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Photocure Announces new Commercial Strategy for Hexvix(R), the Innovative Product for Improved Detection of Bladder Cancer
Date:9/26/2011

onal Cancer Institute. In Europe, bladder cancer is the seventh most common type of cancer in men and the fourteenth in women[1]. Each year in Europe, approximately 36,500 men and 13,000 women die due bladder cancer (Ferlay et al., 2001).It is notoriously difficult to detect. The most common, initial sign is red-colored urine, which calls for urine cytology and cystoscopy.

Important Risk and Safety Information about Cysview (hexaminolevulinate HCl)

INDICATIONS: Cysview is an optical imaging agent for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder in patients with known or suspected lesion(s) on the basis of a prior cystoscopy. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system for blue light cystoscopy as an adjunct to the white light setting. Limitations - Cysview is not a replacement for random biopsies or other procedures used in the detection of bladder cancer. It is not for repeat use; the potential risks associated with repetitive exposure have not been studied. CONTRAINDICATIONS: Cysview is contraindicated in patients with porphyria, gross hematuria, BCG immunotherapy or intravesical chemotherapy within 90 days prior, or with known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. WARNINGS AND PRECAUTIONS:Anaphylaxis: Anaphylaxis, including anaphylactoid shock, has been reported following administration of Cysview. Failed Detection - Cysview may fail to detect some bladder tumors, including malignant lesions. False Fluorescence: Fluorescent areas detected during blue light cystoscopy may result from inflammation, cystoscopic trauma, scar tissue or bladder mucosal biopsy from a previous cystoscopic examination. Urine and/or blood within the bladder may interfere with the detection of tissue fluorescence. ADVERSE REACTIONS: Clinical Study Experience: The most common adverse react
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SOURCE Photocure ASA
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