Land: USA
Språk: engelska
Källa: 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)
ICU Medical Inc.
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 in a single-dose 1000 mL semi-rigid irrigation container (NDC No. 0409–6140–09; NDC No. 0990-6140-09). ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: July, 2020 EN-5962 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
New Drug Application
RINGERS IRRIGATION- SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE IRRIGANT INJECTION, SOLUTION ICU MEDICAL INC. ---------- 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 These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. Each 100 mL of Ringer’s Irrigation, USP contains: Sodium chloride 860 mg; potassium chloride 30 mg; calcium chloride dihydrate 33 mg. The pH is 5.7 (5.0 — 7.5). The solution is isotonic (309 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na 147.5; K 4; Ca 4.5; Cl 156. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as 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. 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. Water for Injection, USP is chemically designated H O. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moi Läs hela dokumentet