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Terms & Conditions

Minimum order quantity is 9 kits (9 kits = 1 case).
No returned goods accepted or credit memos issued, except for product shipped in error by Photocure, Inc. or products damaged in transit. Must be reported to Photocure, Inc. within ten (10) business days of receipt and must be returned to Photocure, Inc. within 25 days of receipt. Contact Photocure, Inc. customer service at 1-855-297-8439 phone or 1-414-434-6952 fax.
Payment terms are 30 days, unless exception is approved by Photocure Finance Director.
Shipping FOB destination by ground standard delivery with prepaid freight passed through to customer.
All orders received by 2 pm CST will ship from the warehouse the next business day.
Customer agrees to pay expediting fee and overnight shipping fee if those services are requested.
Late payment interest 1% per month as allowed by law.

Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.
Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis, and abnormal urinalysis have been reported after administration of Cysview.
The most common adverse reactions seen in clinical trials were bladder spasm, dysuria, hematuria, and bladder pain.

Product indication for Cysview® (hexaminolevulinate HCl)

Cysview is an optical imaging agent indicated 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) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder.

Cysview is used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC®) as an adjunct to White Light Cystoscopy.

Important Risk & Safety Information

Limitations of use
Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.

Warnings and precautions
Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis, and abnormal urinalysis have been reported after administration of Cysview. The most common adverse reactions seen in clinical trials were bladder spasm, dysuria, hematuria, and bladder pain.

Contraindications
Cysview should not be used in patients with porphyria, gross hematuria, or with known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. Cysview may fail to detect some malignant lesions. False-positive fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, and recent BCG therapy or intravesical chemotherapy. No specific drug interaction studies have been performed.

Use in specific populations
Safety and effectiveness have not been established in pediatric patients. There are no available data on Cysview use in pregnant women. Adequate reproductive and developmental toxicity studies in animals have not been performed. Systemic absorption following administration of Cysview is expected to be minimal. There are no data on the presence of hexaminolevulinate in human or animal milk, the effects on a breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Cysview and any potential adverse effects on the breastfed infant from Cysview or from the underlying maternal condition.

Use of the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system
Cysview is approved for use with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system. For system set up and general information for the safe use of the PDD system, please refer to the KARL STORZ instruction manuals for each of the components.

Prior to Cysview administration, read the Full Prescribing Information and follow the preparation and reconstitution instructions.