FDA label 9db807f2-1585-433a-951b-761cb5b836c8

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
5751bfda-7cad-43e7-955d-4a850541575b
SPL ID
9db807f2-1585-433a-951b-761cb5b836c8
Version
9
Effective date
2021-04-30
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:44

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.