瑪威克錠10毫克

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

有效成分:

CLADRIBINE

可用日期:

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)

ATC代码:

L04AA40

药物剂型:

錠劑

组成:

CLADRIBINE (1004001700) MG

每包单位数:

鋁箔盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

NerPharMa S.r.l. VIALE PASTEUR, 10, 20014 NERVIANO (MI), ITALY IT

治疗领域:

cladribine

疗效迹象:

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)

產品總結:

有效日期: 2029/05/22; 英文品名: Mavenclad Tablets 10mg

授权日期:

2019-05-22

资料单张

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