Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine

FDA Drug Profile — Kabiven, Perikabiven

Drug Details

Generic Name
Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine
Brand Names
Kabiven, Perikabiven
Application Number
NDA200656
Sponsor
Fresenius Kabi USA, LLC
NDC Codes
2
Dosage Forms
INJECTION, EMULSION
Routes
INTRAVENOUS
Active Ingredients
ALANINE, ARGININE, ASPARTIC ACID, CALCIUM CHLORIDE, DEXTROSE MONOHYDRATE, GLUTAMIC ACID, GLYCINE, HISTIDINE, ISOLEUCINE, LEUCINE, LYSINE HYDROCHLORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, METHIONINE, PHENYLALANINE, POTASSIUM CHLORIDE, PROLINE, SERINE, SODIUM ACETATE, SODIUM GLYCEROPHOSPHATE ANHYDROUS, SOYBEAN OIL, THREONINE, TRYPTOPHAN, TYROSINE, VALINE

Indications and Usage

1 INDICATIONS AND USAGE KABIVEN 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. KABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. Limitations of Use: KABIVEN 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 )] . KABIVEN 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. KABIVEN 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 )