Applies to the following strengths: 100 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Diagnostic
Slowly instill 50 mL of reconstituted solution into the emptied bladder via an intravesical catheter; retain in the bladder for at least 1 hour (not to exceed 3 hours) before evacuating and performing cystoscopic examination
- This medicinal product is for diagnostic use only.
- This medicinal product is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC) as an adjunct to the white light cystoscopy.
Use For use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) based on a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
- Hypersensitivity to the active component or any of the ingredients
- Gross hematuria
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
- This procedure should only be performed by healthcare professionals trained to use cystoscopy.
- The bladder should be drained before the instillation.
- Instill 50 mL of reconstituted solution into the emptied bladder via an intravesical catheter.
- The solution should be retained in the bladder for 1 hour before evacuating and performing cystoscopic examination.
- Avoid skin contact with this medicinal product. If skin does come in contact, wash immediately with soap and water and dry. After voiding the bladder of this medicinal product, routinely wash the patient's perineal skin region with soap and water and dry.
- First perform a complete cystoscopic examination of the entire bladder under white light and then repeat the examination of the entire bladder under blue light. Record and document information about location and appearance of suspicious lesions and areas seen under both white and blue light.
- The bladder should be viewed by an approved light source (see manufacturer package insert/local protocol). The light source enables both white light cystoscopy and blue light fluorescence cystoscopy. Familiarity with this system is essential before beginning the procedure and before instilling this medicinal product into the bladder. For system set up and general information for the safe use refer to the instruction manual.
Store the kit at 20C to 25°C (68F to 77°F); excursions are permitted to 15C to 30°C (59F to 86°F).
- Do not use beyond the expiration date printed on the carton.
- The manufacturer product information should be consulted.
- Reconstitute the powder with the supplied 50 mL diluent under aseptic conditions.
- Use the solution shortly after reconstitution; if unable to use, the solution may be stored for up to 2 hours in a refrigerator at 2C to 8C (36F to 46°F) in the labeled syringe. Discard after 2 hours.
- This medicinal product is not a replacement for random bladder biopsies or other procedures used to detect bladder cancer.
- The possibility of hypersensitivity including serious anaphylactic/anaphylactoid reactions should be considered; advanced life support facilities should be readily available.
- This medicinal product should not be used in patients at high risk of bladder inflammation (e.g., after BCG therapy, or in moderate to severe leukocyturia. Widespread inflammation of the bladder should be excluded by cystoscopy before this medicinal product is administered. Inflammation may lead to increased porphyrin build up and increased risk of local toxicity upon illumination, and false fluorescence.
- If a wide-spread inflammation in the bladder becomes evident during white light inspection, the blue light inspection should be avoided.
- There is an increased risk of false fluorescence in the resection area in patients who recently have undergone surgical procedures of the bladder.
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