Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Verteporfin
Novartis Pharmaceuticals UK Ltd
S01LA01
Verteporfin
15mg
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 11080200; GTIN: 5016833008316
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. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Visudyne is and what it is used for 2. What you need to know before you are given Visudyne 3. How Visudyne is used 4. Possible side effects 5. How to store Visudyne 6. Contents of the pack and other information 1. WHAT VISUDYNE IS AND WHAT IT IS USED FOR WHAT VISUDYNE IS Visudyne contains the active substance verteporfin, which is activated by light from a laser in a treatment called photodynamic therapy. When you are given an infusion of Visudyne, it is distributed within your body through the blood vessels, including the blood vessels at the back of the eye. When the laser light is shone into the eye, Visudyne is activated. WHAT VISUDYNE IS USED FOR Visudyne is used to treat the wet form of age-related macular degeneration and pathological myopia. These diseases lead to vision loss. Vision loss is caused by new blood vessels (choroidal neovascularisation) that damage the retina (the light-sensitive membrane that lines the back of the eye). There are two types of choroidal neovascularisation: classic and occult. Visudyne is used for the treatment of predominantly classic choroidal neovascularisation in adults with age-related macular degeneration, and also for the treatment of all types of choroidal neovascularisation in adults with pathological myopia. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VISUDYNE YOU SHOULD NOT BE GIVEN VIS Przeczytaj cały dokument
OBJECT 1 VISUDYNE 15 MG, POWDER FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 20-Nov-2017 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product Visudyne ® 15 mg powder for solution for infusion 2. Qualitative and quantitative composition Each vial contains 15 mg of verteporfin. After reconstitution, 1 ml contains 2 mg of verteporfin. 7.5 ml of reconstituted solution contains 15 mg of verteporfin. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for infusion Dark green to black powder. 4. Clinical particulars 4.1 Therapeutic indications Visudyne is indicated for the treatment of - adults with exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV) or - adults with subfoveal choroidal neovascularisation secondary to pathological myopia. 4.2 Posology and method of administration Visudyne should be administered only by ophthalmologists experienced in the management of patients with age-related macular degeneration or with pathological myopia. Posology _Adults, including the elderly (≥65 years old) _ Visudyne photodynamic therapy (PDT) is a two-step process: The first step is a 10-minute intravenous infusion of Visudyne at a dose of 6 mg/m 2 body surface area, diluted in 30 ml infusion solution (see section 6.6). The second step is the light activation of Visudyne at 15 minutes after the start of the infusion (see Method of administration). Patients should be re-evaluated every 3 months. In the event of recurrent CNV leakage, Visudyne therapy may be given up to 4 times per year. _Treatment of the second eye with Visudyne _ There are no clinical data to support concomitant treatment of the second eye. However, if treatment of the second eye is deemed necessary, light should be applied to the second eye immediately after light application in the first eye but no later than 20 minutes from the start of the infusion. _Special populations _ _Hepatic impairment_ Visudyne t Przeczytaj cały dokument