olimel 7.6% - multibriefs · events and for approximating rates. the safety and clinical efficacy...

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Most critically ill patients receive LESS THAN HALF the recommended protein during their first week in the ICU 1-3 ...NOW THERE’S A SOLUTION. Olimel 7.6%

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Page 1: Olimel 7.6% - MultiBriefs · events and for approximating rates. The safety and clinical efficacy of OLIMEL (amino acids WITH electrolytes, dextrose, lipids) or (amino acids, dextrose,

Most critically ill patients receive LESS THAN HALF the recommended protein during their first week in the ICU1-3

...NOW THERE’S A SOLUTION.

Olimel 7.6%

Page 2: Olimel 7.6% - MultiBriefs · events and for approximating rates. The safety and clinical efficacy of OLIMEL (amino acids WITH electrolytes, dextrose, lipids) or (amino acids, dextrose,

Most critically ill patients receive LESS THAN HALF the recommended protein during their first week in the ICU1-3

NOW APPROVED IN CANADA!Olimel 7.6% is Baxter’s latest generation of industry-leading Parenteral Nutrition triple-chamber bags

Olimel 7.6% combines more than 20 years of proven clinical evidence of olive oil with the highest protein AND lowest glucose formulation available in a standardized, triple-chamber bag.4-6, 19

• 650mL • 1000mL

• 1500mL• 2000mL

AVAILABLE WITH OR WITHOUT ELECTROLYTES IN A WIDE RANGE OF SIZES:4,7

GLUCOSE 73 g/L

KCAL 950 kcal/L

PROTEIN 76 g/L

LIPIDS 35 g/L

Max.1140 kcal/L

Max.76 g/L

Max.140 g/L

Max.40 g/L

Based on the maximum available in other Olimel formulations

Page 3: Olimel 7.6% - MultiBriefs · events and for approximating rates. The safety and clinical efficacy of OLIMEL (amino acids WITH electrolytes, dextrose, lipids) or (amino acids, dextrose,

Olimel 7.6% gives you the HIGH PROTEIN, LOW GLUCOSE solution to reach protein targets in LESS FLUID

REACH PROTEIN TARGETS IN LESS FLUID

Loss of lean body mass and fluid overload are associated with negative

clinical outcomes.1,8-11 With 76g of Amino Acid per Liter, Olimel 7.6% delivers the

highest protein AND lowest glucose formulation available in a standardized,

triple-chamber bag.4-6, 19

REDUCE RISK OF HYPERGLYCEMIA

Hyperglycemia is associated with an increased risk of

infections.3 With only 73 g/L, Olimel 7.6% has one of the

lowest glucose levels available in a triple-chamber bag.4-6, 19

PRESERVE IMMUNE FUNCTION

Lipid emulsions may modulate patient immune response, increasing the risk of complications.12,13 Olimel 7.6% contains an olive oil-based lipid emulsion that

is associated with fewer infections and may preserve immune function.14-18

Page 4: Olimel 7.6% - MultiBriefs · events and for approximating rates. The safety and clinical efficacy of OLIMEL (amino acids WITH electrolytes, dextrose, lipids) or (amino acids, dextrose,

Olimel 7.6%

For more information on Olimel 7.6% and our complete portfolio of clinical nutrition solutions, CONTACT YOUR BAXTER REPRESENTATIVEOR VISIT WWW.BAXTER.CA

REACH PROTEIN TARGETS. Olimel 7.6% delivers the highest protein AND lowest glucose formulation available in a standardized, triple-chamber bag.4-6, 19

PRESERVE IMMUNE FUNCTION. Olimel contains an olive oil-based lipid emulsion that may preserve immune function.14-18

PRESCRIBE TO PRESERVE.

CAMP/179/18-0001 7/2018

OLIMEL 7.6%E and OLIMEL 7.6% are licensed in Canada.Olimel is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossbile, insufficient or contraindicated.

Page 5: Olimel 7.6% - MultiBriefs · events and for approximating rates. The safety and clinical efficacy of OLIMEL (amino acids WITH electrolytes, dextrose, lipids) or (amino acids, dextrose,

References

1. Hoffer LJ, et al. F1000 Research 2016;5:2531.2. McClave SA, et al. JPEN J Parenter Enteral Nutr 2009;33:277-316.3. Singer P, et al. Clin Nutr 2009;05:387-400.4. OLIMEL N12 SmPC, 2017.5. SmofKabiven SmPC, 2017.6. NutriFlex SmPC, 2015.7. OLIMEL N12E SmPC, 2017.8. Elke G, et al. Crit Care 2014;18:R29.9. Schwickert WE, Hall J. Chest 2007;131:1541-9.10. Cunha HF, et al. Rev Bras Ter Intensiva 2013;25:49-55.11. Nicolo M, et al. JPEN J Parenter Enteral Nutr 2016;40:45-51.12. Wanten GJ, Calder PC. AM J Clin Nutr 2007;85:1171-84.13. Piper SN, et al. Eur J Anaesthesiol 2009;26:1076-82.14. Calder PC, et al. Intensive Care med 2010;36:735-49.

15. Granato D, et al. JPEN J Parenter Enteral Nutr 2000;24:113-8.16. Olthof E, et al. Clin Nutr 2013;32:643-649.17. Pontes-Arruda A, Clin Nutr Suppl 2009;4:19-23.18. Waitzberg DL, et al. JPEN J Parenter Enteral Nutr 2006;30:351-67.19. Trimix HP SmPC, 2017

Consult the product monograph at www.baxter.ca for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The product monograph is also available upon request. Call us at 1-800-387-8399.

Page 6: Olimel 7.6% - MultiBriefs · events and for approximating rates. The safety and clinical efficacy of OLIMEL (amino acids WITH electrolytes, dextrose, lipids) or (amino acids, dextrose,

OLIMEL 7.6% and OLIMEL 7.6% E (containing 12 g Nitrogen/L) Injectable Emulsion. COMPOSITION For OLIMEL 7.6% :Active substances: Refined olive oil + refined soybean oil; Alanine; Arginine; Aspartic acid; Glutamic acid; Glycine; Histidine; Isoleucine; Leucine; Lysine; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Glucose anhydrous. For OLIMEL 7.6% E: Active substances: Refined olive oil + refined soybean oil; Alanine; Arginine; Aspartic acid; Glutamic acid; Glycine; Histidine; Isoleucine; Leucine; Lysine; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Sodium acetate, trihydrate; Sodium glycerophosphate, hydrated; Potassium chloride; Magnesium chloride, hexahydrate; Calcium chloride, dehydrate; Glucose anhydrous Therapeutic indications OLIMEL (amino acids WITH electrolytes, dextrose, lipids) or (amino acids, dextrose, lipids) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated. Geriatrics: There are no known differences in safety and effectiveness of parenteral nutrition formulations in the adult population based upon age. Pediatrics: There have been no studies performed in the pediatric population. Contraindications: The use of OLIMEL is contra-indicated in the following populations/situations:Known hypersensitivity to egg, soybean products, olive products or any of the active substances, excipients, or components of the container. Known allergy to corn or corn products since the products contain corn-derived dextrose, patients with acute renal failure and without undergoing renal replacement therapy, patients with severe liver failure or hepatic coma, congenital abnormalities of amino acid metabolism, severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia, hypertriglyceridemia-associated acute pancreatitis, severe hyperglycemia. Additional contraindications specific to OLIMEL formulations with electrolytes: hyperkalemia, hypercalcaemia, hyperphosphatemia, hypernatremia, hypermagnesemia, ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including OLIMEL, through the same infusion line (e.g. via Y-site) because of the risk of precipitation of ceftriaxone-calcium salt. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The safety and clinical efficacy of OLIMEL (amino acids WITH electrolytes, dextrose, lipids) or (amino acids, dextrose, lipids) was assessed in a double-blind randomized controlled study over five days. Fifty-six (56) patients requiring parenteral nutrition were enrolled, of whom twenty-eight (28) were treated with OliClinomel (a triple-chamber parenteral nutrition product similar to OLIMEL, that contains the same olive oil/soybean oil lipid, a similar amino acid profile, and dextrose) and twenty-eight (28) were treated with OLIMEL. The goal of the study was to provide information on the safety and nutritional efficacy of OLIMEL in a clinical setting. A total of fifty-three (53) adverse events occurred during treatment; twenty-nine (29) adverse events were observed in fourteen (14) patients in the OLIMEL group versus twenty-four (24) adverse events observed in eleven (11) patients in the OliClinomel (control) group. Of the twenty-nine (29) adverse events observed in the OLIMEL group, seven (7) adverse events were designated as related to treatment. Of the twenty-four (24) adverse events observed in the OliClinomel (control) group, seven (7) patients presented with adverse events that were reported as related to treatment.

Summary of Treatment-Related Adverse Drug Reactions in the OLIMEL Study

Post-Market Adverse Drug Reactions GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Injection site extravasation, Pyrexia, Chills. Class Reactions : The following adverse reactions have been reported with similar products: Pruritus, Fat overload syndrome, Cholestasis, Elevated liver enzymes and Azotemia. Pulmonary vascular precipitates (pulmonary vascular emboli and pulmonary distress). For a detailed dosage and administration, warnings and precautions, interactions, clinical pharmacological and pharmaceutical particulars, please refer to the full Canadian product monograph. Medicinal products are subject to medical prescription. Revision date: June 2018

System Organ Class Adverse Event

Reported Incidence by Treatment GroupOLIMEL (n=28)

up to 40 mL/kg/dayOLICLINOMEL (n=28) up to 40 mL/kg/day

N* % N* %Cardiac disorders Tachycardia 1 3.57 0 0.00

Gastrointestinal disorders Abdominal pain 1 3.57 0 0.00

Diarrhea 1 3.57 1 3.57

Nausea 1 3.57 0 0.00

Immune system disorders Hypersensitivity 0 0.00 1 3.57

Investigations Blood alkaline phosphatase increased 0 0.00 1 3.57

Gamma-glutamyltransferase increased 0 0.00 1 3.57

Metabolism and nutrition disorders Decreased appetite 1 3.57 0 0.00

Hypertriglyceridemia 1 3.57 0 0.00

Renal and urinary disorders Azotemia 0 0.00 1 3.57

Respiratory, thoracic and mediastinal disorders

Respiratory failure 0 0.00 1 3.57

Vascular disorders Hemodynamic instability 0 0.00 1 3.57

Hypertension 1 3.57 0 0.00

*Number of patients reporting the related event

15. Granato D, et al. JPEN J Parenter Enteral Nutr 2000;24:113-8.16. Olthof E, et al. Clin Nutr 2013;32:643-649.17. Pontes-Arruda A, Clin Nutr Suppl 2009;4:19-23.18. Waitzberg DL, et al. JPEN J Parenter Enteral Nutr 2006;30:351-67.19. Trimix HP SmPC, 2017