देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)
B. Braun Medical Inc.
SODIUM CHLORIDE
SODIUM CHLORIDE 0.86 g in 100 mL
IRRIGATION
PRESCRIPTION DRUG
Ringer’s Irrigation USP is indicated for all general irrigation, washing and rinsing 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.
Ringer’s Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Containers). The 1000 mL containers are packaged 16 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
New Drug Application
RINGERS- SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE IRRIGANT B. BRAUN MEDICAL INC. ---------- RINGER'S IRRIGATION USP Package Insert PIC™ (PLASTIC IRRIGATION CONTAINERS) RINGER’S IRRIGATION USP _FOR ALL GENERAL IRRIGATION, WASHING AND RINSING PURPOSES_ NOT FOR INJECTION BY USUAL PARENTERAL ROUTES SEMI-RIGID IRRIGATION CONTAINER RX ONLY DESCRIPTION Ringer’s Irrigation USP is a sterile, nonpyrogenic, solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. Each 100 mL contains: Sodium Chloride USP 0.86 g; Potassium Chloride USP 0.03 g Calcium Chloride Dihydrate USP 0.033 g; Water for Injection USP qs pH: 5.8 (5.0-7.5). The solution is isotonic (310 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na 147; K 4 Ca 4.5; Cl 156 The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Ringer’s Irrigation USP may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. The formulas of the active ingredients are: INGREDIENTS MOLECULAR FORMULAMOLECULAR WEIGHT Sodium Chloride USP NaCl 58.44 Potassium Chloride USP KCl 74.55 Calcium Chloride Dihydrate USP CaCl •2H O 147.01 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 + + ++ − 2 2 container is nontoxic and biologically inert. Not made with natural rub पूरा दस्तावेज़ पढ़ें