SODIUM CHLORIDE irrigant

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Hospira, Inc.

INN (nemzetközi neve):

SODIUM CHLORIDE

Összetétel:

SODIUM CHLORIDE 900 mg in 100 mL

Az alkalmazás módja:

IRRIGATION

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment). NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Termék összefoglaló:

0.9% Sodium Chloride Irrigation, USP is supplied in a single-dose 3000 mL flexible irrigation container (NDC No. 0409-7972-08). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: January, 2010 Printed in USA                            EN-2369 Hospira, Inc., Lake Forest, IL 60045 USA

Engedélyezési státusz:

New Drug Application

Termékjellemzők

SODIUM CHLORIDE- SODIUM CHLORIDE IRRIGANT
HOSPIRA, INC.
----------
0.9% SODIUM CHLORIDE IRRIGATION, USP
FOR ALL GENERAL IRRIGATION, RINSING, DILUTION AND CELL WASHING
PURPOSES
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES
FLEXIBLE IRRIGATION CONTAINER
Rx only
DESCRIPTION
This product is a sterile, nonpyrogenic solution of electrolytes in
water for injection intended only for
sterile irrigation, rinsing, dilution and cell washing purposes.
Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium
chloride 900 mg. pH 5.6 (4.5
— 7.0). The solution is isotonic (308 mOsmol/liter, calc.) and has
the following electrolyte content
(mEq/liter): Na 154; Cl¯ 154.
This irrigation solution contains no bacteriostat, antimicrobial agent
or added buffer and is intended only
for use as a single-dose, short procedure irrigation, or cell washing
fluid. When smaller volumes are
required the unused portion should be discarded.
It may be classified as a sterile irrigant, rinse, diluent, cell wash
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. Solutions in contact with the plastic container may
leach out certain chemical components
from the plastic in very small amounts; however, biological testing
was supportive of the safety of the
plastic container materials. Exposure to temperatures above
25°C/77°F during transport and storage will
lead to minor losses in moisture content. Higher temperatures lead to
greater losses. It is unlikely that
these minor losses will lead to clinically significant changes within
the expiration period.
CLINICAL PHARMACOLOGY
This irrigation solution exerts a mechanical cleansing action for
sterile irrigation of body cavities,
tissues or