Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine
Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Kabiven, Perikabiven. Available dosage form: injection, emulsion.
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
- DEXTROSE MONOHYDRATE, SOYBEAN OIL, SODIUM ACETATE, POTASSIUM CHLORIDE, SODIUM GLYCEROPHOSPHATE ANHYDROUS, MAGNESIUM SULFATE HEPTAHYDRATE, CALCIUM CHLORIDE, LYSINE HYDROCHLORIDE, PHENYLALANINE, LEUCINE, VALINE, HISTIDINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, TYROSINE
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 )