GILVEC Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Glivec 100 mg film-coated tablets. Glivec 400 mg film-coated tablets.
Qualitative and quantitative composition
Glivec 100 mg film-coated tablets: Each film-coated tablet contains 100 mg imatinib (as mesilate). Glivec 400 mg film-coated tablets: Each film-coated tablet contains 400 mg imatinib (as mesilate). For ...
Pharmaceutical form
Film-coated tablet. Glivec 100 mg film-coated tablets: Very dark yellow to brownish-orange film-coated tablet, round with NVR on one side and SA and score on the other side. Glivec 400 mg film-coated tablets: ...
Therapeutic indications
Glivec is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation ...
Posology and method of administration
Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate. For doses other than 400 mg and 800 mg (see ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
When Glivec is co-administered with other medicinal products, there is a potential for drug interactions. Caution should be used when taking Glivec with protease inhibitors, azole antifungals, certain ...
Interaction with other medicinal products and other forms of interaction
Active substances that may increase imatinib plasma concentrations Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential must be advised to use effective contraception during treatment. Pregnancy There are limited data on the use of imatinib in pregnant women. ...
Effects on ability to drive and use machines
Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with imatinib. Therefore, caution should be recommended when driving ...
Undesirable effects
Patients with advanced stages of malignancies may have numerous confounding medical conditions that make causality of adverse reactions difficult to assess due to the variety of symptoms related to the ...
Overdose
Experience with doses higher than the recommended therapeutic dose is limited. Isolated cases of Glivec overdose have been reported spontaneously and in the literature. In the event of overdose the patient ...
Pharmacodynamic properties
Pharmacotherapeutic group: protein-tyrosine kinase inhibitor ATC code: L01XE01 Mechanism of action Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of ...
Pharmacokinetic properties
Pharmacokinetics of Glivec The pharmacokinetics of Glivec have been evaluated over a dosage range of 25 to 1,000 mg. Plasma pharmacokinetic profiles were analysed on day 1 and on either day 7 or day 28, ...
Preclinical safety data
The preclinical safety profile of imatinib was assessed in rats, dogs, monkeys and rabbits. Multiple dose toxicity studies revealed mild to moderate haematological changes in rats, dogs and monkeys, accompanied ...
List of excipients
Tablet core: Cellulose microcrystalline Crospovidone Hypromellose Magnesium stearate Silica, colloidal anhydrous Tablet coat: Iron oxide, red (E172) Iron oxide, yellow (E172) Macrogol Talc Hypromellose ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from moisture.
Nature and contents of container
Glivec 100 mg film-coated tablets: PVC/alu blisters: Packs containing 20, 60, 120 or 180 film-coated tablets. PVDC/alu blisters: Packs containing 60, 120 or 180 film-coated tablets. Glivec 400 mg film-coated ...
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)
Glivec 100 mg film-coated tablets: EU/1/01/198/007 EU/1/01/198/008 EU/1/01/198/011 EU/1/01/198/012 EU/1/01/198/014 EU/1/01/198/015 EU/1/01/198/016 Glivec 400 mg film-coated tablets: EU/1/01/198/009 EU/1/01/198/010 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 07 November 2001 Date of latest renewal: 07 November 2006
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