SODIUM ACETATE injection, solution, concentrate

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

SODIUM ACETATE (UNII: 4550K0SC9B) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37)

Tilgjengelig fra:

Fresenius Kabi USA, LLC

INN (International Name):

SODIUM ACETATE

Sammensetning:

SODIUM CATION 328 mg in 100 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

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

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SODIUM ACETATE- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE
FRESENIUS KABI USA, LLC
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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