Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 1.5% Glycine Irrigation USP is supplied sterile and nonpyrogenic in single-dose 3000 mL flexible irrigation containers packaged 4 per case. NDC REF Size 0264-7390-60 R8406 3000 mL 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 container over 150°F (66°C).; PRINCIPAL DISPLAY PANEL - 3000 mL 1.5% GLYCINE IRRIGATION USP FOR UROLOGIC IRRIGATION REF R8406 NDC 0264-7390-60 LOT EXP. 3000 mL Each 100 mL contains: Glycine USP 1.5 g Water for Injection USP qs pH: 6.1 (4.5-6.5) Calc. Osmolarity: 200 mOsmol/liter Not for Injection. Use only if solution is clear and container and seal are intact. Warning: Do not warm container over 150°F (66°C). Sterile, nonpyrogenic. Single unit container. Discard unused portion. Use aseptic technique. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. Do not remove overwrap until ready for use. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-067 LD-257-6 SET B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y38-000-067 recycle symbol set picture R8406 container label
- HOW SUPPLIED 1.5% Glycine Irrigation USP is supplied sterile and nonpyrogenic in single-dose 3000 mL flexible irrigation containers packaged 4 per case. NDC REF Size 0264-7390-60 R8406 3000 mL 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 container over 150°F (66°C).
- PRINCIPAL DISPLAY PANEL - 3000 mL 1.5% GLYCINE IRRIGATION USP FOR UROLOGIC IRRIGATION REF R8406 NDC 0264-7390-60 LOT EXP. 3000 mL Each 100 mL contains: Glycine USP 1.5 g Water for Injection USP qs pH: 6.1 (4.5-6.5) Calc. Osmolarity: 200 mOsmol/liter Not for Injection. Use only if solution is clear and container and seal are intact. Warning: Do not warm container over 150°F (66°C). Sterile, nonpyrogenic. Single unit container. Discard unused portion. Use aseptic technique. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. Do not remove overwrap until ready for use. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-067 LD-257-6 SET B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y38-000-067 recycle symbol set picture R8406 container label
Overview
Each 100 mL contains: Glycine USP ..................................................................................... 1.5 g Water for Injection USP ................................................................... qs pH: 6.1 (4.5-6.5) Calculated Osmolarity: 200 mOsmol/liter The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Glycine USP NH 2 CH 2 COOH 75.07 1.5% Glycine Irrigation USP is a sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. This solution is slightly hypotonic. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Not made with natural rubber latex, PVC or DEHP.
Indications & Usage
1.5% Glycine Irrigation USP is indicated as an irrigant during transurethral prostatic or bladder surgery.
Dosage & Administration
As required for irrigation. 1.5% Glycine Irrigation USP should be administered only by the appropriate transurethral urologic instrumentation. It has been reported that absorption is significantly increased if the container is higher than 60 cm (24 inches) above the patient. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
WARNINGS Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. The amount of fluid absorbed during a transurethral resection is a function of the volume and hydrostatic pressure of the irrigant used, the number and size of venous sinuses opened, and the duration of the procedure. Since irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes, any irrigation solution must be regarded as a systemic drug. Absorption of large amounts of fluids containing glycine and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics. Absorption of large amounts of irrigating solution can also result in pronounced hyponatremia and water intoxication. After opening container, the contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservative.
Contraindications
1.5% Glycine Irrigation USP is not for injection. It is contraindicated in patients with anuria.
Adverse Reactions
Adverse reactions may include fluid and electrolyte disorders such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema and dehydration; cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pain and thrombophlebitis; other possible reactions include visual disturbances, convulsions, nausea, vomiting, diarrhea, vertigo and urticaria. Literature includes reports on hyponatremia, hyperammonemia, transient blindness, coma (immediate or delayed), and digitalis toxicity in digitalized patients. If an adverse reaction occurs, discontinue the irrigant and reevaluate the clinical status of the patient.
Storage & Handling
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 container over 150°F (66°C).
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