MEKINIST Film-coated tablet (2023)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Mekinist 0.5 mg film-coated tablets. Mekinist 2 mg film-coated tablets.
Qualitative and quantitative composition
<u>Mekinist 0.5 mg film-coated tablets:</u> Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib. <u>Mekinist 2 mg film-coated tablets:</u> Each film-coated ...
Pharmaceutical form
Film-coated tablet (tablet). <u>Mekinist 0.5 mg film-coated tablets:</u> Yellow, modified oval, biconvex, film-coated tablets, approximately 5.0 9.0 mm, with the company logo debossed on one face and ...
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 and 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
<b>Pharmacotherapeutic group:</b> Antineoplastic agents, protein kinase inhibitor, Mitogen-activated protein kinase (MEK) inhibitors <b>ATC code:</b> L01EE01 Mechanism of action Trametinib is a reversible, ...
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 <u>Tablet core:</u> Mannitol (E421) Microcrystalline cellulose (E460) Hypromellose (E464) Croscarmellose sodium (E468) Magnesium stearate (E470b) Sodium laurilsulfate ...
Incompatibilities
Not applicable.
Shelf life
<u>Unopened bottle:</u> 3 years. <u>Opened bottle:</u> 30 days at no more than 30°C.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture. Keep the bottle tightly closed. For storage ...
Nature and contents of container
High-density polyethylene (HDPE) bottle with child-resistant polypropylene closure. The bottle contains a desiccant. <u>Pack sizes:</u> One bottle contains either 7 or 30 tablets. Not all pack sizes may ...
Special precautions for disposal
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)
<u>Mekinist 0.5 mg film-coated tablets:</u> EU/1/14/931/001 EU/1/14/931/002 <u>Mekinist 2 mg film-coated tablets:</u> 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
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: