Negara: Taiwan
Bahasa: China
Sumber: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
CLADRIBINE
台灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)
L04AA40
錠劑
CLADRIBINE (1004001700) MG
鋁箔盒裝
製 劑
須由醫師處方使用
NerPharMa S.r.l. VIALE PASTEUR, 10, 20014 NERVIANO (MI), ITALY IT
cladribine
復發型多發性硬化症(臨床上有發作,且前二年有二次復發者)
有效日期: 2029/05/22; 英文品名: Mavenclad Tablets 10mg
2019-05-22
PAGE 1 593206 593206 INFO-TABLE - VERSION 03 IDENTIFICATION OF THE COMPONENT MATERIAL COMPONENT CODE: 593206 LOCAL BRAND: MAVENCLAD STRENGTH(S): 10 mg TECHNICAL DATA PACKAGING SITE: R-Pharm DEU TECHNICAL LAYOUT REF: PIL_473x598mm, folded to 60x120mm_V02 BARCODE BARCODE TYPE: Laetus ALPHA NUMERIC CONTENT: 321 SPOTMARK: No SPOTMARK VALUE: n/a TRACEABILITY (VERSIONS) VX DATE DESIGNER 01 09.11.2021 Dagmar Michalski 02 18.11.2021 Dagmar Michalski 03 n/a n/a Black PANTONE 186 C Keyline PAGE 2 License No. 000058 1. NAME OF THE MEDICINAL PRODUCT MAVENCLAD tablets 10 mg 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 relapsing multiple sclerosis (Patients have clinically defined relapse, with 2 or more relapses in the previous two years)(MS). 4.2 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. 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 a Baca dokumen lengkapnya