Χώρα: Ολλανδία
Γλώσσα: Ολλανδικά
Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
FINGOLIMODHYDROCHLORIDE SAMENSTELLING overeenkomend met ; FINGOLIMOD
Lupin Europe GmbH Hanauer Landstrasse 139-143 60314 FRANKFURT AM MAIN (DUITSLAND)
FINGOLIMODHYDROCHLORIDE COMPOSITION corresponding to ; FINGOLIMOD
Capsule, hard
ALUMINIUMMAGNESIUMMETASILICAAT, type 1A,B of C ; AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; NATRIUMSTEARYLFUMARAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT
Oraal gebruik
2020-03-30
33 PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE USER Fingolimod Lupin 0,5 mg harde capsules fingolimod This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [Product name] IS AND WHAT IT IS USED FOR WHAT [PRODUCT NAME] IS Fingolimod contains the active substance fingolimod. WHAT [ [ N N A A T T I I O O N N A A L L N N A A M M E E ] ] IS USED FOR [ [ P P r r o o d d u u c c t t n n a a m m e e ] ] 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. [ [ P P r r o o d d u u c c t t n n a a m m e e ] ] 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 protect Διαβάστε το πλήρες έγγραφο
1 _ _ SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 2 SUMMARY OF PRODUCT CHARACTERISTICS 3 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT [Product name] 0.5mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains fingolimod hydrochloride corresponding to 0.5mg fingolimod. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Hard gelatin capsule of 15.8 ± 0.4mm (size 3) with bright yellow opaque cap and white opaque body, imprinted with "FG 0.5" on cap in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Product name] 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 In adults, the recommended dose of [Product name] is one 0.5 mg capsule taken orally once daily. In paediatric patients (10 years of age and above), the recommended dose is dependent on body weight: - Paediatric patients with body weight ≤40 kg: one 0.25 mg capsule taken orally once daily. - Paediatric patients with body weight >40 kg: one 0.5 mg cap Διαβάστε το πλήρες έγγραφο