sodium chloride- Sodium Chloride injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Sodium Chloride (UNII: 451W47IQ8X) (Sodium Chloride - UNII:451W47IQ8X)

Commercializzato da:

Taro Pharmaceuticals U.S.A., Inc.

INN (Nome Internazionale):

Sodium Chloride

Forma farmaceutica:

INJECTION, SOLUTION

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

This parenteral preparation is 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.

Dettagli prodotto:

Sodium Chloride Injection USP, 0.9% is supplied in 5 mL single-dose (NDC 51672-3019-5) and 10 mL single-dose (NDC 51672-3019-3) polypropylene ampules in cartons containing 20 ampules. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Scheda tecnica

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
TARO PHARMACEUTICALS U.S.A., INC.
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SODIUM CHLORIDE INJECTION USP, 0.9%
RX ONLY
POLYPROPYLENE AMPULE
DESCRIPTION
This preparation is designed solely for parenteral use only after
addition of drugs that require dilution
or must be dissolved in an aqueous vehicle prior to injection.
Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic
solution of sodium chloride and
water for injection. Each mL contains sodium chloride 9 mg. It
contains no bacteriostat, antimicrobial
agent or added buffer and is supplied only in single-dose containers
to dilute or dissolve drugs for
injection. 0.308 m0smol/mL (calc.). The solution may contain
hydrochloric acid and/or sodium
hydroxide for pH adjustment. The pH is 5.3 (4.5 to 7.0).
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline compound freely soluble in
water.
The blow-fill-sealed polypropylene plastic ampule is
transparent/translucent in color with a twist-off
top.
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
Sodium Chloride Injection USP,
0.9% when used only as an isotonic vehicle for parenteral injection of
drugs, is unlikely to exert a
significant effect on fluid and electrolyte balance except possibly in
neonates and 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 for
insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mecha