Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R)
B. Braun Medical Inc.
Sorbitol
Sorbitol 3.3 g in 100 mL
IRRIGATION
PRESCRIPTION DRUG
3.3% Sorbitol Irrigation is indicated for use as a urologic irrigation fluid. 3.3% Sorbitol Irrigation is not for injection. It is contraindicated in patients with anuria.
3.3% Sorbitol Irrigation is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Containers). The 2000 mL containers are packaged 8 per case and the 4000 mL containers are packaged 4 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
New Drug Application
SORBITOL- SORBITOL IRRIGANT B. BRAUN MEDICAL INC. ---------- 3.3% SORBITOL IRRIGATION NONELECTROLYTE IRRIGATING FLUID FOR UROLOGIC IRRIGATION ONLY. NOT FOR INJECTION. DESCRIPTION Each 100 mL contains: Sorbitol (from Sorbitol Solution USP) 3.3 g Water for Injection USP qs pH: 5.3 (5.0–7.0) Calculated Osmolarity: 185 mOsmol/liter, hypotonic The formula of the active ingredient is: INGREDIENT MOLECULAR FORMULA MOLECULAR WEIGHT Sorbitol 182.17 Sorbitol is chemically designated D-glucitol (C H O ). Sorbitol, an isomer of mannitol, is a hexitol naturally occurring in many fruits, and is produced commercially by the reduction of glucose. 3.3% Sorbitol Irrigation is a prediluted, sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. The solution is slightly hypotonic. The solution contains no antimicrobial or bacteriostatic agents or added buffers. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The PIC Container is PVC-free and DEHP-free. CLINICAL PHARMACOLOGY In humans, sorbitol is nontoxic and rapidly metabolized. Sorbitol will either be excreted in the urine by the kidneys, or metabolized to carbon dioxide and dextrose. When sorbitol is absorbed intravascularly in amounts which depend primarily on the extent of the surgery, it produces osmotic diuresis. 6 14 6 As a 3.3% solution, sorbitol is recommended for irrigation of the urinary bladder and prostatic bed during transurethral prostatectomy. Unlike dextrose solutions, sor Прочетете целия документ