Krajina: Európska únia
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
adalimumab
Boehringer Ingelheim International GmbH
L04AB04
adalimumab
Immunosuppressants
Hidradenitis Suppurativa; Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Please refer to section 4.1 of the Summary of product characteristics in the product information document.,
Revision: 2
Withdrawn
2017-11-10
68 B. PACKAGE LEAFLET 69 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CYLTEZO 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 Cyltezo and during treatment with Cyltezo. 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 Cyltezo is and what it is used for 2. What you need to know before you use Cyltezo 3. How to use Cyltezo 4. Possible side effects 5. How to store Cyltezo 6. Contents of the pack and other information 7. Instructions for use 1. WHAT CYLTEZO IS AND WHAT IT IS USED FOR Cyltezo contains the active substance adalimumab, a medicine that acts on your body’s immune (defence) system. Cyltezo is intended for the treatment of the inflammatory diseases described below: Rheumatoid arthritis, Polyarticular juvenile idiopathic arthritis, Enthesitis-related arthritis, Ankylosing spondylitis, Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, Psoriatic arthritis, Psoriasis, Hidradenitis suppurativa, Crohn’s disease, Ulcerative colitis and Non-infectious uveitis The active ingredient in Cyltezo, adalimu Prečítajte si celý dokument
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 Cyltezo 40 mg solution for injection in pre-filled syringe Cyltezo 40 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cyltezo 40 mg solution for injection in pre-filled syringe Each 0.8 mL single dose pre-filled syringe contains 40 mg of adalimumab. Cyltezo 40 mg solution for injection in pre-filled pen Each 0.8 mL single dose pre-filled pen contains 40 mg of adalimumab. Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear to slightly opalescent solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis Cyltezo 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. Cyltezo can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Cyltezo reduces the rate of progression of joint damage as measured by X-ray and improves physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis _Polyarticular juvenile idiopathic arthritis _ Adalimumab in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti Prečítajte si celý dokument