Application Nr Approved Date Route Status External Links
NDA200656 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Perikabiven ® Is Indicated As A Source Of Calories, Protein, Electrolytes And Essential Fatty Acids For Adult Patients Requiring Parenteral Nutrition When Oral Or Enteral Nutrition Is Not Possible, Insufficient, Or Contraindicated. Perikabiven ® May Be Used To Prevent Essential Fatty Acid Deficiency Or Treat Negative Nitrogen Balance In Adult Patients. Limitations Of Use: Perikabiven ® Is Not Recommended For Use In Pediatric Patients Under The Age Of 2 Years, Including Preterm Infants Because The Fixed Content Of The Formulation Does Not Meet The Nutritional Requirements Of This Age Group [See Warnings And Precautions (5.1) And Use In Specific Populations (8.4) ] . Perikabiven ® Is Indicated As A Source Of Calories, Protein, Electrolytes And Essential Fatty Acids For Adult Patients Requiring Parenteral Nutrition When Oral Or Enteral Nutrition Is Not Possible, Insufficient, Or Contraindicated. Perikabiven ® May Be Used To Prevent Essential Fatty Acid Deficiency Or Treat Negative Nitrogen Balance In Adult Patients. ( 1 ) Limitations Of Use: Not Recommended For Use In Pediatric Patients < 2 Years Including Preterm Infants Because The Fixed Content Of The Formulation Does Not Meet Nutritional Requirements In This Age Group. ( 1 , 5.1 , 8.4 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 24 Total)

Name Structure ZINC ID(s)
1. Alanine ALANINE ZINC4658553
2. Arginine ARGININE ZINC1532525
3. Aspartic Acid
4. Calcium Chloride
5. Dextrose Monohydrate
6. Glutamic Acid
7. Glycine GLYCINE ZINC4658552
8. Histidine HISTIDINE ZINC6661227
9. Isoleucine ISOLEUCINE ZINC3581355
10. Leucine LEUCINE ZINC3645145
11. Lysine Hydrochloride LYSINE HYDROCHLORIDE ZINC1532522
12. Magnesium Sulfate Heptahydrate
13. Methionine METHIONINE ZINC1532529
14. Phenylalanine PHENYLALANINE ZINC105196
15. Potassium Chloride
16. Proline PROLINE ZINC895071
17. Serine SERINE ZINC895034
18. Sodium Acetate SODIUM ACETATE ZINC5224164
19. Sodium Glycerophosphate Anhydrous
20. Soybean Oil
21. Threonine THREONINE ZINC895103
22. Tryptophan TRYPTOPHAN ZINC83315
23. Tyrosine TYROSINE ZINC266964
24. Valine VALINE ZINC895099

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