BACTERIOSTATIC SODIUM CHLORIDE- sodium chloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medical Purchasing Solutions, LLC

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. Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. Parenteral preparations with benzyl alcohol should not be used for fluid or sodium chloride replacement. Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthetic procedures.

Product summary:

Bacteriostatic 0.9% Sodium Chloride Injection, USP is supplied as: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] LIFESHIELD ® is the trademark of ICU Medical, Inc. and is used under license. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                     LAB-1096-3.0 Revised: 02/2019

Authorization status:

New Drug Application

Summary of Product characteristics

BACTERIOSTATIC SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
BACTERIOSTATIC
0.9% SODIUM CHLORIDE
INJECTION, USP
MULTIPLE-DOSE PLASTIC VIAL
MULTIPLE-DOSE LIFESHIELD PLASTIC VIAL
NOT FOR INHALATION
Rx only
WARNING: NOT FOR USE IN NEONATES.
DESCRIPTION
This preparation is designed for parenteral use only after addition of
drugs that require
dilution or must be dissolved in an aqueous vehicle prior to
injection.
Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile,
nonpyrogenic, isotonic
solution of sodium chloride in water for injection. Each milliliter
(mL) contains sodium
chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a
bacteriostatic preservative.
May contain hydrochloric acid for pH adjustment. It is supplied in a
multiple-dose
container from which repeated withdrawals may be made to dilute or
dissolve drugs for
medication. The pH is 5.0 (4.5 to 7.0).
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely
soluble in water.
The semi-rigid vial is fabricated from a specially formulated
polyolefin. It is a copolymer of
ethylene and propylene. The safety of the plastic has been confirmed
by tests in animals
according to USP biological standards for plastic containers. The
container requires no
vapor barrier to maintain the proper drug concentration.
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
0.9% Sodium Chloride Injection, USP, when used only as a vehicle for
parenteral injection
®
+
−
+
−
of drugs, is unlikely to exert a significant effect on fluid and
electrolyte bala