SODIUM CHLORIDE injection, solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Physicians Total Care, Inc.

INN (Isem Internazzjonali):

SODIUM CHLORIDE

Kompożizzjoni:

SODIUM CHLORIDE 9 mg in 1 mL

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

0.9% Sodium Chloride Injection, USP is supplied in the following: NDC No. Container & Quantity      Size 54868-4464-0          Fliptop Plastic Vial              25 10 mL Store at 20 to 25o C (68 to 77o F) [See USP Controlled Room Temperature.] Revised: November, 2009 Printed in USA EN-2319 Hospira, Inc., Lake Forest, IL 60045 USA

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

SODIUM CHLORIDE - SODIUM CHLORIDE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
0.9% SODIUM CHLORIDE INJECTION, USP
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 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 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 in