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Fat emulsion infusion4/30/2023 ![]() If these tests indicate that liver function is impaired, the therapy should be withdrawn. ®, liver function tests should be performed. Overdosage must be avoided.ĭuring long term intravenous nutrition with Intralipid ® 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. 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 the total 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.Ģ Autopsy 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. The container is nontoxic and biologically inert. This product is not made with natural rubber latex. 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 3.0 kcal per mL of Intralipid Fat Emulsion) has an osmolality of approximately 310 mOsmoL/kg water (which represents 200 mOsmol/L of emulsion) and contains emulsified fat particles of approximately 0.5 micron size. ![]() ![]() The major component fatty acids are linoleic acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), α-linolenic acid (4-11%) and stearic acid (1.4-5.5%).ġ These fatty acids have the following chemical and structural formulas:ģ and is a clear colorless, hygroscopic syrupy liquid. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:Īre saturated and unsaturated fatty acid residues. It is a sterile dosage form which contains several single doses for use in the preparation of three-in-one or total nutrient admixtures (TNAs) in a pharmacy admixture program. Intralipid ® 30% Pharmacy Bulk Package is not intended for direct infusion. In addition, sodium hydroxide has been added to adjust the pH so that the final product pH is 8. It is made up of 30% Soybean Oil, 1.2% Egg Yolk Phospholipids, 1.7% Glycerin, and Water for Injection. Fat Emulsion) Pharmacy Bulk Package is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids for use in a pharmacy admixture program.
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