SODIUM CHLORIDE irrigant

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:

Hospira, Inc.

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 900 mg in 100 mL

Administration route:

IRRIGATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution. NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Product summary:

0.45% Sodium Chloride Irrigation, USP: 0.9% Sodium Chloride Irrigation, USP: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: May, 2009

Authorization status:

New Drug Application

Summary of Product characteristics

SODIUM CHLORIDE- SODIUM CHLORIDE IRRIGANT
HOSPIRA, INC.
----------
0.45% SODIUM CHLORIDE IRRIGATION, USP
0.9% SODIUM CHLORIDE IRRIGATION, USP
For All General Irrigation, Washing, Rinsing and Dilution Purposes
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES
FLEXIBLE IRRIGATION CONTAINER
SEMI-RIGID IRRIGATION CONTAINER
R only
DESCRIPTION
These products are sterile, nonpyrogenic solutions of electrolytes in
water for injection intended only
for sterile irrigation, washing, rinsing and dilution purposes.
Each 100 mL of 0.45% Sodium Chloride Irrigation, USP contains: Sodium
chloride 450 mg; pH 5.6
(4.5 to 7.0). The solution is hypotonic (154 mOsmol/liter, CALC.) and
has the following electrolyte
content (mEq/liter): Na 77; Cl
77.
Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium
chloride 900 mg; pH 5.6 (4.5
to 7.0). May contain sodium hydroxide and/or hydrochloric acid for pH
adjustment. The solution is
isotonic (308 mOsmol/liter, CALC.) and has the following electrolyte
content (mEq/liter): Na 154; Cl
154.
These irrigations contain no bacteriostat, antimicrobial agent or
added buffer and are intended only for
use as single-dose or short procedure irrigation. When smaller volumes
are required the unused
portion should be discarded.
Each of these irrigations may be classified as a sterile irrigant,
wash, rinse, diluent and pharmaceutical
vehicle.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely soluble in
water.
Water for Injection, USP is chemically designated H O.
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride. Water can
permeate from inside the container into the overwrap but not in
amounts sufficient to affect the solution
significantly.
The semi-rigid container is fabricated from a specially formulated
polyolefin. It is a copolymer of
ethylene and propylene. The container requires no vapor barrier to
maintain the proper drug
concentration.
Solutions in contact with the plastic container may leach out certain
chemical c