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MAVENCLAD Tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

MAVENCLAD 10 mg tablets.

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.

Pharmaceutical form

Tablet. White, round, biconvex tablets of 8.5 mm diameter, engraved with C on one side and 10 on the other side.

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).

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, ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Infection with human immunodeficiency virus (HIV). Active chronic infection (tuberculosis or hepatitis). Initiation ...

Special warnings and precautions for use

Haematological monitoring Cladribines mode of action is closely linked to a reduction in lymphocyte count. The effect on lymphocyte count is dose-dependent. Decreases in neutrophil count, red blood cell ...

Interaction with other medicinal products and other forms of interaction

MAVENCLAD contains hydroxypropylbetadex, which may be available for complex formation with other medicinal products, potentially leading to an increase in bioavailability of such a product (especially ...

Fertility, pregnancy and lactation

Contraception in males and females Before initiation of treatment both in year 1 and year 2, women of childbearing potential and males who could potentially father a child should be counselled regarding ...

Effects on ability to drive and use machines

MAVENCLAD has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most clinically relevant adverse reactions reported in MS patients who received cladribine at the recommended cumulative dose of 3.5 mg/kg over 2 years in clinical studies ...

Overdose

There is limited experience with overdose of oral cladribine. Lymphopenia is known to be dose-dependent (see sections 4.4 and 4.8). Particularly close monitoring of haematological parameters is recommended ...

Pharmacodynamic properties

Pharmacotherapeutic group: Selective Immunosuppressants ATC code: L04AA40 Mechanism of action Cladribine is a nucleoside analogue of deoxyadenosine. A chlorine substitution in the purine ring protects ...

Pharmacokinetic properties

Cladribine is a prodrug that has to be phosphorylated intracellularly to become biologically active. Cladribine pharmacokinetics were studied following oral and intravenous administration in MS patients ...

Preclinical safety data

Non-clinical safety pharmacological and toxicological assessment of cladribine in animal models relevant for the safety assessment of cladribine did not yield significant findings other than those predicted ...

List of excipients

Hydroxypropylbetadex (2-hydroxypropyl-ß-cyclodextrin) Sorbitol Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf-life: 3 years.

Special precautions for storage

Store in the original package in order to protect from moisture.

Nature and contents of container

Oriented polyamide (OPA)/aluminium (Al)/polyvinyl chloride (PVC) – aluminium (Al) blister sealed in a cardboard wallet and fixed in a child-resistant outer carton. Pack sizes of 1, 4, 5, 6, 7 or 8 tablets. ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands

Marketing authorization number(s)

EU/1/17/1212/001 EU/1/17/1212/002 EU/1/17/1212/003 EU/1/17/1212/004 EU/1/17/1212/005 EU/1/17/1212/006

Date of first authorization / renewal of the authorization

Date of first authorisation: 22 August 2017

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