देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)
Cardinal Health
SODIUM CHLORIDE
SODIUM CHLORIDE 0.9 g in 100 mL
PRESCRIPTION DRUG
New Drug Application
SODIUM CHLORIDE- SODIUM CHLORIDE IRRIGANT CARDINAL HEALTH ---------- 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: 5.0 (4.5–7.0) Calculated Osmolarity: 310 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 a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The PIC™ Container is PVC-free and DEHP-free. 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. पूरा दस्तावेज़ पढ़ें