SODIUM CHLORIDE injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Cardinal Health 107, LLC

INN (International namn):

SODIUM CHLORIDE

Sammansättning:

SODIUM CHLORIDE 9 mg in 1 mL

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

0.9% Sodium Chloride Injection, USP is supplied in the following: 0.9% Sodium Chloride Injection, USP is available overbagged with 5 x 10 mL Single-dose Plastic Fliptop Vials per bag, NDC 55154-0126-5 0.9% (10 mL) Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.] Instructions for Use of the Syringe Systems Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02. LIFESHIELD® is the trademark of ICU Medical, Inc. and is used under license. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                  LAB-1097-3.0 Distributed by: Cardinal Health Dublin, OH 43017 L28642700223 Revised: 08/2021

Bemyndigande status:

New Drug Application

Produktens egenskaper

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
CARDINAL HEALTH 107, LLC
----------
0.9% SODIUM CHLORIDE
Injection, USP
CARPUJECT™ WITH LUER LOCK
FLIPTOP PLASTIC VIAL
LIFESHIELD FLIPTOP PLASTIC VIAL
_PRESERVATIVE-FREE_
_ _
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.
pH 5.3 (4.5 to
7.0).
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline compound freely
soluble in water.
The glass container is a Type I borosilicate glass and meets the
requirements of the
powdered glass test according to the USP standards.
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
0.9% Sodium
Chloride Injection, USP when used only as an isoto