NORMOSOL-M AND DEXTROSE- dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM ACETATE (UNII: M911911U02) (POTASSIUM CATION - UNII:295O53K152), MAGNESIUM ACETATE (UNII: 0E95JZY48K) (MAGNESIUM CATION - UNII:T6V3LHY838)

Available from:

Hospira, Inc.

INN (International Name):

DEXTROSE MONOHYDRATE

Composition:

DEXTROSE MONOHYDRATE 5 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is indicated for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories from dextrose. Magnesium in the formula may help to prevent iatrogenic magnesium deficiency in patients receiving prolonged parenteral therapy. None known.

Product summary:

Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is supplied in single-dose flexible plastic containers. 0409-7965-03 Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP) 0409-7965-09  Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: August, 2009 EN-2220 Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA  

Authorization status:

New Drug Application

Summary of Product characteristics

NORMOSOL-M AND DEXTROSE- DEXTROSE MONOHYDRATE, SODIUM CHLORIDE,
POTASSIUM
ACETATE, AND MAGNESIUM ACETATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
NORMOSOL
-M AND 5% DEXTROSE INJECTION
MULTIPLE ELECTROLYTES AND 5% DEXTROSE INJECTION TYPE 1, USP
FLEXIBLE PLASTIC CONTAINER
Rx Only
DESCRIPTION
Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5%
Dextrose Injection Type 1,
USP) is a sterile, nonpyrogenic, hypertonic solution of balanced
maintenance electrolytes and 5%
dextrose injection in water for injection.
The solution is administered by intravenous infusion for parenteral
maintenance of routine daily fluid
and electrolyte requirements with minimal carbohydrate calories.
Each 100 mL contains dextrose, hydrous 5 g, sodium chloride, 234 mg,
potassium acetate, 128 mg and
magnesium acetate, anhydrous 21 mg. May contain hydrochloric acid for
pH adjustment. The electrolyte
content (not including hydrochloric acid) and other characteristics
are as follows:
Sodium (Na )
40 mEq/liter
Potassium (K )
13 mEq/liter
Magnesium (Mg
)
3 mEq/liter
Chloride (Cl
)
40 mEq/liter
Bicarbonate (HCO ) as acetate
16 mEq/liter
Caloric value (dextrose)
170 Calories/liter
Tonicity
Hypertonic
Osmolarity
363 mOsmol/liter (calc.)
pH (range)
5.0 (4.0 to 6.5)
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-M and 5% Dextrose Injection is a parenteral fluid,
electrolyte and nutrient replenisher.
Dextrose, USP is chemically designated D-glucose monohydrate (C H O
• H O), a hexose sugar
freely soluble in water. It has the following structural formula:
TM
+
+
++
−
3
−
6
12
6
2
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely soluble in
water.
Potassium Acetate, USP is chemically designated CH COOK, colorless
crystals or white crystalline
powder very soluble in water.
Magnesium acetate is chemically design