SODIUM ACETATE injection, solution, concentrate

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC)

Disponible desde:

Hospira, Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Sodium Acetate Injection, USP 40 mEq 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 40 mEq is contraindicated in patients with hypernatremia or fluid retention.

Resumen del producto:

Sodium Acetate Injection, USP 40 mEq (2 mEq/mL) is supplied as follows: Each vial is partially filled to provide air space for complete vacuum withdrawal of the contents into the intravenous container. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc. Lake Forest, IL 60045 USA LAB-0890-3.0 01/2018

Estado de Autorización:

New Drug Application

Ficha técnica

SODIUM ACETATE- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE
HOSPIRA, INC.
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SODIUM ACETATE
INJECTION, USP
40 MEQ (2 MEQ/ML)
_FOR ADDITIVE USE ONLY AFTER_
_DILUTION IN INTRAVENOUS FLUIDS_.
PLASTIC VIAL
RX ONLY
DESCRIPTION
Sodium Acetate Injection, USP 40 mEq (2 mEq/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 20 mL contains 3.28 g of
sodium acetate (anhydrous) which provides 40 mEq each of sodium (Na )
and acetate (CH COO ). The
solution contains no bacteriostat, antimicrobial agent or added
buffer. May contain acetic acid for pH
adjustment; the pH is 6.5 (6.0 to 7.0). The osmolar concentration is 4
mOsmol/mL (calc).
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 CH COONa, a
hygroscopic powder very
soluble in water.
The semi-rigid container is fabricated from a specially formulated
polyolefin. It is a copolymer of
ethylene and propylene. The safety of the plastic has been confirmed
by tests in animals according to
USP biological standards for plastic containers. The container
requires no vapor barrier to maintain the
proper drug concentration.
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/liter. The sodium
ion exerts a primary role in
controlling total body water and its distribution.
Acetate (CH COO ), a source of hydrogen ion acceptors, is an alternate
source of bicarbonate
(HCO ) by metabolic conversion in the liver. This has been shown to
proceed readily, even in the
presence of severe liver disease.
INDICATIONS AND USAGE
Sodium Acetate Injection, USP 40 mEq is indicated as a source of
sodium, for addition