Glycine (Glycine)

Trade Name : Glycine

Baxter Healthcare Corporation

SOLUTION

Strength 1.5 g/100mL

GLYCINE

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Glycine (Glycine) which is also known as Glycine and Manufactured by Baxter Healthcare Corporation. It is available in strength of 1.5 g/100mL per ml. Read more

Glycine (Glycine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 (NHCHCOOH) 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • The cardiovascular status, especially of the patient with cardiac disease, should be carefully observed before and during transurethral resection of the prostate when using 1.5% Glycine Irrigation, USP, because the quantity of fluid absorbed into the systemic circulation by opened prostatic veins may produce significant expansion of the intravascular fluid and lead to fulminating congestive heart failure.
  • Shift of sodium-free intracellular fluid into the extracellular compartment, following systemic absorption, may lower serum sodium concentration and aggravate preexisting hyponatremia.
  • Care should be exercised if impaired liver function is known or suspected. Under such conditions ammonia resulting from metabolism of glycine may accumulate in the blood.
  • 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.
  • 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.
  • In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.
  • 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 45u00b0C.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
  • 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 (25u00b0C); brief exposure up to 40u00b0C 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 Corporationn
  • Printed in USA
  • 07-19-00-0226
  • Rev. January 2018
  • Baxter and Uromatic are trademarks of Baxter International Inc.
  • 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 (25u00b0C) UNTIL READY TO
  • USE AVOID EXCESSIVE HEAT SEE INSERT
  • 1.5%
  • GLYCINE
  • IRRIGATION USP
  • UROMATIC CONTAINER PL 146 PLASTIC
  • Arrayn- 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
  • 1.5% Glycine Irrigation, USP Carton Label
  • 2B7317
  • 4-3000 ML
  • UROMATIC CONTAINER
  • 1.5% GLYCINE IRRIGATION, USP
  • EXP
  • XXXXX
  • SECONDARY BAR CODE
  • (17) YYMM00 (10) XXXXX
  • LOT
  • XXXXX
  • PRIMARY BAR CODE
  • (01) 503380289474

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