Generic Name and Formulations:
Hexaminolevulinate HCl 100mg/vial; pwd for intravesical administration after reconstitution.
For use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Use with Karl Storz D-Light C Photodynamic Diagnostic system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1).
See literature. Instill 50mL into emptied bladder via a urinary catheter. Retain in bladder for 1 hour before evacuating and performing cystoscopic examination. First perform complete cystoscopic exam of entire bladder under white light, then repeat exam under blue light.
Porphyria. Gross hematuria. BCG immunotherapy or intravesical chemotherapy within the past 90 days.
Not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer or for repetitive use. Do not perform cystoscopy with blue light alone as malignant lesions can be missed unless the bladder is initially examined under white light. Presence of urine or blood may interfere with detection of tissue fluorescence. Pregnancy (Cat.C). Nursing mothers.
Optical imaging agent.
Bladder spasm, dysuria, hematuria, bladder pain, procedural pain, urinary retention, headache; anaphylaxis.
Kit—1 (vial + diluent)
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