NORMOSOL-R AND DEXTROSE- dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesiu

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) (DEXTROSE, UNSPECIFIED FORM - UNII:IY9XDZ35W2), 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), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838)

Disponível em:

ICU Medical Inc.

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Normosol-R and 5% Dextrose Injection is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R and 5% Dextrose also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. The solution 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.

Resumo do produto:

Normosol-R and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is supplied in a 1000 mL single-dose flexible plastic container (NDC No. 0409–7968–09 and 0990-7968-09). ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. TABLE Electrolyte Content, Caloric Value and Characteristics Milliequivalents per Liter HC0 - 3 (alternates) Cal* mOsmol/L Tonicity Na + K + Mg ++ Cl - Acetate Gluconate per Liter (calc.) (total contents) pH Normosol-R and 5% Dextrose 140 5 3 98** 27 23 185 547 Hypertonic 5.2 (4.0 to 6.5) * Normosol-R and 5% Dextrose calories derived from dextrose (170) and gluconate (15). **Not including hydrochloric acid. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. ® Normosol − multiple electrolyte solution, ICU Medical, Inc. Revised: March, 2020 IFU0000172 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

Status de autorização:

New Drug Application

Características técnicas

NORMOSOL-R AND DEXTROSE- DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE
ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM
CHLORIDE INJECTION, SOLUTION
ICU MEDICAL INC.
----------
NORMOSOL
-R AND 5% DEXTROSE INJECTION
_MULTIPLE ELECTROLYTES AND 5% DEXTROSE INJECTION TYPE 1, USP_
FOR REPLACING ACUTE LOSSES OF EXTRACELLULAR FLUID
FLEXIBLE PLASTIC CONTAINER
R only
DESCRIPTION
Normosol-R and 5% Dextrose Injection is a sterile, nonpyrogenic
solution of balanced
electrolytes (with dextrose) in water for injection. The solution is
administered by
intravenous infusion for parenteral replacement of acute losses of
extracellular fluid
(with minimal carbohydrate calories).
Each 100 mL of Normosol-R and 5% Dextrose Injection contains dextrose
5 g; sodium
chloride 526 mg; sodium acetate, anhydrous 222 mg; sodium gluconate
502 mg;
potassium chloride 37 mg; magnesium chloride, hexahydrate 30 mg; pH
adjusted with
hydrochloric acid.
See TABLE for summary of electrolyte content, caloric value and
characteristics of this
solution.
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 and 5% Dextrose Injection is a parenteral fluid,
electrolyte and nutrient
replenisher.
Dextrose, USP is chemically designated D-glucose monohydrate (C H
O • H 0), a
hexose sugar freely soluble in water. It has the following structural
formula:
®
x
6
12
6
2
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: