Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM GLUCONATE (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)
Hospira, Inc.
SODIUM CHLORIDE
SODIUM CHLORIDE 526 mg in 100 mL
IRRIGATION
PRESCRIPTION DRUG
PhysioSol™ 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.
PhysioSolTM Irrigation is supplied in a 1000 mL single-dose semi-rigid irrigation container. (NDC No. 0409-6141-09) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: May, 2010 Printed in USA EN-2512 Hospira, Inc., Lake Forest, IL 60045 USA
New Drug Application
PHYSIOSOL- SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE IRRIGANT HOSPIRA, INC. ---------- PHYSIOSOL IRRIGATION Balanced Electrolyte Solution for Irrigation For All General Irrigation, Washing and Rinsing Purposes NOT FOR INJECTION BY USUAL PARENTERAL ROUTES SEMI-RIGID IRRIGATION CONTAINER Rx only DESCRIPTION PhysioSol™ is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. Each 100 mL of PhysioSol™ Irrigation contains sodium chloride 526 mg, sodium acetate 222 mg, sodium gluconate 502 mg, potassium chloride 37 mg, magnesium chloride hexahydrate 30 mg. The pH is 6.0 (5.0 to 6.5) adjusted with hydrochloric acid. The solution is isotonic (294 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na 140, K 5, Mg 3, Cl 98, HCO 50 alternates (27 as acetate and 23 as gluconate). It contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. PhysioSol may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. Magnesium Chloride, USP is chemically designated magnesium chloride hexahydrate (MgCl • 6H O), colorless, odorless flakes or crystals very 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 Acetate, USP is chemically designated sodium acetate (C H O Na), colorless crystals or white crystalline powder or flakes very soluble in water. It has the following structural formula: TM + + ++ − 3 − ™ 2 2 2 3 2 Sodium gluconate is chemically designated C H NaO , the normal sodium salt of gluconic acid soluble in water. It has the following structural formula: Water for Inject Izlasiet visu dokumentu