Finished product reference
Glycine
Solution · Irrigation · 1.5 % · 1000 mL
- List code
- 2238
Indications
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 of an indwelling catheter to maintain patency.
Dosage and administration (summary)
DOSAGE AND 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.
Contraindications
CONTRAINDICATIONS Anuria.
Warnings and 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.
Pregnancy
Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with 1.5% Glycine Irrigation, USP. It is not known whether 1.5% Glycine Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Storage and supply
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.
Source: Glycine (Glycine) — US FDA prescribing information, 2018-01-02, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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