TANIFLAR Hard capsule (2020)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Novartis Europharm Limited |
|---|---|
| Διεύθυνση | Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
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Περιεχόμενα
Name of the medicinal product
Tafinlar 50 mg hard capsules. Tafinlar 75 mg hard capsules.
Qualitative and quantitative composition
Tafinlar 50 mg hard capsules: Each hard capsule contains dabrafenib mesilate equivalent to 50 mg of dabrafenib. Tafinlar 75 mg hard capsules: Each hard capsule contains dabrafenib mesilate equivalent to ...
Pharmaceutical form
Hard capsule (capsule). Tafinlar 50 mg hard capsules: Opaque dark red capsules, approximately 18 mm long, with capsule shell imprinted with GS TEW and 50 mg. Tafinlar 75 mg hard capsules: Opaque dark pink ...
Therapeutic indications
Melanoma Dabrafenib as monotherapy or in combination with trametinib 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 dabrafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products. Before taking dabrafenib, 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 dabrafenib is given in combination with trametinib, the SmPC of trametinib must be consulted prior to intiation of combination treatment. For additional information on warnings and precautions associated ...
Interaction with other medicinal products and other forms of interaction
Effect of other medicinal products on dabrafenib Dabrafenib is a substrate for the metabolising enzymes CYP2C8 and CYP3A4, while the active metabolites hydroxy-dabrafenib and desmethyl-dabrafenib are CYP3A4 ...
Pregnancy and lactation
Women of childbearing potential/Contraception in females Women of childbearing potential must use effective methods of contraception during therapy and for 2 weeks following discontinuation of dabrafenib ...
Effects on ability to drive and use machines
Dabrafenib has minor influence on the ability to drive and use machines. The clinical status of the patient and the adverse reaction profile of dabrafenib should be borne in mind when considering the patient ...
Undesirable effects
Summary of the safety profile The safety of dabrafenib monotherapy is based on the integrated safety population from five clinical trials, BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), ...
Overdose
There is no specific treatment for an overdose of dabrafenib. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE23 Mechanism of action Dabrafenib is an inhibitor of RAF kinases. Oncogenic mutations in BRAF lead to constitutive ...
Pharmacokinetic properties
Absorption Dabrafenib is absorbed orally with median time to achieve peak plasma concentration of 2 hours post-dose. Mean absolute bioavailability of oral dabrafenib is 95% (90% CI: 81, 110%). Dabrafenib ...
Preclinical safety data
Carcinogenicity studies with dabrafenib have not been conducted. Dabrafenib was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus ...
List of excipients
Capsule content: Microcrystalline cellulose Magnesium stearate Colloidal silicone dioxide Capsule shell: Red iron oxide (E172) Titanium dioxide (E171) Hypromellose (E464) Printing ink: Black iron oxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Opaque white high density polyethylene (HDPE) bottle with polypropylene screw cap and a silica gel desiccant. Each bottle contains either 28 or 120 hard capsules. 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)
Tafinlar 50 mg hard capsules: EU/1/13/865/001 EU/1/13/865/002 Tafinlar 75 mg hard capsules: EU/1/13/865/003 EU/1/13/865/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 August 2013 Date of latest renewal: 08 May 2018
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