Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Canakinumab
Novartis Europharm Limited
L04AC08
canakinumab
Interleukin inhibitors,
Cryopyrin-Associated Periodic Syndromes; Arthritis, Juvenile Rheumatoid; Arthritis, Gouty
Periodic fever syndromesIlaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:Cryopyrin-associated periodic syndromesIlaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including:Muckle-Wells syndrome (MWS),Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA),Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.Tumour necrosis factor receptor associated periodic syndrome (TRAPS)Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS).Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD)Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).Familial Mediterranean fever (FMF)Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate.Ilaris is also indicated for the treatment of:Still’s diseaseIlaris is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate.Gouty arthritisIlaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.
Revision: 30
Authorised
2009-10-23
65 B. PACKAGE LEAFLET 66 PACKAGE LEAFLET: INFORMATION FOR THE USER ILARIS 150 MG POWDER FOR SOLUTION FOR INJECTION canakinumab 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. WHAT IS IN THIS LEAFLET: 1. What Ilaris is and what it is used for 2. What you need to know before you use Ilaris 3. How to use Ilaris 4. Possible side effects 5. How to store Ilaris 6. Contents of the pack and other information 1. WHAT ILARIS IS AND WHAT IT IS USED FOR WHAT ILARIS IS Ilaris contains the active substance canakinumab, a monoclonal antibody that belongs to a group of medicines called interleukin inhibitors. It blocks the activity of a substance called interleukin-1 beta (IL-1 beta) in the body, which is present at increased levels in inflammatory diseases. WHAT ILARIS IS USED FOR Ilaris is used for treatment of the following inflammatory diseases: - Periodic fever syndromes: • Cryopyrin-associated periodic syndromes (CAPS), • Tumour necrosis factor receptor associated periodic syndrome (TRAPS), • Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), • Familial Mediterranean fever (FMF). - Still’s disease including adult onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) - Gouty arthritis More information on each of these diseases is given below. 67 Periodic fever syndromes Ilaris is used in adults and children aged 2 years and older to treat the following: - Cryopyrin-associated periodic syndromes (CAPS) – this is a group of auto-inflammatory diseases, which include: Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ilaris 150 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 150 mg of canakinumab*. After reconstitution, each ml of solution contains 150 mg canakinumab. * human monoclonal antibody produced in mouse myeloma Sp2/0 cells by recombinant DNA technology For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. The powder is white. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: _Cryopyrin-associated periodic syndromes _ Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including: • Muckle-Wells syndrome (MWS), • Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA), • Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash. _Tumour necrosis factor receptor associated periodic syndrome (TRAPS) _ Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS). _Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) _ Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD). _Familial Mediterranean fever (FMF) _ Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate. 3 Ilaris is also indicated for the treatment of: Still’s disease Ilaris is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years Przeczytaj cały dokument