Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
sarilumab
Sanofi Winthrop Industrie
L04AC14
sarilumab
Immunosuppressants
Arthritis, Rheumatoid
Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
Revision: 10
Authorised
2017-06-23
56 B. PACKAGE LEAFLET 57 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KEVZARA 150 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE KEVZARA 200 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE sarilumab 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. • If you have any further questions, ask your doctor, pharmacist, or nurse. • 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. In addition to this leaflet, you will be given a patient alert card, which contains important safety information that you need before and during treatment with Kevzara. WHAT IS IN THIS LEAFLET 1. What Kevzara is and what it is used for 2. What you need to know before you use Kevzara 3. How to use Kevzara 4. Possible side effects 5. How to store Kevzara 6. Contents of the pack and other information 1. WHAT KEVZARA IS AND WHAT IT IS USED FOR WHAT KEVZARA IS Kevzara contains the active substance sarilumab. It is a type of protein called a monoclonal antibody. WHAT KEVZARA IS USED FOR Kevzara is used to treat adults with moderately to severely active rheumatoid arthritis if previous therapy did not work well enough or was not tolerated. Kevzara can be used alone or together with a medicine called methotrexate. It may help you by: • slowing down damage to joints • improving your ability to perform daily activities. HOW KEVZARA WORKS • Kevzara attaches to another protein called interleukin-6 (IL-6) receptor and blocks its action. • IL-6 plays a major role in the symptoms of rheumatoid arthritis such as pain, swollen joints, morning stiffness, and fatigue. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE KEVZARA _ _ DO NOT USE KEVZARA: • if you are allergic to sarilu Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Kevzara 150 mg solution for injection in pre-filled syringe Kevzara 150 mg solution for injection in pre-filled pen Kevzara 200 mg solution for injection in pre-filled syringe Kevzara 200 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kevzara 150 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). Kevzara 150 mg solution for injection in pre-filled pen Each pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). Kevzara 200 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). Kevzara 200 mg solution for injection in pre-filled pen Each pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). Sarilumab is a human monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) Clear, colourless to pale yellow sterile solution of approximately pH 6.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of rheumatoid arthritis. Patients should be given the patient alert card. 3 Posology The recommended dose of sarilumab is 200 mg once every 2 weeks administered as a subcutaneous injection. Reduction of dose from 200 mg on Lesen Sie das vollständige Dokument