Each 100 mL of Nutrilipid® 20% contains: Soybean Oil 20 g Egg Yolk Phospholipid 1.2 g Glycerin USP (glycerol) 2.5 g Sodium Oleate 0.03 g Water for Injection USP qs. Adverse reactions reported in long-term use with other intravenous lipid emulsions include hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, abnormalities in liver function tests, brown pigmentation of the liver and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).ġ1 DESCRIPTION Nutrilipid® 20% is a sterile, nonpyrogenic fat emulsion prepared for intravenous administration. Adverse reactions reported with other intravenous lipid emulsions include hyperlipidemia, hypercoagulability, thrombophlebitis, and thrombocytopenia. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 6 ADVERSE REACTIONS Adverse Reactions described elsewhere in labeling: Death in Preterm Infants Hypersensitivity Reactions Infections Fat Overload Syndrome Refeeding Syndrome Aluminum Toxicity Risk of Parenteral Nutrition Associated Liver Disease Hypertriglyceridemia Adverse reactions have included hyperlipidemia, hypercoagulability, thrombophlebitis, thrombocytopenia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact B.
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