Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
AFLIBERCEPT
BAYER ISRAEL LTD
S01LA05
SOLUTION FOR INTRAVITREAL INJECTION
AFLIBERCEPT 40 MG/ML
INTRAVITREAL
Required
BAYER AG, GERMANY
AFLIBERCEPT
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 CRVO or central RVO)• visual impairment due to diabetic macular oedema (DME)• visual impairment due to myopic choroidal neovascularisation (myopic CNV).
2018-11-30
Draft 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only EYLEA Solution for injection into the eye Each vial contains: An extractable volume of at least 0.1 ml, equivalent to at least 4 mg aflibercept. Inactive ingredients and allergens in this medicine: see section 6 ‘Additional information’ and section 2 under ‘Important information about some of this medicine’s ingredients’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. In addition to the patient information leaflet, Eylea also has a patient safety information guide. This guide contains important safety information that you need to know and that you should follow before you start and during treatment with Eylea. Carefully read the patient safety information guide and patient information leaflet before using this medicine. Keep the guide in case you need to read it again. 1. WHAT IS THIS MEDICINE INTENDED FOR? Eylea is intended to treat adults who have: - neovascular age-related macular degeneration (wet AMD) - impaired vision due to macular edema secondary to retinal vein occlusion (branch RVO [BRVO] or central RVO [CRVO]) - impaired vision due to diabetic macular edema (DME) - impaired vision due to myopic choroidal neovascularisation (myopic CNV). THERAPEUTIC GROUP: ophthalmologicals / anti angiogenics. Aflibercept, the active ingredient 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 in short-sighted patients who have myopic CNV, these factors, in excess, are involved in the abnormal formation of Prečítajte si celý dokument
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. *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 intravitreal injection. The solution is a clear, colourless to pale yellow and iso-osmotic solution. Patient safety information guide The marketing of Eylea is subject to a risk management plan (RMP) including a patient guide. The 'patient safety information guide', emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the guide before starting treatment. Prescriber guide and video This product is marketed with prescriber guide and prescriber video providing recommendations for the risk minimization in the use of Eylea. Please ensure you are familiar with these materials as they contain important safety information. 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). 4.2 Posology and method of administration Eylea is for intravitreal injection only. Eylea mu Prečítajte si celý dokument