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AstraZeneca

Visudyne
verteporfin

Package leaflet: Information for the user


Visudyne 15 mg powder for solution for infusion

verteporfin


Read all of this leaflet carefully before you are given this medicine because it contains important information for you.


What Visudyne looks like and contents of the pack

Visudyne is supplied as a dark green to black powder in a clear glass vial. The powder is reconstituted in water prior to use to form an opaque dark green solution.


Visudyne is available in packs containing 1 vial of powder.


Marketing Authorisation Holder CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24

17489 Greifswald Germany


Manufacturer

Delpharm Huningue S.A.S. 26 rue de la Chapelle 68330 Huningue

France


CHEPLAPHARM Arzneimittel GmbH Ziegelhof 23-24

17489 Greifswald Germany

This leaflet was last revised in

The following information is intended for healthcare professionals only:


Reconstitute Visudyne in 7.0 ml water for injections to produce 7.5 ml of a 2.0 mg/ml solution. Reconstituted Visudyne is an opaque dark green solution. It is recommended that reconstituted Visudyne be inspected visually for particulate matter and discoloration prior to administration. For a dose of 6 mg/m2 body surface (the dose recommended for the treatment) dilute the required amount of Visudyne solution in dextrose 50 mg/ml (5 %) solution for infusion to a final volume of 30 ml. Do not use sodium chloride solution. Use of a standard infusion line filter with hydrophilic membranes (such as polyethersulfone) of a pore size of not less than 1.2 μm is recommended.


For storage conditions, please see section 5 of this leaflet.


The vial and any unused portion of reconstituted solution should be discarded after single use.


If material is spilled, it should be contained and wiped up with a damp cloth. Eye and skin contact should be avoided. Use of rubber gloves and eye protection is recommended. Any unused medicine or waste material should be disposed of in accordance with local requirements.