BACTERIOSTATIC SODIUM CHLORIDE- sodium chloride injection

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Fresenius Kabi USA, LLC

INN (Algemene Internationale Benaming):

SODIUM CHLORIDE

Samenstelling:

SODIUM CHLORIDE 9 mg in 1 mL

Toedieningsweg:

SUBCUTANEOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 . Due to potential toxicity of benzyl alcohol in newborns, Bacteriostatic Sodium Chloride Injection, USP, 0.9% containing benzyl alcohol must not be used in this patient population. Bacteriostatic Sodium Chloride Injection, USP, 0.9% should not be used for fluid or sodium chloride replacement.

Product samenvatting:

Bacteriostatic Sodium Chloride Injection, USP, 0.9%, preserved with benzyl alcohol is available as follows: Use only if solution is clear and seal intact. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

BACTERIOSTATIC SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION
FRESENIUS KABI USA, LLC
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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; benzyl alcohol 0.9%; 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 concentration of electrolytes in the body compartments and sodium
(Na
) plays a major role in
maintaining physiologic equilibrium.
INDICATIONS AND USAGE
These parenteral preparations are indicated only for diluting o