Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R), MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A)
Hospira, Inc.
SORBITOL
SORBITOL 2.7 g in 100 mL
URETHRAL
PRESCRIPTION DRUG
Sorbitol-Mannitol Irrigation is indicated for use as a urologic irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures. NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. Do not use in patients with anuria.
Sorbitol-Mannitol Irrigation is supplied in single-dose 3000 mL flexible irrigation container (NDC No. 0409-7981-08). Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Revised: May, 2009 Printed in USA EN-2127 Hospira, Inc., Lake Forest, IL 60045 USA
New Drug Application
SORBITOL-MANNITOL- SORBITOL AND MANNITOL IRRIGANT HOSPIRA, INC. ---------- SORBITOL-MANNITOL IRRIGATION _NONELECTROLYTIC IRRIGATING FLUID FOR TRANSURETHRAL SURGICAL_ _PROCEDURES_ FOR UROLOGIC IRRIGATION ONLY; NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. FLEXIBLE IRRIGATION CONTAINER Rx only DESCRIPTION Sorbitol-Mannitol Irrigation is a sterile, nonpyrogenic, hypotonic, aqueous solution for urologic nonelectrolyte irrigation during transurethral surgical procedures. Each 100 mL contains sorbitol 2.70 g and mannitol 0.54 g in water for injection. The solution is nonelectrolytic and hypotonic (178 mOsmol/liter calc.); pH 5.2 (4.0 to 7.0). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose irrigation. When smaller volumes are required the unused portion should be discarded. Sorbitol-Mannitol Irrigation is a nonelectrolyte urologic irrigant. Sorbitol, NF is chemically designated D-glucitol (C H O ), white powder, granules or flakes very soluble in water. It has the following structural formula: Mannitol, USP is chemically designated D-mannitol (C H O ), white crystalline powder or free- flowing granules, freely soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 0. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can 6 14 6 6 14 6 2 permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. 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 storag Soma hati kamili