Baxter 1.5% Glycine Irrigation USP 3000 mL UROMATIC Container

Description

Baxter 1.5% Glycine Irrigation USP 3000 mL UROMATIC Container

Baxter 1.5% Glycine Irrigation USP 3000 mL UROMATIC Container is a sterile, nonpyrogenic, nonhemolytic, nonelectrolytic or very weakly ionized solution in single dose UROMATIC containers for use as a urologic irrigating solution. Each liter contains 15 g Glycine, USP (NH2CH2COOH) in water for injection. pH 6.0 (4.5 to 6.5). Osmolarity 200 mOsmol/L (calc.). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. No antimicrobial agent has been added

The UROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

CLINICAL PHARMACOLOGY

1.5% Glycine Irrigation, USP is useful as an irrigating solution for the urinary bladder because this solution is nonhemolytic, nonelectrolytic or very weakly ionized, and provides a high degree of visibility for urologic procedures requiring endoscopy. During transurethral surgical procedures, the solution acts as a lavage for removing blood and tissue fragments. It also maintains the patency of an indwelling catheter in the immediate postoperative period.

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