国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
Rilonacept
Regeneron UK Limited
L04AC08
rilonacept
Immunosuppressants
Cryopyrin-Associated Periodic Syndromes
Rilonacept Regeneron is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) with severe symptoms, including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), in adults and children aged 12 years and older.
Revision: 5
Withdrawn
2009-10-23
Medicinal product no longer authorised 27 B. PACKAGE LEAFLET Medicinal product no longer authorised 28 PACKAGE LEAFLET: INFORMATION FOR THE USER RILONACEPT REGENERON 80 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION rilonacept 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 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. WHAT IS IN THIS LEAFLET: 1. What Rilonacept Regeneron is and what it is used for 2. What you need to know before you use Rilonacept Regeneron 3. How to use Rilonacept Regeneron 4. Possible side effects 5. How to store Rilonacept Regeneron 6. Contents of the pack and other information 1. WHAT RILONACEPT REGENERON IS AND WHAT IT IS USED FOR Rilonacept Regeneron is used to treat adults and adolescents aged 12 years and older with severe symptoms of Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). Rilonacept Regeneron belongs to a group of medicines called interleukin inhibitors. Rilonacept Regeneron blocks the activity of substances including interleukin-1 beta (IL-1 beta). In patients with CAPS, the body produces excessive amounts of IL-1 beta. This may lead to symptoms such as fever, headache, fatigue, skin rash, or painful joints and muscles. By blocking the activity of IL-1 beta, Rilonacept Regeneron leads to an improvement in these symptoms. If you have any questions about how Rilonacept Regeneron works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE RILONACEPT REGENERON DO NOT USE RILONACEPT REGENERON: • if you are allergic to rilonacept or any of the other ingredients of this m 阅读完整的文件
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Rilonacept Regeneron 80 mg/ml powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 220 mg of rilonacept. After reconstitution, each ml of solution contains 80 mg rilonacept. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white to off-white. The solvent is a clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rilonacept Regeneron is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of CAPS. After proper training in the correct injection technique, patients may self-inject Rilonacept Regeneron if their physician determines that it is appropriate and with medical follow-up as necessary. Posology _Adults _ Treatment in adults should be initiated with a loading dose of 320 mg. Dosing should be continued with a once-weekly injection of 160 mg. Rilonacept Regeneron should not be given more often than once weekly. _Paediatric population (12 to 17 years old) _ Treatment should be initiated with a loading dose of 4.4 mg/kg, up to a maximum of 320 mg. Dosing should be continued with a once-weekly injection of 2.2 mg/kg, up to a maximum of 160 mg (see Table 1). Dosing in children must be adjusted as the child grows. The patient or care giver should be advised to speak to the treating physician before adjusting the dose. The experience in children is limited. In the clinical program for CAPS, 8 adolescents aged 12-17 were treated for up to 18 months. M 阅读完整的文件