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