Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37), 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 600 mg in 100 mL
IRRIGATION
PRESCRIPTION DRUG
Lactated Ringer’s Irrigation 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.
Lactated Ringer's Irrigation is supplied sterile and nonpyrogenic in single-dose 3000 mL flexible irrigation container packaged 4 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]; however, brief exposure up to 40°C does not adversely affect the product. Do not warm container over 150°F (66°C).
New Drug Application
LACTATED RINGERS IRRIGATION- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE SOLUTION B. BRAUN MEDICAL INC. ---------- LACTATED RINGER'S IRRIGATION _FOR ALL GENERAL IRRIGATION, WASHING AND RINSING PURPOSES_ NOT FOR INJECTION BY USUAL PARENTERAL ROUTES FLEXIBLE IRRIGATION CONTAINER DESCRIPTION Lactated Ringer’s Irrigation is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. The composition is based on a modification of the injectable formula originally known as Hartmann’s Solution. Each 100 mL of Lactated Ringer’s Irrigation contains: Sodium chloride 600 mg; sodium lactate, anhydrous 310 mg; potassium chloride 30 mg; calcium chloride, dihydrate 20 mg. The pH is 6.75 (6.0 — 7.5). The solution is isotonic (273 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Sodium (Na ) 130; potassium (K ) 4; calcium (Ca ) 3; chloride (Cl¯) 109 and lactate (CH CH(OH)COO¯) 28. Contains sodium hydroxide and may contain hydrochloric acid for pH adjustment. The solution contains no bacteriostatic or 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. Lactated Ringer’s Irrigation may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl • 2H O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated C H NaO , a 60% aqueous solution miscible in water. It has the following structural formula: + + ++ 3 2 2 3 5 3 Water for Injection, USP is chemically designated H O. The plastic container is made from a m Lesen Sie das vollständige Dokument