Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Photocure ASA, Hoffsveien 4, NO-0275 Oslo, N/A, Norway
Hexvix 85 mg, powder and solvent for intravesical solution.
| Pharmaceutical Form |
|---|
|
Powder and solvent for intravesical solution. Powder: white to off-white or pale yellow. Solvent: clear, colourless solution. |
Each vial of powder contains 85 mg hexaminolevulinate (as hexaminolevulinate hydrochloride).
After reconstitution in 50 ml of solvent, 1 ml of the solution contains 1.7 mg hexaminolevulinate, which corresponds to a 8 mmol/l solution of hexaminolevulinate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hexaminolevulinate |
Hexaminolevulinate blue light fluorescence cystoscopy is indicated as adjunct to standard white light cystoscopy to contribute to the diagnosis and management of bladder cancer in patients with known or high suspicion of bladder cancer. |
| List of Excipients |
|---|
|
Powder: None. Solvent: Disodium phosphate dihydrate |
Pack of one 10 ml Type I colourless glass vial with butyl rubber stopper containing powder, and , one 50 ml cyclic olefin copolymer syringe with plunger stopper (bromobutyl rubber) and plunger rod, containing solvent.
Pack sizes: Pack containing 1 vial with powder and 1 prefilled syringe with solvent, with or without a Mini-Spike transfer device.
Not all pack sizes may be marketed.
Photocure ASA, Hoffsveien 4, NO-0275 Oslo, N/A, Norway
PA1024/003/001
Date of first authorisation: 23rd February 2007
Date of last renewal: 17th September 2009
| Drug | Countries | |
|---|---|---|
| HEXVIX | Austria, Estonia, Spain, Finland, France, Ireland, Lithuania, New Zealand, Poland, United Kingdom |
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