Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
SOYBEAN OIL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A)
Baxter Healthcare Corporation
SOYBEAN OIL
SOYBEAN OIL 30 g in 100 mL
PRESCRIPTION DRUG
New Drug Application
INTRALIPID- SOYBEAN OIL EMULSION BAXTER HEALTHCARE CORPORATION ---------- INTRALIPID 30% A 30% I.V. Fat Emulsion in Excel Container PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION DESCRIPTION Intralipid 30% (A 30% I.V. 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. It is made up of 30% Soybean Oil, 1.2% Egg Yolk Phospholipids, 1.7% Glycerin, and Water for Injection. In addition, sodium hydroxide has been added to adjust the pH so that the final product pH is 8. pH range is 6 to 8.9. INTRALIPID 30% PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INFUSION. 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. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure: where -, - and - are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (44-62%), oleic (19-30%), palmitic (7-14%), linolenic (4- 11%) and stearic (1.4-5.5%) . These fatty acids have the following chemical and structural formulas: Linoleic acid C H O Oleic acid C H O Palmitic acid C H O ® ® ® ® 1 18 32 2 18 34 2 16 32 2 Linolenic acid C H O Stearic acid C H O Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure: - and contain saturated and unsaturated fatty acids that abound in neutral fats. R primarily either the choline or the ethanolamine ester of phosphoric acid. Phosphatidylcholine Phosphatidylethanolamine Glycerin is chemically designated C H O and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula: Intralipid 30% (A 30% I.V. Fat Emulsion) has an osmolality of approximately 310 mOsmoL/kg water (whi Olvassa el a teljes dokumentumot