GIOTRIF Film-coated tablets (2020)
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Περιεχόμενα
Name of the medicinal product
GIOTRIF 20 mg film-coated tablets. GIOTRIF 30 mg film-coated tablets. GIOTRIF 40 mg film-coated tablets. GIOTRIF 50 mg film-coated tablets.
Qualitative and quantitative composition
GIOTRIF 20 mg film-coated tablets: One film-coated tablet contains 20 mg afatinib (as dimaleate). Excipient with known effect: One film-coated tablet contains 118 mg lactose (as monohydrate). GIOTRIF 30 ...
Pharmaceutical form
Film-coated tablet (tablet). GIOTRIF 20 mg film-coated tablets: White to yellowish, round, biconvex and bevel-edged film-coated tablet debossed with the code T20 on one side and the Boehringer Ingelheim ...
Therapeutic indications
GIOTRIF as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating ...
Posology and method of administration
Treatment with GIOTRIF should be initiated and supervised by a physician experienced in the use of anticancer therapies. EGFR mutation status should be established prior to initiation of GIOTRIF therapy ...
Contraindications
Hypersensitivity to afatinib or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Assessment of EGFR mutation status When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive ...
Interaction with other medicinal products and other forms of interaction
Interactions with drug transport systems Effects of P-gp and breast cancer resistance protein (BCRP) inhibitors on afatinib In vitro studies have demonstrated that afatinib is a substrate of P-gp and BCRP. ...
Pregnancy and lactation
Women of childbearing potential As a precautionary measure, women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with GIOTRIF. Adequate contraceptive methods ...
Effects on ability to drive and use machines
GIOTRIF has minor influence on the ability to drive and use machines. During treatment, ocular adverse reactions (conjunctivitis, dry eye, keratitis) have been reported in some patients (see section 4.8) ...
Undesirable effects
Summary of the safety profile The types of adverse reactions (ADRs) were generally associated with the EGFR inhibitory mode of action of afatinib. The summary of all ADRs is shown in Table 2. The most ...
Overdose
Symptoms The highest dose of afatinib studied in a limited number of patients in Phase I clinical trials was 160 mg once daily for 3 days and 100 mg once daily for 2 weeks. The adverse reactions observed ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE13 Mechanism of action Afatinib is a potent and selective, irreversible ErbB Family Blocker. Afatinib covalently ...
Pharmacokinetic properties
Absorption Following oral administration of afatinib, C<sub>max</sub> of afatinib were observed approximately 2 to 5 hours post dose. C<sub>max</sub> and AUC<sub>0-∞</sub> values increased slightly more ...
Preclinical safety data
Oral administration of single doses to mice and rats indicated a low acute toxic potential of afatinib. In oral repeated-dose studies for up to 26 weeks in rats or 52 weeks in minipigs the main effects ...
List of excipients
Tablet core: Lactose monohydrate Cellulose, microcrystalline (E460) Silica, colloidal anhydrous (E551) Crospovidone (type A) Magnesium stearate (E470b) Film-coating: GIOTRIF 20 mg film-coated tablets: ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store in the original package in order to protect from moisture and light.
Nature and contents of container
PVC/PVDC perforated unit dose blister. Each blister is packed together with a desiccant sachet in a laminated aluminium pouch and contains 7 1 film-coated tablets. Pack sizes of 7 1, 14 1 or 28 1 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
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany
Marketing authorization number(s)
GIOTRIF 20 mg film-coated tablets: EU/1/13/879/001 EU/1/13/879/002 EU/1/13/879/003 GIOTRIF 30 mg film-coated tablets: EU/1/13/879/004 EU/1/13/879/005 EU/1/13/879/006 GIOTRIF 40 mg film-coated tablets: ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 September 2013 Date of latest renewal: 16 May 2018
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