Country: Indoneżja
Lingwa: Indoneżjan
Sors: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MERCK TBK - Indonesia -
10.00 MG
TABLET
CLADRIBINE
DUS, 1 BLISTER @ 1 TABLET
Obat
NERPHARMA S.R.L. - Italy
Berlakus/d 21-04-2028
2023-04-21
MAVENCLAD® CLADRIBINE 1. 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 5.1 List of Excipients. 2. PHARMACEUTICAL FORM Tablet. White, round, biconvex tablets of 8.5 mm diameter, engraved with 'C' on one side and '10' on the other side. 3. CLINICAL PARTICULARS 3.1 INDICATIONS MAVENCLAD is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (MS) as defined by clinical or imaging features (_see section 4.1 Pharmacodynamic Properties_). 3.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with MAVENCLAD must be initiated and supervised by a physician experienced in the treatment of MS. POSOLOGY The recommended cumulative dose of MAVENCLAD 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 4.1 Pharmacodynamic Properties_). Re-initiation of therapy after year 4 has not been studied. Criteria for initiating and continuing therapy Lymphocyte counts must be ▪ normal before initiating MAVENCLAD in year 1, ▪ at least 800 cells/mm³ before initiating MAVENCLAD 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 MAVENCLAD anymore. Global Ve Aqra d-dokument sħiħ