Application Nr Approved Date Route Status External Links
ANDA075880 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage 6% And 10% Premasol - Sulfite-Free (amino Acid) Injections Are Indicated For The Nutritional Support Of Infants (including Those Of Low Birth Weight) And Young Children Requiring Tpn Via Either Central Or Peripheral Infusion Routes. Parenteral Nutrition With Premasol - Sulfite-Free (amino Acid) Injections Is Indicated To Prevent Nitrogen And Weight Loss Or Treat Negative Nitrogen Balance In Infants And Young Children 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 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 For Additional Information. 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 Infants, 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 5-10% Dextrose Solutions May Be Infused By Peripheral Vein, Supplemented, If Desired, With Fat Emulsion.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 19 Total)

Name Structure ZINC ID(s)
1. Alanine ALANINE ZINC4658553
2. Arginine ARGININE ZINC1532525
3. Aspartic Acid
4. Cysteine Hydrochloride CYSTEINE HYDROCHLORIDE ZINC895042
5. Glutamic Acid
6. Glycine GLYCINE ZINC4658552
7. Histidine HISTIDINE ZINC6661227
8. Isoleucine ISOLEUCINE ZINC3581355
9. Leucine LEUCINE ZINC3645145
10. Lysine Acetate LYSINE ACETATE ZINC1532522
11. Methionine METHIONINE ZINC1532529
12. Phenylalanine PHENYLALANINE ZINC105196
13. Proline PROLINE ZINC895071
14. Serine SERINE ZINC895034
15. Taurine TAURINE ZINC3809490
16. Threonine THREONINE ZINC895103
17. Tryptophan TRYPTOPHAN ZINC83315
18. Tyrosine TYROSINE ZINC266964
19. Valine VALINE ZINC895099

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