MAVENCLAD

Krajina: Indonézia

Jazyk: indonézština

Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Dostupné z:

MERCK TBK - Indonesia -

Dávkovanie:

10.00 MG

Forma lieku:

TABLET

Zloženie:

CLADRIBINE

Počet v balení:

DUS, 1 BLISTER @ 1 TABLET

Trieda:

Obat

Výrobca:

NERPHARMA S.R.L. - Italy

Stav Autorizácia:

Berlakus/d 21-04-2028

Dátum Autorizácia:

2023-04-21

Súhrn charakteristických

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.
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