Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
SODIUM ACETATE (UNII: 4550K0SC9B) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37)
Fresenius Kabi USA, LLC
SODIUM ACETATE
SODIUM CATION 328 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Sodium Acetate Injection, USP (4 mEq per mL) is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Sodium Acetate Injection, USP (4 mEq per mL) is contraindicated in patients with hypernatremia or fluid retention.
Sodium Acetate Injection, USP is packaged in a pharmacy bulk package vial, 20 vials per tray, and is available as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451406 Issued: December 2017
Abbreviated New Drug Application
SODIUM ACETATE- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE FRESENIUS KABI USA, LLC ---------- SODIUM ACETATE INJECTION, USP 451406/Issued: December 2017 SODIUM ACETATE Injection, USP Rx only PHARMACY BULK PACKAGE— NOT FOR DIRECT INFUSION FOR ADDITIVE USE ONLY AFTER DILUTION IN INTRAVENOUS FLUIDS. DESCRIPTION: Sodium Acetate Injection, USP (4 mEq per mL) is a sterile, nonpyrogenic, concentrated solution of sodium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains: 328 mg sodium acetate (anhydrous) which provides 4 mEq each of sodium (Na ) and acetate (CH COO ). The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH may have been adjusted with glacial acetic acid to 6.5 (6.0 to 7.0). The osmolar concentration is 8 mOsmol/mL (calc); specific gravity 1.1511. The solution is intended as an alternative to sodium chloride to provide sodium ion (Na ) for addition to large volume infusion fluids for intravenous use. Sodium acetate, USP anhydrous is chemically designated as CH COONa, a hygroscopic powder very soluble in water. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. CLINICAL PHARMACOLOGY: Sodium is the principal cation of extracellular fluid. It comprises more than 90% of total cations at its normal plasma concentration of approximately 140 mEq/L. The sodium ion exerts a primary role in controlling total body water and its distribution. Acetate (CH COO ) is a hydrogen ion acceptor. It also serves as an alternate source of bicarbonate (HCO ) by metabolic conversion in the liver. This conversion has been shown to proceed readily, even in the presence of severe liver disease. INDICATIONS AND USAGE: Sodium Acetate Injection, USP (4 mEq per mL Les hele dokumentet