Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
B. Braun Medical Inc.
SODIUM CHLORIDE
SODIUM CHLORIDE 0.9 g in 100 mL
IRRIGATION
PRESCRIPTION DRUG
0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution. 0.9% Sodium Chloride Irrigation USP is 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 sterile and nonpyrogenic in single-dose 2000 mL and 3000 mL plastic containers packaged 4 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
New Drug Application
SODIUM CHLORIDE FOR IRRIGATION- SODIUM CHLORIDE FOR IRRIGATION SOLUTION B. BRAUN MEDICAL INC. ---------- 0.9% SODIUM CHLORIDE IRRIGATION USP ISOTONIC SOLUTION FOR IRRIGATION. FOR IRRIGATION ONLY. NOT FOR INJECTION. DESCRIPTION Each 100 mL contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.75 (4.50-7.00) Calculated Osmolarity: 308 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154 0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is: INGREDIENT MOLECULAR FORMULA MOLECULAR WEIGHT Sodium Chloride USP NaCl 58.44 The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Not made with natural rubber latex, PVC or DEHP. CLINICAL PHARMACOLOGY 0.9% Sodium Chloride Irrigation USP is utilized for a variety of clinical indications such as sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations. 0.9% Sodium Chloride Irrigation USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection USP (normal saline). Physiological irrigation solutions are considered generally compatible with living tissues and organs. Sodium, the major cation of the extrac Прочетете целия документ