País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
ranibizumab
Samsung Bioepis NL B.V.
S01LA04
ranibizumab
Ophthalmologicals
Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Byooviz is indicated in adults for:The treatment of neovascular (wet) age-related macular degeneration (AMD)The treatment of visual impairment due to diabetic macular oedema (DME)The treatment of proliferative diabetic retinopathy (PDR)The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)The treatment of visual impairment due to choroidal neovascularisation (CNV)
Revision: 6
Authorised
2021-08-18
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE ADULT PATIENT BYOOVIZ 10 MG/ML SOLUTION FOR INJECTION ranibizumab This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. ADULTS 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 Byooviz is and what it is used for 2. What you need to know before you are given Byooviz 3. How Byooviz is given 4. Possible side effects 5. How to store Byooviz 6. Contents of the pack and other information 1. WHAT BYOOVIZ IS AND WHAT IT IS USED FOR WHAT BYOOVIZ IS Byooviz is a solution which is injected into the eye. Byooviz belongs to a group of medicines called antineovascularisation agents. It contains the active substance called ranibizumab. WHAT BYOOVIZ IS USED FOR Byooviz is used in adults to treat several eye diseases causing vision impairment. These diseases result from damage to the retina (light-sensitive layer at the back of the eye) caused by: - Growth of leaky, abnormal blood vessels. This is observed in diseases such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes). It may also be associated with choroidal neovascularisation (CNV) due to pathologic myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV. - Macular oedema (swelling of the centre of the retina). This swelling can be caused by diabetes (a disease called diabetic macular oedema (DME)) or by the blockage of retinal veins of the retina (a disease called retinal vein occlusion (RVO)). HOW BYOOVIZ WORKS Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Byooviz 10 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains 10 mg ranibizumab*. Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution. This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab to adult patients. *Ranibizumab is a humanised monoclonal antibody fragment produced in _Escherichia coli _ cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale yellow aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Byooviz is indicated in adults for: • The treatment of neovascular (wet) age-related macular degeneration (AMD) • The treatment of visual impairment due to diabetic macular oedema (DME) • The treatment of proliferative diabetic retinopathy (PDR) • The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) • The treatment of visual impairment due to choroidal neovascularisation (CNV) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Byooviz must be administered by a qualified ophthalmologist experienced in intravitreal injections. Posology _Adults _ The recommended dose for Byooviz in adults is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 ml. The interval between two doses injected into the same eye should be at least four weeks. Treatment in adults is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity i.e. no change in visual acuity and in other signs and symptoms of the disease under co Llegiu el document complet