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 10% Freamine® Iii (amino Acid Injection) Is Indicated To Prevent Nitrogen Loss Or Treat Negative Nitrogen Balance In Adults And Pediatric Patients 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) Protein Requirements Are Substantially Increased As With Extensive Burns. Dosage, Route Of Administration, And Concomitant Infusion Of Nonprotein 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 Warnings , Precautions, Pediatric Use , And 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 Mixed With 5% Dextrose Solutions 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). Protein Sparing In Well-Nourished, Mildly Catabolic Patients Such As Routine Postsurgical Patients Who Require Only Short-Term Parenteral Nutrition, Protein Sparing Can Be Achieved By Peripheral Infusion Of Amino Acid Solutions With Or Without Dextrose.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 16 Total)

Name Structure ZINC ID(s)
1. Alanine ALANINE ZINC4658553
2. Arginine ARGININE ZINC1532525
3. Cysteine Hydrochloride CYSTEINE HYDROCHLORIDE ZINC895042
4. Glycine GLYCINE ZINC4658552
5. Histidine HISTIDINE ZINC6661227
6. Isoleucine ISOLEUCINE ZINC3581355
7. Leucine LEUCINE ZINC3645145
8. Lysine Acetate LYSINE ACETATE ZINC1532522
9. Methionine METHIONINE ZINC1532529
10. Phenylalanine PHENYLALANINE ZINC105196
11. Phosphoric Acid
12. Proline PROLINE ZINC895071
13. Serine SERINE ZINC895034
14. Threonine THREONINE ZINC895103
15. Tryptophan TRYPTOPHAN ZINC83315
16. Valine VALINE ZINC895099

Comments