Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
infliximab
Celltrion Healthcare Hungary Kft.
L04AB02
infliximab
Immunosuppressants
Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Rheumatoid arthritisRemsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:adult patients with active disease when the response to disease‑modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate;adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X‑ray, has been demonstrated.Adult Crohn’s diseaseRemsima is indicated for:treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies;treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).Paediatric Crohn’s diseaseRemsima is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.Ulcerative colitisRemsima is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.Paediatric ulcerative colitisRemsima is indicated for treatment of severely active ulcerative colitis in children and adolescents aged six to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6‑MP or AZA, or who are intolerant to or have medical contraindications for such therapies.Ankylosing spondylitisRemsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.Psoriatic arthritisRemsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.Remsima should be administered:in combination with methotrexate;or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X‑ray in patients with polyarticular symmetrical subtypes of the disease.PsoriasisRemsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).
Revision: 37
Authorised
2013-09-10
93 B. PACKAGE LEAFLET 94 PACKAGE LEAFLET: INFORMATION FOR THE USER REMSIMA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION infliximab 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 reminder card, which contains important safety information you need to be aware of before and during your treatment with Remsima. • When starting a new card, keep this card as a reference for 4 months after your last dose of Remsima. • If you have any further questions, ask your doctor. • 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Remsima is and what it is used for 2. What you need to know before you use Remsima 3. How Remsima will be given 4. Possible side effects 5. How to store Remsima 6. Contents of the pack and other information 1. WHAT REMSIMA IS AND WHAT IT IS USED FOR Remsima contains the active substance infliximab. Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha. Remsima belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the following inflammatory diseases: • Rheumatoid arthritis • Psoriatic arthritis • Ankylosing spondylitis (Bechterew’s disease) • Psoriasis. Remsima is also used in adults and children 6 years of age or older for: • Crohn’s disease • Ulcerative colitis. Remsima works by selectively attaching to TNF alpha and blocking its action. TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body. RHEUMATOID ARTHRITIS Rheumatoid arthritis is an inflammatory diseas Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 2 1. NAME OF THE MEDICINAL PRODUCT Remsima 100 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 100 mg of infliximab*. After reconstitution each mL contains 10 mg of infliximab. * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate) The powder is white. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Rheumatoid arthritis Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: • adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate. • adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (see section 5.1). Adult Crohn’s disease Remsima is indicated for: • treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. • treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohn’s disease Remsima is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodu Прочетете целия документ