SODIUM CHLORIDE injection

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Physicians Total Care, Inc.

INN (Tarptautinis Pavadinimas):

SODIUM CHLORIDE

Sudėtis:

SODIUM CHLORIDE 9 mg in 1 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

Bacteriostatic 0.9% Sodium Chloride Injection, USP is supplied in multiple-dose 30 mL plastic fliptop vials (List No. 1966) or in multiple-dose 30 mL plastic LifeShield® fliptop vials* (List No. 1966). *Intended for use with the LifeShield® Blunt Cannula. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: April, 2005   ©Hospira 2005        EN-1169        Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma        74146

Autorizacija statusas:

New Drug Application

Prekės savybės

SODIUM CHLORIDE - SODIUM CHLORIDE INJECTION
PHYSICIANS TOTAL CARE, INC.
----------
BACTERIOSTATIC
0.9% SODIUM CHLORIDE
INJECTION, USP
R only
MULTIPLE-DOSE PLASTIC VIAL
MULTIPLE-DOSE LIFESHIELD PLASTIC VIAL
NOT FOR INHALATION
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 balance except
possibly in neonates and very small