SODUM ACETATE- sodium acetate injection, solution, concentrate

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

American Regent, Inc.

INN (Medzinárodný Name):

SODIUM ACETATE ANHYDROUS

Zloženie:

SODIUM ACETATE ANHYDROUS 328 mg in 1 mL

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Sodium Acetate for Injection, USP CONCENTRATE is indicated as a source of sodium 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 for Injection, USP CONCENTRATE is contraindicated in patients with HYPERNATREMIA.

Prehľad produktov:

Sodium Acetate for Injection, USP CONCENTRATE (4 mEq /mL) NDC 0517-5023-25     50 mL Single Dose Vial     packed in boxes of 25 Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) (See USP Controlled Room Temperature). AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN5023 Rev. 11/05

Stav Autorizácia:

unapproved drug other

Súhrn charakteristických

SODUM ACETATE- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE
AMERICAN REGENT, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
SODIUM ACETATE FOR INJECTION, USP CONCENTRATE
RX ONLY
32.8% (4 MEQ/ML) 7997 MOSMOL/L
CALCULATED PH (6.0-7.0) (8 MOSMOL/ML)
CAUTION: FOR INTRAVENOUS USE ONLY
MUST BE DILUTED PRIOR TO ADMINISTRATION
DESCRIPTION
Sodium Acetate for Injection, USP CONCENTRATE, 4 mEq/mL, is a sterile,
nonpyrogenic,
concentrated solution of Sodium Acetate (C H NaO ) in Water for
Injection. It must be diluted prior to
administration.
Each 50 mL vial contains 16.4 grams of Sodium Acetate (anhydrous)
which provides 200 mEq each of
Sodium (Na ) and Acetate (CH COO ).
The pH is adjusted with acetic acid and the solution contains no
bacteriostatic agent or other
preservative.
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. Unused portion
should be discarded.
CLINICAL PHARMACOLOGY
Sodium is the principal cation of extracellular fluids. The sodium ion
exerts a primary role in
controlling total body water and its distribution. The acetate ion is
completely metabolized in the body,
providing a source of hydrogen ion acceptors.
INDICATIONS AND USAGE
Sodium Acetate for Injection, USP CONCENTRATE is indicated as a source
of sodium 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.
CONTRAINDICATIONS
Sodium Acetate for Injection, USP CONCENTRATE is contraindicated in
patients with
HYPERNATREMIA.
WARNINGS
Sodium Acetate for Injection, USP CONCENTRATE must be diluted before
use. To avoid sodium
overload and water retention, infuse sodium containing solutions
slowly. Do not use unless solution is
clear a