Page 39 - Fresenius Kabi Acute Care 2017 Product Catalog

Kabiven (central PN)
Perikabiven (peripheral or central PN)
NDC
63323-712-10
63323-712-15
63323-712-20
63323-712-25
63323-714-14
63323
-714-19
Product number
831220310
831221310
831222310
831223310
831231310
831232310
Volume / Calories
1026 mL/ 870 kcal
1540 mL/ 1310 kcal
2053 mL/ 1745 kcal
2566 mL/ 2180 kcal
1440 mL/ 970 kcal
1920 1300
mL/ kcal
Unit of sale
4
4
4
3
4
4
BRIEF SUMMARY OF PRESCRIBING
INFORMATION
These highlights do not include all the information needed to use Kabiven and Perikabiven safely and effectively. See
full prescribing information, including Boxed Warning, for Kabiven and Perikabiven available at www.KabivenUSA.com.
KABIVEN® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
Initial U.S. Approval: 2014
PERIKABIVEN® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
Initial U.S. Approval: 2014
DOSAGE AND ADMINISTRATION
• Kabiven is for intravenous infusion only into a central vein
• Perikabiven is for intravenous infusion into a central or peripheral vein
• Recommended dosage depends on clinical status, body weight and nutritional requirements
• Kabiven adult dosage: 19 to 38 mL/kg/day (0.63 to 1.26 g/kg/day of protein, 1.85
to 3.71 g/kg/day of dextrose, 0.74 to 1.48 g/kg/day of lipid)
• The maximum infusion rate for Kabiven
is 2.6 mL/kg/hour (corresponding to
0.09 g/kg/hour of amino acids, 0.25 g/kg/hour of dextrose, the limiting factor, and
0.1 g/kg/hour of lipid)
• Perikabivenadultdosage:27to40mL/kg/day (0.64 to 0.94 g/kg/day of protein,
1.83 to 2.71 g/kg/day of dextrose, 0.95 to 1.4 g/kg/day of lipid)
• ThemaximuminfusionrateforPerikabiven
is 3.7 mL/kg/hour (corresponding to
0.09 g/kg/hour of amino acids, 0.25 g/kg/hour of dextrose, the limiting factor, and
0.13 g/kg/hour lipid)
• Therecommendedinfusionperiodis12to 24 hours
DOSAGE FORMS AND STRENGTHS
• Kabiven and Perikabiven are sterile,
hypertonic emulsions in a three-chamber container. The individual chambers contain
one of the following: amino acids and electrolytes, dextrose, or lipid injectable emulsion, respectively
• Kabivenisavailableinfoursizes2566mL, 2053 mL, 1540 mL and 1026 mL
• Perikabiven is available in two sizes 1920 mL and 1440 mL
CONTRAINDICATIONS
• Known hypersensitivity to egg, soybean proteins, peanut proteins, corn or corn products, or to any of the active substances or excipients
• Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides >1000 mg/dL
• Inborn errors of amino acid metabolism
• Cardiopulmonary instability
• Hemophagocytic syndrome
WARNINGS AND PRECAUTIONS
• Hypersensitivity reactions: Monitor for signs or symptoms and discontinue infusion if reactions occur
• Infection, fat overload, hyperglycemia and refeeding complications: Monitor for signs and symptoms; monitor laboratory parameters
ADVERSE REACTIONS
The most common adverse reactions
to Kabiven (>3%) are nausea, pyrexia, hypertension, vomiting, decreased hemoglobin, decreased total protein, hypokalemia, decreased potassium and increased
gamma glutamyltransferase.
The most common adverse reactions to Perikabiven (> 3%) are hyperglycemia, hypokalemia, pyrexia and increased blood triglycerides.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Coumarin and coumarin derivatives, including warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters
USE IN SPECIFIC POPULATIONS
Renal Impairment: Patients on hemodialysis
or continuous renal replacement therapy may require additional protein supplementation to meet nutritional requirements. If required, adjust the volume of Kabiven or Perikabiven administered based on serum electrolyte levels and fluid balance.
WARNING: DEATH IN PRETERM INFANTS
See full prescribing information for complete boxed warning
• Deathsinpreterminfantshavebeen reported in literature.
• Autopsyfindingsincludedintravascular fat accumulation in the lungs.
• Pretermandlowbirthweightinfants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.
INDICATIONS AND USAGE
Kabiven and Perikabiven are each 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 and Perikabiven may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.
Limitation 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.
PRODUCT INFORMATION