Application Nr Approved Date Route Status External Links
NDA016822 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Parenteral Nutrition With 6.9% Freamine Hbc ® (amino Acid Injection) Is Indicated To Prevent Nitrogen Loss Or Treat Negative Nitrogen Balance In Adults Where (1) The Alimentary Tract, By The Oral, Gastrostomy, Or Jejunostomy Route, Cannot Or Should Not Be Used, Or Adequate Protein Intake Is Not Feasible By These Routes; (2) Gastrointestinal Absorption Of Protein Is Impaired; Or (3) Nitrogen Homeostasis Is Substantially Impaired As With Severe Trauma Or Sepsis. Dosage, Route Of Administration, And Concomitant Infusion Of Non-Protein Calories Are Dependent On Various Factors, Such As Nutritional And Metabolic Status Of The Patient, Anticipated Duration Of Parenteral Nutritional Support, And Vein Tolerance. See Dosage And Administration . Central Venous Nutrition Central Venous Infusion Should Be Considered When Amino Acid Solutions Are To Be Admixed With Hypertonic Dextrose To Promote Protein Synthesis In Hypercatabolic Or Severely Depleted Patients, Or Those Requiring Long-Term Parenteral Nutrition. Peripheral Parenteral Nutrition For Moderately Catabolic Or Depleted Patients In Whom The Central Venous Route Is Not Indicated, Diluted Amino Acid Solutions With Minimal Caloric Supplementation May Be Infused By Peripheral Vein, Supplemented, If Desired, With Fat Emulsion. In Pediatric Patients, The Final Solution Should Not Exceed Twice Normal Serum Osmolarity (718 Mosmol/l).

All Formulated Excipients (0 Total)