Merck Cladribine

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Cladribine 10mg;  

Tersedia dari:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Dosis:

10 mg

Bentuk farmasi:

Tablet

Komposisi:

Active: Cladribine 10mg   Excipient: Hydroxypropyl-beta-cyclodextrin Magnesium stearate Sorbitol Water for injection

Jenis Resep:

Prescription

Indikasi Terapi:

MAVENCLAD is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability. Following completion of the two treatment courses, no further cladribine treatment is required in years three and four. Re-initiation of therapy after year four has not been studied.

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet - 1 tablets - 48 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet - 4 tablets - 48 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet - 5 tablets - 48 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet - 6 tablets - 48 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet - 7 tablets - 48 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet - 8 tablets - 48 months from date of manufacture stored at or below 30°C protect from moisture

Tanggal Otorisasi:

2018-05-17

Karakteristik produk

Version: A006‐0224
Page 1 of 20
Supersedes: A005‐0822
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Merck Cladribine 10 mg tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Merck Cladribine tablet contains 10 mg cladribine.
The tablets also contain hydroxypropylbetadex, sorbitol and magnesium
stearate.
3
PHARMACEUTICAL FORM
Merck Cladribine tablet tablets are uncoated, white, round and
biconvex, and engraved with 'C' on
one side and '10' on the other side.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Merck Cladribine tablet is indicated for the treatment of
relapsing‐remitting multiple sclerosis
(RRMS) to reduce the frequency of clinical relapses and to delay the
progression of physical
disability.
Following completion of the 2 treatment courses, no further cladribine
treatment is required in
years 3 and 4. Re‐initiation of therapy after year 4 has not been
studied.
4.2
Dose and method of administration
DOSE
GENERAL TREATMENT SCHEDULE
The recommended cumulative dose of Cladribine tablet 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 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.
Patients should receive no more than 2 treatment courses over two
consecutive years. The
recommended dose should not be exceeded. Following completion of the 2
treatment courses, no
further cladribine treatment is required in year 3 and year 4 (see
section 5.1 Pharmacodynamic
properties, Clinical trials). Re‐initiation of therapy after year 4
has not been studied.
CRITERIA FOR STARTING AND CONTINUING THERAPY
Screening for infections
HIV infection, active tuberculosis and active hepatitis must be
excluded before initiation of Merck
Cladribine tablet (refer to section 4.3 Contraindications).
Screenin