SODIUM CHLORIDE injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)

Disponible des:

Spectra Medical Deviecs, LLC

Designació comuna internacional (DCI):

SODIUM CHLORIDE

Composición:

SODIUM CHLORIDE 9 mg in 1 mL

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. 0.9% 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 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. The glass ampules made up of Type I glass are used as a primary container for the drug product. Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.

Resumen del producto:

0.9% Sodium Chloride Injection, USP is supplied in the following: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Spectra Medical Devices, LLC Wilmington, MA 01887 [phone] By: Huons Co., Ltd. 100 Bio valley-ro Jecheon-si Chungcheongbuk-do, 27159 Republic of Korea XX#### Rev. # MM/YY

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
SPECTRA MEDICAL DEVIECS, LLC
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SODIUM CHLORIDE INJECTION
0.9% Sodium Chloride
Injection, USP
RX ONLY
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.
0.9% 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 mOsmol/mL (calc.).
0.9% Sodium Chloride Injection, USP contains no preservatives. The
solution may
contain hydrochloric acid and/or sodium hydroxide for pH adjustment.
The pH range is
4.5 to 7.0. The glass ampules made up of Type I glass are used as a
primary container
for the drug product.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline compound freely
soluble in water.
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
0.9% Sodium
Chloride Injection, USP 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 (1.0 to 1.5 liters each for insensible water loss by
perspiration and urine
production