SODIUM CHLORIDE- sodium chloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 9 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows: Preservative Free. Discard unused portion. Use only if solution is clear and seal intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature] www.fresenius-kabi.com/us 45764F Revised: November 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM CHLORIDE - SODIUM CHLORIDE INJECTION
FRESENIUS KABI USA, LLC
----------
SODIUM CHLORIDE INJECTION, USP
0.9%
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, 0.9% is a sterile, nonpyrogenic
solution. The osmolarity
is 0.300 mOsmol/mL (calculated).
Each mL contains: Sodium chloride 9 mg; Water for Injection q.s. It
contains no
bacteriostat, antimicrobial agent or added buffer and is supplied only
in single dose
containers. 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
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 mechanisms. Water
distribution
d