NORMOSOL-R- sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride injection, s

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM GLUCONATE (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)

Disponible desde:

Hospira, Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Normosol-R is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume. None known.

Resumen del producto:

Normosol-R (Multiple Electrolytes Injection Type 1, USP) is supplied in single-dose flexible plastic containers. NDC No. Product Container Size (mL) 0409-7967-03 Normosol-R (Multiple Electrolytes Injection Type 1, USP) 500 0409-7967-09 Normosol-R (Multiple Electrolytes Injection Type 1, USP) 1000 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: May, 2009 Printed in USA EN-2145 Hospira, Inc., Lake Forest, IL 60045 USA

Estado de Autorización:

New Drug Application

Ficha técnica

NORMOSOL-R- SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM
GLUCONATE, POTASSIUM
CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
NORMOSOL -R
_MULTIPLE ELECTROLYTES INJECTION TYPE 1, USP_
FOR REPLACING ACUTE LOSSES OF EXTRACELLULAR FLUID
FLEXIBLE PLASTIC CONTAINER
R only
DESCRIPTION
Normosol-R is a sterile, nonpyrogenic isotonic solution of balanced
electrolytes in water for injection.
The solution is administered by intravenous infusion for parenteral
replacement of acute losses of
extracellular fluid.
Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium
acetate, 222 mg; sodium
gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride
hexahydrate, 30 mg. May contain
HCl and/or NaOH for pH adjustment. pH 6.6 (4.0 to 8.0); 294
mOsmol/liter (calc.).
Electrolytes per 1000 mL (not including pH adjustment): Sodium 140
mEq; potassium 5 mEq; magnesium
3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23 mEq.
The solution contains no bacteriostat, antimicrobial agent or added
buffer (except for pH adjustment) and
is intended only for use as a single-dose injection. When smaller
doses are required the unused portion
should be discarded.
Normosol-R is a parenteral fluid and electrolyte replenisher.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely soluble in
water.
Potassium Chloride, USP is chemically designated KCl, a white granular
powder freely soluble in
water.
Magnesium Chloride, USP is chemically designated magnesium chloride
hexahydrate (MgCl
• 6H O)
deliquescent crystals very soluble in water.
Sodium Acetate, USP, is chemically designated sodium acetate anhydrous
(C H NaO ), a hygroscopic
powder soluble in water. It has the following structural formula:
Sodium gluconate is chemically designated C H NaO , the normal sodium
salt of gluconic acid
soluble in water. It has the following structural formula:
®
x
2
2
2
3
2
6
11
7
Water for Injection, USP is chemically designated H O.
The flexible plastic container is fabricated from