KABIVEN — dextrose monohydrate, soybean oil, sodium acetate, potassium chloride, sodium glycerophosphate anhydrous, magnesium sulfate heptahydrate, calcium chloride, lysine hydrochloride, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosine injection, emulsion
Fresenius Kabi USA, LLC
WARNING: DEATH IN PRETERM INFANTS
Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature.
Autopsy findings included intravascular fat accumulation in the lungs.
Preterm infants and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.
[See Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]
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)].
2 DOSAGE AND ADMINISTRATION
KABIVEN® is for intravenous infusion only into a central vein [see Warnings and Precautions (5.8)].
Use a 1.2 micron in-line filter.
Use of a vented intravenous administration set with the vent in the open position could result in air embolism.
Use a dedicated line without any connections. Multiple connections could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions such as KABIVEN® via a Y-site due to precipitation. However, ceftriaxone and KABIVEN® may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Warnings and Precautions (5.9)] .
Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer.