Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
aflibercept
Bayer AG
S01LA05
aflibercept
Ophthalmologicals
Wet Macular Degeneration; Macular Edema; Diabetes Complications
Eylea is indicated for adults for the treatment of:neovascular (wet) age-related macular degeneration (AMD);visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO);visual impairment due to diabetic macular oedema (DME);visual impairment due to myopic choroidal neovascularisation (myopic CNV).
Revision: 30
Authorised
2012-11-21
100 B. PACKAGE LEAFLET 101 PACKAGE LEAFLET: INFORMATION FOR THE ADULT PATIENT _ _ EYLEA 40 MG/ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE aflibercept ADULTS For information for guardians of babies born prematurely, please see the other side of this package leaflet. [applicable for 1 language] For information for guardians of babies born prematurely, please see further down the page. [applicable for 2 or more languages] 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. _ _ WHAT IS IN THIS LEAFLET 1. What Eylea is and what it is used for 2. What you need to know before you are given Eylea 3. How you will be given Eylea 4. Possible side effects 5. How to store Eylea 6. Contents of the pack and other information 1. WHAT EYLEA IS AND WHAT IT IS USED FOR Eylea is a solution which is injected into the eye to treat eye conditions in adults called - neovascular (wet) age-related macular degeneration (wet AMD), - impaired vision due to macular oedema secondary to retinal vein occlusion (branch RVO (BRVO) or central RVO (CRVO)), - impaired vision due to diabetic macular oedema (DME), - impaired vision due to myopic choroidal neovascularisation (myopic CNV). Aflibercept, the active substance in Eylea, blocks the activity of a group of factors, known as Vascular Endothelial Growth Factor A (VEGF-A) and Placental Growth Factor (PlGF). In patients with wet AMD and myopic CNV, these factors, in excess are involved in the abnormal formation of new blood vessels in the eye. These new blood vessels can cause the leak of blood components into the eye and eventual damage to tissues in the eye responsible for vision. In patients with CRVO, a blockage occurs in the main blood vessel that transports blood away from the retin Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Eylea 40 mg/mL solution for injection in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL solution for injection contains 40 mg aflibercept*. One pre-filled syringe contains an extractable volume of at least 0.09 mL, equivalent to at least 3.6 mg aflibercept. This provides a usable amount to deliver a single dose of 0.05 mL containing 2 mg aflibercept to adult patients or a single dose of 0.01 mL containing 0.4 mg aflibercept to preterm infants. *Fusion protein consisting of portions of human VEGF (Vascular Endothelial Growth Factor) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) The solution is a clear, colourless to pale yellow and iso-osmotic solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eylea is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), • visual impairment due to diabetic macular oedema (DME) (see section 5.1), • visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1). EYLEA is indicated in preterm infants for the treatment of • retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Eylea is for intravitreal injection only. Eylea must only be administered by a qualified physician experienced in administering intravitreal injections. Posology _wet AMD _ _ _ The recommended dose for Eylea is 2 mg aflibercept, equivalent to 0.05 mL. Eylea treatment is initiated with one injection per month for three consecutiv Przeczytaj cały dokument