Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C)
Hospira, Inc.
GLYCINE
GLYCINE 1.5 g in 100 mL
IRRIGATION
PRESCRIPTION DRUG
1.5% Glycine Irrigation, USP is indicated for use as 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.
1.5% Glycine Irrigation, USP is supplied in single-dose 3000 mL flexible irrigation container ( List No. 7974). Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: October 2004 ©Hospira 2004 EN-0577 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA
New Drug Application
GLYCINE- GLYCINE IRRIGANT HOSPIRA, INC. ---------- 1.5% GLYCINE IRRIGATION, USP _NONELECTROLYTE IRRIGATING FLUID FOR TRANSURETHRAL SURGICAL_ _PROCEDURES._ FOR UROLOGIC IRRIGATION ONLY; NOT FOR INJECTION BY USUAL PARENTERAL ROUTES FLEXIBLE IRRIGATION CONTAINER RX ONLY DESCRIPTION 1.5% Glycine Irrigation, USP is a sterile, nonpyrogenic, hypotonic, aqueous solution of glycine intended only for urologic irrigation during transurethral surgical procedures. Each 100 mL contains 1.5 g of glycine in water for injection. The solution is nonelectrolytic, hypotonic and has an osmolarity of 200 mOsmol/liter (calc.); pH 6.0 (4.5 to 6.5). 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. 1.5% Glycine Irrigation is a urologic nonelectrolyte irrigant. Glycine, USP is chemically designated aminoacetic acid (C H NO ), a white crystalline powder freely soluble in water. It has the following structural formula: NH CH COOH Water for Injection, USP is chemically designated H 0. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can 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. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. 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 Izlasiet visu dokumentu