FDA label c24f9a52-426e-4746-a217-624adf1d6450
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
- SPL set ID
- 5f7be402-f25a-428e-b81f-6a4a00de894c
- SPL ID
- c24f9a52-426e-4746-a217-624adf1d6450
- Version
- 3
- Effective date
- 2021-06-30
- 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 01:30:33
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | c24f9a52-426e-4746-a217-624adf1d6450 | id | |
| spl set id | 5f7be402-f25a-428e-b81f-6a4a00de894c | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS FOR UROLOGIC IRRIGATION ONLY. NOT FOR INJECTION. Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. 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 sorbitol and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics. Hyperglycemia from metabolism of sorbitol may occur in patients with diabetes mellitus. Hyperlactatemia from metabolism of sorbitol may potentially produce a significant lactic acidemia in metabolically compromised patients. 3.3% Sorbitol Irrigation must be used with caution in patients unable to metabolize sorbitol rapidly enough to avoid the development of hyperosmolar states. Do not warm above 150°F (66°C). After opening container, its 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 preservatives.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Occasional adverse reactions may occur which include slight increases in postoperative serum glucose, inhibition of intestinal absorption of vitamin B 12 , fluid and electrolyte disturbances, such as acidosis, electrolyte loss, edema, dryness of the mouth, thirst and dehydration, cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia and angina-like pains. In addition, patients unable to metabolize sorbitol rapidly enough may develop hyperosmolar states. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.