Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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. Directions for Use 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. 1. Suspend container using hanger hole. 2. Remove protector from outlet port. 3. Attach irrigation set. Refer to complete directions accompanying set. 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.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1.5% Glycine Irrigation USP Container Label 1.5% Glycine Irrigation USP Container Label LOT EXP 3000 mL 2B7317 NOT FOR INJECTION NDC 0338-0289-47 1.5% GLYCINE IRRIGATION USP EACH 100 mL CONTAINS 1.5g GLYCINE USP NO ANTIMICROBIAL AGENT HAS BEEN ADDED pH 6.0 (4.5 to 6.5) HYPOTONIC OSMOLARITY 200 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION IRRIGATING SOLUTION FOR USE IN UROLOGICAL PROCEDURES AND CYSTOSCOPIC EXAMINATIONS SEE DIRECTION SHEET COLOR VARIATION IN THIS PRODUCT IS NORMAL AND DOES NOT ALTER EFFICACY OR VISUALIZATION DURING TUR PROCEDURES CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT 1.5% GLYCINE IRRIGATION USP UROMATIC CONTAINER PL 146 PLASTIC Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA BAXTER UROMATIC AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC FOR PRODUCT INFORMATION 1-800-933-0303 Glycine Representative Container Label
- HOW SUPPLIED 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. Directions for Use 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. 1. Suspend container using hanger hole. 2. Remove protector from outlet port. 3. Attach irrigation set. Refer to complete directions accompanying set. 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.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1.5% Glycine Irrigation USP Container Label 1.5% Glycine Irrigation USP Container Label LOT EXP 3000 mL 2B7317 NOT FOR INJECTION NDC 0338-0289-47 1.5% GLYCINE IRRIGATION USP EACH 100 mL CONTAINS 1.5g GLYCINE USP NO ANTIMICROBIAL AGENT HAS BEEN ADDED pH 6.0 (4.5 to 6.5) HYPOTONIC OSMOLARITY 200 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION IRRIGATING SOLUTION FOR USE IN UROLOGICAL PROCEDURES AND CYSTOSCOPIC EXAMINATIONS SEE DIRECTION SHEET COLOR VARIATION IN THIS PRODUCT IS NORMAL AND DOES NOT ALTER EFFICACY OR VISUALIZATION DURING TUR PROCEDURES CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT 1.5% GLYCINE IRRIGATION USP UROMATIC CONTAINER PL 146 PLASTIC Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA BAXTER UROMATIC AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC FOR PRODUCT INFORMATION 1-800-933-0303 Glycine Representative Container Label
Overview
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 2 CH 2 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.
Indications & 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 of an indwelling catheter to maintain patency.
Dosage & Administration
The volume of solution needed will vary with the nature and duration of the urologic procedure. If desired, warm in overwrap to near body temperature in a water bath or oven heated to not more than 45°C. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Warnings & Precautions
WARNINGS Not for injection. Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes; thus 1.5% Glycine Irrigation, USP must be regarded as a systemic drug. Absorption of large amounts of fluids containing glycine may significantly alter cardiopulmonary and renal dynamics. Careful cardiovascular monitoring should be maintained due to the possibility of fluid overload. Should fluid overload occur, intensive fluid and electrolyte management is necessary. Monitoring of fluid and electrolyte levels beyond the acute phase may be considered due to the possibility of delayed fluid absorption. (See ADVERSE REACTIONS, Post-Marketing Experience). The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.
Contraindications
Anuria.
Adverse Reactions
Adverse reactions may result from intravascular absorption of glycine. Large intravenous doses of glycine are known to cause salivation, nausea and lightheadedness. Other consequences of absorption of urologic irrigating solutions include fluid and electrolyte disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth, thirst, dehydration, coma from hyponatremia, secondary hyponatremia due to fluid overload, and hyperammonemia with resultant coma and/or encephalopathy; cardiovascular disorders such as hypotension, tachycardia, angina-like pains; pulmonary disorders such as pulmonary congestion; and other general reactions such as blurred vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo, backache, transient blindness and urticaria. Allergic reactions from glycine are unknown or exceedingly rare. Should adverse reactions occur, discontinue the irrigation and re-evaluate the clinical status of the patient. Post-Marketing Experience Following off-label use of 1.5% Glycine Irrigation, USP for hysteroscopic procedures in women, life-threatening adverse events related to fluid overload have been reported.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.