sds - medline.com€¦ · 29/9/2014 · sds sagent pharmaceuticals, inc. adenosine injection, usp...

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




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(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.




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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.




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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.




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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.




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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




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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




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(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




SDS No.: SDS 001



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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




SDS No.: SDS 001



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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.

1/10Tel : +1-888-GHS-7769 (447-7769) / +1-450-GHS-7767 (447-7767)www.kmkregservices.com www.askdrluc.com www.ghssmart.com


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




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.


:

:

:

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".



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




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.




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.




Specific target organ toxicity (single exposure)

Specific target organ toxicity (repeated exposure)

Aspiration hazard








Information on the likely routes of exposure




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




:

:

:

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 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




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



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


No products were found.



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


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.


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

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) 2/10

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


06/06/2014 EN (English) 3/10

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.


06/06/2014 EN (English) 4/10

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.


06/06/2014 EN (English) 5/10

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)


06/06/2014 EN (English) 6/10

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)


: 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)


06/06/2014 EN (English) 7/10

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.


06/06/2014 EN (English) 8/10

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


06/06/2014 EN (English) 9/10

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.


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


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


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



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.


5. FIRE FIGHTING MEASURES

Flammability

None anticipated for this aqueous product.

Fire & Explosion Hazard


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


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


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


11. TOXICOLOGICAL INFORMATION: continued

Carcinogen Lists

IARC: Not listed NTP: Not listed OSHA: Not listed

Specific Target Organ Toxicity

– Single Exposure

NA


– 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


Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity

NA

IMDG STATUS Not regulated


Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity NA

Notes: DOT - US Department of Transportation Regulations

6


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






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


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


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


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


SAFETY DATA SHEET

_______________________________________________________________________________________________________


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.


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


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


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


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


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


Reactivity: No data availableChemical Stability: StablePossibility of Hazardous Reactions

Oxidizing Properties: No data availableConditions to Avoid: NoneIncompatible Materials: NoneHazardous DecompositionProducts:

No data available


Information on Toxicological Effects_______________________________________________________________________________________________________

PZ03049

Odor Threshold: No data available.Molecular Formula: Mixture

Water for injection

Molecular Weight: Mixture

No data available


SODIUM HYDROXIDE

Physical State: Liquid

No data available


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.


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


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


IARC: Group 3 (Not Classifiable)


SAFETY DATA SHEET

_______________________________________________________________________________________________________


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


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



CERCLA/SARA 313 Emission reporting


HYDROCHLORIC ACID



Not Listed

Page 7 of 8


CERCLA/SARA 313 Emission reporting

Dextrose, monohydrate

1.0 %

CERCLA/SARA 313 Emission reporting Not ListedCalifornia Proposition 65 Not Listed


5000 lb2270 kg

EU EINECS/ELINCS List Not Listed


CERCLA/SARA - Section 302 Extremely HazardousTPQs

500 lb

CERCLA/SARA - Section 302 Extremely HazardousSubstances EPCRA RQs

5000 lb




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.


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


Diphenhydramine Hydrochloride Injection, USP

None.

GHS product identifier

Synonyms



:

:


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.


Not classified.Classification of the substance or mixture

:

Signal word : No signal word.

Hazard statements : No known significant effects or critical hazards.


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.


: None known.



: None.

Substance/mixture


: Mixture



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.



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.


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.




Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may be delayed following exposure.



No known significant effects or critical hazards.:Eye contact


Skin contact

Ingestion




:

:

:

Eye contact : No known significant effects or critical hazards.







No special protection is required.



Decomposition products may include the following materials:carbon dioxidecarbon monoxidenitrogen oxideshalogenated compounds





Extinguishing media

:

:

:

None known.


:


:


:

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).

:




Spill



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).:




Section 7. Handling and storageConditions for safe storage,including any incompatibilities


:


Hand protection


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


:

:


:




: 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



Skin protection


None.




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



Flash point

Not available.

Not applicable.

Not available.

4 to 6.5

Viscosity Not available.



:

:

:

:

:

:

:

:

:

:

:

:

:

:

:

Appearance

Boiling point : Not available.



: Not available.

Burning rate Not applicable.:

Burning time : Not applicable.

SADT Not available.:


Solubility in water : Not available.






Reactive or incompatible with the following materials: oxidizing materials and acids.

:

:

:








Acute toxicity

Product/ingredient name Result Species Dose Exposure

Carcinogenicity

Mutagenicity

Teratogenicity



Sensitization


Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may be delayed following exposure.





Skin contact

Ingestion




:

:

:





Aspiration hazard






Short term exposure


Long term exposure










Diphenhydramine Hydrochloride LD50 Oral Rat 500 mg/kg -












Oral 10000 mg/kg

Route ATE value








Toxicity



: Not available.

Mobility in soil




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




-

-

-

-

-

-

-

Not regulated.

-

-

Not regulated. Not regulated.

- - -

DOT Classification IMDG IATA

UN number



Packing group





No. No. No.


: Not available.

:




: Not listed


: Not listed


: Not listed


: Not listed


: Not listed



SARA 302/304



SARA 311/312





None of the components are listed.


Massachusetts :

California Prop. 65



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


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.


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)


Version :

:

1

06/15/2013


Revised Section(s) : Not applicable.



Section 16. Other informationUN = United Nations



1

SAFETY DATA SHEET

Product Name: Epinephrine Injection



Address

Hospira, Inc.



USA

Emergency Telephone

Hospira, Inc., Non-emergency



224 212-2000

Product Name Epinephrine Injection

Synonyms 4-[1-hydroxy-2-(methylamino) ethyl]-1,2 benzenediol


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.





STOT – RE 2

Label Element(s)

Pictogram

Signal Word Warning

Hazard Statement(s) May cause damage to organs through prolonged or repeated exposure


Prevention Do not breathe vapor or spray

Wash hands thoroughly after handling




attention.

2



Active Ingredient Name L-Epinephrine

Chemical Formula C9H13NO3


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).













Flammability




Extinguishing Media




Procedures









Handling

No special handling required for hazard control under conditions of normal product

use.



product insert.


3





L-Epinephrine 8 hr TWA: Not

Established

8 hr TWA: Not

Established

8 hr TWA: Not

Established

8 hr TWA: Not

Established

















Skin Protection


is recommended.

Eye Protection



recommended.



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)



Flash Point NA

Evaporation Rate NA



Vapor Pressure NA


Relative Density NA

Solubility With acids, epinephrine forms salts that are freely soluble in water.




Viscosity NA

4



Reactivity

Not determined.

Chemical Stability


Hazardous Reactions

Not determined

Conditions to Avoid

Not determined

Incompatibilities

Not determined


Products


irritating vapors and/or toxic fumes of carbon oxides (COx) and nitrogen oxides

(NOx).



Acute Toxicity - Not determined for the product formulation. Information for the active ingredient is as follows:



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



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.


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



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



– Single Exposure

NA


– Repeat Exposure

Based on clinical use, possible target organs include the nervous system,

cardiovascular system, eyes, and respiratory system.







Waste Disposal




Disposal


regulations.

6





Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity

NA



Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity

NA



Hazard Class NA

UN Number NA

Packing Group NA




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







Hazard Class

NA

Hazard Category

NA

Pictogram

NA

Signal Word

NA

Hazard Statement

NA






attention.

7


15. REGULATORY INFORMATION: continued




Symbol NA


Risk Phrases NA














NE Not established






















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

mailto:[email protected]

1

SAFETY DATA SHEET

Product Name: Lidocaine Hydrochloride and Epinephrine Injection



Address

Hospira, Inc.



USA

Emergency Telephone #’s




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


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.




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







attention.

2



Active Ingredient Name Lidocaine Hydrochloride Epinephrine

Chemical Formula C14H22N2O HCl C9H13NO3


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.













Flammability

None anticipated from this aqueous product.


None anticipated from this aqueous product.

Extinguishing Media




Procedures





specified by site spill control procedures. Absorb any liquid with suitable material and




Handling


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





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


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.













Skin Protection


is recommended.

Eye Protection



recommended.



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



Flash Point NA

Evaporation Rate NA



Vapor Pressure NA


Relative Density NA

Solubility Very soluble in water and in alcohol; soluble in chloroform;

insoluble in ether




Viscosity NA

4



Reactivity

Not determined

Chemical Stability


Hazardous Reactions

Not determined

Conditions to Avoid

Not determined

Incompatibilities

Strongly alkaline conditions. Methyl vinyl ether; zinc.


Products



and hydrogen chloride.



Acute Toxicity: - Not determined for the product formulation. Information for the active ingredients is as follows:



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



Potential


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



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.


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.


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



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



– Single Exposure

NA


– Repeat Exposure

Based on clinical use, possible target organs include the nervous system and the

cardiovascular system.







Waste Disposal



Epinephrine is listed as a hazardous waste. However, it is not the sole active

ingredient in this product.


Disposal


regulations.




Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity

NA



Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity

NA



Hazard Class NA

UN Number NA

Packing Group NA



7



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







Hazard Class

NA

Hazard Category

NA

Pictogram

NA

Signal Word

NA

Hazard Statement

NA






attention.




Symbol NA


Risk Phrases NA





8











NE Not established






















1

SAFETY DATA SHEET

Product Name: Naloxone Hydrochloride Injection, USP



Address

Hospira, Inc.



USA

Emergency Telephone




224 212-2000

Product Name Naloxone Hydrochloride Injection, USP

Synonyms 17-Allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride


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.






Label Element(s)

Pictogram NA

Signal Word NA








attention.

2



Active Ingredient Name Naloxone Hydrochloride

Chemical Formula C19H21NO4 • HCl


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.













Flammability




Extinguishing Media




Procedures









Handling


use.



product insert.


3





Naloxone Hydrochloride 8-hr TWA: Not

Established

8-hr TWA: Not

Established

8-hr TWA: Not

Established

8-hr TWA: Not

Established

















Skin Protection


is recommended.

Eye Protection



recommended.



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)



Flash Point NA

Evaporation Rate NA



Vapor Pressure 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




Viscosity NA

4



Reactivity

Not determined.

Chemical Stability


Hazardous Reactions

Not determined

Conditions to Avoid

Not determined

Incompatibilities

Not determined


Products


irritating vapors and/or toxic fumes of carbon oxides (COx), nitrogen oxides (NOx)




Acute Toxicity: Not determined for the product formulation. Information for the active ingredient is as follows:



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



Potential



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.


Dermal Irritation/ Corrosion



of this product with eyes may produce irritation with redness and tearing.


Sensitization


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



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



– Single Exposure

NA


– Repeat Exposure

Based on clinical use, possible target organs include the nervous system and







Notes:


Waste Disposal




Disposal


regulations.




Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity

NA



Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity

NA



Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity NA Notes: DOT - US Department of Transportation Regulations

6





US SARA 302 Status

US SARA 313 Status

Not listed

Not listed


US PROP 65 (Calif.)

Not listed







Hazard Class

NA

Hazard Category

NA

Pictogram

NA

Signal Word

NA

Hazard Statement

NA






attention.




Symbol NA


Risk Phrases NA





7











NE Not established






















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


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


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


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


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


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.


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


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.


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



SAFETY DATA SHEET

_______________________________________________________________________________________________________

Additional Consideration forLarge Spills:



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


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


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


Czech Republic OEL - TWA 0.5 mg/m3

ACGIH Threshold Limit Value (TWA)

SAFETY DATA SHEET

_______________________________________________________________________________________________________


_______________________________________________________________________________________________________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


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


0.3 mg/m3

UK - Biological Exposure Limit: 15 µmol/mol creatinine

Calcium stearate


ACGIH Threshold Limit Value (TWA) 10 mg/m3

Vietnam OEL - TWAs

Lithuania OEL - TWA 5 mg/m3

0.5 mg/m3


Starch, pregelatinized

Glyceryl monostearate

Romania OEL - TWA


0.006 ppm0.05 mg/m3

Australia TWA 10 mg/m3


Belgium OEL - TWA 10 mg/m3


Bulgaria OEL - TWA 10.0 mg/m3


Lithuania OEL - TWA 5 mg/m3

Slovakia OEL - TWA


SAFETY DATA SHEET

_______________________________________________________________________________________________________


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.


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


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


No data available

Odor: No data available.

Silicon dioxide, colloidal NFNo data available

Odor Threshold: No data available.


OSHA - Final PELS - TWAs:

No data available

Molecular Formula: Mixture

15 mg/m3

Molecular Weight: Mixture


Portugal OEL - TWA 10 mg/m3


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


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


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.



Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))

_______________________________________________________________________________________________________PD027


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


Mouse Oral LD50 115mg/kg


Rabbit Dermal LD50 > 280mg/kg

SAFETY DATA SHEET

_______________________________________________________________________________________________________


Genetic Toxicity: (Study Type, Cell Type/Organism, Result)

Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))



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


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


Embryo / Fetal Development Rabbit Oral 240 mg/kg/day NOAEL Not Teratogenic

Nitroglycerin


2 Year(s) Rat Oral 434 mg/kg/day LOAEL Liver, Male reproductive system

Version: 3.2

SAFETY DATA SHEET

_______________________________________________________________________________________________________


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.


Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture

Canada - WHMIS: ClassificationsWHMIS hazard class:Class D, Division 2, Subdivision B

_______________________________________________________________________________________________________PD027





Nitroglycerin


Version: 3.2



Page 9 of 11


Nitroglycerin


RCRA - P Series Wastes Listed


CERCLA/SARA 313 Emission reporting 1.0 %CERCLA/SARA Hazardous Substancesand their Reportable Quantities:

10 lb4.54 kg

SAFETY DATA SHEET

_______________________________________________________________________________________________________



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


Page 10 of 11


Lactose NF, monohydrate

Calcium stearate

California Proposition 65




Not Listed

Inventory - United States TSCA - Sect. 8(b) PresentAustralia (AICS): Present




Australia (AICS):


Present




REACH - Annex IV - Exemptions from theobligations of Register:

Present

Australia (AICS): PresentREACH - Annex IV - Exemptions from theobligations of Register:

Present



EU EINECS/ELINCS List Not Listed






EU EINECS/ELINCS List


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.


Prepared by:Product Stewardship Hazard Communication

Pfizer Global Environment, Health, and Safety Operations



_______________________________________________________________________________________________________PD027



Ondansetron Injection, USP (single dose)

Zofran Injection



Synonyms

Product type



:

:

:


Identified uses


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



:








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.



: None known.




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%



: 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


:


Mixture





Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical attention if symptoms occur.


Eye contact

Skin contact

Inhalation

Ingestion :

:

:

:


Notes to physician : Treat symptomatically. Contact poison treatment specialist immediately if large quantities have been ingested or inhaled.









Skin contact

Ingestion




:

:

:








No special measures are required.



No specific data.





Extinguishing media

:

:

:

None known.


:


:


:




:






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



Conditions for safe storage,including any incompatibilities



:

:






Hand protection




Eye/face protection


:

:


:




: Good general ventilation should be sufficient to control worker exposure to airborne contaminants.


Hygiene measures :

Control parameters



Skin protection


None.


Physical state

Melting point

Vapor pressure

Relative density

Vapor density


Not available.

Not available.

Not available.

Not available.

Not available.Odor

pH

Colorless.Color


Flash point Not available.

3.3 to 4


:

:

:

:

:

:

:

:

:

:

:

Appearance




: Not available.



Section 9. Physical and chemical propertiesSolubility Soluble in the following materials: cold water and hot water.

Auto-ignition temperature Not available.

Not available.



:

:

:

:







Reactive or incompatible with the following materials: oxidizing materials, acids and alkalis.

:

:

:






Acute toxicity

Carcinogenicity


Sensitization








Aspiration hazard


: Dermal contact. Eye contact. Ingestion.



















Skin contact

Ingestion




:

:

:








Short term exposure




Long term exposure






Toxicity



: Not available.

Mobility in soil







:Disposal methods


-

-

-

-

-

-

-

Not regulated.

-

-


- - -


UN number



Packing group





No. No. No.


: Not available.

:




: Not listed


: Not listed


: Not listed


: Not listed








Massachusetts :

California Prop. 65


: Not listed




State regulations

SARA 302/304




SARA 311/312




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.




: Not listed


: Not listed


: Not listed


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


Version :

:

1

12/15/2013





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



Flumazenil Injection

Not available.


Synonyms



:

:


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.


5 and 10 ml vials.



:








GHS label elements



: None known.



: Not available.

Substance/mixture


: Mixture



Section 3. Composition/information on ingredientsIngredient name CAS number%



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




Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical attention if symptoms occur.


Eye contact

Skin contact

Inhalation

Ingestion :

:

:

:


Notes to physician : Treat symptomatically. Contact poison treatment specialist immediately if large quantities have been ingested or inhaled.









Skin contact

Ingestion




:

:

:








No special protection is required.



No specific data.





Extinguishing media

:

:

:

None known.


:


:


:




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 storageConditions for safe storage,including any incompatibilities


:


Hand protection




Eye/face protection


:

:


:




: 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.


Hygiene measures :

Control parameters



Skin protection


None.




Physical state

Melting point

Vapor pressure

Relative density

Vapor density

Solubility


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



Flash point

Not available.

Not applicable.

Not available.

3.5 to 4.5




:

:

:

:

:

:

:

:

:

:

:

:

:

:

:

Appearance




: Not available.

Burning rate Not applicable.:

Burning time : Not applicable.

SADT Not available.:


Solubility in water : Not available.






Reactive or incompatible with the following materials: oxidizing materials.

:

:

:








Acute toxicity

Carcinogenicity

Mutagenicity

Teratogenicity



Sensitization







Skin contact

Ingestion




:

:

:





Aspiration hazard






Short term exposure




Long term exposure





















Other information : FDA Class C








Toxicity



: Not available.

Mobility in soil





:Disposal methods




-

-

-

-

-

-

-

Not regulated.

-

-


- - -


UN number



Packing group





No. No. No.


: Not available.

:


Section 15. Regulatory informationU.S. Federal regulations

Clean Water Act (CWA) 311: Acetic acid

:


: Not listed


: Not listed


: Not listed


: Not listed


: Not listed



SARA 302/304









Massachusetts :

California Prop. 65




State regulations

SARA 311/312



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.




: Not listed


: Not listed


: Not listed



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


Version :

:

1

09/15/2013





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.


1

SAFETY DATA SHEET

Product Name: Sodium Chloride Injection, USP



Address

Hospira, Inc.



USA

Emergency Telephone




224 212-2000

Product Name

Sodium Chloride Injection, USP

Synonyms Table salt


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.




Health Hazards

Hazard Class Hazard Category

Eye Damage / Irritation 2A

Label Element(s)

Pictogram

Signal Word

Warning

Hazard Statement(s)

Causes serious eye irritation




Wear eye protection/face protection




attention.

2



Active Ingredient Name Sodium Chloride

Chemical Formula NaCl


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.


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


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





Provide symptomatic/supportive care as necessary


Flammability




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




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.


Handling


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



Exposure Guidelines

Exposure Limits


Sodium Chloride 8-hr TWA: Not

Established

8-hr TWA: Not

Established

8-hr TWA: Not

Established

8-hr TWA: Not

Established


ACGIH TLV: American Conference of Governmental Industrial Hygienists – Threshold Limit Value.

AIHA WEEL: Workplace Environmental Exposure Level EEL: Employee Exposure Limit.



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.



Appearance/Physical State A sterile, non-pyrogenic, concentrated solution

Odor NA

Odor Threshold NA

pH 5.0 (4.5 to 7.0)



Flash Point NA

Evaporation Rate NA



Vapor Pressure NA


Relative Density NA

Solubility Freely soluble in water; practically insoluble in dehydrated alcohol




Viscosity NA

4



Reactivity

Not determined. None anticipated from this product.

Chemical Stability


Hazardous Reactions

Not determined

Conditions to Avoid

Not determined

Incompatibilities

Not determined


Products


irritating vapors and/or toxic fumes of hydrogen chloride and sodium oxide.






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


Occupational Exposure Potential



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.


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




Sensitization


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


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.


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.




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.


Waste Disposal




Disposal


regulations.

6





Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity

NA



Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity

NA



Hazard Class NA

UN Number NA

Packing Group NA




US TSCA Status Exempt. However, sodium chloride is listed on the TSCA inventory.


US SARA 302 Status

US SARA 313 Status

Not listed

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




Hazard Class

NA

Hazard Category

NA

Pictogram

NA

Signal Word

NA

Hazard Statement

NA



Wear eye protection/face protection




attention.




Symbol NA


Risk Phrases NA





7











NE Not established






















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


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


Revision date: 11-Nov-2009

Emergency telephone number:ChemSafe (24 hours): +44 (0)208 762 8322


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


_______________________________________________________________________________________________________

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.


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


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.


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.


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.

_______________________________________________________________________________________________________PZ01067

Page 2 of 7


Material Name: Methylprednisolone Sodium Succinate forInjection (preservative-free)

Version: 1.0


_______________________________________________________________________________________________________


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:



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.


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.


Solvent Solubility: Soluble: Alcohols

_______________________________________________________________________________________________________PZ01067

Color: White

Page 3 of 7

Molecular Formula: Mixture Molecular Weight: Mixture

Pfizer OEL TWA-8 Hr: 4 µg/m3, Skin



Version: 1.0

Methylprednisolone Sodium Succinate

Physical State: Powder


_______________________________________________________________________________________________________

9. PHYSICAL AND CHEMICAL PROPERTIESSolubility: Soluble: Water


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


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.



Irritation / Sensitization: (Study Type, Species, Severity)

_______________________________________________________________________________________________________PZ01067

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


Mouse Intraperitoneal LD 50 1409 mg/kg


Rat Subcutaneous LD 50 >3000 mg/kg

Rat Oral LD 50 17 g/kg

Rat Oral LD 50 > 5000 mg/kg



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

Page 4 of 7


_______________________________________________________________________________________________________


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)


12. ECOLOGICAL INFORMATIONEnvironmental Overview: Environmental properties have not been investigated. Releases to the environment should be

avoided.


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.

_______________________________________________________________________________________________________PZ01067

Direct DNA Interaction Not applicable Negative


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

Page 5 of 7

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





_______________________________________________________________________________________________________

14. TRANSPORT INFORMATIONNot regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.


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

_______________________________________________________________________________________________________PZ01067


Sodium phosphate, monobasic

Lactose

Inventory - United States TSCA - Sect. 8(b) Listed



Australia (AICS): Listed

Inventory - United States TSCA - Sect. 8(b)


Listed


Version: 1.0


Page 6 of 7


_______________________________________________________________________________________________________



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



_______________________________________________________________________________________________________PZ01067




Version: 1.0

Page 7 of 7




2270 kg final RQ5000 lb final RQ


Inventory - United States TSCA - Sect. 8(b) Listed


SAFETY DATA SHEET

1. Identification

Product identifier VENTOLIN HFA


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


Hazard(s) not otherwise classified (HNOC)


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.

1 / 10

Material name: VENTOLIN HFA

126598 Version #: 15 Revision date: 10-21-2014 Issue date: 10-21-2014

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.

2 / 10



SDS US

8. Exposure controls/personal protection


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.


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.

3 / 10



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.


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.


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

4 / 10



SDS US

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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SDS US

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)


Hydrolysis

Half-life (Hydrolysis-neutral)

ALBUTEROL SULFATE > 1 Years Measured

Biodegradability

Percent degradation (Aerobic biodegradation-soil)

ALBUTEROL SULFATE 1.3 - 38.7 %, 64 days


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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SDS US

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


-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


Allowed.Cargo aircraft only

Other information

Allowed.Passenger & cargo

IMDG

UN1950UN number

AEROSOLS, asphyxiantUN proper shipping name

2Class


5ASubsidiary risk

2.2Label(s)

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SDS US

Not applicable.Packing group

No.Marine pollutant


Not available.EmS


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.

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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

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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.

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SDS US

1

SAFETY DATA SHEET

Product Name: Verapamil Hydrochloride Injection



Address

Hospira, Inc.



USA

Emergency Telephone




224 212-2000

Product Name Verapamil Hydrochloride Injection

Synonyms benzeneacetonitrile, -[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino]

propyl]-3,4-dimethoxy--(1-methylethyl) hydrochloride


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.






Label Element(s)

Pictogram NA

Signal Word NA








attention.

2



Active Ingredient Name Verapamil Hydrochloride

Chemical Formula C27H38N2O4 • HCl


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.













Flammability




Extinguishing Media




Procedures









Handling


use.



product insert.


3





Verapamil Hydrochloride 8-hr TWA: Not

Established

8-hr TWA: Not

Established

8-hr TWA: Not

Established

8-hr TWA: Not

Established







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


is recommended.

Eye Protection



recommended.



Appearance/Physical State Clear aqueous solution

Odor NA

Odor Threshold NA

pH 4.9 (4.0 to 6.5)



Flash Point NA

Evaporation Rate NA



Vapor Pressure NA


Relative Density NA

Solubility NA




Viscosity NA

4



Reactivity

Not determined.

Chemical Stability


Hazardous Reactions

Not determined

Conditions to Avoid

Not determined

Incompatibilities

Not determined


Products









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



Potential



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.


Dermal Irritation/ Corrosion None anticipated from normal handling of this product.


of this product with eyes may produce irritation with redness and tearing.


Sensitization


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



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



– Single Exposure

NA


– 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







Notes:


Waste Disposal




Disposal


regulations.

6





Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity

NA



Hazard Class NA

UN Number NA

Packing Group NA

Reportable Quantity

NA



Hazard Class NA

UN Number NA

Packing Group NA






US SARA 302 Status

US SARA 313 Status

Not listed

Not listed


US PROP 65 (Calif.)

Not listed







Hazard Class

NA

Hazard Category

NA

Pictogram

NA

Signal Word

NA

Hazard Statement

NA






attention.

7


15. REGULATORY INFORMATION: continued




Symbol NA


Risk Phrases NA














NE Not established






















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