Pajjiż: Malta
Lingwa: Ingliż
Sors: Medicines Authority
HEXAMINOLEVULINATE
IPSEN M.E.P.E Ag. Dimitriou 63 Alimos, 17456 Athens, Greece
V04CX
HEXAMINOLEVULINATE 85 mg
POWDER AND SOLVENT FOR SOLUTION FOR INTRAVESICAL USE
HEXAMINOLEVULINATE 85 mg
POM
DIAGNOSTIC AGENTS
Withdrawn
2005-06-30
PAGE 1 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HEXVIX ® 85 MG POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION Hexaminolevulinate _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Hexvix is and what it is used for 2. What you need to know before you are given Hexvix 3. How to use Hexvix 4. Possible side effects 5. How to store Hexvix 6. Contents of the pack and other information 1. WHAT HEXVIX IS AND WHAT IT IS USED FOR This medicine is for diagnostic use only. This medicine is used to help identify bladder cancers. It is given before your doctor uses a special device called a ‘cystoscope’ to look inside of your bladder. A cystoscope helps to see possible tumours and thereby removing abnormal cells, which illuminate in blue light after the administration of Hexvix. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HEXVIX DO NOT HAVE HEXVIX • If you are allergic (hypersensitive) to the active ingredient, or any other ingredients of Hexvix, including the liquid used to dissolve it (see Section 6 Further Information). • If you have ‘porphyria’ (a rare inherited blood disease). WARNINGS AND PRECAUTIONS Check with your doctor before having Hexvix: • If you have a urinary infection or burning feeling when you pass urine. • If you have had BCG therapy on your bladder recently. • If you have had an operation on your bladder recently. These conditions may cause local reactions in your bladder, which can make it more difficult for your doctor to interpret what he sees during the examination. TAKING OTHER MEDICINES PAGE 2 OF 7 Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obta Aqra d-dokument sħiħ
PAGE 1 OF 8 SUMMARY OF THE PRODUCT CHARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT Hexvix 85 mg, powder and solvent for intravesical solution. 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION 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. 3 P HARMACEUTICAL F ORM Powder and solvent for intravesical solution. Powder: white to off-white or pale yellow Solvent: clear, colourless solution 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Hexvix 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. See 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hexvix cystoscopy should only be performed by health care professionals trained specifically in Hexvix cystoscopy. The bladder should be drained before the instillation. _Adults (including the elderly) _ 50 ml of 8 mmol/l reconstituted solution (see section 6.6) is instilled into the bladder through a catheter. The patient should retain the fluid for approximately 60 minutes. Following evacuation of the bladder, the cystoscopic examination in blue light should start within approximately 60 minutes. The cystoscopic examination should not be performed more than 3 hours after Hexvix is instilled in the bladder. Also if the retention time in the bladder is considerable shorter than one hour, examination should start no earlier than after 60 minutes. No minimum retention time has been identified making examination non-informative. For optimal visualisation it is recommended to examine and map the entire bladder under both white and blue light before any surgical measures are initiated. Biopsies of all mapped les Aqra d-dokument sħiħ