BACTERIOSTATIC SODIUM CHLORIDE- sodium chloride injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Disponível em:

APP Pharmaceuticals, LLC

DCI (Denominação Comum Internacional):

SODIUM CHLORIDE

Composição:

SODIUM CHLORIDE 9 mg in 1 mL

Via de administração:

SUBCUTANEOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

These parenteral preparations are indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.  NOT FOR INHALATION. Bacteriostatic Sodium Chloride Injection, USP, 0.9% should not be used for fluid or sodium chloride replacement.

Resumo do produto:

Bacteriostatic Sodium Chloride Injection, USP, 0.9%, preserved with parabens is available as follows:   Product No. NDC No. Strength 205910 63323-259-10 0.9% 10 mL multiple dose vial, in packages of 25. 205930 63323-259-30 0.9% 30 mL multiple dose vial, in packages of 25. Use only if solution is clear and seal intact. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status de autorização:

unapproved drug other

Características técnicas

BACTERIOSTATIC SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION
APP PHARMACEUTICALS, LLC
_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._
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BACTERIOSTATIC SODIUM CHLORIDE INJECTION USP
0.9%
_NOT FOR USE IN NEWBORNS_
DESCRIPTION
Bacteriostatic Sodium Chloride Injection, USP, 0.9% is a sterile,
nonpyrogenic, isotonic solution.
Each mL contains: Sodium chloride 9 mg; methylparaben 0.12%;
propylparaben 0.012%; Water for
Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been
added for pH adjustment (pH
4.5-7.0).
Sodium chloride occurs as colorless cubic crystals or white
crystalline powder and has a saline taste.
Sodium chloride is freely soluble in water. It is soluble in glycerin
and slightly soluble in alcohol.
The empirical formula for sodium chloride is NaCl and the molecular
weight is 58.44.
CLINICAL PHARMACOLOGY
Sodium chloride in water dissociates to provide sodium (Na ) and
chloride (Cl ) ions. These ions are
normal constituents of the body fluids (principally extracellular) and
are essential for maintaining
electrolyte balance.
The distribution and excretion of sodium (Na ) and chloride (Cl ) are
largely under the control of the
kidney which maintains a balance between intake and output.
The small volume of fluid and amount of sodium chloride provided by
Bacteriostatic Sodium Chloride
Injection, USP, 0.9%, when used only as a vehicle for parenteral
injection of drugs, is unlikely to exert
a significant effect on fluid and electrolyte balance except possibly
in very small infants.
Water is an essential constituent of all body tissues and accounts for
approximately 70% of total body
weight. Average normal adult daily requirement ranges from two to
three liters (1 to 1.5 liters each of
insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water
distribution depends primarily on
the concentr