OLIMEL

1 Dosing Considerations Dosing of OLIMEL (amino acids, dextrose, lipids) is based upon protein, energy, and electrolyte requirements of the individual patient. Some patients with renal and hepatic disease may benefit from reduced protein intakes.

Some patients with diabetes mellitus or glucose intolerance may benefit from reduced carbohydrate intake. Patients with parenteral nutrition induced liver disease may benefit from reduction in lipid intake. Patients with renal disease have decreased capacity to excrete phosphorus.

Levels of this electrolyte should be carefully monitored in these patients. 2 Recommended Dose and Dosage Adjustment Adults Due to its high osmolarity (1120-1360 mOsmol/L), OLIMEL must only be administered through a central vein. The dosage depends on the patient’s energy expenditure, clinical status, body weight, and ability to metabolize the constituents of OLIMEL, as well as additional energy or proteins/amino acids given orally/enterally; therefore, the bag size should be chosen accordingly.

35 g nitrogen /kg body weight (1 to 2 g of amino acids/kg), depending on the patient's nutritional status and degree of catabolic stress. 5 g of amino acids/kg). 5 mL per expended kcal. *This is dependent on not over feeding the patient calories or protein.

The maximum daily dose should not be exceeded. Due to the static composition of the multi-chamber bag, the ability to simultaneously meet all nutrient needs of the 6 patient may not be possible. Clinical situations may exist where patients require amounts of nutrients varying from the composition of the static bag.

In this situation the impact of any volume (dose) adjustments must take into consideration the resultant effect this will have on the dosing of all other nutrient components of OLIMEL products. 2 mmol/kg/day of phosphate. In those situations, healthcare professionals may consider adjusting the volume (dose) of OLIMEL in order to meet these increased requirements.

0 g Energy: Total calories approx. 1140 kcal 1710 kcal 2270 kcal Non-amino acid calories approx. 0 mmol Acetate 31 mmol 46 mmol 62 mmol pH approx. 4 Osmolarity approx. 0 g Energy: Total calories approx. 1070 kcal 1600 kcal 2140 kcal Non-amino acid calories approx.

0 mmol Acetate 40 mmol 60 mmol 80 mmol pH approx. 4 Osmolarity approx. 7 g Energy: Total calories approx. 620 kcal 950 kcal 1420 kcal 1900 kcal Non-amino acid calories approx. 2 mmol Acetate 35 mmol 54 mmol 80 mmol 107 mmol pH approx. 4 Osmolarity approx.

1 Adverse Reaction Overview See WARNINGS AND PRECAUTIONS. 2 Clinical Trial Adverse 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, 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.

3 Post-Market Adverse Reactions In addition, the following adverse reactions have been reported in the postmarketing experience, listed by MedDRA System Organ Class (SOC), then by Preferred Term (PT) in order of severity.

1 Pregnant Women ................................................................................................. 2 Breast-feeding .....................................................................................................

3 Pediatrics ............................................................................................................. 37 4 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS OLIMEL (amino acids, dextrose, lipids) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.

1 Pediatrics Pediatrics (<18 years of age): There have been no studies performed in the pediatric population. 2 Geriatrics Geriatrics (> 65 years of age): There are no known differences in safety and effectiveness of parenteral nutrition formulations in the adult population based upon age.

2 CONTRAINDICATIONS The use of OLIMEL (amino acids, dextrose, lipids) is contraindicated in the following populations/situations: • Known hypersensitivity to egg, soybean or peanut products, olive products or any of the active substances, excipients, or components of the container.

For a complete listing, see the DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. • 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 […]

The use of OLIMEL (amino acids, dextrose, lipids) is contraindicated in the following populations/situations: • Known hypersensitivity to egg, soybean or peanut products, olive products or any of the active substances, excipients, or components of the container.

For a complete listing, see the DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. • 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 5