Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
adalimumab
Amgen Europe B.V.
L04AB04
adalimumab
Immunosuppressants
Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Hidradenitis Suppurativa; Psoriasis; Arthritis, Rheumatoid
Please refer to section 4.1 of the Summary of product characteristics in the product information document. ,
Revision: 2
Withdrawn
2017-03-22
61 B. PACKAGE LEAFLET 62 PACKAGE LEAFLET: INFORMATION FOR THE USER SOLYMBIC 20 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE SOLYMBIC 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE adalimumab 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. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given SOLYMBIC and during treatment with SOLYMBIC. Keep this Patient Alert Card with you. - If you have any further questions, ask your doctor or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4). WHAT IS IN THIS LEAFLET 1. What SOLYMBIC is and what it is used for 2. What you need to know before you use SOLYMBIC 3. How to use SOLYMBIC 4. Possible side effects 5. How to store SOLYMBIC 6. Contents of the pack and other information 1. WHAT SOLYMBIC IS AND WHAT IT IS USED FOR SOLYMBIC contains the active substance adalimumab, a selective immuno suppressive agent. SOLYMBIC is intended for treatment of rheumatoid arthritis, enthesitis-related arthritis in children 6 to 17 years, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, paediatric psoriasis (patients weighing either 23 to 28 kg or 47 kg and greater), Crohn’s disease in adults and children, ulcerative colitis and non-infectious uveitis affecting the back of the e Прочетете целия документ
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 SOLYMBIC 20 mg solution for injection in pre-filled syringe. SOLYMBIC 40 mg solution for injection in pre-filled syringe. SOLYMBIC 40 mg solution for injection in pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SOLYMBIC 20 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 20 mg of adalimumab in 0.4 mL (50 mg/mL) solution. SOLYMBIC 40 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 40 mg of adalimumab in 0.8 mL (50 mg/mL) solution. SOLYMBIC 40 mg solution for injection in pre-filled pen Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 mL (50 mg/mL) solution. Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _ _ SOLYMBIC 20 mg solution for injection in pre-filled syringe SOLYMBIC 40 mg solution for injection in pre-filled syringe Solution for injection. SOLYMBIC 40 mg solution for injection in pre-filled pen (SureClick) Solution for injection. Clear and colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis SOLYMBIC in combination with methotrexate, is indicated for: • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. SOLYMBIC can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate Прочетете целия документ