Active Ingredient: Hexaminolevulinate
Hexaminolevulinate blue light fluorescence cystoscopy is indicated as adjunct to standard white light cystoscopy to contribute to the diagnosis and management of bladder cancer in patients with known or high suspicion of bladder cancer.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Urethral, 1.7 milligrams hexaminolevulinate, one dose.
After reconstitution in 50 ml of solvent, 1 ml of the solution contains 1.7 mg hexaminolevulinate, which corresponds to a 8 mmol/l solution of hexaminolevulinate.
The reconstituted solution is instilled into the bladder through a catheter. The patient should retain the fluid for approximately 60 minutes.
Following evacuation of the bladder, the cystoscopic examination in blue light should start within approximately 60 minutes. The cystoscopic examination should not be performed more than 3 hours after hexaminolevulinate is instilled in the bladder.
Also if the retention time in the bladder is considerably shorter than one hour, examination should start no earlier than after 60 minutes. No minimum retention time has been identified making examination non-informative.
For optimal visualisation it is recommended to examine and map the entire bladder under both white and blue light before any surgical measures are initiated. Biopsies of all mapped lesions should normally be taken under white light and complete resection should be verified by switching to blue light.
Only CE marked cystoscopic equipment should be used, equipped with necessary filters to allow both standard white light cystoscopy and blue light (wavelength 380–450 nm) fluorescence cystoscopy.
The light doses given during cystoscopy will vary. Typical total light doses (white light and blue light) range between 180 and 360 J at an intensity of 0.25 mW/cm².
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