Fish oil, Medium-chain triglycerides, Olive oil and Soybean oil

SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

SMOFlipid provides a biologically utilizable source of calories and essential fatty acids. Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are also important for membrane structure and function, as precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.

• For intravenous infusion into a central or peripheral vein. • SMOFlipid Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures. • Protect the admixed PN solution from light. • Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and eliminate lipids, and consideration of additional energy given to the patient. • For information on the age-appropriate infusion rate, see the full prescribing information. Age Nutritional Requirements Initial Recommended Dosage Maximum Dosage Birth to 2 years of age (including preterm and term neonates) 0.5 to 1 g/kg/day 3 g/kg/day Pediatric patients 2 to <12 years of age 1 to 2 g/kg/day 3 g/kg/day Pediatric patients 12 to 17 years of age 1 g/kg/day 2.5 g/kg/day Adults 1 to 2 g/kg/day 2.5 g/kg/day

Use of SMOFlipid is contraindicated in patients with: • Known hypersensitivity to fish, egg, soybean, peanut or any of the active or inactive ingredients in SMOFlipid • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL) • Known hypersensitivity to fish, egg, soybean, peanut or any of the active or inactive ingredients. • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).

• Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported. • Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who receive parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests, if abnormalities occur, consider discontinuation or dosage reduction. • Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur. • Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty Acid Deficiency: Monitor for signs and symptoms, monitor laboratory parameters. • Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm neonates.

Adverse reactions described elsewhere in this Prescribing Information are: • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants • Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders • Hypersensitivity Reactions • Infections • Fat Overload Syndrome • Refeeding Syndrome • Hypertriglyceridemia • Aluminum Toxicity • Essential Fatty Acid Deficiency Most common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and hyperglycemia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase, and nosocomial infection.

Soybean and olive oils in SMOFlipid contain vitamin K 1 which may counteract the anticoagulant activity of vitamin K antagonists such as warfarin. In patients who receive concomitant SMOFlipid and warfarin, increase monitoring of laboratory parameters for anticoagulant activity. Vitamin K Antagonists (e.g., warfarin): Anticoagulant activity may be counteracted, increase monitoring of coagulation parameters.

Store below 25°C (77°F). Do not freeze. If not used immediately, the product should be stored at 2°C to 8°C (36°F to 46°F) for no longer than 24 hours. If not used immediately, the product should be stored for no longer than 24 hours at 2°C to 8°C (36°F to 46°F). If not used immediately, admixtures should be stored at 2°C to 8°C (36°F to 46°F) for no longer than 24 hours. Store in overpouch until ready for use. After removal from storage, infuse within 12 hours when using a Y-connector or within 24 hours if used as part of an admixture. After removal from storage, and once the closure is penetrated, use Pharmacy Bulk Package contents within 4 hours.