TYVERB Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Tyverb 250 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet (tablet). Oval, biconvex, yellow film-coated tablets, with GS XJG debossed on one side.
Therapeutic indications
Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with capecitabine for patients with advanced or metastatic disease with ...
Posology and method of administration
Tyverb treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products. HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+ with gene ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Data have shown that Tyverb combined with chemotherapy is less effective than trastuzumab when combined with chemotherapy. Cardiac toxicity Lapatinib has been associated with reports of decreases in LVEF ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on lapatinib Lapatinib is predominantly metabolised by CYP3A (see section 5.2). In healthy volunteers receiving ketoconazole, a strong CYP3A4 inhibitor, at 200 mg twice ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should be advised to use adequate contraception and avoid becoming pregnant while receiving treatment with Tyverb and for at least 5 days ...
Effects on ability to drive and use machines
Tyverb has no influence on the ability to drive and use machines. A detrimental effect on such activities cannot be predicted from the pharmacology of lapatinib. The clinical status of the patient and ...
Undesirable effects
Summary of the safety profile The safety of lapatinib has been evaluated as monotherapy or in combination with other chemotherapies for various cancers in more than 20,000 patients, including 198 patients ...
Overdose
There is no specific antidote for the inhibition of EGFR (ErbB1) and/or HER2 (ErbB2) tyrosine phosphorylation. The maximum oral dose of lapatinib that has been administered in clinical studies is 1800 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors ATC code: L01XE07 Mechanism of action Lapatinib, a 4-anilinoquinazoline, is an inhibitor of the ...
Pharmacokinetic properties
Absorption The absolute bioavailability following oral administration of lapatinib is unknown, but it is incomplete and variable (approximately 70% coefficient of variation in AUC). Serum concentrations ...
Preclinical safety data
Lapatinib was studied in pregnant rats and rabbits given oral doses of 30, 60, and 120 mg/kg/day. There were no teratogenic effects; however, minor anomalies (left-sided umbilical artery, cervical rib ...
List of excipients
Tablet core: Microcrystalline cellulose Povidone (K30) Sodium starch glycolate (Type A) Magnesium stearate Tablet coating: Hypromellose Titanium dioxide (E171) Macrogol (400) Polysorbate 80 Iron oxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf life Blister packs: 2 years. Bottles: 3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Tyverb is supplied in either blister packs or bottles. Blister packs: Tyverb/capecitabine combination posology: Each pack of Tyverb contains 70 film-coated tablets in foil blisters (polyamide/aluminium/polyvinyl ...
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)
EU/1/07/440/001-007
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 June 2008 Date of latest renewal: 17 February 2015
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