| Document Date: 2010-06-03 18:47:48
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Company Study Drug Group / GE Healthcare / / Event Product Issues / Product Recall / / IndustryTerm optical imaging agent / non-pyrogenic solution / chemical formula / mL solution / optical imaging drug / lower energy level / colorless solution / healthcare providers / imaging / / MedicalCondition scar / tumor / non-muscle invasive papillary cancer / extensive mucosal inflammation / cancer / ADVERSE REACTIONS Anaphylaxis / cystitis / headache / urinary retention / WARNINGS AND PRECAUTIONS Anaphylaxis Anaphylaxis / hematuria / Carcinogenesis / bladder inflammation / gross hematuria / bladder cancer / Anaphylaxis / wide-spread mucosal inflammation / carcinoma / bladder spasm / tremor / T1 bladder cancer / pain / green-red color blindness / T2 tumors / suspected bladder cancer / complete tumor / anaphylactoid shock / hypersensitivity / bladder tumors / inflammation / porphyria / / MedicalTreatment catheter / catheters / catheterization / antibiotics / chemotherapy / immunotherapy / / Organization DOSAGE AND ADMINISTRATION / FDA / OSAGE AND ADMINISTRATION / Cysview administration / not fluoresce following Cysview administration / / Person Foley / / / Position representative / / Product sodium chloride / mL of the diluent / / Technology Pharmacokinetics / Pharmacodynamics System / chemotherapy / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Cysview safely and effectively. See full prescribing information for Cysview. Cysview (hexaminolevulinate hydrochlor