions.
Plastic Syringe Rx only DESCRIPTION 25% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection administered by intravenous injection to restore blood glucose levels in hypoglycemia and as a source of carbohydrate calories. Each milliliter (mL) of fluid contains dextrose, hydrous, 250 mg which delivers 3.4 kcal/gram (0.85 kcal/mL). The solution has an osmolarity of 1.39 mOsmol/mL (calc.). pH is 4.5 (3.2 to 6.5). May contain hydrochloric acid and sodium hydroxide for pH adjustment.
The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded with the entire unit.
25% Dextrose Injection, USP is a dextrose (glucose) and nutrient (carbohydrate) replenisher. Dextrose, USP is chemically designated D-glucose monohydrate, (C6H12O6 • H2O), a hexose sugar
freely soluble in water. It has the following structural formula:
The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.
CLINICAL PHARMACOLOGY When administered intravenously, this solution restores blood glucose levels in hypoglycemia and provides a source of carbohydrate calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injection undergoes oxidation to carbon dioxide and water.
25% Dextrose Injection, USP provides a concentrated solution sufficiently nonirritating for slow intravenous injection to infants for terminating acute symptomatic episodes of hypoglycemia in the neonate and in older infants (fasting blood glucose below 40 mg/100 mL). Values as low as
EN-2304 Page 2 of 3
20 mg/100 mL are not uncommon in normal asymptomatic infants the first few days of life (longer in premature infants).
Symptoms of hypoglycemia in the newborn and small infants may be difficult to evaluate and convulsions often are the first or only recognized manifestation of depressed blood glucose levels. Because of widely varied etiology, the precise cause may be difficult to establish. Hypoglycemia (deficient blood glucose) due to organic or functional hyperinsulinism, may be only temporarily abated by administration of dextrose (glucose) and may rebound to hypoglycemia levels as release of additional insulin is evoked. In addition to various other causes, an idiopathic form of hypoglycemia in infancy has been described, as well as occasional transitory hypoglycemia in the neonatal period which disappears in later infancy. Fetal hyperinsulinism in response to maternal hyperglycemia of diabetic mothers has been observed. Occasionally convulsions associated with severe hypoglycemia are observed in infants of diabetic mothers.
Since glucose is the only sugar utilized for metabolic requirements of human neural tissue, it is essential to restore deficient blood glucose levels from any cause in order to prevent or correct central nervous system dysfunction.
INDICATIONS AND USAGE 25% Dextrose Injection is indicated in the treatment of acute symptomatic episodes of hypoglycemia in the neonate or older infant to restore depressed blood glucose levels and control symptoms. Other drugs, such as epinephrine and glucagon, should be considered in patients unresponsive or intolerant to dextrose (glucose). Oral feeding of dextrose may be necessary in infants with frequently recurring hypoglycemic episodes or to prevent recurrences due to hyperinsulinemia.
25% Dextrose Injection also provides a minimal source of carbohydrate calories.
CONTRAINDICATIONS A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present.
WARNINGS 25% Dextrose Injection, USP is hypertonic and may cause phlebitis and thrombosis at the site of injection.
Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as loss of consciousness.
PRECAUTIONS Frequent monitoring of serum glucose concentrations is required when intravenous dextrose is given to pediatric patients, particularly neonates and low birth weight infants. Do not administer unless the solution is clear and seal is intact. Discard unused portion.
Solutions containing dextrose should be used with caution in infants of diabetic mothers except as may be indicated in neonates who are hypoglycemic.
Care should be exercised to insure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis should occur during administration, the injection should be stopped and corrective measures instituted.
Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with 25% dextrose solutions in polypropylene syringes have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
Pregnancy Category C. Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.
EN-2304 Page 3 of 3
ADVERSE REACTIONS Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause mental confusion and/or loss of consciousness.
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
OVERDOSAGE In the event of overdosage (hyperglycemia) during therapy, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS.)
DOSAGE AND ADMINISTRATION When possible, glucose concentrations of greater than 12% should be administered by central vein to reduce the risk for phlebitis and thrombosis. 25% Dextrose Injection, USP is administered only by slow intravenous injection.
The dosage and constant infusion rate of intravenous dextrose must be selected with caution, particularly in neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. In the neonate, an injection of 250 to 500 mg (1 to 2 mL)/kg/dose (5 to 10 mL of 25% dextrose in a 5 kg infant) is recommended to control acute symptomatic hypoglycemia (tremors, convulsions, etc.).
Larger or repeated single doses (up to 10 or 12 mL of 25% dextrose) may be required in severe cases or older infants. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results.
Subsequent continuous intravenous infusion of 10% dextrose injection may be needed to stabilize blood glucose levels. Further treatment should be guided by evaluation of the underlying disorder.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)
HOW SUPPLIED 25% Dextrose Injection, USP is supplied in single-dose containers as follows:
NDC No. Container Size 0409-1775-10 Ansyr™ Plastic Syringe 10 mL
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: November, 2009 Printed in USA EN-2304 Hospira, Inc. Lake Forest, IL 60045 USA
1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKINGProduct Identifier
Material Name: Dextrose Injection, USP
Trade Name: Not establishedSynonyms: 50% Dextrose Injection, USP Concentrated Dextrose for Intravenous AdministrationChemical Family: Mixture
Relevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use: Pharmaceutical product used for electrolyte replacement
Details of the Supplier of the Safety Data Sheet
2. HAZARDS IDENTIFICATION
Classification of the Substance or MixtureGHS - Classification Not classified as hazardous
Label ElementsSignal Word: Not ClassifiedHazard Statements: Not classified in accordance with international standards for workplace safety.
Other Hazards No data availableNote: This document has been prepared in accordance with standards for workplace safety, which
requires the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warning included may not apply in all cases.Your needs may vary depending upon the potential for exposure in your workplace.
3. COMPOSITION / INFORMATION ON INGREDIENTS
HazardousIngredient CAS Number EU
EINECS/ELINCSList
GHS Classification %
_______________________________________________________________________________________________________PZ03049
Page 1 of 8
Contact E-Mail: [email protected]
Revision date: 30-Jun-2016
Hospira, A Pfizer Company275 North Field DriveLake Forest, Illinois 600451-800-879-3477
Hospira UK LimitedHorizonHoney LaneHurleyMaidenhead, SL6 6RJUnited Kingdom
Version: 1.0
Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300
SAFETY DATA SHEET
Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887
SAFETY DATA SHEET
_______________________________________________________________________________________________________
3. COMPOSITION / INFORMATION ON INGREDIENTSHYDROCHLORIC ACID 7647-01-0 231-595-7 Skin Corr.1B (H314)
STOT SE 3 (H335)**
SODIUM HYDROXIDE 1310-73-2 215-185-5 Skin Corr. 1A (H314) **
Ingredient CAS Number EUEINECS/ELINCS
List
GHS Classification %
Water for injection 7732-18-5 231-791-2 Not Listed *Dextrose, monohydrate 5996-10-1 Not Listed Not Listed 50
Additional Information: * Proprietary** to adjust pHIngredient(s) indicated as hazardous have been assessed under standards for workplacesafety. In accordance with 29 CFR 1910.1200, the exact percentage composition of thismixture has been withheld as a trade secret.
For the full text of the CLP/GHS abbreviations mentioned in this Section, see Section 16
4. FIRST AID MEASURES
Description of First Aid MeasuresEye Contact: If irritation occurs or persists, get medical attention. Flush eyes with water as a precaution
Skin Contact: If irritation occurs, wash exposed area with soap and water, remove contaminated clothing andobtain medical assistance.
Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation: Not an expected route of exposure.
Most Important Symptoms and Effects, Both Acute and DelayedSymptoms and Effects ofExposure:
No data available
Medical ConditionsAggravated by Exposure:
None known
Indication of the Immediate Medical Attention and Special Treatment NeededNotes to Physician: None
5. FIRE FIGHTING MEASURES
Extinguishing Media: Extinguish fires with CO2, extinguishing powder, foam, or water.
Special Hazards Arising from the Substance or MixtureHazardous CombustionProducts:
Formation of toxic gases is possible during heating or fire. May include oxides of carbonsodium
Fire / Explosion Hazards: Not applicable
Advice for Fire-FightersDuring all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.
_______________________________________________________________________________________________________PZ03049
Material Name: Dextrose Injection, USPVersion: 1.0Page 2 of 8
Revision date: 30-Jun-2016
SAFETY DATA SHEET
_______________________________________________________________________________________________________
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions, Protective Equipment and Emergency ProceduresPersonnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.
Environmental PrecautionsPlace waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.
Methods and Material for Containment and Cleaning UpMeasures for Cleaning /Collecting:
Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spillarea thoroughly.
Additional Consideration forLarge Spills:
Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained personnel.
7. HANDLING AND STORAGE
Precautions for Safe HandlingNo special handling requirements for normal use of this material.
Conditions for Safe Storage, Including any IncompatibilitiesStorage Conditions: Store as directed by product packaging.Incompatible Materials: None
Specific end use(s): Pharmaceutical drug product
8. EXPOSURE CONTROLS / PERSONAL PROTECTIONControl Parameters
Refer to available public information for specific member state Occupational Exposure Limits.
_______________________________________________________________________________________________________PZ03049
Bulgaria OEL - TWA 5 ppm8.0 mg/m3
Version: 1.0Page 3 of 8
Cyprus OEL - TWA 5 ppm8 mg/m3
ACGIH Ceiling Threshold Limit:
Czech Republic OEL - TWA 8 mg/m3
2 ppm
Estonia OEL - TWA 5 ppm8 mg/m3
Germany - TRGS 900 - TWAs 2 ppm3 mg/m3
Australia PEAK 5 ppm7.5 mg/m3
Germany (DFG) - MAK 2 ppm3.0 mg/m3
Revision date: 30-Jun-2016
Greece OEL - TWA 5 ppm7 mg/m3
Hungary OEL - TWA 8 mg/m3
Austria OEL - MAKs 5 ppm8 mg/m3
Ireland OEL - TWAs 5 ppm8 mg/m3
Material Name: Dextrose Injection, USP
Belgium OEL - TWA 5 ppm8 mg/m3
HYDROCHLORIC ACID
SAFETY DATA SHEET
_______________________________________________________________________________________________________
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure ControlsEngineering Controls: Engineering controls should be used as the primary means to control exposures.Personal ProtectiveEquipment:
Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).
Hands: Not required for the normal use of this product.Eyes: Wear safety glasses or goggles if eye contact is possible.
_______________________________________________________________________________________________________PZ03049
ACGIH Ceiling Threshold Limit: 2 mg/m3
Australia PEAK 2 mg/m3
Italy OEL - TWA
Austria OEL - MAKs 2 mg/m3
Malta OEL - TWA 5 ppm8 mg/m3
Bulgaria OEL - TWA 2.0 mg/m3
5 ppm8 mg/m3
Czech Republic OEL - TWA 1 mg/m3
Netherlands OEL - TWA
Estonia OEL - TWA 1 mg/m3
8 mg/m3
France OEL - TWA 2 mg/m3
Greece OEL - TWA 2 mg/m3
Poland OEL - TWA 5 mg/m3
Hungary OEL - TWA 2 mg/m3
Japan - OELs - Ceilings
Japan - OELs - Ceilings 2 mg/m3
2 ppm3.0 mg/m3
Latvia OEL - TWA 0.5 mg/m3
Portugal OEL - TWA 5 ppm8 mg/m3
OSHA - Final PELS - TWAs: 2 mg/m3
Revision date: 30-Jun-2016
Poland OEL - TWA 0.5 mg/m3
Romania OEL - TWA
Slovakia OEL - TWA 2 mg/m3
5 ppm8 mg/m3
Slovenia OEL - TWA 2 mg/m3
Sweden OEL - TWAs 1 mg/m3
Slovakia OEL - TWA 5 ppm8.0 mg/m3
Switzerland OEL -TWAs 2 mg/m3
Latvia OEL - TWA 5 ppm8 mg/m3
Slovenia OEL - TWA 5 ppm8 mg/m3
Material Name: Dextrose Injection, USP
Spain OEL - TWA 5 ppm7.6 mg/m3
Lithuania OEL - TWA
Switzerland OEL -TWAs 2 ppm3.0 mg/m3
5 ppm8 mg/m3
Version: 1.0
Vietnam OEL - TWAs 5 mg/m3
Page 4 of 8
SODIUM HYDROXIDE
Luxembourg OEL - TWA 5 ppm8 mg/m3
SAFETY DATA SHEET
_______________________________________________________________________________________________________
8. EXPOSURE CONTROLS / PERSONAL PROTECTIONSkin: Not required for the normal use of this product.Respiratory protection: None required under normal conditions of use.
9. PHYSICAL AND CHEMICAL PROPERTIES
Solvent Solubility: No data availableWater solubility: 7.8 g/100 g @18CWater Solubility: No data availablepH: No data available.Melting/Freezing Point (°C): No data availableBoiling Point (°C): No data available.Partition Coefficient: (Method, pH, Endpoint, Value)
Decomposition Temperature (°C): No data available.
Evaporation Rate (Gram/s): No data availableVapor Pressure (kPa): No data availableVapor Density (g/ml): No data availableRelative Density: No data availableViscosity: No data available
Flammablity:Autoignition Temperature (Solid) (°C): No data availableFlammability (Solids): No data availableFlash Point (Liquid) (°C): No data availableUpper Explosive Limits (Liquid) (% by Vol.): No data availableLower Explosive Limits (Liquid) (% by Vol.): No data available
10. STABILITY AND REACTIVITY
Reactivity: No data availableChemical Stability: StablePossibility of Hazardous Reactions
Oxidizing Properties: No data availableConditions to Avoid: NoneIncompatible Materials: NoneHazardous DecompositionProducts:
No data available
11. TOXICOLOGICAL INFORMATION
Information on Toxicological Effects_______________________________________________________________________________________________________
PZ03049
Odor Threshold: No data available.Molecular Formula: Mixture
Water for injection
Molecular Weight: Mixture
No data available
Revision date: 30-Jun-2016
SODIUM HYDROXIDE
Physical State: Liquid
No data available
Material Name: Dextrose Injection, USP
HYDROCHLORIC ACID
Color: Colorless
No data available
Version: 1.0
Dextrose, monohydrate
Odor: None
No data available
Page 5 of 8
SAFETY DATA SHEET
_______________________________________________________________________________________________________
11. TOXICOLOGICAL INFORMATIONGeneral Information: The information included in this section describes the potential hazards of the individual
ingredients.
Acute Toxicity: (Species, Route, End Point, Dose)
Acute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the test.
Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.
12. ECOLOGICAL INFORMATION
Environmental Overview: Releases to the environment should be avoided. No acute toxicity to aquatic organisms isexpected
Toxicity: No data available
Persistence and Degradability: No data available
Bio-accumulative Potential: No data available
Mobility in Soil: No data available
13. DISPOSAL CONSIDERATIONS
Waste Treatment Methods: Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the material, review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release. It is recommended that waste minimizationbe practiced. The best available technology should be utilized to prevent environmentalreleases. This may include destructive techniques for waste and wastewater.
14. TRANSPORT INFORMATIONThe following refers to all modes of transportation unless specified below.
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.
_______________________________________________________________________________________________________PZ03049
Version: 1.0
HYDROCHLORIC ACID
Page 6 of 8
Rat Oral LD 50 238-277 mg/kg
HYDROCHLORIC ACID
Revision date: 30-Jun-2016
IARC: Group 3 (Not Classifiable)
Material Name: Dextrose Injection, USP
SAFETY DATA SHEET
_______________________________________________________________________________________________________
15. REGULATORY INFORMATION
Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture
16. OTHER INFORMATION
Text of CLP/GHS Classification abbreviations mentioned in Section 3
_______________________________________________________________________________________________________PZ03049
Inventory - United States TSCA - Sect. 8(b) Present
Material Name: Dextrose Injection, USP
Australia (AICS): Present
Australia (AICS):
Standard for the Uniform Schedulingfor Drugs and Poisons:
Schedule 5Schedule 6
Present
EU EINECS/ELINCS List 231-595-7
Water for injection
SODIUM HYDROXIDE
REACH - Annex IV - Exemptions from theobligations of Register:
Present
CERCLA/SARA 313 Emission reporting Not Listed
Version: 1.0
CERCLA/SARA Hazardous Substancesand their Reportable Quantities:
1000 lb454 kg
California Proposition 65 Not Listed
EU EINECS/ELINCS List 231-791-2
Inventory - United States TSCA - Sect. 8(b) Present
CERCLA/SARA 313 Emission reporting
Australia (AICS): Present
HYDROCHLORIC ACID
Standard for the Uniform Schedulingfor Drugs and Poisons:
Schedule 5Schedule 6
Not Listed
Page 7 of 8
EU EINECS/ELINCS List 215-185-5
CERCLA/SARA 313 Emission reporting
Dextrose, monohydrate
1.0 %
CERCLA/SARA 313 Emission reporting Not ListedCalifornia Proposition 65 Not Listed
CERCLA/SARA Hazardous Substancesand their Reportable Quantities:
5000 lb2270 kg
EU EINECS/ELINCS List Not Listed
California Proposition 65 Not Listed
CERCLA/SARA - Section 302 Extremely HazardousTPQs
500 lb
CERCLA/SARA - Section 302 Extremely HazardousSubstances EPCRA RQs
5000 lb
Revision date: 30-Jun-2016
California Proposition 65 Not Listed
Inventory - United States TSCA - Sect. 8(b) Present
SAFETY DATA SHEET
_______________________________________________________________________________________________________
Skin corrosion/irritation-Cat.1A; Skin corrosion/irritation-Cat.1B; H314 - Causes severe skin burns and eye damageSpecific target organ toxicity, single exposure; Respiratory tract irritation-Cat.3; H335 - May cause respiratory irritation
Data Sources: Publicly available toxicity information.
Reasons for Revision: New data sheet.
Revision date: 30-Jun-2016
Prepared by:Product Stewardship Hazard Communication
Pfizer Global Environment, Health, and Safety Operations
Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, itis without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no knowninformation at this time.
End of Safety Data Sheet
_______________________________________________________________________________________________________PZ03049
Revision date: 30-Jun-2016Material Name: Dextrose Injection, USP
Version: 1.0Page 8 of 8
Diphenhydramine Hydrochloride Injection, USP
None.
GHS product identifier
Synonyms
Emergency telephone number (with hours of operation)
Section 1. Identification:
:
:
Supplier's details :
Relevant identified uses of the substance or mixture and uses advised against
Conforms to HazCom 2012/United States
SAFETY DATA SHEETDiphenhydramine Hydrochloride Injection, USP
Pharmaceuticals.
WEST-WARD PHARMACEUTICALSEATONTOWN, NJ 07724
CHEMTREC, U.S. : 1-800-424-9300 International: +1-703-527-3877
Product code : NDC 0641-0376-25, NDC 0641-0376-21
Chemical family :
Product type :
Container information :
Antihistaminic agent.
Regulated prescription drug.
1 ml vials.
Section 2. Hazards identification
Not classified.Classification of the substance or mixture
:
Signal word : No signal word.
Hazard statements : No known significant effects or critical hazards.
Precautionary statements
Prevention : Not applicable.
Response : Not applicable.
Storage : Not applicable.
Disposal : Not applicable.
GHS label elements
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200), this SDS contains valuable information critical to the safe handling and proper use of the product. This SDS should be retained and available for employees and other users of this product.
Hazards not otherwise classified
: None known.
Section 3. Composition/information on ingredients
Other means of identification
: None.
Substance/mixture
CAS number/other identifiers
: Mixture
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Diphenhydramine Hydrochloride Injection, USP
Section 3. Composition/information on ingredientsIngredient name CAS number%
There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
Occupational exposure limits, if available, are listed in Section 8.
Any concentration shown as a range is to protect confidentiality or is due to batch variation.
Water 60 - 100 7732-18-5Diphenhydramine Hydrochloride 1 - 5 147-24-0Benzethonium Chloride 0 - 0.1 121-54-0
Wash out mouth with water. Remove victim to fresh air and keep at rest in a position comfortable for breathing. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.
Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.
Flush contaminated skin with plenty of water. Get medical attention if symptoms occur.
Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical attention if symptoms occur. In case of inhalation of decomposition products in a fire, symptoms may be delayed. The exposed person may need to be kept under medical surveillance for 48 hours.
Section 4. First aid measures
Eye contact
Skin contact
Inhalation
Ingestion :
:
:
:
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : In case of inhalation of decomposition products in a fire, symptoms may be delayed.The exposed person may need to be kept under medical surveillance for 48 hours.
Description of necessary first aid measures
Specific treatments : No specific treatment.
Most important symptoms/effects, acute and delayed
Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may be delayed following exposure.
No known significant effects or critical hazards.:Ingestion
Skin contact : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Eye contact
Over-exposure signs/symptoms
Skin contact
Ingestion
Inhalation No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.
:
:
:
Eye contact : No known significant effects or critical hazards.
Potential acute health effects
See toxicological information (Section 11)
Indication of immediate medical attention and special treatment needed, if necessary
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Diphenhydramine Hydrochloride Injection, USP
Section 5. Fire-fighting measures
No special protection is required.
Hazardous thermal decomposition products
Specific hazards arising from the chemical
Decomposition products may include the following materials:carbon dioxidecarbon monoxidenitrogen oxideshalogenated compounds
No specific fire or explosion hazard.
Fire-fighters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA) with a full face-piece operated in positive pressure mode.
Special protective equipment for fire-fighters
Use an extinguishing agent suitable for the surrounding fire.
Extinguishing media
:
:
:
None known.
Suitable extinguishing media
:
Unsuitable extinguishing media
:
Special protective actions for fire-fighters
:
Section 6. Accidental release measures
Environmental precautions
Personal precautions, protective equipment and emergency procedures
Stop leak if without risk. Move containers from spill area. Prevent entry into sewers,water courses, basements or confined areas. Wash spillages into an effluent treatment plant or proceed as follows. Contain and collect spillage with non-combustible,absorbent material e.g. sand, earth, vermiculite or diatomaceous earth and place in container for disposal according to local regulations (see Section 13). Dispose of via a licensed waste disposal contractor. Note: see Section 1 for emergency contact information and Section 13 for waste disposal.
:
: No action shall be taken involving any personal risk or without suitable training. Keep unnecessary and unprotected personnel from entering. Do not touch or walk through spilled material. Put on appropriate personal protective equipment.
Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers. Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air).
:
Methods and materials for containment and cleaning up
For non-emergency personnel
For emergency responders : If specialized clothing is required to deal with the spillage, take note of any information in Section 8 on suitable and unsuitable materials. See also the information in "For non-emergency personnel".
Spill
Section 7. Handling and storage
Advice on general occupational hygiene
Eating, drinking and smoking should be prohibited in areas where this material is handled, stored and processed. Workers should wash hands and face before eating,drinking and smoking. See also Section 8 for additional information on hygiene measures. Remove contaminated clothing and protective equipment before entering eating areas.
:
Protective measures Put on appropriate personal protective equipment (see Section 8).:
Precautions for safe handling
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Diphenhydramine Hydrochloride Injection, USP
Section 7. Handling and storageConditions for safe storage,including any incompatibilities
Store in accordance with local regulations. Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials (see Section 10) and food and drink. Keep container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed and kept upright to prevent leakage. Do not store in unlabeled containers. Use appropriate containment to avoid environmental contamination.
:
Section 8. Exposure controls/personal protection
Hand protection
Use a properly fitted, air-purifying or supplied air respirator complying with an approved standard if a risk assessment indicates this is necessary. Respirator selection must be based on known or anticipated exposure levels, the hazards of the product and the safe working limits of the selected respirator.
Chemical-resistant, impervious gloves complying with an approved standard should be worn at all times when handling chemical products if a risk assessment indicates this is necessary.
Safety eyewear complying with an approved standard should be used when a risk assessment indicates this is necessary to avoid exposure to liquid splashes, mists,gases or dusts. If contact is possible, the following protection should be worn, unless the assessment indicates a higher degree of protection: safety glasses with side-shields.
Eye/face protection
Respiratory protection :
:
:
Body protection Personal protective equipment for the body should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.
:
Environmental exposure controls
: Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation.
Appropriate engineering controls
: No special ventilation requirements. Good general ventilation should be sufficient to control worker exposure to airborne contaminants. If this product contains ingredients with exposure limits, use process enclosures, local exhaust ventilation or other engineering controls to keep worker exposure below any recommended or statutory limits.
Wash hands, forearms and face thoroughly after handling chemical products, before eating, smoking and using the lavatory and at the end of the working period. Ensure that eyewash stations and safety showers are close to the workstation location.
Hygiene measures :
Control parameters
Individual protection measures
Occupational exposure limits
Skin protection
Other skin protection : Appropriate footwear and any additional skin protection measures should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.
None.
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Diphenhydramine Hydrochloride Injection, USP
Section 9. Physical and chemical properties
Physical state
Melting point
Vapor pressure
Relative density
Vapor density
Solubility
Liquid. [Aqueous solution.]
Not available.
Not available.
Not available.
Not available.
Not available.
Not available.Odor
pH
Colorless.Color
Evaporation rate Not available.
Auto-ignition temperature
Flash point
Not available.
Not applicable.
Not available.
4 to 6.5
Viscosity Not available.
Not available.Odor threshold
Partition coefficient: n-octanol/water
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
Appearance
Boiling point : Not available.
Flammability (solid, gas) : Not available.
Lower and upper explosive (flammable) limits
: Not available.
Burning rate Not applicable.:
Burning time : Not applicable.
SADT Not available.:
Decomposition temperature : Not available.
Solubility in water : Not available.
Section 10. Stability and reactivity
Hazardous decomposition products
Conditions to avoid No specific data.
Under normal conditions of storage and use, hazardous decomposition products should not be produced.
The product is stable.Chemical stability
Reactive or incompatible with the following materials: oxidizing materials and acids.
:
:
:
Incompatible materials :
Possibility of hazardous reactions
: Under normal conditions of storage and use, hazardous reactions will not occur.
Reactivity : No specific test data related to reactivity available for this product or its ingredients.
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Diphenhydramine Hydrochloride Injection, USP
Section 11. Toxicological information
Acute toxicity
Product/ingredient name Result Species Dose Exposure
Carcinogenicity
Mutagenicity
Teratogenicity
Reproductive toxicity
Irritation/Corrosion
Sensitization
Information on the likely routes of exposure
Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may be delayed following exposure.
No known significant effects or critical hazards.:Ingestion
Skin contact : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Eye contact
Symptoms related to the physical, chemical and toxicological characteristics
Skin contact
Ingestion
Inhalation No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.
:
:
:
Eye contact : No known significant effects or critical hazards.
Delayed and immediate effects and also chronic effects from short and long term exposure
Specific target organ toxicity (single exposure)
Specific target organ toxicity (repeated exposure)
Aspiration hazard
Information on toxicological effects
: Dermal contact. Eye contact. Inhalation. Ingestion.
Potential acute health effects
Potential immediate effects
: No known significant effects or critical hazards.
Short term exposure
Potential delayed effects : No known significant effects or critical hazards.
Long term exposure
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
Diphenhydramine Hydrochloride LD50 Oral Rat 500 mg/kg -
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Diphenhydramine Hydrochloride Injection, USP
Section 11. Toxicological information
No known significant effects or critical hazards.General :
No known significant effects or critical hazards.Carcinogenicity :
No known significant effects or critical hazards.Mutagenicity :
No known significant effects or critical hazards.Teratogenicity :
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Potential chronic health effects
Numerical measures of toxicity
Oral 10000 mg/kg
Route ATE value
Acute toxicity estimates
Potential immediate effects
: No known significant effects or critical hazards.
Potential delayed effects : No known significant effects or critical hazards.
Section 12. Ecological information
Bioaccumulative potential
Other adverse effects : No known significant effects or critical hazards.
Toxicity
Persistence and degradability
Soil/water partition coefficient (KOC)
: Not available.
Mobility in soil
There is no data available.
There is no data available.
There is no data available.
Section 13. Disposal considerationsThe generation of waste should be avoided or minimized wherever possible. Disposal of this product, solutions and any by-products should comply with the requirements of environmental protection and waste disposal legislation and any regional local authority requirements. Dispose of surplus and non-recyclable products via a licensed waste disposal contractor. Waste should not be disposed of untreated to the sewer unless fully compliant with the requirements of all authorities with jurisdiction. Waste packaging should be recycled. Incineration or landfill should only be considered when recycling is not feasible. This material and its container must be disposed of in a safe way. Empty containers or liners may retain some product residues. Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers.
:Disposal methods
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Diphenhydramine Hydrochloride Injection, USP
Section 14. Transport information
-
-
-
-
-
-
-
Not regulated.
-
-
Not regulated. Not regulated.
- - -
DOT Classification IMDG IATA
UN number
UN proper shipping name
Transport hazard class(es)
Packing group
Additional information
Environmental hazards
Special precautions for user
Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
No. No. No.
Transport within user’s premises: always transport in closed containers that are upright and secure. Ensure that persons transporting the product know what to do in the event of an accident or spillage.
: Not available.
:
AERG : Not applicable.
Section 15. Regulatory informationU.S. Federal regulations :
Clean Air Act Section 112(b) Hazardous Air Pollutants (HAPs)
: Not listed
Clean Air Act Section 602 Class I Substances
: Not listed
Clean Air Act Section 602 Class II Substances
: Not listed
DEA List I Chemicals (Precursor Chemicals)
: Not listed
DEA List II Chemicals (Essential Chemicals)
: Not listed
TSCA 8(a) CDR Exempt/Partial exemption: Not determined
United States inventory (TSCA 8b): Not determined.
SARA 302/304
SARA 304 RQ : Not applicable.
Composition/information on ingredients
SARA 311/312
No products were found.
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Diphenhydramine Hydrochloride Injection, USP
Section 15. Regulatory information
None of the components are listed.
No products were found.
Massachusetts :
California Prop. 65
New York : None of the components are listed.
New Jersey : None of the components are listed.
Pennsylvania : None of the components are listed.
State regulations
Classification : Not applicable.
Name % Fire hazard
Sudden release of pressure
Reactive Immediate (acute)health hazard
Delayed (chronic)health hazard
Composition/information on ingredients
Australia inventory (AICS): All components are listed or exempted.China inventory (IECSC): Not determined.Japan inventory: All components are listed or exempted.Korea inventory: Not determined.Malaysia Inventory (EHS Register): Not determined.New Zealand Inventory of Chemicals (NZIoC): All components are listed or exempted.Philippines inventory (PICCS): Not determined.Taiwan inventory (CSNN): Not determined.
International regulations
International lists :
Chemical Weapons Convention List Schedule I Chemicals
: Not listed
Chemical Weapons Convention List Schedule II Chemicals
: Not listed
Chemical Weapons Convention List Schedule III Chemicals
: Not listed
Diphenhydramine Hydrochloride 1 - 5 No. No. No. Yes. No.
Section 16. Other informationHistory
Prepared by :
Key to abbreviations : ATE = Acute Toxicity EstimateBCF = Bioconcentration FactorGHS = Globally Harmonized System of Classification and Labelling of ChemicalsIATA = International Air Transport AssociationIBC = Intermediate Bulk ContainerIMDG = International Maritime Dangerous GoodsLogPow = logarithm of the octanol/water partition coefficientMARPOL 73/78 = International Convention for the Prevention of Pollution From Ships,1973 as modified by the Protocol of 1978. ("Marpol" = marine pollution)
Date of issue mm/dd/yyyy
Version :
:
1
06/15/2013
KMK Regulatory Services Inc.
Revised Section(s) : Not applicable.
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Diphenhydramine Hydrochloride Injection, USP
Section 16. Other informationUN = United Nations
Notice to readerTo the best of our knowledge, the information contained herein is accurate. However, neither the above-named supplier, nor any of its subsidiaries, assumes any liability whatsoever for the accuracy or completeness of the information contained herein.Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist.
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1
SAFETY DATA SHEET
Product Name: Epinephrine Injection
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Manufacturer Name And
Address
Hospira, Inc.
275 North Field Drive
Lake Forest, Illinois 60045
USA
Emergency Telephone
Hospira, Inc., Non-emergency
CHEMTREC: North America: 800-424-9300;
International 1-703-527-3887; Australia - 61-290372994; UK - 44-870-8200418
224 212-2000
Product Name Epinephrine Injection
Synonyms 4-[1-hydroxy-2-(methylamino) ethyl]-1,2 benzenediol
2. HAZARD(S) IDENTIFICATION
Emergency Overview Epinephrine Injection is a solution containing epinephrine, a vasoconstrictor agent. In
clinical use, epinephrine is used to relieve respiratory distress due to bronchospasm, to
provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to
prolong the action of anesthetics. Its cardiac effects may be of use in restoring cardiac
rhythm in cardiac arrest due to various causes. In the workplace, this material should
be considered a potent drug and possibly irritating to the skin and eyes. Based on
clinical use, possible target organs include the nervous system, cardiovascular system,
eyes, and respiratory system.
U.S. OSHA GHS Classification
Physical Hazards Hazard Class Hazard Category
Not Classified Not Classified
Health Hazards Hazard Class Hazard Category
STOT – RE 2
Label Element(s)
Pictogram
Signal Word Warning
Hazard Statement(s) May cause damage to organs through prolonged or repeated exposure
Precautionary Statement(s)
Prevention Do not breathe vapor or spray
Wash hands thoroughly after handling
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
2
Product Name: Epinephrine Injection
3. COMPOSITION/INFORMATION ON INGREDIENTS
Active Ingredient Name L-Epinephrine
Chemical Formula C9H13NO3
Component Approximate Percent by Weight CAS Number RTECS Number
L-Epinephrine ≤ 0.1 51-43-4 DO2625000 Non-hazardous ingredients include Water for Injection. Hazardous ingredients present at less than 1% may include sodium chloride, citric
acid, sodium citrate, sodium metabisulfite and hydrochloric acid (for pH adjustment).
4. FIRST AID MEASURES
Eye Contact Remove from source of exposure. Flush with copious amounts of water. If irritation
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Skin Contact Remove from source of exposure. Flush with copious amounts of water. If irritation
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Inhalation Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
Ingestion Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
5. FIRE FIGHTING MEASURES
Flammability
None anticipated for this aqueous product.
Fire & Explosion Hazard
None anticipated for this aqueous product.
Extinguishing Media
As with any fire, use extinguishing media appropriate for primary cause of fire such as
carbon dioxide, dry chemical extinguishing powder or foam.
Special Fire Fighting
Procedures
No special provisions required beyond normal firefighting equipment such as flame
and chemical resistant clothing and self contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES
Spill Cleanup and Disposal Isolate area around spill. Put on suitable protective clothing and equipment as
specified by site spill control procedures. Absorb the liquid with suitable material and
clean affected area with soap and water. Dispose of spill materials according to the
applicable federal, state, or local regulations.
7. HANDLING AND STORAGE
Handling
No special handling required for hazard control under conditions of normal product
use.
Storage No special storage required for hazard control. For product protection, follow storage
recommendations noted on the product case label, the primary container label, or the
product insert.
Special Precautions No special precautions required for hazard control.
3
Product Name: Epinephrine Injection
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure Guidelines Exposure Limits
Component OSHA-PEL ACGIH-TLV AIHA WEEL Hospira EEL
L-Epinephrine 8 hr TWA: Not
Established
8 hr TWA: Not
Established
8 hr TWA: Not
Established
8 hr TWA: Not
Established
Notes: OSHA PEL: US Occupational Safety and Health Administration – Permissible Exposure Limit
ACGIH TLV: American Conference of Governmental Industrial Hygienists – Threshold Limit Value. AIHA WEEL: Workplace Environmental Exposure Level
EEL: Employee Exposure Limit.
TWA: 8-hour Time Weighted Average.
Respiratory Protection
Respiratory protection is normally not needed during intended product use. However,
if the generation of aerosols is likely, and engineering controls are not considered
adequate to control potential airborne exposures, the use of an approved air-purifying
respirator with a HEPA cartridge (N95 or equivalent) is recommended under
conditions where airborne aerosol concentrations are not expected to be excessive. For
uncontrolled release events, or if exposure levels are not known, provide respirators
that offer a high protection factor such as a powered air purifying respirator or
supplied air. A respiratory protection program that meets OSHA's 29 CFR 1910.134
and ANSI Z88.2 requirements must be followed whenever workplace conditions
require respirator use. Personnel who wear respirators should be fit tested and
approved for respirator use as required.
Skin Protection
If skin contact with the product formulation is likely, the use of latex or nitrile gloves
is recommended.
Eye Protection
Eye protection is normally not required during intended product use. However, if eye
contact is likely to occur, the use of chemical safety goggles (as a minimum) is
recommended.
Engineering Controls Engineering controls are normally not needed during the normal use of this product.
9. PHYSICAL/CHEMICAL PROPERTIES
Appearance/Physical State Epinephrine is a white, crystalline powder. Epinephrine Injection is
a clear, colorless liquid.
Odor Not determined.
Odor Threshold NA
pH 3.3 (2.2 to 5.0)
Melting point/Freezing Point NA
Initial Boiling Point/Boiling Point Range NA
Flash Point NA
Evaporation Rate NA
Flammability (solid, gas) NA
Upper/Lower Flammability or Explosive Limits NA
Vapor Pressure NA
Vapor Density (Air =1) NA
Relative Density NA
Solubility With acids, epinephrine forms salts that are freely soluble in water.
Partition Coefficient: n-octanol/water NA
Auto-ignition Temperature NA
Decomposition Temperature NA
Viscosity NA
4
Product Name: Epinephrine Injection
10. STABILITY AND REACTIVITY
Reactivity
Not determined.
Chemical Stability
Stable under standard use and storage conditions.
Hazardous Reactions
Not determined
Conditions to Avoid
Not determined
Incompatibilities
Not determined
Hazardous Decomposition
Products
Not determined. During thermal decomposition, it may be possible to generate
irritating vapors and/or toxic fumes of carbon oxides (COx) and nitrogen oxides
(NOx).
Hazardous Polymerization Not anticipated to occur with this product.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity - Not determined for the product formulation. Information for the active ingredient is as follows:
Ingredient(s) Percent Test Type Route of
Administration Value Units Species
Epinephrine 100 LD50 Intravenous
150
217
50
100
mcg/kg
mcg/kg
mcg/kg
mcg/kg
Rat
Mouse
Rabbit
Dog
Epinephrine 100 LD50 Dermal 62 mg/kg Rat
Epinephrine Hydrochloride 100 LD50 Oral 24 mg/kg Rat
Epinephrine Hydrochloride 100 LD50 Intravenous 140 mcg/kg Mouse
Epinephrine Hydrochloride 100 LD50 Intraperitioneal 4.7 mg/kg Mouse
LD 50: Dosage that produces 50% mortality.
Occupational Exposure
Potential
Though not well absorbed, inhalation or topical application can produce systemic
effects. Avoid liquid aerosol generation and skin contact.
Signs and Symptoms
None anticipated from normal handling of this product. In clinical use, serious adverse
effects may include rapid and large increases in blood pressure, cerebral hemorrhage,
pulmonary arterial hypertension resulting in edema, hyperglycemia, and cardiac
arrhythmia with ventricular fibrillation. Other adverse effects may include fearfulness,
anxiety, sweating, nervousness, palpitations, tenseness, restlessness, headache, tremor,
dizziness and lightheadedness, fever, chills, nausea, vomiting, respiratory difficulty,
tachycardia, dilated pupils, blurred vision, cyanosis, ECG changes, disruption of
cardiac rhythm, hypertension, metabolic acidosis, and injury to the heart. Locally,
tissue necrosis can result at the injection site due to vasoconstriction. Ocular use has
produced conjunctival irritation (burning, stinging, tearing and rebound redness).
Aspiration Hazard None anticipated from normal handling of this product. Inadvertent inhalation of
small amounts of this product may produce irritation and possibly bronchial dilation.
Dermal Irritation/Corrosion None anticipated from normal handling of this product. However, inadvertent contact
with this product may be irritating to broken skin and mucous membranes.
Ocular Irritation/Corrosion None anticipated from normal handling of this product. However, inadvertent contact
of this product with eyes may produce irritation, dilated pupils, and blurred vision.
Dermal or Respiratory
Sensitization
None anticipated from normal handling of this product. However, this product
contains sodium metabisulfite which may elicit allergic reactions in people sensitive to
sulfites.
5
Product Name: Epinephrine Injection
11. TOXICOLOGICAL INFORMATION: continued
Reproductive Effects None anticipated from normal handling of this product. No teratogenic effect was
noted in offspring of pregnant rats given continuous infusions of epinephrine at a dose
about 8 times the normal human dose. An increase in the frequency of cleft palate was
noted in the offspring of one strain of mice treated during pregnancy with epinephrine
at doses that were 40-80 times the normal human dose. An increase in the frequency of
fetal loss was noted in pregnant mice and rabbits given epinephrine at doses that were
200 and 85 times, respectively, the human therapeutic dose. The frequency of
malformations was not increased in offspring of hamsters treated during pregnancy
with 25 times the human subcutaneous dose.
Mutagenicity Salmonella gene mutation tests with L-epinephrine were negative in the TA100 strain
in the presence of S9 metabolic activation, but equivocal in the absence of S9. No
mutagenic activity was observed in strains TA98, TA1535, or TA1537 with or without
S9. Results noted in a CHO cell assay for induction of sister chromatid exchanges
were considered negative and equivocal in the presence and absence of S9 activation,
respectively.
Carcinogenicity No data found for epinephrine. By analogy, in a chronic aerosol inhalation studies in
rats and mice, epinephrine hydrochloride did not significantly increase the incidence of
tumors over controls in these animals. Increased incidences of supurative
inflammation, dilatation of the nasal glands in rats and mice, and hyperplasia of the
respiratory epithelium in rats only were noted in this study.
Carcinogen Lists
IARC: Not listed NTP: Not listed OSHA: Not listed
Specific Target Organ Toxicity
– Single Exposure
NA
Specific Target Organ Toxicity
– Repeat Exposure
Based on clinical use, possible target organs include the nervous system,
cardiovascular system, eyes, and respiratory system.
12. ECOLOGICAL INFORMATION
Aquatic Toxicity Not determined for product.
Persistence/Biodegradability Not determined for product.
Bioaccumulation Not determined for product.
Mobility in Soil Not determined for product.
13. DISPOSAL CONSIDERATIONS
Waste Disposal
All waste materials must be properly characterized. Further, disposal should be
performed in accordance with the federal, state or local regulatory requirements.
Container Handling and
Disposal
Dispose of container and unused contents in accordance with federal, state and local
regulations.
6
Product Name: Epinephrine Injection
14. TRANSPORTATION INFORMATION
ADR/ADG/ DOT STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
ICAO/IATA STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
IMDG STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity NA
Notes: DOT - US Department of Transportation Regulations
15. REGULATORY INFORMATION
US TSCA Status Exempt
US CERCLA Status Epinephrine – Listed. The US Federal EPA waste listing for epinephrine does not
include epinephrine salts. Disposal should be performed in accordance with all federal,
state, and local regulatory requirements.
US SARA 302 Status
US SARA 313 Status
Not listed
Not listed
US RCRA Status Epinephrine – Listed. The US Federal EPA waste listing for epinephrine does not
include epinephrine salts. Disposal should be performed in accordance with all federal,
state, and local regulatory requirements.
US PROP 65 (Calif.)
Not listed
Notes: TSCA, Toxic Substance Control Act; CERCLA, US EPA law, Comprehensive Environmental Response, Compensation, and
Liability Act; SARA, Superfund Amendments and Reauthorization Act; RCRA, US EPA, Resource Conservation and Recovery Act; Prop
65, California Proposition 65
GHS/CLP Classification* *In the EU, classification under GHS/CLP does not apply to certain substances and
mixtures, such as medicinal products as defined in Directive 2001/83/EC, which are in
the finished state, intended for the final user.
Hazard Class
NA
Hazard Category
NA
Pictogram
NA
Signal Word
NA
Hazard Statement
NA
Prevention Do not breathe vapor or spray
Wash hands thoroughly after handling
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
7
Product Name: Epinephrine Injection
15. REGULATORY INFORMATION: continued
EU Classification* *Medicinal products are exempt from the requirements of the EU Dangerous
Preparations Directive.
Classification(s) NA
Symbol NA
Indication of Danger NA
Risk Phrases NA
Safety Phrases S23: Do not breathe vapor/spray
S24: Avoid contact with the skin
S25: Avoid contact with eyes
S37/39 Wear suitable gloves and eye/face protection.
16. OTHER INFORMATION Notes:
ACGIH TLV American Conference of Governmental Industrial Hygienists – Threshold Limit Value
CAS Chemical Abstracts Service Number
CERCLA US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act
DOT US Department of Transportation Regulations
EEL Employee Exposure Limit
IATA International Air Transport Association
LD50 Dosage producing 50% mortality
NA Not applicable/Not available
NE Not established
NIOSH National Institute for Occupational Safety and Health
OSHA PEL US Occupational Safety and Health Administration – Permissible Exposure Limit
Prop 65 California Proposition 65
RCRA US EPA, Resource Conservation and Recovery Act
RTECS Registry of Toxic Effects of Chemical Substances
SARA Superfund Amendments and Reauthorization Act
STEL 15-minute Short Term Exposure Limit
STOT - SE Specific Target Organ Toxicity – Single Exposure
STOT - RE Specific Target Organ Toxicity – Repeated Exposure
TSCA Toxic Substance Control Act
TWA 8-hour Time Weighted Average
MSDS Coordinator: Hospira GEHS
Date Prepared: October 18, 2012
Date Revised: June 02, 2014
Disclaimer: The information and recommendations contained herein are based upon tests believed to be reliable. However, Hospira
does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A
WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE
MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE.
Adjustment to conform to actual conditions of usage may be required. Hospira assumes no responsibility for results
obtained or for incidental or consequential damages, including lost profits, arising from the use of these data. No
warranty against infringement of any patent, copyright or trademark is made or implied.
FULL PRESCRIBING INFORMATIONEpinephrine injection, USP auto-injector0.3 mg, 0.15 mg1871-01
1871-01
1873-01
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use EPINEPHRINE INJECTION, USP AUTO-INJECTOR safely and effectively. See full prescribing information for EPINEPHRINE INJECTION, USP AUTO-INJECTOR.Epinephrine injection, USP auto-injector 0.3 mg, 0.15 mg, for intramuscular or subcutaneous useInitial U.S. Approval: 1939--------------------------RECENT MAJOR CHANGES-------------------------Dosage and Administration (2) 05/2016Warnings and Precautions (5.2, 5.3) 05/2016---------------------------INDICATIONS AND USAGE--------------------------Epinephrine injection, USP auto-injector contains epinephrine, a non-selective alpha and beta-adrenergic receptor agonist, indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis. (1)-----------------------DOSAGE AND ADMINISTRATION----------------------• Patients greater than or equal to 30 kg (66 lbs): Epinephrine
injection, USP auto-injector 0.3 mg (2)• Patients 15 to 30 kg (33 lbs-66 lbs): Epinephrine injection, USP
auto-injector 0.15 mg (2)Inject epinephrine injection, USP auto-injector intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Each device is a single-use injection. (2)---------------------DOSAGE FORMS AND STRENGTHS---------------------• Injection, 0.3 mg: 0.3 mg/0.3 mL epinephrine injection, USP, pre-
filled auto-injector (3)• Injection, 0.15 mg: 0.15 mg/0.15 mL epinephrine injection, USP,
pre-filled auto-injector (3)-----------------------------CONTRAINDICATIONS----------------------------None. (4)-----------------------WARNINGS AND PRECAUTIONS-----------------------• In conjunction with use, seek immediate medical or hospital care.
(5.1)• Do not inject intravenously, into buttock, or into digits, hands, or
feet. (5.2)
• To minimize the risk of injection related injury, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection when administering to young children. (5.2)
• Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection. Advise patients to seek medical care if they develop signs or symptoms of infection. (5.3)
• The presence of a sulfite in this product should not deter use. (5.4)• Administer with caution in patients with heart disease; may
aggravate angina pectoris or produce ventricular arrhythmias. (5.5)-----------------------------ADVERSE REACTIONS-----------------------------Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties. (6)To report SUSPECTED ADVERSE REACTIONS, contact Impax Laboratories, Inc. at 1-800-934-6729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.-----------------------------DRUG INTERACTIONS-----------------------------• Cardiac glycosides or diuretics: observe for development of cardiac
arrhythmias. (7)• Tricyclic antidepressants, monoamine oxidase inhibitors,
levothyroxine sodium, and certain antihistamines: potentiate effects of epinephrine. (7)
• Beta-adrenergic blocking drugs: antagonize cardiostimulating and bronchodilating effects of epinephrine. (7)
• Alpha-adrenergic blocking drugs: antagonize vasoconstricting and hypertensive effects of epinephrine. (7)
• Ergot alkaloids: may reverse the pressor effects of epinephrine. (7)----------------------USE IN SPECIFIC POPULATIONS-----------------------• Elderly patients may be at greater risk of developing adverse
reactions. (5.5, 8.5)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: July 2016
FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS 5.1 Emergency Treatment 5.2 Injection-Related Complications 5.3 Serious Infections at the Injection Site 5.4 Allergic Reactions Associated with Sulfite 5.5 Disease Interactions6 ADVERSE REACTIONS7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers
8.4 Pediatric Use 8.5 Geriatric Use10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage and Handling17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGEEpinephrine injection, USP auto-injector is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.Epinephrine injection, USP auto-injector is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema.Epinephrine injection, USP auto-injector is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.2 DOSAGE AND ADMINISTRATIONSelection of the appropriate epinephrine injection, USP auto-injector dosage strength is determined according to patient body weight. • Patients greater than or equal to 30 kg (approximately 66 pounds or more): epinephrine injection, USP auto-injector 0.3 mg • Patients 15 to 30 kg (33 pounds to 66 pounds): epinephrine injection, USP auto-injector 0.15 mgInject epinephrine injection, USP auto-injector intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed an epinephrine injection, USP auto-injector and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection [see Warnings and Precautions (5.2)].Each epinephrine injection, USP auto-injector contains a single dose of epinephrine for single use injection. Since the doses of epinephrine delivered from epinephrine injection, USP auto-injector are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated.With severe persistent anaphylaxis, repeat injections with an additional epinephrine injection, USP auto-injector may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Warnings and Precautions (5.1)].The epinephrine solution in the viewing window of epinephrine injection, USP auto-injector should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light [see How Supplied/Storage and Handling (16.2)].3 DOSAGE FORMS AND STRENGTHS • Injection, 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector • Injection, 0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector4 CONTRAINDICATIONSNone.5 WARNINGS AND PRECAUTIONS5.1 Emergency TreatmentEpinephrine injection, USP auto-injector is intended for immediate administration as emergency supportive therapy and is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Indications and Usage (1), Dosage and Administration (2) and Patient Counseling Information (17)].
5.2 Injection-Related ComplicationsEpinephrine injection, USP auto-injector should only be injected into the anterolateral aspect of the thigh [see Dosage and Administration (2) and Patient Counseling Information (17)].Do not inject intravenously. • Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to a sharp rise in blood pressure.
Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.Do not inject into buttock. • Injection into the buttock may not provide effective treatment of anaphylaxis. Advise the patient to go immediately to the nearest emergency
room for further treatment of anaphylaxis. Additionally, injection into the buttock has been associated with the development of Clostridial infections (gas gangrene). Cleansing with alcohol does not kill bacterial spores, and therefore, does not lower the risk.
Do not inject into digits, hands or feet. • Since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may result in loss of blood flow to the affected
area. Advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection. Treatment of such inadvertent administration should consist of vasodilation, in addition to further appropriate treatment of anaphylaxis [see Adverse Reactions (6)].
• Lacerations, bent needles, and embedded needles have been reported when epinephrine has been injected into the thigh of young children who are uncooperative and kick or move during an injection. To minimize the risk of injection related injury when administering epinephrine injection, USP auto-injector to young children, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection.
5.3 Serious Infections at the Injection SiteRare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject epinephrine injection, USP auto-injector into the buttock [see Warnings and Precautions (5.2)]. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.5.4 The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.The alternatives to using epinephrine in a life-threatening situation may not be satisfactory.
5.5 Disease InteractionsSome patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, and/or any other person who might be in a position to administer epinephrine injection, USP auto-injector to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used. • Patients with Heart Disease Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary
artery or organic heart disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias [see Drug Interactions (7) and Adverse Reactions (6)].
• Other Patients and Diseases Epinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderly individuals, and pregnant women. Patients
with Parkinson’s disease may notice a temporary worsening of symptoms.6 ADVERSE REACTIONSDue to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below.Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [see Warnings and Precautions (5.5)].Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see Warnings and Precautions (5.5) and Drug Interactions (7)].Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see Warnings and Precautions (5.5)].Angina may occur in patients with coronary artery disease [see Warnings and Precautions (5.5)].Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see Warnings and Precautions (5.2)].Adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.Lacerations, bent needles, and embedded needles have been reported when epinephrine injection, USP auto-injector has been injected into the thigh of young children who are uncooperative and kick or move during an injection [see Warnings and Precautions (5.2)].Injection into the buttock has resulted in cases of gas gangrene [see Warnings and Precautions (5.2)].Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh [see Warnings and Precautions (5.3)].7 DRUG INTERACTIONSPatients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see Warnings and Precautions (5.5)].The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol.The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha-adrenergic blocking drugs, such as phentolamine.Ergot alkaloids may also reverse the pressor effects of epinephrine.8 USE IN SPECIFIC POPULATIONS8.1 PregnancyTeratogenic Effects: Pregnancy Category C.There are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women.Epinephrine was teratogenic in rabbits, mice and hamsters. Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both).Epinephrine has been shown to have teratogenic effects when administered subcutaneously in rabbits at approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2
approximately 7 times the maximum daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal subcutaneous dose of 1 mg/kg/day for 10 days), and in hamsters at approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days).These effects were not seen in mice at approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2
8.3 Nursing MothersIt is not known whether epinephrine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when epinephrine injection, USP auto-injector is administered to a nursing woman.8.4 Pediatric UseEpinephrine injection, USP auto-injector may be administered to pediatric patients at a dosage appropriate to body weight [see Dosage and Administration (2)]. Clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Since the dose of epinephrine delivered from epinephrine injection, USP auto-injector is fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.8.5 Geriatric UseClinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. Therefore, epinephrine injection, USP auto-injector should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [see Warnings and Precautions (5.5) and Overdosage (10)].10 OVERDOSAGEOverdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of a rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.11 DESCRIPTIONEpinephrine injection, USP auto-injector 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components.
sterile solution.Each epinephrine injection, USP auto-injector 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution.
0.3 mL and 0.15 mL epinephrine solution are dispensed for epinephrine injection, USP auto-injector 0.3 mg and epinephrine injection, USP auto-injector 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded.Each 0.3 mL in epinephrine injection, USP auto-injector 0.3 mg contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.Each 0.15 mL in epinephrine injection, USP auto-injector 0.15 mg contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not chlorobutanol, 0.225 sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.
Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure:
Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles.Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [see Patient Counseling Information (17)].12 CLINICAL PHARMACOLOGY12.1 Mechanism of ActionEpinephrine acts on both alpha- and beta-adrenergic receptors.12.2 PharmacodynamicsThrough its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension.Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing, and dyspnea that may occur during anaphylaxis.Epinephrine also alleviates pruritus, urticaria, and angioedema, and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.When given intramuscularly or subcutaneously, epinephrine has a rapid onset and short duration of action.13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityLong-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted.Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro and to be an oxidative mutagen in a WP2 bacterial reverse mutation assay.Epinephrine was positive in the DNA Repair test with B. subtilis (REC) assay, but was not mutagenic in the Salmonella bacterial reverse mutation assay.The potential for epinephrine to impair fertility has not been evaluated.This should not prevent the use of epinephrine under the conditions noted under Indications and Usage (1).16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied
Rx only16.2 Storage and HandlingProtect from light. Epinephrine is light sensitive and should be stored in the carrying-case provided to protect it from light. Store at room temperature (20° to 25°C (68° to 77°F)); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.17 PATIENT COUNSELING INFORMATION[see FDA-Approved Patient Labeling (Patient Information and Instructions for Use)]A healthcare provider should review the patient instructions and operation of epinephrine injection, USP auto-injector, in detail, with the patient or caregiver.Epinephrine is essential for the treatment of anaphylaxis. Carefully instruct patients who are at risk of or with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, about the circumstances under which epinephrine should be used.Administration and TrainingInstruct patients and/or caregivers in the appropriate use of epinephrine injection, USP auto-injector. Epinephrine injection, USP auto-injector should be injected into the middle of the outer thigh (through clothing if necessary). Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection. Lacerations, bent needles, and embedded needles have been reported when epinephrine injection, USP auto-injector has been injected into the thigh of young children who are uncooperative and kick during an injection [see Warnings and Precautions (5.2)].Each epinephrine injection, USP auto-injector is a single-use injection. Advise patients to seek immediate medical care in conjunction with administration of epinephrine injection, USP auto-injector.Complete patient information, including dosage, directions for proper administration and precautions can be found inside each epinephrine injection, USP auto-injector carton. A printed label on the surface of epinephrine injection, USP auto-injector shows instructions for use and a diagram depicting the injection process.Instruct patients and/or caregivers to use the Trainer to familiarize themselves with the use of epinephrine injection, USP auto-injector in an allergic emergency. The Trainer may be used multiple times.Adverse ReactionsEpinephrine may produce symptoms and signs that include an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These signs and symptoms usually subside rapidly, especially with rest, quiet, and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson’s disease may notice a temporary worsening of symptoms [see Warnings and Precautions (5.5)].Accidental InjectionAdvise patients to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands or feet, treatment should be directed at vasodilation if there is such an accidental injection to these areas [see Warnings and Precautions (5.2)].Serious Infections at the Injection SiteRare cases of skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [see Warnings and Precautions (5.3)].Storage and HandlingInstruct patients to inspect the epinephrine solution visually through the viewing window periodically. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown), cloudy, or contains particles. Epinephrine is light sensitive, store in the outer case provided to protect it from light. Instruct patients that epinephrine injection, USP auto-injector must be properly disposed of once the blue caps have been removed or after use [see How Supplied/Storage and Handling (16.2)].Complete patient information, including dosage, directions for proper administration and precautions are provided inside each epinephrine injection, USP auto-injector carton.Manf. by:Hospira, Inc.McPherson, KS 67460Dist. by:Impax GenericsHayward, CA 94544© 2016 Impax Laboratories, Inc., Hayward, CA. All rights reserved. For inquiries call 1-800-934-67291871-01Rev. 07/2016
OH
HO
HOH
C CH2NHCH3
May 10, 2013 Dear Valued Customer: This letter is in reference to your request for Material Safety Data Sheet (MSDS) on the following product(s):
Diphenhydramine Caps
The above listed item(s) are exempt from the requirement to have MSDS. Ethical, over-the-counter, supplemental, and cosmetic products in final dosage forms, which are supplied for patient care, are not subject to hazardous materials standards. The items do not pose a danger to persons handling the products in the forms in which they are supplied. Therefore, these products are exempt from MSDS Requirements under OSHA Hazard Communication Standards 1910.1200(b)(6)(vii) and 1910.1200(b)(5)(iii), which provide the following exemptions:
1. Any drug, as that term is defined in the Federal Food, Drug, and Cosmetic Act (21 USC §
301), when it is in solid, final form for direct administration to the patient (e.g., tablets or pills) 2. Drugs which are packaged by the chemical manufacturer for sale to consumers in a retail
establishment (e.g., over-the-counter drugs) 3. Drugs intended for personal consumption by employees while in the workplace (e.g., first aid
supplies) 4. Cosmetics which are packaged for sale to consumers in a retail establishment, and cosmetics
intended for personal consumption by employees while in the work place. 5. Any food, food additives, color additives, drug, cosmetic, or medical or veterinary device or
product, including materials intended for use as ingredients in such products (e.g. flavors and fragrances).
Major Pharmaceutical drug products are prescribed, stored, prepared, dispensed, and administered according to the directions within the product labeling and packaging and are regulated by the Food and Drug Administration according to 21 CFR § 211.132. If you have any questions or require additional information, please feel free to contact [email protected] Sincerely, THE HARVARD DRUG GROUP, LLC MAJOR PHARMACEUTICALS
1
SAFETY DATA SHEET
Product Name: Lidocaine Hydrochloride and Epinephrine Injection
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Manufacturer Name And
Address
Hospira, Inc.
275 North Field Drive
Lake Forest, Illinois 60045
USA
Emergency Telephone #’s
Hospira, Inc., Non-Emergency
CHEMTREC: North America: 800-424-9300;
International 1-703-527-3887; Australia - 61-290372994; UK - 44-870-8200418
224 212-2000
Product Name
Lidocaine Hydrochloride and Epinephrine Injection
Synonyms Acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride; 2',6'-
Acetoxylidide, 2-(diethylamino)-, hydrochloride; (-)-3,4-Dihydroxy-a-[(methylamino)
methyl] benzyl alcohol
2. HAZARD(S) IDENTIFICATION
Emergency Overview
Lidocaine hydrochloride and Epinephrine Injection is a solution containing lidocaine
hydrochloride, an amide-type local anesthetic used as a local anesthetic for pain
management, and epinephrine, a vasoconstrictor agent. In the workplace, this material
should be considered possibly irritating to the skin, eyes and respiratory tract, and a
potent drug. Based on clinical use, possible target organs include the nervous system
and cardiovascular system.
U.S. OSHA GHS Classification
Physical Hazards Hazard Class Hazard Category
Not Classified Not Classified
Health Hazards
Hazard Class Hazard Category
STOT – RE 2
Label Element(s)
Pictogram
Signal Word
Warning
Hazard Statement(s)
May cause damage to organs through prolonged or repeated exposures
Precautionary Statement(s)
Prevention Do not breathe vapor or spray
Wash hands thoroughly after handling
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
2
Product Name: Lidocaine Hydrochloride and Epinephrine Injection
3. COMPOSITION/INFORMATION ON INGREDIENTS
Active Ingredient Name Lidocaine Hydrochloride Epinephrine
Chemical Formula C14H22N2O HCl C9H13NO3
Component Approximate Percent by Weight CAS Number RTECS Number
Lidocaine Hydrochloride ≤ 2.0% 73-78-9 AN7600000
Epinephrine ≤ 0.002 51-43-4 DO2625000 Non-hazardous ingredients include Water for Injection. Hazardous ingredients present at less than 1% may include sodium chloride; sodium
hydroxide and/or hydrochloric acid are added to adjust the pH; citric acid and sodium metabisulfite may be added as stabilizer. Multiple-dose
vials contain methylparaben 1 mg/mL added as preservative.
4. FIRST AID MEASURES
Eye Contact Remove from source of exposure. Flush with copious amounts of water. If irritation
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Skin Contact Remove from source of exposure. Flush with copious amounts of water. If irritation
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Inhalation Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
Ingestion Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
5. FIRE FIGHTING MEASURES
Flammability
None anticipated from this aqueous product.
Fire & Explosion Hazard
None anticipated from this aqueous product.
Extinguishing Media
As with any fire, use extinguishing media appropriate for primary cause of fire such as
carbon dioxide, dry chemical extinguishing powder or foam.
Special Fire Fighting
Procedures
No special provisions required beyond normal firefighting equipment such as flame
and chemical resistant clothing and self contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES
Spill Cleanup and Disposal Isolate area around spill. Put on suitable protective clothing and equipment as
specified by site spill control procedures. Absorb any liquid with suitable material and
clean affected area with soap and water. Dispose of spill materials according to the
applicable federal, state, or local regulations.
7. HANDLING AND STORAGE
Handling
No special handling required under conditions of normal product use.
Storage No special storage required for hazard control. For product protection, follow
temperature storage recommendations noted on the product case label, the primary
container label, or the product insert.
Special Precautions No special precautions are required for hazard controls.
3
Product Name: Lidocaine Hydrochloride and Epinephrine Injection
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure Guidelines Exposure Limits
Component OSHA-PEL ACGIH-TLV AIHA WEEL Hospira EEL
Lidocaine Hydrochloride 8-hr TWA: Not
Established
8-hr TWA: Not
Established
8-hr TWA: Not
Established
8-hr TWA: Not
Established
Epinephrine 8-hr TWA: Not
Established
8-hr TWA: Not
Established
8-hr TWA: Not
Established
8 hr TWA: Not
Established
Notes: OSHA PEL: US Occupational Safety and Health Administration – Permissible Exposure Limit
ACGIH TLV: American Conference of Governmental Industrial Hygienists – Threshold Limit Value.
AIHA WEEL: Workplace Environmental Exposure Level EEL: Employee Exposure Limit.
TWA: 8 hour Time Weighted Average.
Respiratory Protection
Respiratory protection is normally not needed during intended product use. However,
if the generation of aerosols is likely, and engineering controls are not considered
adequate to control potential airborne exposures, the use of an approved air-purifying
respirator with a HEPA cartridge (N95 or equivalent) is recommended under
conditions where airborne aerosol concentrations are not expected to be excessive. For
uncontrolled release events, or if exposure levels are not known, provide respirators
that offer a high protection factor such as a powered air purifying respirator or
supplied air. A respiratory protection program that meets OSHA's 29 CFR 1910.134
and ANSI Z88.2 requirements must be followed whenever workplace conditions
require respirator use. Personnel who wear respirators should be fit tested and
approved for respirator use as required.
Skin Protection
If skin contact with the product formulation is likely, the use of latex or nitrile gloves
is recommended.
Eye Protection
Eye protection is normally not required during intended product use. However, if eye
contact is likely to occur, the use of chemical safety goggles (as a minimum) is
recommended.
Engineering Controls Engineering controls are normally not needed during the normal use of this product.
9. PHYSICAL/CHEMICAL PROPERTIES
Appearance/Physical State Clear, colorless liquid
Odor NA
Odor Threshold NA
pH The pH of a 2% solution is between 3.3 and 5.5
Melting point/Freezing Point NA
Initial Boiling Point/Boiling Point Range NA
Flash Point NA
Evaporation Rate NA
Flammability (solid, gas) NA
Upper/Lower Flammability or Explosive Limits NA
Vapor Pressure NA
Vapor Density (Air =1) NA
Relative Density NA
Solubility Very soluble in water and in alcohol; soluble in chloroform;
insoluble in ether
Partition Coefficient: n-octanol/water NA
Auto-ignition Temperature NA
Decomposition Temperature NA
Viscosity NA
4
Product Name: Lidocaine Hydrochloride and Epinephrine Injection
10. STABILITY AND REACTIVITY
Reactivity
Not determined
Chemical Stability
Stable under standard use and storage conditions.
Hazardous Reactions
Not determined
Conditions to Avoid
Not determined
Incompatibilities
Strongly alkaline conditions. Methyl vinyl ether; zinc.
Hazardous Decomposition
Products
Not determined. During thermal decomposition, it may be possible to generate
irritating vapors and/or toxic fumes of carbon oxides (COx), nitrogen oxides (NOx),
and hydrogen chloride.
Hazardous Polymerization Not anticipated to occur with this product.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity: - Not determined for the product formulation. Information for the active ingredients is as follows:
Ingredient(s) Percent Test Type Route of
Administration Value Units Species
Lidocaine Hydrochloride 100 LD50 Oral 220
292
mg/kg
mg/kg Mouse
Lidocaine Hydrochloride 100 LD50 Intraperitoneal 122
63
mg/kg
mg/kg
Rat
Mouse
Lidocaine Hydrochloride 100 LD50 Intravenous
21
15
25.6
24.5
mg/kg
mg/kg
mg/kg
mg/kg
Rat
Mouse
Rabbit
Guinea Pig
Lidocaine Hydrochloride 100 LD50 Intratracheal 28 mg/kg Rabbit
L-Epinephrine 100 LD50 Intravenous 150
217
mcg/kg
mcg/kg
Rat
Mouse
L-Epinephrine 100 LD50 Dermal 62 mg/kg Rat
Epinephrine Hydrochloride 100 LD50 Oral 90 mg/kg Mouse
Epinephrine Hydrochloride 100 LD50 Intravenous 70 mcg/kg Rat
Epinephrine Hydrochloride 100 LD50 Intraperitoneal 1.25
7.8
mg/kg
mg/kg
Rat
Mouse
L-Epinephrine Hydrochloride 100 LD50 Oral 24 mg/kg Rat
LD 50: Dosage that produces 50% mortality.
Occupational Exposure
Potential
Information on the absorption of this product via inhalation or skin contact is not
available. Published reports suggest that some local anesthetics have some potential to
be absorbed through intact skin. Avoid liquid aerosol generation and skin contact.
5
Product Name: Lidocaine Hydrochloride and Epinephrine Injection
11. TOXICOLOGICAL INFORMATION: continued
Signs and Symptoms
None anticipated from normal handling of this product. Inadvertent contact with this
product may cause irritation, followed by numbness. Ingestion may cause numbness
of the tongue and anesthetic effects on the stomach. In clinical use, this product
produces numbness when injected. In normal clinical use, adverse effects may include
fever, headaches, agitation, tingling of extremities, general hypotension, bradycardia,
dizziness, nausea, vomiting, anemia, back pain, post-operative pain and fetal distress.
Systemic absorption can produce central nervous system (CNS) stimulation and/or
CNS depression. CNS depression may progress to coma and cardio-respiratory arrest.
Signs of cardiovascular toxicity may include changes in cardiac conduction,
excitability, refractoriness, contractility, and peripheral vascular resistance. Toxic
blood levels may cause atrioventricular block, ventricular arrhythmias, cardiac arrest,
and sometimes death. In addition, decreased cardiac output and arterial blood pressure
may occur. Allergic-type reactions are rare but may occur due to sensitivity to the
local anesthetic or to other formulation ingredients. These reactions are characterized
by signs such as urticaria, pruritus, erythema, angioneurotic edema (including
laryngeal, edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope,
excessive sweating, elevated temperature, and possibly, anaphylactic-like symptoms
(including severe hypotension). Cross sensitivity with other amide-type local
anesthetics has been reported.
Aspiration Hazard None anticipated from normal handling of this product.
Dermal Irritation/Corrosion None anticipated from normal handling of this product. However, inadvertent contact
with this product may be irritating to broken skin and mucous membranes, and may
produce numbness.
Ocular Irritation/Corrosion None anticipated from normal handling of this product. However, inadvertent contact
of this product with eyes may produce irritation, numbness, and blurred vision.
Dermal or Respiratory
Sensitization
None anticipated from normal handling of this product. However, inadvertent contact
of this product with the respiratory system may produce irritation and numbness.
Rarely, allergic-type reactions have been reported during the clinical use of lidocaine.
This product may contain sodium metabisulfite which may cause an allergic-type
reaction in people sensitive to sulfites.
Reproductive Effects None anticipated from normal handling of this product. In a fertility study in rats,
lidocaine given subcutaneously at a dosage of 30 mg/kg (180 mg/m2) to mating pairs
did not produce alterations in fertility or general reproductive performance of rats.
Subcutaneous administration of lidocaine to pregnant rats at a dosage of to 50 mg/kg
did not produce evidence of harm to the fetus. In rabbits, there was no evidence of
harm to the fetus at a subcutaneous dosage of 5 mg/kg. Treatment of rabbits with a
subcutaneous dosage of 25 mg/kg produced evidence of maternal toxicity and
evidence of delayed fetal development, including a non-significant decrease in fetal
weight and an increase in minor skeletal anomalies. The effect of lidocaine on post-
natal development was evaluated in rats by treating pregnant female rats daily
subcutaneously at dosages of 2, 10, and 50 mg/kg from day 15 of pregnancy and up to
20 days post partum. No signs of adverse effects were seen either in dams or in the
pups up to and including the dose of 10 mg/kg; however, the number of surviving pups
was reduced at 50 mg/kg, both at birth and the duration of lactation period; this effect
is most likely secondary to maternal toxicity. A second study evaluated the effects of
lidocaine on post-natal development in the rat that included assessment of the pups
from weaning to sexual maturity. Rats were treated subcutaneously for 8 months with
10 or 30 mg/kg lidocaine, a treatment duration that included 3 mating periods. There
was no evidence of altered post-natal development in any offspring; however, both
doses of lidocaine significantly reduced the average number of pups per litter
surviving until weaning of offspring from the first 2 mating periods.
6
Product Name: Lidocaine Hydrochloride and Epinephrine Injection
11. TOXICOLOGICAL INFORMATION: continued
Mutagenicity The mutagenic potential of lidocaine was evaluated in the Ames Salmonella reverse
mutation assay, an in vitro chromosome aberrations assay in human lymphocytes and
in an in vivo mouse micronucleus assay. There was no indication of any mutagenic
effect in these studies.
Carcinogenicity Long-term studies in animals to evaluate the carcinogenic potential of most local
anesthetics, including lidocaine, have not been conducted.
Carcinogen Lists
IARC: Not listed NTP: Not listed OSHA: Not listed
Specific Target Organ Toxicity
– Single Exposure
NA
Specific Target Organ Toxicity
– Repeat Exposure
Based on clinical use, possible target organs include the nervous system and the
cardiovascular system.
12. ECOLOGICAL INFORMATION
Aquatic Toxicity Not determined for product.
Persistence/Biodegradability Not determined for product.
Bioaccumulation Not determined for product.
Mobility in Soil Not determined for product.
13. DISPOSAL CONSIDERATIONS
Waste Disposal
All waste materials must be properly characterized. Further, disposal should be
performed in accordance with the federal, state or local regulatory requirements.
Epinephrine is listed as a hazardous waste. However, it is not the sole active
ingredient in this product.
Container Handling and
Disposal
Dispose of container and unused contents in accordance with federal, state and local
regulations.
14. TRANSPORTATION INFORMATION
ADR/ADG/ DOT STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
ICAO/IATA STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
IMDG STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity NA
Notes: DOT - US Department of Transportation Regulations
7
Product Name: Lidocaine Hydrochloride and Epinephrine Injection
15. REGULATORY INFORMATION
US TSCA Status Exempt. However, lidocaine hydrochloride is listed on the TSCA inventory.
US CERCLA Status Epinephrine - Listed
US SARA 302 Status
US SARA 313 Status
Not listed
Not listed
US RCRA Status Epinephrine - Listed
US PROP 65 (Calif.)
Not listed
Notes: TSCA, Toxic Substance Control Act; CERCLA, US EPA law, Comprehensive Environmental Response, Compensation, and
Liability Act; SARA, Superfund Amendments and Reauthorization Act; RCRA, US EPA, Resource Conservation and Recovery Act; Prop
65, California Proposition 65
GHS/CLP Classification* *In the EU, classification under GHS/CLP does not apply to certain substances and
mixtures, such as medicinal products as defined in Directive 2001/83/EC, which are in
the finished state, intended for the final user.
Hazard Class
NA
Hazard Category
NA
Pictogram
NA
Signal Word
NA
Hazard Statement
NA
Prevention Do not breathe vapor or spray
Wash hands thoroughly after handling
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
EU Classification* *Medicinal products are exempt from the requirements of the EU Dangerous
Preparations Directive.
Classification(s) NA
Symbol NA
Indication of Danger NA
Risk Phrases NA
Safety Phrases S23: Do not breathe vapor/spray
S24: Avoid contact with the skin
S25: Avoid contact with eyes
S37/39 Wear suitable gloves and eye/face protection.
8
Product Name: Lidocaine Hydrochloride and Epinephrine Injection
16. OTHER INFORMATION Notes:
ACGIH TLV American Conference of Governmental Industrial Hygienists – Threshold Limit Value
CAS Chemical Abstracts Service Number
CERCLA US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act
DOT US Department of Transportation Regulations
EEL Employee Exposure Limit
IATA International Air Transport Association
LD50 Dosage producing 50% mortality
NA Not applicable/Not available
NE Not established
NIOSH National Institute for Occupational Safety and Health
OSHA PEL US Occupational Safety and Health Administration – Permissible Exposure Limit
Prop 65 California Proposition 65
RCRA US EPA, Resource Conservation and Recovery Act
RTECS Registry of Toxic Effects of Chemical Substances
SARA Superfund Amendments and Reauthorization Act
STEL 15-minute Short Term Exposure Limit
STOT - SE Specific Target Organ Toxicity – Single Exposure
STOT - RE Specific Target Organ Toxicity – Repeated Exposure
TSCA Toxic Substance Control Act
TWA 8-hour Time Weighted Average
MSDS Coordinator: Hospira GEHS
Date Prepared: October 18, 2012
Date Revised: June 02, 2014
Disclaimer: The information and recommendations contained herein are based upon tests believed to be reliable. However, Hospira
does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A
WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE
MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE.
Adjustment to conform to actual conditions of usage may be required. Hospira assumes no responsibility for results
obtained or for incidental or consequential damages, including lost profits, arising from the use of these data. No
warranty against infringement of any patent, copyright or trademark is made or implied.
1
SAFETY DATA SHEET
Product Name: Naloxone Hydrochloride Injection, USP
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Manufacturer Name And
Address
Hospira, Inc.
275 North Field Drive
Lake Forest, Illinois 60045
USA
Emergency Telephone
Hospira, Inc., Non-Emergency
CHEMTREC: North America: 800-424-9300;
International 1-703-527-3887; Australia - 61-290372994; UK - 44-870-8200418
224 212-2000
Product Name Naloxone Hydrochloride Injection, USP
Synonyms 17-Allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride
2. HAZARD(S) IDENTIFICATION
Emergency Overview Naloxone Hydrochloride Injection, USP, is a solution containing naloxone
hydrochloride, a competitive antagonist of opioid receptors. Clinically, Naloxone
prevents or reverses the effects of opioids including respiratory depression, sedation
and hypotension. In the workplace, this material should be considered potentially
irritating to the eyes and respiratory tract, and a potent drug. Based on clinical use,
possible target organs include the nervous system and cardiovascular system.
U.S. OSHA GHS Classification
Physical Hazards Hazard Class Hazard Category
Not Classified Not Classified
Health Hazards Hazard Class Hazard Category
Not Classified Not Classified
Label Element(s)
Pictogram NA
Signal Word NA
Hazard Statement(s) NA
Precautionary Statement(s)
Prevention Do not breathe vapor or spray
Wash hands thoroughly after handling
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
2
Product Name: Naloxone Hydrochloride Injection, USP
3. COMPOSITION/INFORMATION ON INGREDIENTS
Active Ingredient Name Naloxone Hydrochloride
Chemical Formula C19H21NO4 • HCl
Component Approximate Percent by Weight CAS Number RTECS Number
Naloxone Hydrochloride 0.04 357-08-4 QD2275000 Non-hazardous ingredients include Water for Injection. Hazardous ingredients present at less than 1% may include sodium chloride.
Hydrochloric acid may be use to adjust the pH. Multiple-dose solutions contain methylparaben and propylparaben which are added as
preservatives.
4. FIRST AID MEASURES
Eye Contact Remove from source of exposure. Flush with copious amounts of water. If irritation
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Skin Contact Remove from source of exposure. Flush with copious amounts of water. If irritation
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Inhalation Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
Ingestion Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
5. FIRE FIGHTING MEASURES
Flammability
None anticipated for this aqueous product.
Fire & Explosion Hazard
None anticipated for this aqueous product.
Extinguishing Media
As with any fire, use extinguishing media appropriate for primary cause of fire such as
carbon dioxide, dry chemical extinguishing powder or foam.
Special Fire Fighting
Procedures
No special provisions required beyond normal firefighting equipment such as flame
and chemical resistant clothing and self contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES
Spill Cleanup and Disposal Isolate area around spill. Put on suitable protective clothing and equipment as
specified by site spill control procedures. Absorb the liquid with suitable material and
clean affected area with soap and water. Dispose of spill materials according to the
applicable federal, state, or local regulations.
7. HANDLING AND STORAGE
Handling
No special handling required for hazard control under conditions of normal product
use.
Storage No special storage required for hazard control. For product protection, follow storage
recommendations noted on the product case label, the primary container label, or the
product insert.
Special Precautions No special precautions required for hazard control.
3
Product Name: Naloxone Hydrochloride Injection, USP
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure Guidelines Exposure Limits
Component OSHA-PEL ACGIH-TLV AIHA WEEL Hospira EEL
Naloxone Hydrochloride 8-hr TWA: Not
Established
8-hr TWA: Not
Established
8-hr TWA: Not
Established
8-hr TWA: Not
Established
Notes: OSHA PEL: US Occupational Safety and Health Administration – Permissible Exposure Limit
ACGIH TLV: American Conference of Governmental Industrial Hygienists – Threshold Limit Value. AIHA WEEL: Workplace Environmental Exposure Level
EEL: Employee Exposure Limit.
TWA: 8-hour Time Weighted Average.
Respiratory Protection
Respiratory protection is normally not needed during intended product use. However,
if the generation of aerosols is likely, and engineering controls are not considered
adequate to control potential airborne exposures, the use of an approved air-purifying
respirator with a HEPA cartridge (N95 or equivalent) is recommended under
conditions where airborne aerosol concentrations are not expected to be excessive. For
uncontrolled release events, or if exposure levels are not known, provide respirators
that offer a high protection factor such as a powered air purifying respirator or
supplied air. A respiratory protection program that meets OSHA's 29 CFR 1910.134
and ANSI Z88.2 requirements must be followed whenever workplace conditions
require respirator use. Personnel who wear respirators should be fit tested and
approved for respirator use as required.
Skin Protection
If skin contact with the product formulation is likely, the use of latex or nitrile gloves
is recommended.
Eye Protection
Eye protection is normally not required during intended product use. However, if eye
contact is likely to occur, the use of chemical safety goggles (as a minimum) is
recommended.
Engineering Controls Engineering controls are normally not needed during the normal use of this product.
9. PHYSICAL/CHEMICAL PROPERTIES
Appearance/Physical State A sterile, nonpyrogenic solution of naloxone hydrochloride in water
Odor NA
Odor Threshold NA
pH 4.0 (3.0 to 6.5)
Melting point/Freezing Point NA
Initial Boiling Point/Boiling Point Range NA
Flash Point NA
Evaporation Rate NA
Flammability (solid, gas) NA
Upper/Lower Flammability or Explosive Limits NA
Vapor Pressure NA
Vapor Density (Air =1) NA
Relative Density NA
Solubility Naloxone hydrochloride is a white to slightly off-white powder
soluble in water, in dilute acids, and in strong alkali; slightly soluble
in alcohol; practically insoluble in ether and chloroform
Partition Coefficient: n-octanol/water NA
Auto-ignition Temperature NA
Decomposition Temperature NA
Viscosity NA
4
Product Name: Naloxone Hydrochloride Injection, USP
10. STABILITY AND REACTIVITY
Reactivity
Not determined.
Chemical Stability
Stable under standard use and storage conditions.
Hazardous Reactions
Not determined
Conditions to Avoid
Not determined
Incompatibilities
Not determined
Hazardous Decomposition
Products
Not determined. During thermal decomposition, it may be possible to generate
irritating vapors and/or toxic fumes of carbon oxides (COx), nitrogen oxides (NOx)
and hydrogen chloride.
Hazardous Polymerization Not anticipated to occur with this product.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity: Not determined for the product formulation. Information for the active ingredient is as follows:
Ingredient(s) Percent Test Type Route of
Administration Value Units Species
Naloxone Hydrochloride 100 LD50 Oral >1000
>1000
mg/kg
mg/kg
Rat
Mouse
Naloxone Hydrochloride 100 LD50 Intravenous 107
90
mg/kg
mg/kg
Rat
Mouse
LD 50: Dosage that produces 50% mortality.
Occupational Exposure
Potential
Information on the absorption of this product via inhalation or skin contact is not
available. Avoid liquid aerosol generation and skin contact.
Signs and Symptoms
None anticipated from normal handling of this product. This material should be
considered potentially irritating to eyes. In clinical use, adverse events associated with
the use of naloxone hydrochloride injection in postoperative patients include
hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea,
pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been
reported as sequelae of these events. When given to normal subjects, cognitive
impairment and behavioral symptoms, including irritability, anxiety, tension,
suspiciousness, sadness, difficulty concentrating, and lack of appetite were reported.
In addition, somatic symptoms, including dizziness, heaviness, sweating, nausea, and
stomachaches were also noted.
Aspiration Hazard None anticipated from normal handling of this product.
Dermal Irritation/ Corrosion
None anticipated from normal handling of this product.
Ocular Irritation/ Corrosion None anticipated from normal handling of this product. However, inadvertent contact
of this product with eyes may produce irritation with redness and tearing.
Dermal or Respiratory
Sensitization
None anticipated from normal handling of this product.
Reproductive Effects
None anticipated from normal handling of this product. Reproduction studies
conducted in mice and rats at doses 4-times and 8-times, respectively, the dose of a 50
kg human given 10 mg/day (based on surface area) demonstrated no embryotoxic or
teratogenic effects due to naloxone.
5
Product Name: Naloxone Hydrochloride Injection, USP
11. TOXICOLOGICAL INFORMATION: continued
Mutagenicity
Naloxone was weakly positive in the Ames mutagenicity and in the in vitro human
lymphocyte chromosome aberration test but was negative in the in vitro Chinese
hamster V79 cell HGPRT mutagenicity assay and in the in vivo rat bone marrow
chromosome aberration study.
Carcinogenicity
Studies in animals to assess the carcinogenic potential of naloxone have not been
conducted.
Carcinogen Lists
IARC: Not listed NTP: Not listed OSHA: Not listed
Specific Target Organ Toxicity
– Single Exposure
NA
Specific Target Organ Toxicity
– Repeat Exposure
Based on clinical use, possible target organs include the nervous system and
cardiovascular system.
12. ECOLOGICAL INFORMATION
Aquatic Toxicity Not determined for product.
Persistence/Biodegradability Not determined for product.
Bioaccumulation Not determined for product.
Mobility in Soil Not determined for product.
Notes:
13. DISPOSAL CONSIDERATIONS
Waste Disposal
All waste materials must be properly characterized. Further, disposal should be
performed in accordance with the federal, state or local regulatory requirements.
Container Handling and
Disposal
Dispose of container and unused contents in accordance with federal, state and local
regulations.
14. TRANSPORTATION INFORMATION
ADR/ADG/ DOT STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
ICAO/IATA STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
IMDG STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity NA Notes: DOT - US Department of Transportation Regulations
6
Product Name: Naloxone Hydrochloride Injection, USP
15. REGULATORY INFORMATION
US TSCA Status Exempt
US CERCLA Status Not listed
US SARA 302 Status
US SARA 313 Status
Not listed
Not listed
US RCRA Status Not listed
US PROP 65 (Calif.)
Not listed
Notes: TSCA, Toxic Substance Control Act; CERCLA, US EPA law, Comprehensive Environmental Response, Compensation, and
Liability Act; SARA, Superfund Amendments and Reauthorization Act; RCRA, US EPA, Resource Conservation and Recovery Act; Prop
65, California Proposition 65
GHS/CLP Classification* *In the EU, classification under GHS/CLP does not apply to certain substances and
mixtures, such as medicinal products as defined in Directive 2001/83/EC, which are in
the finished state, intended for the final user.
Hazard Class
NA
Hazard Category
NA
Pictogram
NA
Signal Word
NA
Hazard Statement
NA
Prevention Do not breathe vapor or spray.
Wash hands thoroughly after handling.
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
EU Classification* *Medicinal products are exempt from the requirements of the EU Dangerous
Preparations Directive.
Classification(s) NA
Symbol NA
Indication of Danger NA
Risk Phrases NA
Safety Phrases S23: Do not breathe vapor/spray
S24: Avoid contact with the skin
S25: Avoid contact with eyes
S37/39 Wear suitable gloves and eye/face protection.
7
Product Name: Naloxone Hydrochloride Injection, USP
16. OTHER INFORMATION Notes:
ACGIH TLV American Conference of Governmental Industrial Hygienists – Threshold Limit Value
CAS Chemical Abstracts Service Number
CERCLA US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act
DOT US Department of Transportation Regulations
EEL Employee Exposure Limit
IATA International Air Transport Association
LD50 Dosage producing 50% mortality
NA Not applicable/Not available
NE Not established
NIOSH National Institute for Occupational Safety and Health
OSHA PEL US Occupational Safety and Health Administration – Permissible Exposure Limit
Prop 65 California Proposition 65
RCRA US EPA, Resource Conservation and Recovery Act
RTECS Registry of Toxic Effects of Chemical Substances
SARA Superfund Amendments and Reauthorization Act
STEL 15-minute Short Term Exposure Limit
STOT - SE Specific Target Organ Toxicity – Single Exposure
STOT - RE Specific Target Organ Toxicity – Repeated Exposure
TSCA Toxic Substance Control Act
TWA 8-hour Time Weighted Average
MSDS Coordinator: Hospira GEHS
Date Prepared: October 19, 2012
Date Revised: June 02, 2014
Disclaimer: The information and recommendations contained herein are based upon tests believed to be reliable. However, Hospira
does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A
WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE
MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE.
Adjustment to conform to actual conditions of usage may be required. Hospira assumes no responsibility for results
obtained or for incidental or consequential damages, including lost profits, arising from the use of these data. No
warranty against infringement of any patent, copyright or trademark is made or implied.
1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKINGProduct Identifier
Material Name: Nitroglycerin Tablets (0.4, and 0.6 mg)
Trade Name: NITROSTAT; VERNIESChemical Family: Mixture
Relevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use: Pharmaceutical product for the treatment of angina pectoris
Details of the Supplier of the Safety Data Sheet
2. HAZARDS IDENTIFICATION
Classification of the Substance or MixtureGHS - Classification
Acute Oral Toxicity: Category 4Acute Toxicity - Dusts and Mists: Category 4Specific target organ systemic toxicity (repeated exposure): Category 2
EU Classification:EU Indication of danger: Toxic
EU Risk Phrases:R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed.R33 - Danger of cumulative effects.
Label ElementsSignal Word: WarningHazard Statements: H304 - May be fatal if swallowed and enters airways
H332 - Harmful if inhaledH373 - May cause damage to organs through prolonged or repeated exposure: cardiovascular
_______________________________________________________________________________________________________PD027
Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887
Version: 3.2
Contact E-Mail: [email protected]
SAFETY DATA SHEET
Page 1 of 11
Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-800-879-3477
Pfizer LtdRamsgate RoadSandwich, KentCT13 9NJUnited Kingdom+00 44 (0)1304 616161
Revision date: 12-Apr-2015
Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300
SAFETY DATA SHEET
_______________________________________________________________________________________________________
Precautionary Statements: P260 - Do not breathe dust/fume/gas/mist/vapors/sprayP264 - Wash hands thoroughly after handlingP270 - Do not eat, drink or smoke when using this productP271 - Use only outdoors or in a well-ventilated areaP304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a positioncomfortable for breathingP301+ P312 - IF SWALLOWED: Call a POISON CENTRE or doctor/physician if you feelunwellP330 - Rinse mouthP314 - Get medical attention/advice if you feel unwellP501 - Dispose of contents/container in accordance with all local and national regulations
Other Hazards No data availableAustralian Hazard Classification(NOHSC):
Hazardous Substance. Non-Dangerous Goods.
Note: This document has been prepared in accordance with standards for workplace safety, whichrequire the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warnings included may not apply in all cases.Your needs may vary depending upon the potential for exposure in your workplace.
3. COMPOSITION / INFORMATION ON INGREDIENTS
HazardousIngredient CAS Number EU
EINECS/ELINCSList
EU Classification GHSClassification
%
Nitroglycerin 55-63-0 200-240-8 T+; R26/27/28E; R3R33
N; R51-53
Acute Tox. 2(H300)
Acute Tox. 2(H310)
STOT RE 2 (H373)Aquatic Chronic 2
(H411)Acute Tox. 2
(H330)Unst. Expl. (H200)
1.14 - 1.5
Glyceryl monostearate 31566-31-1 250-705-4 Not Listed Not Listed *Silicon dioxide, colloidal NF 7631-86-9 231-545-4 Not Listed Not Listed *Calcium stearate 1592-23-0 216-472-8 Not Listed Not Listed *Starch, pregelatinized 9005-25-8 232-679-6 Not Listed Not Listed *
Ingredient CAS Number EUEINECS/ELINCS
List
EU Classification GHSClassification
%
Lactose NF, monohydrate 64044-51-5 Not Listed Not Listed Not Listed *
_______________________________________________________________________________________________________PD027
Version: 3.2Page 2 of 11
Revision date: 12-Apr-2015Material Name: Nitroglycerin Tablets (0.4, and 0.6 mg)
SAFETY DATA SHEET
_______________________________________________________________________________________________________
Additional Information: * ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for workplacesafety. In accordance with 29 CFR 1910.1200, the exact percentage composition of thismixture has been withheld as a trade secret.
For the full text of the R phrases and CLP/GHS abbreviations mentioned in this Section, see Section 16
4. FIRST AID MEASURES
Description of First Aid MeasuresEye Contact: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention
immediately.
Skin Contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical attention.
Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately.
Most Important Symptoms and Effects, Both Acute and DelayedSymptoms and Effects ofExposure:
For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological Information.
Medical ConditionsAggravated by Exposure:
None known
Indication of the Immediate Medical Attention and Special Treatment NeededNotes to Physician: None
5. FIRE FIGHTING MEASURES
Extinguishing Media: Use carbon dioxide, dry chemical, or water spray.
Special Hazards Arising from the Substance or MixtureHazardous CombustionProducts:
Formation of toxic gases is possible during heating or fire.
Fire / Explosion Hazards: Not applicable
Advice for Fire-FightersDuring all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions, Protective Equipment and Emergency ProceduresPersonnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.
Environmental PrecautionsPlace waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.
Methods and Material for Containment and Cleaning UpMeasures for Cleaning /Collecting:
Contain the source of spill if it is safe to do so. Collect spilled material by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area thoroughly.
_______________________________________________________________________________________________________PD027
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Revision date: 12-Apr-2015Material Name: Nitroglycerin Tablets (0.4, and 0.6 mg)
SAFETY DATA SHEET
_______________________________________________________________________________________________________
Additional Consideration forLarge Spills:
Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained personnel.
7. HANDLING AND STORAGE
Precautions for Safe HandlingMinimize dust generation and accumulation. If tablets or capsules are crushed and/or broken, avoid breathing dust and avoidcontact with eyes, skin, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Washthoroughly after handling. Releases to the environment should be avoided. Review and implement appropriate technical andprocedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potentialpoints of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA filtration systemsor other equivalent controls.
Conditions for Safe Storage, Including any IncompatibilitiesStorage Conditions: Store as directed by product packaging.
Specific end use(s): Pharmaceutical product
8. EXPOSURE CONTROLS / PERSONAL PROTECTIONControl Parameters
Refer to available public information for specific member state Occupational Exposure Limits.
_______________________________________________________________________________________________________PD027
Estonia OEL - TWA 0.03 ppm0.3 mg/m3
0.05 ppm
Finland OEL - TWA 0.03 ppm0.3 mg/m3
France OEL - TWA 0.1 ppm1 mg/m3
ACGIH - Skin Absorption Designation Skin - potential significant contribution to overall exposure by thecutaneous route
Germany - TRGS 900 - TWAs 0.01 ppm0.094 mg/m3
Revision date: 12-Apr-2015
Germany (DFG) - MAK 0.01 ppm0.094 mg/m3
Germany - Biological Exposure Limit: 0.5 µg/L
Australia TWA 0.05 ppm0.46 mg/m3
Greece OEL - TWA 0.2 ppm2 mg/m3
Material Name: Nitroglycerin Tablets (0.4, and 0.6 mg)
Hungary OEL - TWA 0.5 mg/m3
Austria OEL - MAKs
Ireland OEL - TWAs 0.05 ppm0.5 mg/m3
0.05 ppm0.5 mg/m3
Japan - OELs - Ceilings 0.05 ppm0.46 mg/m3
Nitroglycerin
Lithuania OEL - TWA 0.03 ppm0.3 mg/m3
Belgium OEL - TWA 0.05 ppm0.47 mg/m3
OSHA - Final PELs - Skin Notations: prevent or reduce skin absorption
Version: 3.2Page 4 of 11
Czech Republic OEL - TWA 0.5 mg/m3
ACGIH Threshold Limit Value (TWA)
SAFETY DATA SHEET
_______________________________________________________________________________________________________
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
_______________________________________________________________________________________________________PD027
0.05 ppm0.47 mg/m3
Version: 3.2
Silicon dioxide, colloidal NF
Page 5 of 11
Australia TWA 2 mg/m3
Slovenia OEL - TWA 0.05 ppm0.47 mg/m3
Austria OEL - MAKs 4 mg/m3
0.3 mg/m3
Czech Republic OEL - TWA 0.1 mg/m3
4.0 mg/m3
Poland OEL - TWA
Estonia OEL - TWA 2 mg/m3
Spain OEL - TWA 0.05 ppm0.5 mg/m3
Finland OEL - TWA 5 mg/m3
0.5 mg/m3
Germany - TRGS 900 - TWAs 4 mg/m3
Sweden OEL - TWAs
Germany (DFG) - MAK 4 mg/m3
0.03 ppm0.3 mg/m3
Ireland OEL - TWAs 6 mg/m3
2.4 mg/m3
Latvia OEL - TWA 1 mg/m3
Switzerland OEL -TWAs 0.01 ppm0.094 mg/m3
OSHA - Final PELs - Table Z-3 Mineral D: 20 mppcfListed
Portugal OEL - TWA
Slovakia OEL - TWA 4.0 mg/m3
0.05 ppm
Switzerland OEL -TWAs 4 mg/m3
0.3 mg/m3
UK - Biological Exposure Limit: 15 µmol/mol creatinine
Calcium stearate
Revision date: 12-Apr-2015
ACGIH Threshold Limit Value (TWA) 10 mg/m3
Vietnam OEL - TWAs
Lithuania OEL - TWA 5 mg/m3
0.5 mg/m3
Sweden OEL - TWAs 5 mg/m3
Starch, pregelatinized
Glyceryl monostearate
Romania OEL - TWA
ACGIH Threshold Limit Value (TWA) 10 mg/m3
0.006 ppm0.05 mg/m3
Australia TWA 10 mg/m3
ACGIH Threshold Limit Value (TWA) 10 mg/m3
Belgium OEL - TWA 10 mg/m3
Material Name: Nitroglycerin Tablets (0.4, and 0.6 mg)
Bulgaria OEL - TWA 10.0 mg/m3
Czech Republic OEL - TWA 4.0 mg/m3
Lithuania OEL - TWA 5 mg/m3
Slovakia OEL - TWA
Sweden OEL - TWAs 5 mg/m3
SAFETY DATA SHEET
_______________________________________________________________________________________________________
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure ControlsEngineering Controls: Engineering controls should be used as the primary means to control exposures. General
room ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this section.
Personal ProtectiveEquipment:
Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).
Hands: Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing operations.
Eyes: Wear safety glasses or goggles if eye contact is possible.Skin: Impervious protective clothing is recommended if skin contact with drug product is possible and
for bulk processing operations.Respiratory protection: If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate
respirator with a protection factor sufficient to control exposures to below the OEL.
9. PHYSICAL AND CHEMICAL PROPERTIES
Solvent Solubility: No data availableWater Solubility: No data availablepH: No data available.Melting/Freezing Point (°C): No data availableBoiling Point (°C): No data available.Partition Coefficient: (Method, pH, Endpoint, Value)
Decomposition Temperature (°C): No data available.
Evaporation Rate (Gram/s): No data availableVapor Pressure (kPa): No data availableVapor Density (g/ml): No data available
_______________________________________________________________________________________________________PD027
Spain OEL - TWA 10 mg/m3
10 mg/m3
5 mg/m3
Calcium stearate
Switzerland OEL -TWAs 3 mg/m3
No data availableGlyceryl monostearate
Ireland OEL - TWAs
No data available
Physical State: Tablet
Lactose NF, monohydrate
10 mg/m3
4 mg/m3
No data available
Color: White
Nitroglycerin
Revision date: 12-Apr-2015
No data available
Odor: No data available.
Silicon dioxide, colloidal NFNo data available
Odor Threshold: No data available.
Starch, pregelatinized
OSHA - Final PELS - TWAs:
No data available
Molecular Formula: Mixture
15 mg/m3
Molecular Weight: Mixture
Material Name: Nitroglycerin Tablets (0.4, and 0.6 mg)
Portugal OEL - TWA 10 mg/m3
Version: 3.2Page 6 of 11
Slovakia OEL - TWA 4 mg/m3
Greece OEL - TWA
SAFETY DATA SHEET
_______________________________________________________________________________________________________
Relative Density: No data availableViscosity: No data available
Flammablity:Autoignition Temperature (Solid) (°C): No data availableFlammability (Solids): No data availableFlash Point (Liquid) (°C): No data availableUpper Explosive Limits (Liquid) (% by Vol.): No data availableLower Explosive Limits (Liquid) (% by Vol.): No data availableThe active ingredient in this formulation is highly
explosive. However, based on the amount of active ingredientcontained in this product it is not expected to pose an explosionrisk.
Polymerization: Will not occur
10. STABILITY AND REACTIVITY
Reactivity: No data availableChemical Stability: Stable under normal conditions of use.Possibility of Hazardous Reactions
Oxidizing Properties: No data availableConditions to Avoid: Avoid direct sunlight, conditions that might generate heat, and sources of ignition.Incompatible Materials: As a precautionary measure, keep away from strong oxidizersHazardous DecompositionProducts:
None known
11. TOXICOLOGICAL INFORMATION
Information on Toxicological EffectsGeneral Information: The information included in this section describes the potential hazards of the individual
ingredients.Short Term: May be absorbed through the skin and cause systemic effects. Chest pain, acute myocardial
infarction, and sudden death have occurred during temporary withdrawal of organic nitratesfrom industrial workers exposed for long periods of time.
Known Clinical Effects: Headache, which may be severe and persistent, may occur immediately after use. Vertigo,dizziness, weakness, palpitation, and other manifestations of postural hypotension maydevelop occasionally. Flushing, drug rash, and exfoliative dermatitis have been reported inpatients receiving nitrate therapy.
Acute Toxicity: (Species, Route, End Point, Dose)
Acute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the test.
Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))
_______________________________________________________________________________________________________PD027
Material Name: Nitroglycerin Tablets (0.4, and 0.6 mg)
Rat Dermal LD50 > 29mg/kg
Mouse IP LD50 200 mg/kg
Rat IV LD50 23.2mg/kg
Version: 3.2
Nitroglycerin
Page 7 of 11
Rat Oral LD50 105 mg/kg
Revision date: 12-Apr-2015
Mouse Oral LD50 115mg/kg
Glyceryl monostearate
Rabbit Dermal LD50 > 280mg/kg
SAFETY DATA SHEET
_______________________________________________________________________________________________________
11. TOXICOLOGICAL INFORMATION
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))
Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.
12. ECOLOGICAL INFORMATION
Environmental Overview: Based on the concentration of the active ingredient in the formulation, No harmful effects toaquatic organisms are expected.
Toxicity:
Aquatic Toxicity: (Species, Method, End Point, Duration, Result)
Persistence and Degradability: No data available
Bio-accumulative Potential: No data available
Mobility in Soil: No data available
_______________________________________________________________________________________________________PD027
Page 8 of 11
2 Year(s) Mouse Oral 1058 mg/kg/day NOAEL Not carcinogenic
Nitroglycerin
Nitroglycerin
Lepomis macrochirus (Bluegill Sunfish) LC50 96 Hours 1.91 mg/L
Nitroglycerin
Midge LC50 48 Hours 20 mg/L
Bacterial Mutagenicity (Ames) Salmonella Positive
Silicon dioxide, colloidal NF
In Vivo Dominant Lethal Assay Rat Negative
IARC: Group 3 (Not Classifiable)
Fertility and Embryonic Development Rat Oral434 mg/kg/day NOAEL Negative
In Vitro Cytogenetics Rat Negative
Revision date: 12-Apr-2015
Embryo / Fetal Development Rabbit Oral 240 mg/kg/day NOAEL Not Teratogenic
Nitroglycerin
Material Name: Nitroglycerin Tablets (0.4, and 0.6 mg)
2 Year(s) Rat Oral 434 mg/kg/day LOAEL Liver, Male reproductive system
Version: 3.2
SAFETY DATA SHEET
_______________________________________________________________________________________________________
13. DISPOSAL CONSIDERATIONS
Waste Treatment Methods: Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the material, review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release. It is recommended that waste minimizationbe practiced. The best available technology should be utilized to prevent environmentalreleases. This may include destructive techniques for waste and wastewater.
14. TRANSPORT INFORMATIONThe following refers to all modes of transportation unless specified below.
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.
15. REGULATORY INFORMATION
Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture
Canada - WHMIS: ClassificationsWHMIS hazard class:Class D, Division 2, Subdivision B
_______________________________________________________________________________________________________PD027
Revision date: 12-Apr-2015
California Proposition 65 Not Listed
Material Name: Nitroglycerin Tablets (0.4, and 0.6 mg)
Inventory - United States TSCA - Sect. 8(b) Present
Nitroglycerin
Australia (AICS): Present
Version: 3.2
Standard for the Uniform Schedulingfor Drugs and Poisons:
Schedule 3Schedule 4
Page 9 of 11
EU EINECS/ELINCS List 200-240-8
Nitroglycerin
Glyceryl monostearate
RCRA - P Series Wastes Listed
CERCLA/SARA 313 Emission reporting Not Listed
CERCLA/SARA 313 Emission reporting 1.0 %CERCLA/SARA Hazardous Substancesand their Reportable Quantities:
10 lb4.54 kg
SAFETY DATA SHEET
_______________________________________________________________________________________________________
15. REGULATORY INFORMATION
16. OTHER INFORMATION
Text of R phrases and GHS Classification abbreviations mentioned in Section 3
Explosives-Unstable explsoives; H200 - Unstable explosiveAcute toxicity, oral-Cat.2; H300 - Fatal if swallowedAcute toxicity, dermal-Cat.2; H310 - Fatal in contact with skinAcute toxicity, inhalation-Cat.2; H330 - Fatal if inhaledSpecific target organ toxicity, repeated exposure-Cat.2; H373 - May cause damage to organs through prolonged or repeated exposureHazardous to the aquatic environment, chronic toxicity-Cat.2; H411 - Toxic to aquatic life with long lasting effects
E - ExplosiveT+ - Very toxicN - Dangerous for the environment
_______________________________________________________________________________________________________PD027
Version: 3.2
Australia (AICS): Present
Page 10 of 11
EU EINECS/ELINCS List 231-545-4
Lactose NF, monohydrate
Calcium stearate
California Proposition 65
CERCLA/SARA 313 Emission reporting Not Listed
CERCLA/SARA 313 Emission reporting Not Listed
California Proposition 65 Not Listed
Not Listed
Inventory - United States TSCA - Sect. 8(b) PresentAustralia (AICS): Present
California Proposition 65 Not Listed
EU EINECS/ELINCS List 216-472-8
Starch, pregelatinized
Australia (AICS):
CERCLA/SARA 313 Emission reporting Not Listed
Present
California Proposition 65 Not Listed
Inventory - United States TSCA - Sect. 8(b) Present
Inventory - United States TSCA - Sect. 8(b) Present
REACH - Annex IV - Exemptions from theobligations of Register:
Present
Australia (AICS): PresentREACH - Annex IV - Exemptions from theobligations of Register:
Present
Revision date: 12-Apr-2015
EU EINECS/ELINCS List 232-679-6
EU EINECS/ELINCS List Not Listed
Silicon dioxide, colloidal NF
Australia (AICS): Present
CERCLA/SARA 313 Emission reporting Not Listed
Material Name: Nitroglycerin Tablets (0.4, and 0.6 mg)
California Proposition 65 Not Listed
EU EINECS/ELINCS List
Inventory - United States TSCA - Sect. 8(b) Present
250-705-4
SAFETY DATA SHEET
_______________________________________________________________________________________________________
R 3 - Extreme risk of explosion by shock, friction, fire or other sources of ignition.R33 - Danger of cumulative effects.R26/27/28 - Very toxic by inhalation, in contact with skin and if swallowed.R51/53 - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
Reasons for Revision: Updated Section 2 - Hazard Identification. Updated Section 3 - Composition / Information onIngredients. Updated Section 7 - Handling and Storage.
Revision date: 12-Apr-2015
Prepared by:Product Stewardship Hazard Communication
Pfizer Global Environment, Health, and Safety Operations
Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, itis without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no knowninformation at this time.
End of Safety Data Sheet
_______________________________________________________________________________________________________PD027
Revision date: 12-Apr-2015Material Name: Nitroglycerin Tablets (0.4, and 0.6 mg)
Version: 3.2Page 11 of 11
Ondansetron Injection, USP (single dose)
Zofran Injection
Regulated prescription drug.
GHS product identifier
Synonyms
Product type
Emergency telephone number (with hours of operation)
Section 1. Identification:
:
:
:
Supplier's details :
Identified uses
Ondansetron Injection, USP (single dose)
SAFETY DATA SHEETConforms to HazCom 2012/United States
West-Ward Pharmaceutical Corp.465 Industrial Way West Eatontown NJ 07724 USA
CHEMTREC, U.S. : 1-800-424-9300 International: +1-703-527-388724/7
Pharmaceutical.
Product code : NDC 0641-6078-01, NDC 0641-6078-25, NDC 0641-6080-01, NDC 0641-6080-25
Chemical family : Antiemetic.
Container information : 2 mL vial
Section 2. Hazards identification
Not classified.Classification of the substance or mixture
:
Signal word : No signal word.
Hazard statements : No known significant effects or critical hazards.
Precautionary statements
Prevention : Not applicable.
Response : Not applicable.
Storage : Not applicable.
Disposal : Not applicable.
GHS label elements
General : Read label before use. Keep out of reach of children. If medical advice is needed,have product container or label at hand.
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200), this SDS contains valuable information critical to the safe handling and proper use of the product. This SDS should be retained and available for employees and other users of this product.
Hazards not otherwise classified
: None known.
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Ondansetron Injection, USP (single dose)
Section 3. Composition/information on ingredients
Water 60 - 100 7732-18-5Sodium Chloride 0.1 - 1 7647-14-5Ondansetron Hydrochloride 0.1 - 1 99614-01-4Citric Acid Monohydrate 0 - 0.1 5949-29-1Sodium Citrate, dihydrate 0 - 0.1 6132-04-3
Ingredient name CAS number%
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
Other means of identification
: Zofran Injection
CAS number : Not applicable.
Substance/mixture
Product code : NDC 0641-6078-01, NDC 0641-6078-25, NDC 0641-6080-01, NDC 0641-6080-25
CAS number/other identifiers
:
Occupational exposure limits, if available, are listed in Section 8.
Mixture
Any concentration shown as a range is to protect confidentiality or is due to batch variation.
Wash out mouth with water. Remove victim to fresh air and keep at rest in a position comfortable for breathing. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.
Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.
Flush contaminated skin with plenty of water. Get medical attention if symptoms occur.
Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical attention if symptoms occur.
Section 4. First aid measures
Eye contact
Skin contact
Inhalation
Ingestion :
:
:
:
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : Treat symptomatically. Contact poison treatment specialist immediately if large quantities have been ingested or inhaled.
Description of necessary first aid measures
Specific treatments : No specific treatment.
Most important symptoms/effects, acute and delayed
Inhalation : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Ingestion
Skin contact : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Eye contact
Over-exposure signs/symptoms
Skin contact
Ingestion
Inhalation No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.
:
:
:
Eye contact : No known significant effects or critical hazards.
Potential acute health effects
See toxicological information (Section 11)
Indication of immediate medical attention and special treatment needed, if necessary
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Ondansetron Injection, USP (single dose)
Section 5. Fire-fighting measures
No special measures are required.
Hazardous thermal decomposition products
Specific hazards arising from the chemical
No specific data.
No specific fire or explosion hazard.
Fire-fighters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA) with a full face-piece operated in positive pressure mode.
Special protective equipment for fire-fighters
Use an extinguishing agent suitable for the surrounding fire.
Extinguishing media
:
:
:
None known.
Suitable extinguishing media
:
Unsuitable extinguishing media
:
Special protective actions for fire-fighters
:
Section 6. Accidental release measures
Environmental precautions
Personal precautions, protective equipment and emergency procedures
:
: No action shall be taken involving any personal risk or without suitable training. Keep unnecessary and unprotected personnel from entering. Do not touch or walk through spilled material. Put on appropriate personal protective equipment.
Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers. Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air).
Methods and materials for containment and cleaning up
For non-emergency personnel
For emergency responders : If specialized clothing is required to deal with the spillage, take note of any information in Section 8 on suitable and unsuitable materials. See also the information in "For non-emergency personnel".
Stop leak if without risk. Move containers from spill area. Prevent entry into sewers,water courses, basements or confined areas. Wash spillages into an effluent treatment plant or proceed as follows. Contain and collect spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth and place in container for disposal according to local regulations (see Section 13).Dispose of via a licensed waste disposal contractor. Note: see Section 1 for emergency contact information and Section 13 for waste disposal.
:Spill
Section 7. Handling and storage
Advice on general occupational hygiene
Conditions for safe storage,including any incompatibilities
Eating, drinking and smoking should be prohibited in areas where this material is handled, stored and processed. Workers should wash hands and face before eating,drinking and smoking. See also Section 8 for additional information on hygiene measures.
Store in accordance with local regulations. Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials (see Section 10) and food and drink. Keep container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed and kept upright to prevent leakage. Do not store in unlabeled containers. Use appropriate containment to avoid environmental contamination.
:
:
Protective measures Put on appropriate personal protective equipment (see Section 8).:
Precautions for safe handling
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Ondansetron Injection, USP (single dose)
Section 8. Exposure controls/personal protection
Hand protection
Use a properly fitted, air-purifying or supplied air respirator complying with an approved standard if a risk assessment indicates this is necessary. Respirator selection must be based on known or anticipated exposure levels, the hazards of the product and the safe working limits of the selected respirator.
Chemical-resistant, impervious gloves complying with an approved standard should be worn at all times when handling chemical products if a risk assessment indicates this is necessary.
Safety eyewear complying with an approved standard should be used when a risk assessment indicates this is necessary to avoid exposure to liquid splashes, mists,gases or dusts. If contact is possible, the following protection should be worn, unless the assessment indicates a higher degree of protection: safety glasses with side-shields.
Eye/face protection
Respiratory protection :
:
:
Body protection Personal protective equipment for the body should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.
:
Environmental exposure controls
: Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation.
Appropriate engineering controls
: Good general ventilation should be sufficient to control worker exposure to airborne contaminants.
Wash hands, forearms and face thoroughly after handling chemical products, before eating, smoking and using the lavatory and at the end of the working period. Ensure that eyewash stations and safety showers are close to the workstation location.
Hygiene measures :
Control parameters
Individual protection measures
Occupational exposure limits
Skin protection
Other skin protection : Appropriate footwear and any additional skin protection measures should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.
None.
Section 9. Physical and chemical properties
Physical state
Melting point
Vapor pressure
Relative density
Vapor density
Liquid. [Aqueous solution.]
Not available.
Not available.
Not available.
Not available.
Not available.Odor
pH
Colorless.Color
Evaporation rate Not available.
Flash point Not available.
3.3 to 4
Not available.Odor threshold
:
:
:
:
:
:
:
:
:
:
:
Appearance
Boiling point : Not available.
Flammability (solid, gas) : Not available.
Lower and upper explosive (flammable) limits
: Not available.
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Ondansetron Injection, USP (single dose)
Section 9. Physical and chemical propertiesSolubility Soluble in the following materials: cold water and hot water.
Auto-ignition temperature Not available.
Not available.
Viscosity Not available.
Partition coefficient: n-octanol/water
:
:
:
:
Decomposition temperature : Not available.
Section 10. Stability and reactivity
Hazardous decomposition products
Conditions to avoid No specific data.
Under normal conditions of storage and use, hazardous decomposition products should not be produced.
The product is stable.Chemical stability
Reactive or incompatible with the following materials: oxidizing materials, acids and alkalis.
:
:
:
Incompatible materials :
Possibility of hazardous reactions
: Under normal conditions of storage and use, hazardous reactions will not occur.
Reactivity : No specific test data related to reactivity available for this product or its ingredients.
Section 11. Toxicological information
Acute toxicity
Carcinogenicity
Irritation/Corrosion
Sensitization
Information on the likely routes of exposure
Inhalation : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Ingestion
Skin contact : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Eye contact
Specific target organ toxicity (single exposure)
Specific target organ toxicity (repeated exposure)
Aspiration hazard
Information on toxicological effects
: Dermal contact. Eye contact. Ingestion.
Potential acute health effects
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
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Ondansetron Injection, USP (single dose)
Section 11. Toxicological information
No known significant effects or critical hazards.General :
No known significant effects or critical hazards.Carcinogenicity :
No known significant effects or critical hazards.Mutagenicity :
No known significant effects or critical hazards.Teratogenicity :
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Symptoms related to the physical, chemical and toxicological characteristics
Skin contact
Ingestion
Inhalation No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.
:
:
:
Eye contact : No known significant effects or critical hazards.
Potential chronic health effects
Delayed and immediate effects and also chronic effects from short and long term exposure
Numerical measures of toxicity
Acute toxicity estimates
Potential immediate effects
: No known significant effects or critical hazards.
Short term exposure
Potential delayed effects : No known significant effects or critical hazards.
Potential immediate effects
: No known significant effects or critical hazards.
Long term exposure
Potential delayed effects : No known significant effects or critical hazards.
There is no data available.
Section 12. Ecological information
Bioaccumulative potential
Other adverse effects : No known significant effects or critical hazards.
Toxicity
Persistence and degradability
Soil/water partition coefficient (KOC)
: Not available.
Mobility in soil
There is no data available.
There is no data available.
There is no data available.
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Ondansetron Injection, USP (single dose)
Section 13. Disposal considerationsThe generation of waste should be avoided or minimized wherever possible. Disposal of this product, solutions and any by-products should comply with the requirements of environmental protection and waste disposal legislation and any regional local authority requirements. Dispose of surplus and non-recyclable products via a licensed waste disposal contractor. Waste should not be disposed of untreated to the sewer unless fully compliant with the requirements of all authorities with jurisdiction. Waste packaging should be recycled. Incineration or landfill should only be considered when recycling is not feasible. This material and its container must be disposed of in a safe way. Empty containers or liners may retain some product residues. Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers.
:Disposal methods
Section 14. Transport information
-
-
-
-
-
-
-
Not regulated.
-
-
Not regulated. Not regulated.
- - -
DOT Classification IMDG IATA
UN number
UN proper shipping name
Transport hazard class(es)
Packing group
Additional information
Environmental hazards
Special precautions for user
Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
No. No. No.
Transport within user’s premises: always transport in closed containers that are upright and secure. Ensure that persons transporting the product know what to do in the event of an accident or spillage.
: Not available.
:
AERG : Not applicable.
Section 15. Regulatory informationU.S. Federal regulations :
Clean Air Act Section 112(b) Hazardous Air Pollutants (HAPs)
: Not listed
Clean Air Act Section 602 Class I Substances
: Not listed
Clean Air Act Section 602 Class II Substances
: Not listed
DEA List I Chemicals (Precursor Chemicals)
: Not listed
TSCA 8(a) CDR Exempt/Partial exemption: Not determined
United States inventory (TSCA 8b): Not determined.
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Ondansetron Injection, USP (single dose)
Section 15. Regulatory information
None of the components are listed.
No products were found.
Massachusetts :
California Prop. 65
DEA List II Chemicals (Essential Chemicals)
: Not listed
New York : None of the components are listed.
New Jersey : None of the components are listed.
Pennsylvania : None of the components are listed.
State regulations
SARA 302/304
SARA 304 RQ : Not applicable.
No products were found.
Composition/information on ingredients
SARA 311/312
Classification : Not applicable.
No products were found.
Composition/information on ingredients
Australia inventory (AICS): Not determined.China inventory (IECSC): Not determined.Japan inventory: All components are listed or exempted.Korea inventory: Not determined.Malaysia Inventory (EHS Register): Not determined.New Zealand Inventory of Chemicals (NZIoC): Not determined.Philippines inventory (PICCS): Not determined.Taiwan inventory (CSNN): Not determined.
International regulations
International lists :
Chemical Weapons Convention List Schedule I Chemicals
: Not listed
Chemical Weapons Convention List Schedule II Chemicals
: Not listed
Chemical Weapons Convention List Schedule III Chemicals
: Not listed
Section 16. Other informationHistory
Prepared by :
Key to abbreviations : ATE = Acute Toxicity EstimateBCF = Bioconcentration FactorGHS = Globally Harmonized System of Classification and Labelling of ChemicalsIATA = International Air Transport AssociationIBC = Intermediate Bulk ContainerIMDG = International Maritime Dangerous GoodsLogPow = logarithm of the octanol/water partition coefficient
Date of issue mm/dd/yyyy
Version :
:
1
12/15/2013
KMK Regulatory Services Inc.
Revised Section(s) : Not applicable.
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Ondansetron Injection, USP (single dose)
Section 16. Other informationMARPOL 73/78 = International Convention for the Prevention of Pollution From Ships,1973 as modified by the Protocol of 1978. ("Marpol" = marine pollution)UN = United Nations
Notice to readerTo the best of our knowledge, the information contained herein is accurate. However, neither the above-named supplier, nor any of its subsidiaries, assumes any liability whatsoever for the accuracy or completeness of the information contained herein.Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist.
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Flumazenil Injection
Not available.
GHS product identifier
Synonyms
Emergency telephone number (with hours of operation)
Section 1. Identification:
:
:
Supplier's details :
Relevant identified uses of the substance or mixture and uses advised against
Conforms to HazCom 2012/United States
SAFETY DATA SHEETFlumazenil Injection
Pharmaceuticals.
WEST-WARD PHARMACEUTICALSEATONTOWN, NJ 07724
CHEMTREC, U.S. : 1-800-424-9300 International: +1-703-527-3877
Product code : NDC 0641-6031-01 NDC 0641-6031-10 NDC 0641-6032-01 NDC 0641-6032-10
Chemical family :
Product type :
Container information :
Benzodiazepine receptor antagonist.
Regulated prescription drug.
5 and 10 ml vials.
Section 2. Hazards identification
Not classified.Classification of the substance or mixture
:
Signal word : No signal word.
Hazard statements : No known significant effects or critical hazards.
Precautionary statements
Prevention : Not applicable.
Response : Not applicable.
Storage : Not applicable.
Disposal : Not applicable.
GHS label elements
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200), this SDS contains valuable information critical to the safe handling and proper use of the product. This SDS should be retained and available for employees and other users of this product.
Hazards not otherwise classified
: None known.
Section 3. Composition/information on ingredients
Other means of identification
: Not available.
Substance/mixture
CAS number/other identifiers
: Mixture
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Flumazenil Injection
Section 3. Composition/information on ingredientsIngredient name CAS number%
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
Occupational exposure limits, if available, are listed in Section 8.
Water 60 - 100 7732-18-54H-Imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic acid, 8-fluoro-5,6-dihydro-5-methyl-6-oxo-,ethyl ester
0 - 0.1 78755-81-4
Sodium chloride 0.1 - 1 7647-14-5Methyl 4-hydroxybenzoate 0.1 - 1 99-76-3Propyl 4-hydroxybenzoate 0.1 - 1 94-13-3Disodium dihydrogen ethylenediaminetetraacetate 0.1 - 1 139-33-3Acetic acid 0.1 - 1 64-19-7
Wash out mouth with water. Remove victim to fresh air and keep at rest in a position comfortable for breathing. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.
Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.
Flush contaminated skin with plenty of water. Get medical attention if symptoms occur.
Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical attention if symptoms occur.
Section 4. First aid measures
Eye contact
Skin contact
Inhalation
Ingestion :
:
:
:
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : Treat symptomatically. Contact poison treatment specialist immediately if large quantities have been ingested or inhaled.
Description of necessary first aid measures
Specific treatments : No specific treatment.
Most important symptoms/effects, acute and delayed
Inhalation : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Ingestion
Skin contact : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Eye contact
Over-exposure signs/symptoms
Skin contact
Ingestion
Inhalation No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.
:
:
:
Eye contact : No known significant effects or critical hazards.
Potential acute health effects
See toxicological information (Section 11)
Indication of immediate medical attention and special treatment needed, if necessary
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Flumazenil Injection
Section 5. Fire-fighting measures
No special protection is required.
Hazardous thermal decomposition products
Specific hazards arising from the chemical
No specific data.
No specific fire or explosion hazard.
Fire-fighters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA) with a full face-piece operated in positive pressure mode.
Special protective equipment for fire-fighters
Use an extinguishing agent suitable for the surrounding fire.
Extinguishing media
:
:
:
None known.
Suitable extinguishing media
:
Unsuitable extinguishing media
:
Special protective actions for fire-fighters
:
Section 6. Accidental release measures
Environmental precautions
Personal precautions, protective equipment and emergency procedures
Stop leak if without risk. Move containers from spill area. Prevent entry into sewers,water courses, basements or confined areas. Wash spillages into an effluent treatment plant or proceed as follows. Contain and collect spillage with non-combustible,absorbent material e.g. sand, earth, vermiculite or diatomaceous earth and place in container for disposal according to local regulations (see Section 13). Dispose of via a licensed waste disposal contractor. Note: see Section 1 for emergency contact information and Section 13 for waste disposal.
:
: No action shall be taken involving any personal risk or without suitable training. Keep unnecessary and unprotected personnel from entering. Do not touch or walk through spilled material. Put on appropriate personal protective equipment.
Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers. Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air).
:
Methods and materials for containment and cleaning up
For non-emergency personnel
For emergency responders : If specialized clothing is required to deal with the spillage, take note of any information in Section 8 on suitable and unsuitable materials. See also the information in "For non-emergency personnel".
Spill
Section 7. Handling and storage
Advice on general occupational hygiene
Eating, drinking and smoking should be prohibited in areas where this material is handled, stored and processed. Workers should wash hands and face before eating,drinking and smoking. See also Section 8 for additional information on hygiene measures.
:
Protective measures Put on appropriate personal protective equipment (see Section 8).:
Precautions for safe handling
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Flumazenil Injection
Section 7. Handling and storageConditions for safe storage,including any incompatibilities
Store in accordance with local regulations. Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials (see Section 10) and food and drink. Keep container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed and kept upright to prevent leakage. Do not store in unlabeled containers. Use appropriate containment to avoid environmental contamination.
:
Section 8. Exposure controls/personal protection
Hand protection
Use a properly fitted, air-purifying or supplied air respirator complying with an approved standard if a risk assessment indicates this is necessary. Respirator selection must be based on known or anticipated exposure levels, the hazards of the product and the safe working limits of the selected respirator.
Chemical-resistant, impervious gloves complying with an approved standard should be worn at all times when handling chemical products if a risk assessment indicates this is necessary.
Safety eyewear complying with an approved standard should be used when a risk assessment indicates this is necessary to avoid exposure to liquid splashes, mists,gases or dusts. If contact is possible, the following protection should be worn, unless the assessment indicates a higher degree of protection: safety glasses with side-shields.
Eye/face protection
Respiratory protection :
:
:
Body protection Personal protective equipment for the body should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.
:
Environmental exposure controls
: Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation.
Appropriate engineering controls
: No special ventilation requirements. Good general ventilation should be sufficient to control worker exposure to airborne contaminants. If this product contains ingredients with exposure limits, use process enclosures, local exhaust ventilation or other engineering controls to keep worker exposure below any recommended or statutory limits.
Wash hands, forearms and face thoroughly after handling chemical products, before eating, smoking and using the lavatory and at the end of the working period. Ensure that eyewash stations and safety showers are close to the workstation location.
Hygiene measures :
Control parameters
Individual protection measures
Occupational exposure limits
Skin protection
Other skin protection : Appropriate footwear and any additional skin protection measures should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.
None.
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Flumazenil Injection
Section 9. Physical and chemical properties
Physical state
Melting point
Vapor pressure
Relative density
Vapor density
Solubility
Liquid. [Aqueous solution.]
Not available.
Not available.
Not available.
Not available.
Easily soluble in the following materials: cold water and hot water.
Not available.Odor
pH
Clear.Color
Evaporation rate Not available.
Auto-ignition temperature
Flash point
Not available.
Not applicable.
Not available.
3.5 to 4.5
Viscosity Not available.
Not available.Odor threshold
Partition coefficient: n-octanol/water
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
Appearance
Boiling point : Not available.
Flammability (solid, gas) : Not available.
Lower and upper explosive (flammable) limits
: Not available.
Burning rate Not applicable.:
Burning time : Not applicable.
SADT Not available.:
Decomposition temperature : Not available.
Solubility in water : Not available.
Section 10. Stability and reactivity
Hazardous decomposition products
Conditions to avoid No specific data.
Under normal conditions of storage and use, hazardous decomposition products should not be produced.
The product is stable.Chemical stability
Reactive or incompatible with the following materials: oxidizing materials.
:
:
:
Incompatible materials :
Possibility of hazardous reactions
: Under normal conditions of storage and use, hazardous reactions will not occur.
Reactivity : No specific test data related to reactivity available for this product or its ingredients.
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Flumazenil Injection
Section 11. Toxicological information
Acute toxicity
Carcinogenicity
Mutagenicity
Teratogenicity
Reproductive toxicity
Irritation/Corrosion
Sensitization
Information on the likely routes of exposure
Inhalation : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Ingestion
Skin contact : No known significant effects or critical hazards.
No known significant effects or critical hazards.:Eye contact
Symptoms related to the physical, chemical and toxicological characteristics
Skin contact
Ingestion
Inhalation No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.
:
:
:
Eye contact : No known significant effects or critical hazards.
Delayed and immediate effects and also chronic effects from short and long term exposure
Specific target organ toxicity (single exposure)
Specific target organ toxicity (repeated exposure)
Aspiration hazard
Information on toxicological effects
: Dermal contact. Eye contact. Inhalation. Ingestion.
Potential acute health effects
Potential immediate effects
: No known significant effects or critical hazards.
Short term exposure
Potential delayed effects : No known significant effects or critical hazards.
Potential immediate effects
: No known significant effects or critical hazards.
Long term exposure
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
There is no data available.
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Flumazenil Injection
Section 11. Toxicological information
No known significant effects or critical hazards.General :
No known significant effects or critical hazards.Carcinogenicity :
No known significant effects or critical hazards.Mutagenicity :
No known significant effects or critical hazards.Teratogenicity :
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Potential chronic health effects
Other information : FDA Class C
Numerical measures of toxicity
Acute toxicity estimates
Potential delayed effects : No known significant effects or critical hazards.
There is no data available.
Section 12. Ecological information
Bioaccumulative potential
Other adverse effects : No known significant effects or critical hazards.
Toxicity
Persistence and degradability
Soil/water partition coefficient (KOC)
: Not available.
Mobility in soil
There is no data available.
There is no data available.
There is no data available.
Section 13. Disposal considerationsThe generation of waste should be avoided or minimized wherever possible. Disposal of this product, solutions and any by-products should comply with the requirements of environmental protection and waste disposal legislation and any regional local authority requirements. Dispose of surplus and non-recyclable products via a licensed waste disposal contractor. Waste should not be disposed of untreated to the sewer unless fully compliant with the requirements of all authorities with jurisdiction. Waste packaging should be recycled. Incineration or landfill should only be considered when recycling is not feasible. This material and its container must be disposed of in a safe way. Empty containers or liners may retain some product residues. Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers.
:Disposal methods
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Flumazenil Injection
Section 14. Transport information
-
-
-
-
-
-
-
Not regulated.
-
-
Not regulated. Not regulated.
- - -
DOT Classification IMDG IATA
UN number
UN proper shipping name
Transport hazard class(es)
Packing group
Additional information
Environmental hazards
Special precautions for user
Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
No. No. No.
Transport within user’s premises: always transport in closed containers that are upright and secure. Ensure that persons transporting the product know what to do in the event of an accident or spillage.
: Not available.
:
AERG : Not applicable.
Section 15. Regulatory informationU.S. Federal regulations
Clean Water Act (CWA) 311: Acetic acid
:
Clean Air Act Section 112(b) Hazardous Air Pollutants (HAPs)
: Not listed
Clean Air Act Section 602 Class I Substances
: Not listed
Clean Air Act Section 602 Class II Substances
: Not listed
DEA List I Chemicals (Precursor Chemicals)
: Not listed
DEA List II Chemicals (Essential Chemicals)
: Not listed
TSCA 8(a) CDR Exempt/Partial exemption: Not determined
United States inventory (TSCA 8b): Not determined.
SARA 302/304
SARA 304 RQ : Not applicable.
Composition/information on ingredients
No products were found.
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Flumazenil Injection
Section 15. Regulatory information
None of the components are listed.
No products were found.
Massachusetts :
California Prop. 65
New York : None of the components are listed.
New Jersey : None of the components are listed.
Pennsylvania : None of the components are listed.
State regulations
SARA 311/312
Classification : Not applicable.
Composition/information on ingredients
Australia inventory (AICS): Not determined.China inventory (IECSC): Not determined.Japan inventory: Not determined.Korea inventory: Not determined.Malaysia Inventory (EHS Register): Not determined.New Zealand Inventory of Chemicals (NZIoC): Not determined.Philippines inventory (PICCS): Not determined.Taiwan inventory (CSNN): Not determined.
International regulations
International lists :
Chemical Weapons Convention List Schedule I Chemicals
: Not listed
Chemical Weapons Convention List Schedule II Chemicals
: Not listed
Chemical Weapons Convention List Schedule III Chemicals
: Not listed
No products were found.
Section 16. Other informationHistory
Prepared by :
Key to abbreviations : ATE = Acute Toxicity EstimateBCF = Bioconcentration FactorGHS = Globally Harmonized System of Classification and Labelling of ChemicalsIATA = International Air Transport AssociationIBC = Intermediate Bulk ContainerIMDG = International Maritime Dangerous GoodsLogPow = logarithm of the octanol/water partition coefficientMARPOL 73/78 = International Convention for the Prevention of Pollution From Ships,1973 as modified by the Protocol of 1978. ("Marpol" = marine pollution)UN = United Nations
Date of issue mm/dd/yyyy
Version :
:
1
09/15/2013
KMK Regulatory Services Inc.
Revised Section(s) : Not applicable.
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Flumazenil Injection
Section 16. Other informationNotice to readerTo the best of our knowledge, the information contained herein is accurate. However, neither the above-named supplier, nor any of its subsidiaries, assumes any liability whatsoever for the accuracy or completeness of the information contained herein.Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist.
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1
SAFETY DATA SHEET
Product Name: Sodium Chloride Injection, USP
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Manufacturer Name And
Address
Hospira, Inc.
275 North Field Drive
Lake Forest, Illinois 60045
USA
Emergency Telephone
Hospira, Inc., Non-Emergency
CHEMTREC: North America: 800-424-9300;
International 1-703-527-3887; Australia - 61-290372994; UK - 44-870-8200418
224 212-2000
Product Name
Sodium Chloride Injection, USP
Synonyms Table salt
2. HAZARD(S) IDENTIFICATION
Emergency Overview
Sodium Chloride Injection, USP is a solution containing sodium chloride. In clinical
use, sodium chloride is used in the management of deficiencies of sodium and chloride
ions in salt-losing conditions. In the workplace, concentrated sodium chloride
solutions may be irritating to the eyes and respiratory tract. Based on clinical use,
possible target organs may include the cardiovascular system, gastrointestinal system
and nervous system.
U.S. OSHA GHS Classification
Physical Hazards Hazard Class Hazard Category
Not Classified Not Classified
Health Hazards
Hazard Class Hazard Category
Eye Damage / Irritation 2A
Label Element(s)
Pictogram
Signal Word
Warning
Hazard Statement(s)
Causes serious eye irritation
Precautionary Statement(s)
Prevention Do not breathe vapor or spray
Wash hands thoroughly after handling
Wear eye protection/face protection
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
2
Product Name: Sodium Chloride Injection, USP
3. COMPOSITION/INFORMATION ON INGREDIENTS
Active Ingredient Name Sodium Chloride
Chemical Formula NaCl
Component Approximate Percent by Weight CAS Number RTECS Number
Sodium Chloride 1 to 24 7647-14-5 VZ4725000 Non-hazardous ingredients include Water for Injection. Hazardous ingredients present at less than 1% may include hydrochloric acid which
is added to adjust the pH.
4. FIRST AID MEASURES
Eye Contact Remove from source of exposure. Flush with copious amounts of water. If
irritation persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Skin Contact Remove from source of exposure. Flush with copious amounts of water. If
irritation persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Inhalation Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
Ingestion Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary
5. FIRE FIGHTING MEASURES
Flammability
None anticipated for this aqueous product.
Fire & Explosion Hazard
None anticipated for this aqueous product.
Extinguishing Media
As with any fire, use extinguishing media appropriate for primary cause of fire such
as carbon dioxide, dry chemical extinguishing powder or foam.
Special Fire Fighting Procedures No special provisions required beyond normal firefighting equipment such as flame
and chemical resistant clothing and self contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES
Spill Cleanup and Disposal Isolate area around spill. Put on suitable protective clothing and equipment as
specified by site spill control procedures. Absorb the liquid with suitable material
and clean affected area with soap and water. Dispose of spill materials according to
the applicable federal, state, or local regulations.
7. HANDLING AND STORAGE
Handling
No special handling required under conditions of normal product use.
Storage No special storage required for hazard control. For product protection, follow
storage recommendations noted on the product case label, the primary container
label, or the product insert.
Special Precautions
No special precautions required for hazard control.
3
Product Name: Sodium Chloride Injection, USP
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure Guidelines
Exposure Limits
Component OSHA-PEL ACGIH-TLV AIHA WEEL Hospira EEL
Sodium Chloride 8-hr TWA: Not
Established
8-hr TWA: Not
Established
8-hr TWA: Not
Established
8-hr TWA: Not
Established
Notes: OSHA PEL: US Occupational Safety and Health Administration – Permissible Exposure Limit
ACGIH TLV: American Conference of Governmental Industrial Hygienists – Threshold Limit Value.
AIHA WEEL: Workplace Environmental Exposure Level EEL: Employee Exposure Limit.
TWA: 8-hour Time Weighted Average.
Respiratory Protection
Respiratory protection is normally not needed during intended product use.
However, if the generation of aerosols is likely, and engineering controls are not
considered adequate to control potential airborne exposures, the use of an approved
air-purifying respirator with a HEPA cartridge (N95 or equivalent) is recommended
under conditions where airborne aerosol concentrations are not expected to be
excessive. For uncontrolled release events, or if exposure levels are not known,
provide respirators that offer a high protection factor such as a powered air purifying
respirator or supplied air. A respiratory protection program that meets OSHA's 29
CFR 1910.134 and ANSI Z88.2 requirements must be followed whenever workplace
conditions require respirator use. Personnel who wear respirators should be fit
tested and approved for respirator use as required.
Skin Protection
If skin contact with the product formulation is likely, the use of latex or nitrile
gloves is recommended.
Eye Protection
Eye protection is normally not required during intended product use. However, if
eye contact is likely to occur, the use of chemical safety goggles (as a minimum) is
recommended.
Engineering Controls Engineering controls are normally not needed during the normal use of this product.
9. PHYSICAL/CHEMICAL PROPERTIES
Appearance/Physical State A sterile, non-pyrogenic, concentrated solution
Odor NA
Odor Threshold NA
pH 5.0 (4.5 to 7.0)
Melting point/Freezing Point NA
Initial Boiling Point/Boiling Point Range NA
Flash Point NA
Evaporation Rate NA
Flammability (solid, gas) NA
Upper/Lower Flammability or Explosive Limits NA
Vapor Pressure NA
Vapor Density (Air =1) NA
Relative Density NA
Solubility Freely soluble in water; practically insoluble in dehydrated alcohol
Partition Coefficient: n-octanol/water NA
Auto-ignition Temperature NA
Decomposition Temperature NA
Viscosity NA
4
Product Name: Sodium Chloride Injection, USP
10. STABILITY AND REACTIVITY
Reactivity
Not determined. None anticipated from this product.
Chemical Stability
Stable under standard use and storage conditions.
Hazardous Reactions
Not determined
Conditions to Avoid
Not determined
Incompatibilities
Not determined
Hazardous Decomposition
Products
Not determined. During thermal decomposition, it may be possible to generate
irritating vapors and/or toxic fumes of hydrogen chloride and sodium oxide.
Hazardous Polymerization Not anticipated to occur with this product.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity - Not determined for the product formulation. Information for the active ingredient is as follows:
Ingredient(s) Percent Test Type Route of
Administration Value Units Species
Sodium Chloride 100 LD50 Oral 3000 mg/kg Rat
Sodium Chloride 100 LD50 Oral 4000 mg/kg Mouse
Sodium Chloride 100 LD50 Dermal > 10,000 mg/kg Rabbit
Sodium Chloride 100 LC50(1hr) Inhalation > 42,000 mg/m3 Rat
Sodium Chloride 100 LD50 Intraperitoneal 2600
2602
mg/kg
mg/kg
Rat
Mouse
Sodium Chloride 100 LD50 Intravenous 645 mg/kg Mouse
LD 50: Dosage that produces 50% mortality.
Occupational Exposure Potential
Information on the absorption of this product via inhalation or skin contact is not
available. Avoid liquid aerosol generation and skin contact.
Signs and Symptoms
None anticipated from normal handling of this product. In the workplace, this
product should be considered potentially irritating to the eyes and respiratory tract.
In clinical use, gastrointestinal effects associated with acute oral ingestion of
excessive amounts of sodium chloride include nausea, vomiting, diarrhea, and
abdominal cramps. Excessive use of chloride salts may cause a loss of bicarbonate
with an acidifying effect. Retention of excess sodium and accumulation of excess
water may also occur and may lead to pulmonary and peripheral edema.
Hypernatremia has rarely occurred with the use of saline for induction of emesis or
for gastric lavage. However, hypernatremia may occur after inappropriate
intravenous use of hypertonic saline. The most serious effect of hypernatremia is
dehydration of the brain which causes somnolence and confusion progressing to
convulsions, coma, respiratory failure, and death. Other symptoms include thirst,
reduced salivation and lachrymation, fever, sweating, tachycardia, hypertension or
hypotension, headache, dizziness, restlessness, irritability, weakness, and muscular
twitching and rigidity.
Aspiration Hazard None anticipated from normal handling of this product.
Dermal Irritation/ Corrosion None anticipated from normal handling of this product. In animal studies, sodium
chloride was reported to be a mild skin irritant. However, inadvertent contact of this
product with skin is not anticipated to produce irritation.
Ocular Irritation/ Corrosion None anticipated from normal handling of this product. In animal studies, sodium
chloride was reported to be a mild to moderate irritant. Inadvertent contact of this
product with eyes may produce irritation with redness and discomfort.
5
Product Name: Sodium Chloride Injection, USP
11. TOXICOLOGICAL INFORMATION: continued
Dermal or Respiratory
Sensitization
None anticipated from normal handling of this product.
Reproductive Effects None anticipated from normal handling of this product. Physiological sodium
chloride solutions are often used as negative controls in teratology experiments and
do not appear to produce adverse effects on embryological development.
Administration of sodium chloride has been reported not to be teratogenic in rats,
hamsters, and pigs. Subcutaneous injection of 1900 or 2500 mg sodium chloride in
pregnant mice increased the incidence of minor skeletal anomalies in the offspring.
Increased neonatal body weight was reported in offspring of rats fed high (8%) salt
diets when compared to the offspring of dams fed low salt diets.
Mutagenicity Sodium chloride was negative in the Ames test, with and without metabolic
activation. Sodium chloride was positive for genotoxicity in an in vitro mouse
lymphoma assay.
Carcinogenicity The carcinogenic potential of sodium chloride has not been fully evaluated.
Carcinogen Lists
IARC: Not listed NTP: Not listed OSHA: Not listed
Specific Target Organ Toxicity –
Single Exposure
NA
Specific Target Organ Toxicity –
Repeat Exposure
Based on clinical use, possible target organs may include the cardiovascular system,
gastrointestinal system and nervous system.
12. ECOLOGICAL INFORMATION
Aquatic Toxicity Not determined for product. Information for sodium chloride is as follows:
LC50(96hr, flow through) = 9675-11,100 mg/L in freshwater fish
LC50(96hr, static) = 7341-17,550 mg/L in freshwater fish
LC50(24hr, static) = 13,750 - 14,125 mg/L in freshwater fish
LC50(48 hr) = 3310 mg/L in Daphnia magna.
Persistence/Biodegradability Not determined for product.
Bioaccumulation Not determined for product.
Mobility in Soil Not determined for product.
Notes:
1. EC50: Concentration in water that produces 50% mortality in Daphnia sp. 2. LC50: Concentration in water that produces 50% mortality in fish.
3. EC50: Concentration in water that produces 50% inhibition of growth in algae.
13. DISPOSAL CONSIDERATIONS
Waste Disposal
All waste materials must be properly characterized. Further, disposal should be
performed in accordance with the federal, state or local regulatory requirements.
Container Handling and
Disposal
Dispose of container and unused contents in accordance with federal, state and local
regulations.
6
Product Name: Sodium Chloride Injection, USP
14. TRANSPORTATION INFORMATION
ADR/ADG/ DOT STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
ICAO/IATA STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
IMDG STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity NA
Notes: DOT - US Department of Transportation Regulations
15. REGULATORY INFORMATION
US TSCA Status Exempt. However, sodium chloride is listed on the TSCA inventory.
US CERCLA Status Not listed
US SARA 302 Status
US SARA 313 Status
Not listed
Not listed
US RCRA Status Not listed
US PROP 65 (Calif.) Not listed
Notes: TSCA, Toxic Substance Control Act; CERCLA, US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act; SARA,
Superfund Amendments and Reauthorization Act; RCRA, US EPA, Resource Conservation and Recovery Act; Prop 65, California Proposition 65
GHS/CLP Classification* *In the EU, classification under GHS/CLP does not apply to certain substances and
mixtures, such as medicinal products as defined in Directive 2001/83/EC, which are in
the finished state, intended for the final user.
Hazard Class
NA
Hazard Category
NA
Pictogram
NA
Signal Word
NA
Hazard Statement
NA
Prevention Do not breathe vapor or spray
Wash hands thoroughly after handling
Wear eye protection/face protection
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
EU Classification* *Medicinal products are exempt from the requirements of the EU Dangerous
Preparations Directive.
Classification(s) NA
Symbol NA
Indication of Danger NA
Risk Phrases NA
Safety Phrases S23: Do not breathe vapor/spray
S24: Avoid contact with the skin
S25: Avoid contact with eyes
S37/39 Wear suitable gloves and eye/face protection.
7
Product Name: Sodium Chloride Injection, USP
16. OTHER INFORMATION Notes:
ACGIH TLV American Conference of Governmental Industrial Hygienists – Threshold Limit Value
CAS Chemical Abstracts Service Number
CERCLA US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act
DOT US Department of Transportation Regulations
EEL Employee Exposure Limit
IATA International Air Transport Association
LD50 Dosage producing 50% mortality
NA Not applicable/Not available
NE Not established
NIOSH National Institute for Occupational Safety and Health
OSHA PEL US Occupational Safety and Health Administration – Permissible Exposure Limit
Prop 65 California Proposition 65
RCRA US EPA, Resource Conservation and Recovery Act
RTECS Registry of Toxic Effects of Chemical Substances
SARA Superfund Amendments and Reauthorization Act
STEL 15-minute Short Term Exposure Limit
STOT - SE Specific Target Organ Toxicity – Single Exposure
STOT - RE Specific Target Organ Toxicity – Repeated Exposure
TSCA Toxic Substance Control Act
TWA 8-hour Time Weighted Average
MSDS Coordinator: Hospira GEHS
Date Prepared: October 19, 2012
Date Revised: June 02, 2014
Disclaimer: The information and recommendations contained herein are based upon tests believed to be reliable. However, Hospira
does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A
WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE
MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE.
Adjustment to conform to actual conditions of usage may be required. Hospira assumes no responsibility for results
obtained or for incidental or consequential damages, including lost profits, arising from the use of these data. No
warranty against infringement of any patent, copyright or trademark is made or implied.
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Material Name: Methylprednisolone Sodium Succinate for Injection (preservative-free)Trade Name: Solu-MedrolChemical Family: MixtureIntended Use: Pharmaceutical product used as anti-inflammatory
2. HAZARDS IDENTIFICATION
Appearance: White powderSignal Word: DANGER
Statement of Hazard: May damage the unborn child.May cause damage to blood and blood forming organs through prolonged or repeatedexposure.
Additional Hazard Information:Short Term: May cause eye irritation (based on components) May be harmful if absorbed through the skin.Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on blood and
blood forming organs.Known Clinical Effects: Adverse clinical reactions include the development of hypersensitivity and/or irritation leading
to rashes, itching, and burning. Clinical use has resulted in hormonal alterations. Drugs of thisclass may cause Cushing's syndrome, manifested by moon face, obesity, headache, acne,thirst, increased urination, impotence, menstrual irregularities, facial hair growth, and mentalchanges.
EU Indication of danger: Toxic to reproduction: Category 1Harmful
EU Hazard Symbols:
EU Risk Phrases:R61 - May cause harm to the unborn child.R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed.
Australian Hazard Classification(NOHSC):
Hazardous Substance. Non-Dangerous Goods.
_______________________________________________________________________________________________________PZ01067
Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300
Revision date: 11-Nov-2009
Emergency telephone number:ChemSafe (24 hours): +44 (0)208 762 8322
Contact E-Mail: [email protected]
Version: 1.0
MATERIAL SAFETY DATA SHEET
Page 1 of 7
Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-212-573-2222
Pfizer LtdRamsgate RoadSandwich, KentCT13 9NJUnited Kingdom+00 44 (0)1304 616161
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
2. HAZARDS IDENTIFICATIONNote: This document has been prepared in accordance with standards for workplace safety, which
require the inclusion of all known hazards of the active substance or its intermediatesregardless of the potential risk. The precautionary statements and warnings included may notapply in all cases. Your needs may vary depending upon the potential for exposure in yourworkplace.
3. COMPOSITION/INFORMATION ON INGREDIENTS
HazardousIngredient CAS Number EU EINECS/ELINCS List Classification %
Methylprednisolone Sodium Succinate 2375-03-3 219-156-8 Repr.Cat.1;R61Xn;R48/22
67-87
Ingredient CAS Number EU EINECS/ELINCS List Classification %Lactose 63-42-3 200-559-2 Not Listed *Sodium phosphate, monobasic 7558-80-7 231-449-2 Not Listed *Sodium phosphate, dibasic 7558-79-4 231-448-7 Not Listed *
Additional Information: * ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for workplacesafety.
For the full text of the R phrases mentioned in this Section, see Section 16
4. FIRST AID MEASURES
Eye Contact: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attentionimmediately.
Skin Contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical attention.
Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately.
Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological Information.
5. FIRE FIGHTING MEASURES
Extinguishing Media: Use carbon dioxide, dry chemical, or water spray.
Hazardous Combustion Products: Formation of toxic gases is possible during heating or fire.
Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.
Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.
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Revision date: 11-Nov-2009
Material Name: Methylprednisolone Sodium Succinate forInjection (preservative-free)
Version: 1.0
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
6. ACCIDENTAL RELEASE MEASURES
Health and Safety Precautions: Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8). Minimize exposure.
Measures for Cleaning / Collecting: Contain the source of spill if it is safe to do so. Collect spilled material by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area thoroughly.
Measures for EnvironmentalProtections:
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken toavoid environmental release.
Additional Consideration for LargeSpills:
Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained personnel.
7. HANDLING AND STORAGE
General Handling: Minimize dust generation and accumulation. Avoid contact with eyes, skin and clothing. Avoidbreathing dust. When handling, use appropriate personal protective equipment (see Section8). Wash thoroughly after handling. Releases to the environment should be avoided. Reviewand implement appropriate technical and procedural waste water and waste disposal measuresto prevent occupational exposure or environmental releases. Potential points of processemissions of this material to the atmosphere should be controlled with dust collectors, HEPAfiltration systems or other equivalent controls.
Storage Conditions: Store as directed by product packaging.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Engineering Controls: Engineering controls should be used as the primary means to control exposures. Generalroom ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this section.
Environmental Exposure Controls: Refer to specific Member State legislation for requirements under Community environmentallegislation.
Personal Protective Equipment: Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).
Hands: Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing operations.
Eyes: Wear safety glasses or goggles if eye contact is possible.Skin: Impervious protective clothing is recommended if skin contact with drug product is possible and
for bulk processing operations.Respiratory protection: If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate
respirator with a protection factor sufficient to control exposures to below the OEL.
9. PHYSICAL AND CHEMICAL PROPERTIES
Solvent Solubility: Soluble: Alcohols
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Color: White
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Molecular Formula: Mixture Molecular Weight: Mixture
Pfizer OEL TWA-8 Hr: 4 µg/m3, Skin
Revision date: 11-Nov-2009
Material Name: Methylprednisolone Sodium Succinate forInjection (preservative-free)
Version: 1.0
Methylprednisolone Sodium Succinate
Physical State: Powder
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
9. PHYSICAL AND CHEMICAL PROPERTIESSolubility: Soluble: Water
10. STABILITY AND REACTIVITY
Stability: Stable under normal conditions of use.Conditions to Avoid: Fine particles (such as dust and mists) may fuel fires/explosions.Incompatible Materials: As a precautionary measure, keep away from strong oxidizers
11. TOXICOLOGICAL INFORMATION
General Information: The information included in this section describes the potential hazards of various forms of theactive ingredients. The remaining information describes the potential hazards of the individualingredients.
Acute Toxicity: (Species, Route, End Point, Dose)
Acute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the test.
Irritation / Sensitization: (Study Type, Species, Severity)
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Methylprednisolone
Lactose
Rat Oral LD 50 > 2000 mg/kg
Sodium phosphate, dibasic
Mouse Oral LD 50 450 mg/kg
Rat Oral LD50 > 10 g/kg
Rat Intraperitoneal LD 50 1000 mg/kg
Revision date: 11-Nov-2009
Mouse Intraperitoneal LD 50 1409 mg/kg
Methylprednisolone Sodium Succinate
Rat Subcutaneous LD 50 >3000 mg/kg
Rat Oral LD 50 17 g/kg
Rat Oral LD 50 > 5000 mg/kg
Material Name: Methylprednisolone Sodium Succinate forInjection (preservative-free)
Sodium phosphate, dibasic
Rat Intravenous LD 50 718 mg/kg
Eye Irritation Rabbit Mild
Sodium phosphate, monobasic
Skin Irritation Rabbit Mild
Mouse Intravenous LD 50 953 mg/kg
Methylprednisolone
Version: 1.0
Skin Irritation Rabbit No effect
Rat Intraperitoneal LD 50 512 mg/kg
Rat Oral LD 50 8290 mg/kg
Mouse Intraperitoneal LD 50 902 mg/kg
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MATERIAL SAFETY DATA SHEET
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11. TOXICOLOGICAL INFORMATION
Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)
Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.
12. ECOLOGICAL INFORMATIONEnvironmental Overview: Environmental properties have not been investigated. Releases to the environment should be
avoided.
13. DISPOSAL CONSIDERATIONS
Disposal Procedures: Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the material, review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release. It is recommended that waste minimizationbe practiced. The best available technology should be utilized to prevent environmentalreleases. This may include destructive techniques for waste and wastewater.
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Direct DNA Interaction Not applicable Negative
Methylprednisolone Sodium Succinate
In Vitro Cytogenetics Not applicable Negative
Methylprednisolone
Methylprednisolone
Reproductive & Fertility Rat Subcutaneous 40 mg/kg/day LOAEL Fetotoxicity
Bacterial Mutagenicity (Ames) Salmonella Negative
Version: 1.0
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Unscheduled DNA Synthesis Rat Hepatocyte Negative
Embryo / Fetal Development Rat Subcutaneous 40 mg/kg/day LOAEL Teratogenic
Mammalian Cell Mutagenicity Chinese Hamster Ovary (CHO) cells Negative
42 Day(s) Dog Oral 167 µg/kg/day LOAEL Adrenal gland
Direct DNA Interaction Negative
Methylprednisolone
Eye Irritation Rabbit No effect
Reproductive & Fertility Rat Subcutaneous 0.004 mg/kg/day NOAEL Paternal toxicity
6 Week(s) Rat Subcutaneous 500 µg/kg/day LOAEL None identified
Reproductive & Fertility Rat Subcutaneous 0.02 mg/kg/day LOAEL FetotoxicityEmbryo / Fetal Development Rat Subcutaneous 1.0 mg/kg/day LOAEL Fetotoxicity, Teratogenic
14 Week(s) Rat Subcutaneous 0.4 µg/kg/day NOAEL Blood forming organs Adrenal gland
Embryo / Fetal Development Mouse Intramuscular 330 mg/kg/day LOAEL Teratogenic
Skin Sensitization - GPMT Guinea Pig No effect
Embryo / Fetal Development Rabbit Intramuscular 0.1 mg/kg/day LOAEL Teratogenic
52 Week(s) Rat Subcutaneous 4 µg/kg/day NOAEL Blood forming organs Adrenal gland
Revision date: 11-Nov-2009
Methylprednisolone Sodium Succinate
Material Name: Methylprednisolone Sodium Succinate forInjection (preservative-free)
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
14. TRANSPORT INFORMATIONNot regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.
15. REGULATORY INFORMATION
EU Symbol: TEU Indication of danger: Toxic to reproduction: Category 1
Harmful
EU Risk Phrases:R61 - May cause harm to the unborn child.R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed.
EU Safety Phrases:S36/37 - Wear suitable protective clothing and gloves.S22 - Do not breathe dust.S53 - Avoid exposure - obtain special instructions before use.
OSHA Label:DANGERMay damage the unborn child.May cause damage to blood and blood forming organs through prolonged or repeated exposure.
Canada - WHMIS: ClassificationsWHMIS hazard class:Class D, Division 2, Subdivision A
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EU EINECS/ELINCS List 200-559-2
Sodium phosphate, monobasic
Lactose
Inventory - United States TSCA - Sect. 8(b) Listed
Revision date: 11-Nov-2009
Material Name: Methylprednisolone Sodium Succinate forInjection (preservative-free)
Australia (AICS): Listed
Inventory - United States TSCA - Sect. 8(b)
EU EINECS/ELINCS List 231-449-2
Listed
Sodium phosphate, dibasic
Version: 1.0
Australia (AICS): Listed
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MATERIAL SAFETY DATA SHEET
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15. REGULATORY INFORMATION
16. OTHER INFORMATION
Text of R phrases mentioned in Section 3
R61 - May cause harm to the unborn child.R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed.
Data Sources: Publicly available toxicity information. Pfizer proprietary drug development information. Safetydata sheets for individual ingredients.
Prepared by: Toxicology and Hazard CommunicationPfizer Global Environment, Health, and Safety Operations
Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, itis without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no knowninformation at this time.
End of Safety Data Sheet
_______________________________________________________________________________________________________PZ01067
Australia (AICS): Listed
Material Name: Methylprednisolone Sodium Succinate forInjection (preservative-free)
EU EINECS/ELINCS List 231-448-7
Version: 1.0
Page 7 of 7
Methylprednisolone Sodium Succinate
CERCLA/SARA Hazardous Substancesand their Reportable Quantities:
Australia (AICS): Listed
2270 kg final RQ5000 lb final RQ
EU EINECS/ELINCS List 219-156-8
Inventory - United States TSCA - Sect. 8(b) Listed
Revision date: 11-Nov-2009
SAFETY DATA SHEET
1. Identification
Product identifier VENTOLIN HFA
Other means of identification
Synonyms VENTOLIN HFA INHALATION AEROSOL * ALBUTEROL INHALATION AEROSOL * ALBUTEROL134A 200 ACTN * AEROLIN INHALER HFA * FESEMA INHALER HFA * SULBUTAN INHALADOR* SULTANOL INHALER HFA * SULTANOL N INHALER HFA * VENTILAN INALADOR *VENTOLIN EVOHALER 100 MCG 200 DOSE * VENTOLINE INHALER HFA * VENTORLINEVOHALER * NDC NO 0173-0682-20 * ALBUTEROL SULFATE (SALBUTAMOL SULPHATE),FORMULATED PRODUCT
Recommended use Medicinal Product.
This safety data sheet is written to provide health, safety and environmental information for peoplehandling this formulated product in the workplace. It is not intended to provide information relevantto medicinal use of the product. In this instance patients should consult prescribinginformation/package insert/product label or consult their pharmacist or physician. For health andsafety information for individual ingredients used during manufacturing, refer to the appropriatesafety data sheet for each ingredient.
Recommended restrictions No other uses are advised.
Manufacturer/Importer/Supplier/Distributor information
Manufacturer
GlaxoSmithKline US
5 Moore Drive
Research Triangle Park, NC 27709 USA
US General Information (normal business hours): +1-888-825-5249
Email Address: [email protected]
Website: www.gsk.com
EMERGENCY PHONE NUMBERS -
TRANSPORT EMERGENCIES::
US / International toll call +1 703 527 3887
available 24 hrs/7 days; multi-language response
2. Hazard(s) identification
Classified hazards
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
Label elements
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
Hazard(s) not otherwise classified (HNOC)
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
3. Composition/information on ingredients
Mixtures
CAS number %Chemical name Common name and synonyms
1,2,2,2-TETRAFLUOROETHANE * C2H2F4* OHS76816
811-97-21,1,1,2-TETRAFLUOROETHANE 99.7 - 99.83
ALBUTEROL SULPHATE * SALBUTAMOLHEMISULPHATE * AH 3365F *SALBUTAMOL SULPHATE *BIS[(TERT-BUTYL)(BETA,3,4-TRIHYDROXYPHENETHYL)AMMONIU M]SULFATE
51022-70-9ALBUTEROL SULFATE 0.17< 0.3
*Designates that a specific chemical identity and/or percentage of composition has been withheld as a trade secret.
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Material name: VENTOLIN HFA
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SDS US
4. First-aid measures
Inhalation Move to fresh air. If breathing is difficult, trained personnel should give oxygen. Call a physician ifsymptoms develop or persist. Under normal conditions of intended use, this material is notexpected to be an inhalation hazard.
Skin contact Immediately flush skin with plenty of water. Take off contaminated clothing and wash before reuse.Get medical attention if symptoms occur.
Eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
Ingestion If swallowed, rinse mouth with water (only if the person is conscious). If ingestion of a largeamount does occur, call a poison control center immediately. Do not induce vomiting withoutadvice from poison control center.
Most important
symptoms/effects, acute and
delayed
The following adverse effects have been noted with therapeutic use of this material: headache;changes in blood pressure; altered heart rate and pulse.
Indication of immediate
medical attention and special
treatment needed
No specific antidotes are recommended. Treat according to locally accepted protocols. Foradditional guidance, refer to the current prescribing information or to the local poison controlinformation center.
General information In the case of accident or if you feel unwell, seek medical advice immediately (show the labelwhere possible). Ensure that medical personnel are aware of the material(s) involved, and takeprecautions to protect themselves.
5. Fire-fighting measures
Suitable extinguishing media Water. Foam. Dry chemical powder. Carbon dioxide (CO2).
Unsuitable extinguishing
media
None known.
Specific hazards arising from
the chemical
Pressurized container may explode when exposed to heat or flame. During fire, gases hazardousto health may be formed.
Special protective equipment
and precautions for firefighters
Self-contained breathing apparatus and full protective clothing must be worn in case of fire.
Fire fighting
equipment/instructions
Move containers from fire area if you can do so without risk.
Specific methods Use standard firefighting procedures and consider the hazards of other involved materials.
General fire hazards Aerosol containers may violently rupture when exposed to the heat of fire.
6. Accidental release measures
Personal precautions,
protective equipment and
emergency procedures
Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Wearappropriate protective equipment and clothing during clean-up. Ensure adequate ventilation. Localauthorities should be advised if significant spillages cannot be contained. For personal protection,see section 8 of the SDS.
Methods and materials for
containment and cleaning up
Large Spills: Stop the flow of material, if this is without risk. Dike the spilled material, where this ispossible. Cover with plastic sheet to prevent spreading. Absorb in vermiculite, dry sand or earthand place into containers. Following product recovery, flush area with water.
Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly toremove residual contamination.
Never return spills to original containers for re-use. For waste disposal, see section 13 of the SDS.
Environmental precautions Avoid release to the environment. Avoid discharge into drains, water courses or onto the ground.
7. Handling and storage
Precautions for safe handling Avoid prolonged exposure. Do not taste or swallow. When using, do not eat, drink or smoke.Provide adequate ventilation. Wear appropriate personal protective equipment. Wash handsthoroughly after handling. Observe good industrial hygiene practices.
Conditions for safe storage,
including any incompatibilities
The pressure in sealed containers can increase under the influence of heat. Keep away from heat,sparks and open flame. Store in a cool, dry place out of direct sunlight. Store in original tightlyclosed container. Store away from incompatible materials (see Section 10 of the SDS). Therecommended temperature for storage is 15 - 25 °C.
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SDS US
8. Exposure controls/personal protection
Occupational exposure limits
GSK
ValueComponents Type
8 HR TWA 10 mcg/m3ALBUTEROL SULFATE(CAS 51022-70-9)
OHC 4
US. AIHA Workplace Environmental Exposure Level (WEEL) Guides
ValueComponents Type
TWA 4240 mg/m31,1,1,2-TETRAFLUOROETHANE (CAS 811-97-2)
1000 ppm
Biological limit values No biological exposure limits noted for the ingredient(s).
Exposure guidelines
Appropriate engineering
controls
Good general ventilation (typically 10 air changes per hour) should be used. Ventilation ratesshould be matched to conditions. If applicable, use process enclosures, local exhaust ventilation,or other engineering controls to maintain airborne levels below recommended exposure limits. Ifexposure limits have not been established, maintain airborne levels to an acceptable level.
Individual protection measures, such as personal protective equipment
Eye/face protection Not normally needed. If contact is likely, safety glasses with side shields are recommended.
Skin protection
Hand protection Not normally needed. For prolonged or repeated skin contact use suitable protective gloves.
Other Not normally needed. Wear suitable protective clothing as protection against splashing orcontamination.
Respiratory protection No personal respiratory protective equipment normally required. Use a NIOSH/MSHA approvedrespirator if there is a risk of exposure to dust/fume at levels exceeding the exposure limits.
Thermal hazards Wear appropriate thermal protective clothing, when necessary.
General hygiene
considerations
Always observe good personal hygiene measures, such as washing after handling the materialand before eating, drinking, and/or smoking. Routinely wash work clothing and protectiveequipment to remove contaminants. For advice on suitable monitoring methods, seek guidancefrom a qualified environment, health and safety professional.
9. Physical and chemical properties
Appearance
Physical state Liquid.
Form Aerosol.
Color Not available.
Odor Not available.
Odor threshold Not available.
pH Not available.
Melting point/freezing point Not available.
Initial boiling point and boiling
range
-14.8 °F (-26 °C)
Flash point Not available.
Evaporation rate Not available.
Flammability (solid, gas) Not available.
Upper/lower flammability or explosive limits
Flammability limit - lower
(%)
Not available.
Flammability limit - upper
(%)
Not available.
Explosive limit - lower (%) Not available.
Explosive limit - upper (%) Not available.
Vapor pressure Not available.
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SDS US
Vapor density Not available.
Relative density Not available.
Solubility(ies)
Solubility (water) Not available.
Partition coefficient
(n-octanol/water)
Not available.
Auto-ignition temperature Not available.
Decomposition temperature Not available.
Viscosity Not available.
10. Stability and reactivity
Reactivity The product is stable and non-reactive under normal conditions of use, storage and transport.
Chemical stability Material is stable under normal conditions.
Possibility of hazardous
reactions
Hazardous polymerization does not occur.
Conditions to avoid Contact with incompatible materials. Avoid direct sunlight, conditions that might generate heat andsources of ignition.
Incompatible materials Strong oxidizing agents.
Hazardous decomposition
products
None known. Irritating and/or toxic fumes and gases may be emitted upon the product'sdecomposition.
11. Toxicological information
Information on likely routes of exposure
Inhalation Under normal conditions of intended use, this material is not expected to be an inhalation hazard.
Skin contact Health injuries are not known or expected under normal use.
Eye contact Health injuries are not known or expected under normal use.
Ingestion Health injuries are not known or expected under normal use.
Symptoms related to the
physical, chemical and
toxicological characteristics
The following adverse effects have been noted with therapeutic use of this material: headache;changes in blood pressure; altered heart rate and pulse.
Information on toxicological effects
Acute toxicity Health injuries are not known or expected under normal use.
Test ResultsComponents Species
1,1,1,2-TETRAFLUOROETHANE (CAS 811-97-2)
LCL0 Rat
Inhalation
Acute
567000 ppm, 4 hour
LOEC Rat 200000 mg/day CNS depression.
NOAEC Rat
Inhalation
Subchronic
50000 ppm, 13 weeks
ALBUTEROL SULFATE (CAS 51022-70-9)
LD50 Rat
Oral
Acute
660 mg/kg
LOEL Dog
Oral
Chronic
2 mg/kg/day, 1 years
LOEL Rat
Oral
Subacute
30 mg/kg/day, 30 Day
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Test ResultsComponents Species
LOEL Rat
Inhalation
Subchronic
600 mcg/kg/day, 26 weeks
NOAEL Dog 1710 mcg/kg/day, 13 weeks
Rat 512 mcg/kg/day, 6 months
1.9 mg/kg/day, 13 weeks
NOEL Dog 220 mcg/kg/day, 26 weeks
* Estimates for product may be based on additional component data not shown.
Skin corrosion/irritation Health injuries are not known or expected under normal use.
Serious eye damage/eye
irritation
Not available.
Respiratory or skin sensitization
Respiratory sensitization Due to lack of data the classification is not possible.
Skin sensitization Not available.
Germ cell mutagenicity No data available to indicate product or any components present at greater than 0.1% aremutagenic or genotoxic.
Mutagenicity
1,1,1,2-TETRAFLUOROETHANE AmesResult: Negative
ALBUTEROL SULFATE AmesResult: Negative
Chromosomal Aberration Assay In VitroResult: Negative
1,1,1,2-TETRAFLUOROETHANE Chromosomal Aberration Assay In VivoResult: Negative
Dominant lethal assay, Inhalation study.Result: NegativeSpecies: Rat
In vivo cytogeneticsResult: Negative
ALBUTEROL SULFATE Mouse micronucleus testResult: Negative
1,1,1,2-TETRAFLUOROETHANE Unscheduled DNA Synthesis in vivo, Inhalation study.Result: NegativeSpecies: Rat
Carcinogenicity This product is not considered to be a carcinogen by IARC, ACGIH, NTP, or OSHA. Notclassifiable as to carcinogenicity to humans.
1,1,1,2-TETRAFLUOROETHANE 2500 - 5000 ppm InhalationResult: NegativeSpecies: RatTest Duration: 2 years
5000 ppm InhalationResult: NegativeSpecies: RatTest Duration: 78 weeks
ALBUTEROL SULFATE Result: NegativeSpecies: Mouse
Result: NegativeSpecies: Rat
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050)
Not listed.
Reproductive toxicity Components in this product have been shown to cause birth defects and reproductive disorders inlaboratory animals.
Reproductivity
ALBUTEROL SULFATE 2.5 mg/kg/day Embryofetal Development, Species-specificResult: Developmental effects including cleft palateSpecies: Mouse
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Reproductivity
1,1,1,2-TETRAFLUOROETHANE 40000 ppm Foetal development - inhalationResult: Maternal toxicity; Foetal NOAELSpecies: Rabbit
ALBUTEROL SULFATE 50 mg/kg/day Embryofetal DevelopmentResult: Cranial malformationsSpecies: Rabbit
50 mg/kg/day FertilityResult: NegativeSpecies: Rat
1,1,1,2-TETRAFLUOROETHANE 50000 ppm Foetal development - inhalationResult: Maternal toxicity, delayed foetal development.Species: Rat
ALBUTEROL SULFATE Embryofetal DevelopmentResult: NegativeSpecies: Rat
Specific target organ toxicity -
single exposure
Heart.
1,1,1,2-TETRAFLUOROETHANE Species: DogOrgan: Heart
Specific target organ toxicity -
repeated exposure
Heart.
Aspiration hazard Due to lack of data the classification is not possible.
Further information Caution - Pharmaceutical agent.
1,1,1,2-TETRAFLUOROETHANE 0, Asphyxiant
12. Ecological information
Ecotoxicity Not expected to be harmful to aquatic organisms.
Components Test ResultsSpecies
ALBUTEROL SULFATE (CAS 51022-70-9)
Aquatic
Acute
IC50Activated SludgeRespiration
> 1000 mg/l, 3 days OECD 209Residential sludge
EC50Crustacea 292 mg/l, 48 hours Static test, OECD201
Water flea (Daphnia magna)
NOEC 100.3 mg/l, 48 hours Static testWater flea (Daphnia magna)
Chronic
LOECCrustacea > 100 mg/l, 8 days Static renewal test,EPA 1002
Water flea (Ceriodaphnia dubia)
* Estimates for product may be based on additional component data not shown.
NOEC 100 mg/l, 8 daysWater flea (Ceriodaphnia dubia)
Persistence and degradability
Hydrolysis
Half-life (Hydrolysis-neutral)
ALBUTEROL SULFATE > 1 Years Measured
Biodegradability
Percent degradation (Aerobic biodegradation-soil)
ALBUTEROL SULFATE 1.3 - 38.7 %, 64 days
Bioaccumulative potential
Partition coefficient n-octanol / water (log Kow)
1,1,1,2-TETRAFLUOROETHANE 1.274
Bioconcentration factor (BCF)
ALBUTEROL SULFATE 1 Calculated
Mobility in soil
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Adsorption
Soil/sediment sorption - log Koc
ALBUTEROL SULFATE -1.6 - -1.15 Measured
Mobility in general
Volatility
Henry's law
ALBUTEROL SULFATE 0 atm m^3/mol Calculated
Distribution
Octanol/water distribution coefficient log DOW
ALBUTEROL SULFATE -1.5, pH 5
-2.8, pH 7
-2.8, pH 9
Other adverse effects Not available.
13. Disposal considerations
Disposal instructions Collect and reclaim or dispose in sealed containers at licensed waste disposal site. Do notdischarge into drains, water courses or onto the ground. Dispose in accordance with all applicableregulations.
Hazardous waste code The waste code should be assigned in discussion between the user, the producer and the wastedisposal company.
Waste from residues / unused
products
Dispose of in accordance with local regulations. Empty containers or liners may retain someproduct residues. This material and its container must be disposed of in a safe manner (see:Disposal instructions). Avoid discharge into water courses or onto the ground.
Contaminated packaging Empty containers should be taken to an approved waste handling site for recycling or disposal.Since emptied containers may retain product residue, follow label warnings even after container isemptied.
14. Transport information
DOT
UN1950UN number
Aerosols, non-flammableUN proper shipping name
2.2Class
Transport hazard class(es)
-Subsidiary risk
2.2Label(s)
Not applicable.Packing group
Not available.Special precautions for user
306Packaging exceptions
NonePackaging non bulk
NonePackaging bulk
IATA
UN1950UN number
Aerosols, non-flammableUN proper shipping name
2.2Transport hazard class(es)
-Subsidiary class(es)
Not available.Packaging group
No.Environmental hazards
2.2Labels required
2LERG Code
Not available.Special precautions for user
Allowed.Cargo aircraft only
Other information
Allowed.Passenger & cargo
IMDG
UN1950UN number
AEROSOLS, asphyxiantUN proper shipping name
2Class
Transport hazard class(es)
5ASubsidiary risk
2.2Label(s)
7 / 10
Material name: VENTOLIN HFA
126598 Version #: 15 Revision date: 10-21-2014 Issue date: 10-21-2014
SDS US
Not applicable.Packing group
No.Marine pollutant
Environmental hazards
Not available.EmS
Not available.Special precautions for user
MARPOL Annex II applies to liquids used in a ship's operation that pose a threat to the marineenvironment. These materials may not be transported in bulk.
Transport in bulk according to
Annex II of MARPOL 73/78 and
the IBC Code
DOT
IATA
General information Classifications are for the material when offered for transport as fully regulated. Depending on thespecific transport details (Ship-From/Ship To locations, quantities being shipped, type ofpackaging and mode of transport) it may be possible to ship this material in a manner other thanfully regulated. (One example is IATA Limited or Excepted Quantity. There are others.) Be sure toreview all regulatory agency packaging instructions and special provisions, referenced in thissection, to identify options applicable to the specifics of your shipment.
15. Regulatory information
US federal regulations
TSCA Section 12(b) Export Notification (40 CFR 707, Subpt. D)
Not regulated.
CERCLA Hazardous Substance List (40 CFR 302.4)
Not listed.
SARA 304 Emergency release notification
Not regulated.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050)
Not listed.
Superfund Amendments and Reauthorization Act of 1986 (SARA)
Hazard categories Immediate Hazard - YesDelayed Hazard - NoFire Hazard - NoPressure Hazard - YesReactivity Hazard - No
SARA 302 Extremely hazardous substance
Not listed.
SARA 311/312 Hazardous
chemical
No
SARA 313 (TRI reporting)
Not regulated.
8 / 10
Material name: VENTOLIN HFA
126598 Version #: 15 Revision date: 10-21-2014 Issue date: 10-21-2014
SDS US
Other federal regulations
Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List
Not regulated.
Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130)
Not regulated.
Safe Drinking Water Act
(SDWA)
Not regulated.
US state regulations
US. California Controlled Substances. CA Department of Justice (California Health and Safety Code Section 11100)
Not listed.
US. Massachusetts RTK - Substance List
Not regulated.
US. New Jersey Worker and Community Right-to-Know Act
Not listed.
US. Pennsylvania Worker and Community Right-to-Know Law
Not listed.
US. Rhode Island RTK
Not regulated.
US. California Proposition 65
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): This material is not known to containany chemicals currently listed as carcinogens or reproductive toxins.
International Inventories
Country(s) or region Inventory name On inventory (yes/no)*
YesAustralia Australian Inventory of Chemical Substances (AICS)
YesCanada Domestic Substances List (DSL)
NoCanada Non-Domestic Substances List (NDSL)
NoChina Inventory of Existing Chemical Substances in China (IECSC)
YesEurope European Inventory of Existing Commercial ChemicalSubstances (EINECS)
NoEurope European List of Notified Chemical Substances (ELINCS)
NoJapan Inventory of Existing and New Chemical Substances (ENCS)
YesKorea Existing Chemicals List (ECL)
NoNew Zealand New Zealand Inventory
NoPhilippines Philippine Inventory of Chemicals and Chemical Substances(PICCS)
NoUnited States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory
*A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s)A "No" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governingcountry(s).
16. Other information, including date of preparation or last revision
Issue date 10-21-2014
Revision date 10-21-2014
Version # 15
Further information HMIS® is a registered trade and service mark of the NPCA. Refer to NFPA 654, Standard for thePrevention of Fire and Dust Explosions from the Manufacturing, Processing, and Handling ofCombustible Particulate Solids, for safe handling.
HMIS® ratings Health: 1*Flammability: 0Physical hazard: 3
NFPA ratings Health: 1Flammability: 0Instability: 3
References GSK Hazard Determination
9 / 10
Material name: VENTOLIN HFA
126598 Version #: 15 Revision date: 10-21-2014 Issue date: 10-21-2014
SDS US
Disclaimer The information and recommendations in this safety data sheet are, to the best of our knowledge,accurate as of the date of issue. Nothing herein shall be deemed to create any warranty, expressor implied. It is the responsibility of the user to determine the applicability of this information andthe suitability of the material or product for any particular purpose.
Revision Information This document has undergone significant changes and should be reviewed in its entirety.
10 / 10
Material name: VENTOLIN HFA
126598 Version #: 15 Revision date: 10-21-2014 Issue date: 10-21-2014
SDS US
1
SAFETY DATA SHEET
Product Name: Verapamil Hydrochloride Injection
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Manufacturer Name And
Address
Hospira, Inc.
275 North Field Drive
Lake Forest, Illinois 60045
USA
Emergency Telephone
Hospira, Inc., Non-Emergency
CHEMTREC: North America: 800-424-9300;
International 1-703-527-3887; Australia - 61-290372994; UK - 44-870-8200418
224 212-2000
Product Name Verapamil Hydrochloride Injection
Synonyms benzeneacetonitrile, -[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino]
propyl]-3,4-dimethoxy--(1-methylethyl) hydrochloride
2. HAZARD(S) IDENTIFICATION
Emergency Overview Verapamil Hydrochloride Injection is a solution containing verapamil
hydrochloride, a calcium-channel blocking agent used in the treatment of
hypertension, cardiac arrhythmias, and some cases of angina pectoris. In the
workplace, this material should be considered potentially irritating to the eyes and
respiratory tract and a potent drug. Based on clinical use, possible target organs
include the cardiovascular system.
U.S. OSHA GHS Classification
Physical Hazards Hazard Class Hazard Category
Not Classified Not Classified
Health Hazards Hazard Class Hazard Category
Not Classified Not Classified
Label Element(s)
Pictogram NA
Signal Word NA
Hazard Statement(s) NA
Precautionary Statement(s)
Prevention Do not breathe vapor or spray
Wash hands thoroughly after handling
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
2
Product Name: Verapamil Hydrochloride Injection
3. COMPOSITION/INFORMATION ON INGREDIENTS
Active Ingredient Name Verapamil Hydrochloride
Chemical Formula C27H38N2O4 • HCl
Component Approximate Percent by Weight CAS Number RTECS Number
Verapamil Hydrochloride ≤0.25 152-11-4 YV8320000 Non-hazardous ingredients include Water for Injection. Hazardous ingredients present at less than 1% include sodium chloride.
Hydrochloric acid is used to adjust the pH.
4. FIRST AID MEASURES
Eye Contact Remove from source of exposure. Flush with copious amounts of water. If irritation
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Skin Contact Remove from source of exposure. Flush with copious amounts of water. If irritation
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Inhalation Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
Ingestion Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
5. FIRE FIGHTING MEASURES
Flammability
None anticipated for this aqueous product.
Fire & Explosion Hazard
None anticipated for this aqueous product.
Extinguishing Media
As with any fire, use extinguishing media appropriate for primary cause of fire such as
carbon dioxide, dry chemical extinguishing powder or foam.
Special Fire Fighting
Procedures
No special provisions required beyond normal firefighting equipment such as flame
and chemical resistant clothing and self contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES
Spill Cleanup and Disposal Isolate area around spill. Put on suitable protective clothing and equipment as
specified by site spill control procedures. Absorb the liquid with suitable material and
clean affected area with soap and water. Dispose of spill materials according to the
applicable federal, state, or local regulations.
7. HANDLING AND STORAGE
Handling
No special handling required for hazard control under conditions of normal product
use.
Storage No special storage required for hazard control. For product protection, follow storage
recommendations noted on the product case label, the primary container label, or the
product insert.
Special Precautions No special precautions required for hazard control.
3
Product Name: Verapamil Hydrochloride Injection
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure Guidelines Exposure Limits
Component OSHA-PEL ACGIH-TLV AIHA WEEL Hospira EEL
Verapamil Hydrochloride 8-hr TWA: Not
Established
8-hr TWA: Not
Established
8-hr TWA: Not
Established
8-hr TWA: Not
Established
Notes: OSHA PEL: US Occupational Safety and Health Administration – Permissible Exposure Limit
ACGIH TLV: American Conference of Governmental Industrial Hygienists – Threshold Limit Value. AIHA WEEL: Workplace Environmental Exposure Level
EEL: Employee Exposure Limit.
TWA: 8-hour Time Weighted Average.
Respiratory Protection
Respiratory protection is normally not needed during intended product use. However,
if the generation of dusts or aerosols is likely, and engineering controls are not
considered adequate to control potential airborne exposures, the use of an approved
air-purifying respirator with a HEPA cartridge (N95 or equivalent) is recommended
under conditions where airborne dust or aerosol concentrations are not expected to be
excessive. For uncontrolled release events, or if exposure levels are not known,
provide respirators that offer a high protection factor such as a powered air purifying
respirator or supplied air. A respiratory protection program that meets OSHA's 29
CFR 1910.134 and ANSI Z88.2 requirements must be followed whenever workplace
conditions require respirator use. Personnel who wear respirators should be fit tested
and approved for respirator use as required.
Skin Protection
If skin contact with the product formulation is likely, the use of latex or nitrile gloves
is recommended.
Eye Protection
Eye protection is normally not required during intended product use. However, if eye
contact is likely to occur, the use of chemical safety goggles (as a minimum) is
recommended.
Engineering Controls Engineering controls are normally not needed during the normal use of this product.
9. PHYSICAL/CHEMICAL PROPERTIES
Appearance/Physical State Clear aqueous solution
Odor NA
Odor Threshold NA
pH 4.9 (4.0 to 6.5)
Melting point/Freezing Point NA
Initial Boiling Point/Boiling Point Range NA
Flash Point NA
Evaporation Rate NA
Flammability (solid, gas) NA
Upper/Lower Flammability or Explosive Limits NA
Vapor Pressure NA
Vapor Density (Air =1) NA
Relative Density NA
Solubility NA
Partition Coefficient: n-octanol/water NA
Auto-ignition Temperature NA
Decomposition Temperature NA
Viscosity NA
4
Product Name: Verapamil Hydrochloride Injection
10. STABILITY AND REACTIVITY
Reactivity
Not determined.
Chemical Stability
Stable under standard use and storage conditions.
Hazardous Reactions
Not determined
Conditions to Avoid
Not determined
Incompatibilities
Not determined
Hazardous Decomposition
Products
Not determined. During thermal decomposition, it may be possible to generate
irritating vapors and/or toxic fumes of carbon oxides (COx), nitrogen oxides (NOx),
and hydrogen chloride.
Hazardous Polymerization Not anticipated to occur with this product.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity - Not determined for the product formulation. Information for the active ingredient is as follows:
Ingredient(s) Percent Test Type Route of
Administration Value Units Species
Verapamil Hydrochloride 100 LD50 Oral
108, 150
163
140
>400
mg/kg
mg/kg
mg/kg
mg/kg
Rat
Mouse
Guinea Pig
Dog
Verapamil Hydrochloride 100 LD50 Intravenous 16
5.8
mg/kg
mg/kg
Rat
Mouse
LD 50: Dosage that produces 50% mortality.
Occupational Exposure
Potential
Information on the absorption of this product via inhalation or skin contact is not
available. Avoid liquid aerosol generation and skin contact.
Signs and Symptoms
None anticipated from normal handling of this product. In clinical use, adverse effects
on the heart include bradycardia, AV block, worsening heart failure, and transient
asystole. Other adverse effects include nausea, constipation, hypotension, dizziness,
flushing, headaches, fatigue, tinnitus, dyspnea, and peripheral edema. There have been
reports of skin reactions and some cases of abnormal liver function and hepatotoxicity.
Gingival hyperplasia has occurred. Hyperprolactinemia has been reported in some
patients receiving verapamil. Gynaecomastia has been reported rarely.
Aspiration Hazard None anticipated from normal handling of this product.
Dermal Irritation/ Corrosion None anticipated from normal handling of this product.
Ocular Irritation/ Corrosion None anticipated from normal handling of this product. However, inadvertent contact
of this product with eyes may produce irritation with redness and tearing.
Dermal or Respiratory
Sensitization
None anticipated from normal handling of this product.
Reproductive Effects
None anticipated from normal handling of this product. Studies in female rats at daily
dietary doses up to 5.5 times (55 mg/kg/day) the maximum recommended human dose
did not show impaired fertility. Effects on male fertility have not been determined.
5
Product Name: Verapamil Hydrochloride Injection
11. TOXICOLOGICAL INFORMATION: continued
Reproductive Effects:
continued
Reproduction studies have been performed in rabbits and rats at oral verapamil doses
up to 1.5 (15 mg/kg/day) and 6 (60 mg/kg/day) times the human oral daily dose,
respectively, and have revealed no evidence of teratogenicity. In the rat, this dose was
embryocidal and retarded fetal growth and development, probably because of adverse
maternal effects reflected in reduced weight gains of the dams. This oral dose has also
been shown to cause hypotension in rats.
Mutagenicity
Verapamil was not mutagenic in the Ames test in 5 test strains at 3 mg per plate with
or without metabolic activation.
Carcinogenicity
Studies in rats using verapamil dosages of 6 times the recommended maximum human
dosage for 18 months did not reveal evidence of carcinogenicity.
There was no evidence of a carcinogenic potential of verapamil administered in the
diet of rats for 2 years at dosages of 10, 35, and 120 mg/kg per day or approximately
1x, 3.5x, and 12x, respectively, the maximum recommended human daily dose (480
mg per day or 9.6 mg/kg/day).
Carcinogen Lists
IARC: Not listed NTP: Not listed OSHA: Not listed
Specific Target Organ Toxicity
– Single Exposure
NA
Specific Target Organ Toxicity
– Repeat Exposure
In chronic animal toxicology studies, verapamil caused lenticular and/or suture line
changes at 30 mg/kg/day or greater, and frank cataracts at 62.5 mg/kg/day or greater in
the beagle dog but not in the rat. Development of cataracts due to verapamil has not
been reported in man. Based on clinical use, possible target organs include the
cardiovascular system.
12. ECOLOGICAL INFORMATION
Aquatic Toxicity Not determined for product.
Persistence/Biodegradability Not determined for product.
Bioaccumulation Not determined for product.
Mobility in Soil Not determined for product.
Notes:
13. DISPOSAL CONSIDERATIONS
Waste Disposal
All waste materials must be properly characterized. Further, disposal should be
performed in accordance with the federal, state or local regulatory requirements.
Container Handling and
Disposal
Dispose of container and unused contents in accordance with federal, state and local
regulations.
6
Product Name: Verapamil Hydrochloride Injection
14. TRANSPORTATION INFORMATION
ADR/ADG/ DOT STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
ICAO/IATA STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity
NA
IMDG STATUS Not regulated
Proper Shipping Name NA
Hazard Class NA
UN Number NA
Packing Group NA
Reportable Quantity NA
Notes: DOT - US Department of Transportation Regulations
15. REGULATORY INFORMATION
US TSCA Status Exempt
US CERCLA Status Not listed
US SARA 302 Status
US SARA 313 Status
Not listed
Not listed
US RCRA Status Not listed
US PROP 65 (Calif.)
Not listed
Notes: TSCA, Toxic Substance Control Act; CERCLA, US EPA law, Comprehensive Environmental Response, Compensation, and
Liability Act; SARA, Superfund Amendments and Reauthorization Act; RCRA, US EPA, Resource Conservation and Recovery Act; Prop
65, California Proposition 65
GHS/CLP Classification* *In the EU, classification under GHS/CLP does not apply to certain substances and
mixtures, such as medicinal products as defined in Directive 2001/83/EC, which are in
the finished state, intended for the final user.
Hazard Class
NA
Hazard Category
NA
Pictogram
NA
Signal Word
NA
Hazard Statement
NA
Prevention Do not breathe vapor or spray
Wash hands thoroughly after handling
Response Get medical attention if you feel unwell.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,
if present and easy to do. Continue rinsing. If eye irritation persists, get medical
attention.
7
Product Name: Verapamil Hydrochloride Injection
15. REGULATORY INFORMATION: continued
EU Classification* *Medicinal products are exempt from the requirements of the EU Dangerous
Preparations Directive.
Classification(s) NA
Symbol NA
Indication of Danger NA
Risk Phrases NA
Safety Phrases S23: Do not breathe vapor/spray
S24: Avoid contact with the skin
S25: Avoid contact with eyes
S37/39 Wear suitable gloves and eye/face protection.
16. OTHER INFORMATION Notes:
ACGIH TLV American Conference of Governmental Industrial Hygienists – Threshold Limit Value
CAS Chemical Abstracts Service Number
CERCLA US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act
DOT US Department of Transportation Regulations
EEL Employee Exposure Limit
IATA International Air Transport Association
LD50 Dosage producing 50% mortality
NA Not applicable/Not available
NE Not established
NIOSH National Institute for Occupational Safety and Health
OSHA PEL US Occupational Safety and Health Administration – Permissible Exposure Limit
Prop 65 California Proposition 65
RCRA US EPA, Resource Conservation and Recovery Act
RTECS Registry of Toxic Effects of Chemical Substances
SARA Superfund Amendments and Reauthorization Act
STEL 15-minute Short Term Exposure Limit
STOT - SE Specific Target Organ Toxicity – Single Exposure
STOT - RE Specific Target Organ Toxicity – Repeated Exposure
TSCA Toxic Substance Control Act
TWA 8-hour Time Weighted Average
MSDS Coordinator: Hospira GEHS
Date Prepared: October 19, 2012
Date Revised: June 02, 2014
Disclaimer: The information and recommendations contained herein are based upon tests believed to be reliable. However, Hospira
does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A
WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE
MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE.
Adjustment to conform to actual conditions of usage may be required. Hospira assumes no responsibility for results
obtained or for incidental or consequential damages, including lost profits, arising from the use of these data. No
warranty against infringement of any patent, copyright or trademark is made or implied.