Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)
Hospira, 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 in single-dose 3000 mL flexible irrigation containers (NDC No. 0409–7828–08). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: May, 2009 Printed in USA EN-2136 Hospira, Inc., Lake Forest, IL 60045 USA
New Drug Application
LACTATED RINGERS- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE IRRIGANT HOSPIRA, INC. ---------- LACTATED RINGER’S IRRIGATION _FOR ALL GENERAL IRRIGATION, WASHING AND RINSING PURPOSES_ NOT FOR INJECTION BY USUAL PARENTERAL ROUTES FLEXIBLE IRRIGATION CONTAINER R Only 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 6.6 (6.0 — 7.5). The solution is isotonic (274 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 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. 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: x + + ++ − 3 − 2 2 3 5 3 Water for Injection, USP is chemically designated H O. The flexible plastic container is fabricated f Pročitajte cijeli dokument