Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
Hospira, Inc.
SODIUM CHLORIDE
SODIUM CHLORIDE 900 mg in 100 mL
IRRIGATION
PRESCRIPTION DRUG
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.
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
New Drug Application
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 Les hele dokumentet