Boxed Warning:
Deaths in preterm infants after infusion of intravenous fat emulsions have been reported in the medical literature. Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. Strict adherence to the total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and should not in any case exceed 1 g/kg in four hours. Premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. The infant's ability to eliminate infused fat from the circulation must be carefully monitored (such as triglyceride and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.
Safety Information
Caution should be exercised when administering intravenous fat emulsion to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders or when there is danger of fat embolism. The too rapid administration of intravenous fat emulsion can cause fluid and/or fat overloading, resulting in dilution or serum electrolyte concentrations, overhydration, congested states, pulmonary edema, impaired pulmonary diffusion capacity or metabolic acidosis.
This product contains aluminum that may be toxic.
Indications and Usage
Intravenous fat emulsion is indicated as a source of calories for patients requiring parenteral nutrition. Where such nutrition is required for extended periods of time (more than 5 days), intravenous fat emulsion is also indicated as a source of essential fatty acids to prevent or reverse biochemical changes in fatty acid composition of plasma lipids (elevated triene/tetraene ration) and the clinical manifestations of EFAD.
Pharmacy bulk packages are not for direct infusion. Sterile Water for Injection and 50% and 70% Dextrose for Injection, USP Pharmacy Bulk Package are for use only with automated compounding devices.