Olive oil and Soybean oil

CLINOLIPID is indicated in adults 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.

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 important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.

• Use a 1.2 micron in-line filter when administering to a patient. • For infusion into a central or peripheral vein. • See full prescribing information for administration and admixing instructions. • CLINOLIPID 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 parenteral 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.

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

The following clinically significant adverse reactions are described elsewhere in the labeling: • 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 (≥5%) adverse drug reactions from clinical trials in adults were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia, and abnormal liver function tests.

No drug interaction studies have been performed with CLINOLIPID. Olive and soybean oils have a natural content of Vitamin K 1 that may counteract the anticoagulant activity of coumadin derivatives, including warfarin. The anticoagulant activity of coumarin derivatives, including warfarin, may be counteracted.

If not used immediately, the product should be stored for no longer than 24 hours at not more than 25°C (77°F). Store in overpouch until ready to use.