Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
Cladribine
Merck Europe B.V.
L04AA40
cladribine
Immunosuppressants
Multiple Sclerosis
Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.
Revision: 9
Authorised
2017-08-22
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER MAVENCLAD 10 MG TABLETS cladribine 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 MAVENCLAD is and what it is used for 2. What you need to know before you take MAVENCLAD 3. How to take MAVENCLAD 4. Possible side effects 5. How to store MAVENCLAD 6. Contents of the pack and other information 1. WHAT MAVENCLAD IS AND WHAT IT IS USED FOR MAVENCLAD contains the active substance cladribine, a cytotoxic (cell killing) substance that works mostly on lymphocytes, cells of the immune system that are involved in inflammation. MAVENCLAD is a medicine used to treat MULTIPLE SCLEROSIS (MS) in ADULTS . MS is a disease in which inflammation destroys the protective sheath around the nerves. Treatment with MAVENCLAD has been shown to reduce flare-ups of symptoms and to slow down progression of disability. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAVENCLAD DO NOT TAKE MAVENCLAD - if you are ALLERGIC to CLADRIBINE or any of the OTHER INGREDIENTS of this medicine (listed in section 6). - if you are HIV POSITIVE , meaning you are infected with the human immunodeficiency virus (HIV). - if you have active tuberculosis or liver inflammation (hepatitis). - if you have a WEAKENED IMMUNE SYSTEM due to medical conditions or because you are TAKING OTHER MEDICINES THAT WEAKEN YOUR IMMUNE SYSTEM OR reduce the production of blood cells in your BONE MARROW . These include: - ciclosporin, cyclophosphamide and azathioprine (used to suppress the immune system, for Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT MAVENCLAD 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of cladribine. Excipients with known effect Each tablet contains 64 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, round, biconvex tablets of 8.5 mm diameter, engraved with 'C' on one side and '10' on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MAVENCLAD is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features (see section 5.1). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated and supervised by a physician experienced in the treatment of MS. Posology The recommended cumulative dose is 3.5 mg/kg body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year. If medically necessary (e.g. for recovery of lymphocytes), the treatment course in year 2 can be delayed for up to 6 months. Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight. For details, see Tables 1 and 2 below. _ _ Following completion of the 2 treatment courses, no further cladribine treatment is required in years 3 and 4 (see section 5.1). Re-initiation of therapy after year 4 has not been studied. _ _ _Criteria for initiating and continuing therapy _ Lymphocyte counts must be • normal before initiating treatment in year 1, • at least 800 cells/mm³ before initiating treatment in year 2. _ _ If necessary, the treatment course in year 2 can be delayed for up to 6 months to allow for recovery of lymphocytes. If this recovery takes more than 6 months, the patient should not receive cladribine tablets Citiți documentul complet