国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Fingolimod
Clonmel Healthcare Ltd
L04AA27
Fingolimod
0.5 milligram(s)
Capsule, hard
fingolimod
Not marketed
2021-01-29
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER FINGOLIMOD CLONMEL 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 Clonmel is and what it is used for 2. What you need to know before you take Fingolimod Clonmel 3. How to take Fingolimod Clonmel 4. Possible side effects 5. How to store Fingolimod Clonmel 6. Contents of the pack and other information 1. WHAT FINGOLIMOD CLONMEL IS AND WHAT IT IS USED FOR WHAT FINGOLIMOD CLONMEL IS The active substance of Fingolimod Clonmel is fingolimod. WHAT FINGOLIMOD CLONMEL IS USED FOR Fingolimod Clonmel is used in adults, adolescents and children aged 10 years and older and with a body weight > 40 kg 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 Clonmel 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. 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 characterised by repeated attacks (relapses) of nervous system symptoms that reflect inflammation within the CNS. Symptoms 完全なドキュメントを読む
Health Products Regulatory Authority 22 April 2021 CRN00C767 Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fingolimod Clonmel 0.5 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.5 mg fingolimod (as hydrochloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule Hard gelatine capsule of 13.53 mm with a yellow opaque cap and a white opaque body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fingolimod Clonmel is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older and with a body weight > 40 kg: -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) -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 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 is 0.5 mg taken orally once daily. In paediatric patients (10 years of age and above), the recommended dose is dependent on body weight: In paediatric patients with a body weight > 40 kg: the recommended dose is 0.5 mg taken orally once daily. In paediatric patients with body weight ≤ 40 kg: Fingolimod Clonmel is not suitable. Other fingolimod-containing medicinal products are available in a lower strength (as 0.25 mg capsules). When switching from a 0.25 mg to a 0.5 mg daily dose, it is recommended to repeat the same first dose monitoring as for treatment initiation. The same first dose monitoring as 完全なドキュメントを読む