Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
Teriflunomide
Sanofi Winthrop Industrie
L04AA31
teriflunomide
Selective immunosuppressants
Multiple Sclerosis
AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).
Revision: 26
Authorised
2013-08-26
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ AUBAGIO 7 MG FILM-COATED TABLETS AUBAGIO 14 MG FILM-COATED TABLETS teriflunomide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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. See section 4. WHAT IS IN THIS LEAFLET 1. What AUBAGIO is and what it is used for 2. What you need to know before you take AUBAGIO 3. How to take AUBAGIO 4. Possible side effects 5. How to store AUBAGIO 6. Contents of the pack and other information 1. WHAT AUBAGIO IS AND WHAT IT IS USED FOR WHAT AUBAGIO IS AUBAGIO contains the active substance teriflunomide which is an immunomodulatory agent and adjusts the immune system to limit its attack on the nervous system. WHAT AUBAGIO IS USED FOR AUBAGIO is used in adults and in children and adolescents (10 years of age and older) to treat relapsing remitting multiple sclerosis (MS). WHAT MULTIPLE SCLEROSIS IS MS is a long-term illness that affects the central nervous system (CNS). The CNS is made up of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (called myelin) around the nerves in the CNS. This loss of myelin is called demyelination. This stops nerves from working properly. People with relapsing form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms caused by their nerves not working properly. These symptoms vary from patient to patient but usually involve: - difficulty walking - vision problems - balance problems. Symptoms may disappear completely after the relapse is over, but over time, some problems may remain betwe সম্পূর্ণ নথি পড়ুন
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT AUBAGIO 7 mg film-coated tablets AUBAGIO 14 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AUBAGIO 7 mg film-coated tablets Each film-coated tablet contains 7 mg of teriflunomide. _Excipient with known effect _ Each tablet contains 72 mg of lactose (as monohydrate). AUBAGIO 14 mg film-coated tablets Each film-coated tablet contains 14 mg of teriflunomide. _Excipient with known effect _ Each tablet contains 72 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) AUBAGIO 7 mg film-coated tablets Very light greenish-bluish grey to pale greenish-blue, hexagonal film-coated 7.5 mm tablet with imprint on one side (‘7’) and engraved with the corporate logo on other side. AUBAGIO 14 mg film-coated tablets Pale blue to pastel blue, pentagonal film-coated 7.5 mm tablet with imprint on one side (‘14’) and engraved with a corporate logo on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment should be initiated and supervised by a physician experienced in the management of multiple sclerosis. 3 Posology _Adults _ In adults, the recommended dose of teriflunomide is 14 mg once daily. _Paediatric population (10 years and older) _ In paediatric patients (10 years of age and above), the recommended dose is dependent on body weight: - Paediatric patients with body weight >40 kg: 14 mg once daily. - Paediatric patients with body weight ≤40 kg: 7 mg once daily. Paediatric patients who reach a stable body weight above 40 kg should be switched to 14 mg once daily. Film-coated tablets can be taken with or without fo সম্পূর্ণ নথি পড়ুন