Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hexaminolevulinate hydrochloride
Photocure ASA
V04CX06
Hexaminolevulinate hydrochloride
85mg
Powder and solvent for intravesical solution
Intravesical
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 3582186001370
_________________________________________________________________________________________________________ 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 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 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. _________________________________________________________________________________________________________ Page 2 of 7 These conditions may cause local reactions in your b Прочитайте повний документ
OBJECT 1 HEXVIX 85MG Summary of Product Characteristics Updated 13-Dec-2016 | Ipsen Ltd 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 healthcare 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 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 any surgical measures are i Прочитайте повний документ