Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
etanercept
Pfizer Europe MA EEIG
L04AB01
etanercept
Immunosuppressants
Arthritis, Psoriatic; Spondylitis, Ankylosing; Psoriasis
Rheumatoid arthritis;Juvenile idiopathic arthritisPsoriatic arthritis;Axial spondyloarthritis;Plaque psoriasis;Paediatric plaque psoriasis.
Revision: 8
Withdrawn
2017-02-13
138 B. PACKAGE LEAFLET Medicinal product no longer authorised 139 PACKAGE LEAFLET: INFORMATION FOR THE USER LIFMIOR 25 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Etanercept 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 (BOTH SIDES) 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 and during treatment with LIFMIOR. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you or a child in your care. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or those of the child you are caring for. • 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 Information in this leaflet is organised under the following 7 sections: 1. What LIFMIOR is and what it is used for 2. What you need to know before you use LIFMIOR 3. How to use LIFMIOR 4. Possible side effects 5. How to store LIFMIOR 6. Contents of the pack and other information 7. Instructions for preparing and giving an injection of LIFMIOR (See overleaf) 1. WHAT LIFMIOR IS AND WHAT IT IS USED FOR LIFMIOR is a medicine that is made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. LIFMIOR works by reducing the inflammation associated with certain diseases. In adults (aged 18 and over), LIFMIOR can be used for moderate or severe RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, severe AXIAL SPONDYLOARTHRITIS including ANKYLOSING SPONDYLITIS, and moderate Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 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 LIFMIOR 25 mg powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 25 mg of etanercept. Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. This Fc component contains the hinge, CH 2 and CH 3 regions, but not the CH 1 region of IgG1. Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. The specific activity of etanercept is 1.7 x 10 6 units/mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection (powder for injection). The powder is white. The solvent is a clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis LIFMIOR in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. LIFMIOR can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. LIFMIOR is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. LIFMIOR, alone or in combination with methotrexate, has Olvassa el a teljes dokumentumot