Iv fat emulsion infusion free#

The adverse reactions observed can be separated into two classes: Nursing Mothers: Caution should be exercised when Intralipid ® should be given to a pregnant woman only if clearly needed. ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

® have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.Īnimal reproduction studies have not been conducted with Intralipid If these tests indicate that liver function is impaired, the therapy should be withdrawn.įrequent (some advise daily) platelet counts should be done in neonatal patients receiving parenteral nutrition with Intralipidĭrug product contains no more than 25 mcg/L of aluminum.Ĭarcinogenesis, Mutagenesis, Impairment of Fertility: ® 10%, liver function tests should be performed. Overdosage must be avoided.ĭuring long term intravenous nutrition with Intralipid ® 10% is administered, the patients capacity to eliminate the infused fat from the circulation must be monitored by use of an appropriate laboratory determination of serum triglycerides. The lipemia must clear between daily infusions.

Iv fat emulsion infusion free#

The infant’s ability to eliminate the infused fat from the circulation must be carefully monitored (such as serum triglycerides and/or plasma free fatty acid levels). 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 the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. Strict adherence to the recommended total daily dose is mandatory hourly infusion rate should be as slow as possible in each case and fat should not in any case exceed 1 g fat/kg in four hours. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.ĭeaths in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature.Īutopsy findings included intravascular fat accumulation in the lungs. The container-emulsion unit is a closed system and is not dependent upon entry of external air during administration. This product is not made with natural rubber latex. The container is nontoxic and biologically inert. The container does not contain DEHP (di(2-ethylhexyl) phthalate) or PVC. It contains no plasticizers and exhibits virtually no leachables.

The film is polypropylene based comprising three co-extruded layers. The primary plastic container (Biofine™) is made from multilayered film specifically designed for parenteral nutrition drug products. The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion. The total caloric value, including fat, phospholipid and glycerin, is 1.1 kcal per mL of Intralipid ® 10% (A 10% Intravenous Fat Emulsion) has an osmolality of approximately 300 mOsmol/kg water (which represents 260 mOsmol/L of emulsion) and contains emulsified fat particles of approximately 0.5 micron size. 3 and is a clear colorless, hygroscopic syrupy liquid.