SODIUM CHLORIDE injection, solution

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:

B. Braun Medical Inc.

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 9 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE  of drug additives to be administered in this manner. This solution is contraindicated where the administration of sodium or chloride could be clinically detrimental.

Product summary:

0.9% Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in partial fill polyolefin containers. The 100/150 mL product is packaged 64 per case. The 50/100 mL product is packaged 84 per case. The 25/100 mL product is packaged 116 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Authorization status:

New Drug Application

Summary of Product characteristics

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
----------
0.9% SODIUM CHLORIDE INJECTION USP
PARTIAL FILL
DESCRIPTION
Each mL of 0.9% Sodium Chloride Injection USP contains:
Sodium Chloride USP 9 mg; Water for Injection USP qs
pH adjusted with Hydrochloric Acid NF
pH: 5.5 (4.5–7.0)
Calculated Osmolarity: 310 mOsmol/liter
Concentration of Electrolytes (mEq/100 mL): Sodium 15.4 Chloride 15.4
This solution is sterile, nonpyrogenic, isotonic and contains no
bacteriostatic or
antimicrobial agents.
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULAMOLECULAR WEIGHT
Sodium Chloride USP
NaCl
58.44
Not made with natural rubber latex, PVC or DEHP.
The plastic container is a copolymer of ethylene and propylene
formulated and
developed for parenteral drugs. The copolymer contains no plasticizers
and exhibits
virtually no leachability. The safety of the plastic container has
been confirmed by
biological evaluation procedures. The material passes Class VI testing
as specified in the
U.S. Pharmacopeia for Biological Tests — Plastic Containers. These
tests have shown
that the container is nontoxic and biologically inert.
The container/solution unit is a closed system and is not dependent
upon entry of
external air during administration. The container has two ports, one
is for the
intravenous administration set and the other is a medication addition
site. Each is
covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of
the container to
properly identify the ports.
No vapor barrier is necessary.
CLINICAL PHARMACOLOGY
0.9% Sodium Chloride Injection USP provides electrolytes and is a
source of water for
hydration. It is capable of inducing diuresis depending on the
clinical condition of the
patient.
Sodium, the major cation of the extracellular fluid, functions
primarily in the control of
water distribution, fluid balance, and osmotic pressure of body
fluids. Sodium is also
associated with chloride and bicarbonate in the regulation of the
acid-base equilibrium of
body flu