Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Hexaminolevulinate hydrochloride
Photocure ASA
V04CX
Hexaminolevulinate hydrochloride
85 milligram(s)
Powder and solvent for intravesical solution
Other diagnostic agents
Marketed
2007-02-23
Page 1 of 6 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 your bladder. A cystoscope helps to see possible tumours and thereby removal of 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 ‘Contents of the pack and other information’). If you have ‘porphyria’ (a rare inherited blood disease). WARNINGS AND PRECAUTIONS Talk to your doctor or nurse 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. Page 2 of 6 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. OTHER MEDICINES AND HEXVIX Please tell your doctor if you are taking or have recently taken any oth Прочитать полный документ
Health Products Regulatory Authority 15 February 2022 CRN00CFHL Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hexvix 85 mg, powder and solvent for intravesical solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 PHARMACEUTICAL FORM Powder and solvent for intravesical solution. Powder: white to off-white or pale yellow Solvent: clear, colourless solution 4 CLINICAL PARTICULARS 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 section 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. Posology _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 considerably 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 Прочитать полный документ