GLYCINE solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C)

Dostopno od:

Baxter Healthcare Corporation

INN (mednarodno ime):

GLYCINE

Sestava:

GLYCINE 1.5 g in 100 mL

Pot uporabe:

IRRIGATION

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

1.5% Glycine Irrigation, USP is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder. It may be used for lavage of an indwelling catheter to maintain patency. Anuria.

Povzetek izdelek:

1.5% Glycine Irrigation, USP in UROMATIC plastic containers is available as follows: 2B7317 3000mL NDC 0338-0289-47 Color variation in this product is normal and does not alter efficacy or visualization during TUR procedures. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product. Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. Use Aseptic Technique. Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA 07-19-00-0226 Rev. January 2018 Baxter and Uromatic are trademarks of Baxter International Inc.

Status dovoljenje:

New Drug Application

Lastnosti izdelka

GLYCINE- GLYCINE SOLUTION
BAXTER HEALTHCARE CORPORATION
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1.5% GLYCINE IRRIGATION, USP
IN UROMATIC PLASTIC CONTAINER
DESCRIPTION
1.5% Glycine Irrigation, USP 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 (NH CH COOH) 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.
Glycine which enters the systemic circulation is converted to serine
and glyoxylic acid.
INDICATIONS AND USAGE
1.5% Glycine Irrigation, USP is indicated for use as a urologic
irrigating fluid with endoscopic
instruments during transurethral procedures requiring distension,
irrigation, and lavage of the urinary
bladder. It may be used for lavage