Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
CLADRIBINE
MERCK SERONO LTD
L01BB04
TABLETS
CLADRIBINE 10 MG
PER OS
Required
MERCK EUROPE B.V., THE NETHERLANDS
CLADRIBINE
Mavenclad 10mg tablets is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features
2018-01-10
Prescribers Guide 2 CONTENT Introduction to MAVENCLAD ® 3 Treatment regimens 4 Monitoring during treatment 7 • Lymphocyte counts • Severe infections • Progressive Multifocal Leukoencephalopathy (PML) • Malignancies Prevention of pregnancy 10 • Information for Female Patients • Information for Male Patients 3 Introduction to MAVENCLAD ® This guide provides information on the most important risks associated with MAVENCLAD ® and the activities required to minimise these risks The patient guide is part of the risk minimisation measures, and use of the material in your discussion with the patient, may support the early identification of signs and symptoms of potential adverse reactions and their timely treatment This guide should be read in conjunction with the information provided in the approved Prescribing Information (PI) of MAVENCLAD ® Careful consideration should be given to the information in the PI regarding blood count monitoring and screening for latent infections before initiating treatment YEAR 1 YEAR 3 YEAR 2 YEAR 4 No additional active treatment with MAVENCLAD ® Month 2 Month 2 2 treatment weeks 2 treatment weeks Month 1 Month 1 4 Treatment regimens MAVENCLAD ® therapy consists of two treatment courses administered at the beginning of two consecutive years 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 The dose administered is dependent on the individual patient’s body weight (see Figure) 5 Following completion of the 2 treatment courses in two consecutive years, no further cladribine treatment is required in years 3 and 4 MAVENCLAD ® tablets are packed in a reclosable, child resistant carton The package leaflet will include a step-by-step guide on how to handle the package and take MAVENCLAD ® tablets The number of MAVENCLAD ® tablets is calculated according to the body weight of the patient The table below provides the number of MAVENCLAD ® tablets to be taken each w Baca dokumen lengkapnya
1 PRESCRIBING INFORMATION MAVENCLAD 10 MG TABLETS 1. NAME OF THE MEDICINAL PRODUCT MAVENCLAD 10 mg tablets 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. PATIENT GUIDE The marketing of Mavenclad is subject to a risk management plan (RMP) including a Patient guide. The Patient guide, emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. PRESCRIBER GUIDE This product is marketed with prescriber providing important safety information. Please ensure you are familiar with this material as it contains important safety information. 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 highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features (see section 5.1). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with MAVENCLAD must be initiated and supervised by a physician experienced in the treatment of MS. 2 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 bee Baca dokumen lengkapnya