Application Nr Approved Date Route Status External Links
NDA019437 1986-04-03 Intravenous RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Aminosyn Ii 8.5% With Electrolytes, Sulfite-Free, (an Amino Acid Injection) Infused With Dextrose By Peripheral Vein Infusion Is Indicated As A Source Of Nitrogen In The Nutritional Support Of Patients In Whom, For Short Periods Of Time, Oral Nutrition Cannot Be Tolerated, Is Undesirable, Or Inadequate. Aminosyn Ii 8.5% With Electrolytes Can Be Administered Peripherally With Dilute (5 To 10%) Dextrose Solution And I.v. Fat Emulsion As A Source Of Nutritional Support. This Form Of Nutritional Support Can Help To Preserve Protein And Reduce Catabolism In Stress Conditions Where Oral Intake Is Inadequate. When Administered With Concentrated Dextrose Solution With Or Without Fat Emulsions, Aminosyn Ii 8.5% With Electrolytes Is Also Indicated For Central Vein Infusion To Prevent Or Reverse Negative Nitrogen Balance In Patients Where: (a) The Alimentary Tract, By The Oral, Gastrostomy Or Jejunostomy Route Cannot Or Should Not Be Used; (b) Gastrointestinal Absorption Of Protein Is Impaired; (c) Metabolic Requirements For Protein Are Substantially Increased As With Extensive Burns And (d) Morbidity And Mortality May Be Reduced By Replacing Amino Acids Lost From Tissue Breakdown, Thereby Preserving Tissue Reserves, As In Acute Renal Failure.

All Formulated Excipients (0 Total)