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

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Kauptu það núna

Download Vara einkenni (SPC)
11-07-2020

Virkt innihaldsefni:

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)

Fáanlegur frá:

Hospira, Inc.

INN (Alþjóðlegt nafn):

DEXTROSE

Samsetning:

DEXTROSE 5 g in 100 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

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). 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, Hospira Revised: May, 2009 Printed in USA EN-2133 Hospira, Inc., Lake Forest, IL 60045 USA

Leyfisstaða:

New Drug Application

Vara einkenni

                                NORMOSOL-R AND DEXTROSE- DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE
ANHYDROUS,
SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
INJECTION, SOLUTION
HOSPIRA, INC.
----------
NORMOS OL
-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 0) 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:
So
                                
                                Lestu allt skjalið