KABIVEN- dextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptop

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SOYBEAN OIL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A), SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), SODIUM GLYCEROPHOSPHATE ANHYDROUS (UNII: YP1H63LJ2K) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR), MAGNESIUM SULFATE HEPTAHYDRATE (UN

Verfügbar ab:

Fresenius Kabi USA, LLC

INN (Internationale Bezeichnung):

DEXTROSE MONOHYDRATE

Zusammensetzung:

DEXTROSE MONOHYDRATE 9.8 g in 100 mL

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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)] . The use of KABIVEN is contraindicated in: - Neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate's bloodstream [see Limitations of Use (1), Warnings and Precautions (5.5), Use in Specific Populations (8.4)]. - Pat

Produktbesonderheiten:

KABIVEN is a sterile emulsion available in the following 4 sizes: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. If accidentally frozen, discard the bag. It is recommended that the product be stored at 5°C to 25°C (41°F to 77°F). Do not remove container from overpouch until intended for use. After breaking the vertical seals, chemical and physical in-use stability of the mixed three chamber bag has been demonstrated for 48 hours at 25°C (77°F). If not used immediately, the activated bag can be stored for up to 7 days under refrigeration [2° to 8°C (36º to 46°F)]. After removal from refrigeration, the activated bag should be used within 48 hours. The product should be used immediately after the introduction of additives. If not used immediately, the storage time and conditions prior to use should not be longer than 24 hours at 2° to 8°C (36° to 46°F). After removal from storage at 2° to 8°C (36° to 46°F), the admixture should be infused within 24 hours. Any mixture remaining must be discarded.

Berechtigungsstatus:

New Drug Application

Fachinformation

KABIVEN- DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, 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
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KABIVEN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KABIVEN.
KABIVEN (AMINO ACIDS, ELECTROLYTES, DEXTROSE AND LIPID INJECTABLE
EMULSION), FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Boxed Warning (Removed)
5/2023
Dosage and Administration (2.1)
5/2023
Warnings and Precautions (5.1)
5/2023
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. (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)
DOSAGE AND ADMINISTRATION
For intravenous infusion only into a central vein. (2.1, 5.10)
See full prescribing information regarding preparation,
administration, instructions for use, the
recommended dosage in adults, and dosage modifications for patients
with renal impairment. (2.1, 2.2,
2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
KABIVEN is a sterile, hypertonic emulsion in a three-chamber
container. The individual chambers
contain one of the following: amino acids and electrolytes, dextrose,
or lipid injectable emulsion. (3)
KABIVEN is available in four sizes 2,566 mL, 2,053 mL, 1,540 mL and
1,026 mL. (3)
CONTRAINDICATIONS
Concomitant treatment with ceftriaxone in neonates (28 days of age or
younger). (4)
Known hypersensitivity to eg