দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Fingolimod
MSN Labs Europe Limited
L04AA27
Fingolimod
Capsule, hard
fingolimod
Not marketed
2020-11-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FINGOLIMOD MSN 0.5 MG HARD CAPSULES Fingolimod 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 Fingolimod MSN is and what it is used for 2. What you need to know before you take Fingolimod MSN 3. How to take Fingolimod MSN 4. Possible side effects 5. How to store Fingolimod MSN 6. Contents of the pack and other information 1. WHAT FINGOLIMOD MSN IS AND WHAT IT IS USED FOR WHAT FINGOLIMOD MSN IS Fingolimod MSN contains the active substance fingolimod. WHAT FINGOLIMOD MSN IS USED FOR Fingolimod MSN is used in adults to treat relapsing-remitting multiple sclerosis (MS), more specifically in: - Patients who have failed to respond despite treatment with an MS treatment. or - Patients who have rapidly evolving severe MS. Fingolimod MSN does not cure MS, but it helps to reduce the number of relapses and to slow down the progression of physical disabilities due to MS. Fingolimod is also authorised for use in children aged 10 years and older. A fingolimod containing drug product from a different company is registered in the European Union. Ask your doctor or pharmacist if you have further questions. WHAT IS MULTIPLE SCLEROSIS MS is a long-term condition that affects the central nervous system (CNS), comprised of the brain and spinal cord. In MS inflammation destroys the protective sheath (called myelin) around the nerves in the CNS and stops the nerves from working properly. This is called demyelination. Relapsing-remitting MS is characterized by repeated att সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 10 August 2022 CRN00CWP7 Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fingolimod MSN 0.5 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mg capsule contains 0.5 mg fingolimod (as hydrochloride) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Hard capsules, size 3, with a white cap imprinted "0.5 mg" and a white body imprinted "MF" with black ink. The capsules contain a white to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fingolimod MSN is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1). or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI. For paediatric patients aged 10 years and older a fingolimod containing drug product from a different company is registered in the European Union. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment should be initiated and supervised by a physician experienced in multiple sclerosis. Posology In adults, the recommended dose of Fingolimod MSN is one 0.5 mg capsule taken orally once daily. The same first dose monitoring as for treatment initiation is recommended when treatment is interrupted for: 1 day or more during the first 2 weeks of treatment. more than 7 days during weeks 3 and 4 of treatment. more than 2 weeks after one month of treatment. If the treatment interruption is of shorter duration than the above, the treatment should be continued with the next dose as planned (see sect সম্পূর্ণ নথি পড়ুন