Country: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
FINGOLIMODHYDROCHLORIDE 0,56 mg/stuk SAMENSTELLING overeenkomend met ; FINGOLIMOD 0,5 mg/stuk
FINGOLIMODHYDROCHLORIDE 0,56 mg/stuk SAMENSTELLING overeenkomend met ; FINGOLIMOD 0,5 mg/stuk
Capsule, hard
AMMONIA (E 527) ; CARMELLOSE CALCIUM (E 466) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; NATRIUMSTEARYLFUMARAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; TARTRAZINE (E 102) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110) ; ZWARTE INKT
Oraal gebruik
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER FINGOLIMOD DEVATIS 0,25 MG, HARDE CAPSULES FINGOLIMOD DEVATIS 0,5 MG, HARDE 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 Devatis is and what it is used for 2. What you need to know before you take Fingolimod Devatis 3. How to take Fingolimod Devatis 4. Possible side effects 5. How to store Fingolimod Devatis 6. Contents of the pack and other information 1. WHAT FINGOLIMOD DEVATIS IS AND WHAT IT IS USED FOR WHAT FINGOLIMOD DEVATIS IS Fingolimod Devatis contains the active substance fingolimod. WHAT FINGOLIMOD DEVATISIS USED FOR Fingolimod Devatis is used in adults and in children and adolescents (10 years of age and above) 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 Devatis 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. Symp Baca dokumen lengkap
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fingolimod Devatis 0.25 mg, harde capsules Fingolimod Devatis 0.5 mg, harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fingolimod Devatis 0.25 mg hard capsules Each hard capsule contains 0.25 mg fingolimod (as hydrochloride). Fingolimod Devatis 0.5 mg hard capsules Each hard capsule contains 0.5 mg fingolimod (as hydrochloride). Excipients with known effect: Each hard capsule contains 0.028 mg of Tartrazine (E102) and 0.003 mg of Sunset yellow FCF (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Fingolimod Devatis 0.25 mg hard capsules Size ‘3’ hard gelatin capsules with ivory opaque cap and body, imprint with black ink “F 0.25” on cap, containing white to off-white powder mixture. Fingolimod Devatis 0.5 mg hard capsules Size ‘3’ hard gelatin capsules with yellow opaque cap and white opaque body, imprint with black ink “F 0.5” on cap, containing white to off-white powder mixture. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fingolimod Devatis 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: - 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment should be initiated and supervised by a physician experienced in multiple sclerosis. Posology 2 In adults, the recommended dose of fingolimod is one 0.5 mg capsule taken orally once daily. In paediatri Baca dokumen lengkap