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

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