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MEKINIST Film-coated tablets (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Mekinist 0.5 mg film-coated tablets. Mekinist 2 mg film-coated tablets.

Qualitative and quantitative composition

Mekinist 0.5 mg film-coated tablets: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib. Mekinist 2 mg film-coated tablets: Each film-coated tablet contains ...

Pharmaceutical form

Film-coated tablet (tablet). Mekinist 0.5 mg film-coated tablets: Yellow, modified oval, biconvex, film-coated tablets, approximately 4.8 8.9 mm, with GS debossed on one face and TFC on the opposing face. ...

Therapeutic indications

Melanoma Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 ...

Posology and method of administration

Treatment with trametinib should only be initiated and supervised by a physician experienced in the administration of anti-cancer medicinal products. Before taking trametinib, patients must have confirmation ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

When trametinib is given in combination with dabrafenib, the SmPC of dabrafenib must be consulted prior to initiation of treatment. For additional information on warnings and precautions associated with ...

Interaction with other medicinal products and other forms of interaction

Effect of other medicinal products on trametinib As trametinib is metabolised predominantly via deacetylation mediated by hydrolytic enzymes (e.g. carboxyl-esterases), its pharmacokinetics are unlikely ...

Fertility, pregnancy and lactation

Women of childbearing potential / Contraception in females Female patients of reproductive potential must be advised to use effective methods of contraception during treatment with trametinib and for 16 ...

Effects on ability to drive and use machines

Trametinib has minor influence on the ability to drive or use machines. The clinical status of the patient and the adverse reaction profile should be borne in mind when considering the patients ability ...

Undesirable effects

Summary of the safety profile The safety of trametinib monotherapy has been evaluated in the integrated safety population of 329 patients with BRAF V600 mutant unresectable or metastatic melanoma treated ...

Overdose

In clinical trials with trametinib monotherapy one case of accidental overdose was reported; a single dose of 4 mg. No AEs were reported following this event of trametinib overdose. In clinical trials ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor ATC code: L01XE25 Mechanism of action Trametinib is a reversible, highly selective, allosteric inhibitor of mitogen-activated ...

Pharmacokinetic properties

Absorption Trametinib is absorbed orally with median time to achieve peak concentrations of 1.5 hours post-dose. The mean absolute bioavailability of a single 2 mg tablet dose is 72% relative to an intravenous ...

Preclinical safety data

Carcinogenicity studies with trametinib have not been conducted. Trametinib was not genotoxic in studies evaluating reverse mutations in bacteria, chromosomal aberrations in mammalian cells and micronuclei ...

List of excipients

Mekinist 0.5 mg film-coated tablets: Tablet core: Mannitol (E421) Microcrystalline cellulose (E460) Hypromellose (E464) Croscarmellose sodium (E468) Magnesium stearate (E470b) Sodium laurilsulfate Colloidal ...

Incompatibilities

Not applicable.

Shelf life

Unopened bottle: 2 years. Opened bottle: 30 days at no more than 30°C.

Special precautions for storage

Store in a refrigerator (2°C to 8°C). Store in the original package in order to protect from light and moisture. Keep the bottle tightly closed. For storage conditions after first opening of the medicinal ...

Nature and contents of container

High-density polyethylene (HDPE) bottle with child-resistant polypropylene closure. The bottle contains a desiccant. Pack sizes: One bottle contains either 7 or 30 tablets. Not all pack sizes may be marketed ...

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

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization number(s)

Mekinist 0.5 mg film-coated tablets: EU/1/14/931/001 EU/1/14/931/002 Mekinist 2 mg film-coated tablets: EU/1/14/931/005 EU/1/14/931/006

Date of first authorization / renewal of the authorization

Date of first authorisation: 30 June 2014 Date of latest renewal: 14 February 2019

Πηγαίο έγγραφο

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