IRESSA Film-coated tablets (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
IRESSA 250 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 250 mg of gefitinib. Excipients with known effect: Each tablet contains 163.5 mg of lactose (as monohydrate). Each tablet contains 3.86 mg of sodium. For the full list of excipients, ...
Pharmaceutical form
Film-coated tablets (tablet). Tablets are brown, round, biconvex, impressed with IRESSA 250 on one side and plain on the other.
Therapeutic indications
IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4).
Posology and method of administration
Treatment with IRESSA should be initiated and supervised by a physician experienced in the use of anti-cancer therapies. Posology The recommended posology of IRESSA is one 250 mg tablet once a day. If ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6).
Special warnings and precautions for use
When considering the use of IRESSA as a treatment for locally advanced or metastatic NSCLC, it is important that EGFR mutation assessment of the tumour tissue is attempted for all patients. If a tumour ...
Interaction with other medicinal products and other forms of interaction
The metabolism of gefitinib is via the cytochrome P450 isoenzyme CYP3A4 (predominantly) and via CYP2D6. Active substances that may increase gefitinib plasma concentrations In vitro studies have shown that ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential must be advised not to get pregnant during therapy. Pregnancy There are no data from the use of gefitinib in pregnant women. Studies in animals ...
Effects on ability to drive and use machines
During treatment with gefitinib, asthenia has been reported. Therefore, patients who experience this symptom should be cautious when driving or using machines.
Undesirable effects
Summary of the safety profile In the pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 IRESSA-treated patients), the most frequently reported adverse drug reactions (ADRs), ...
Overdose
There is no specific treatment in the event of overdose of gefitinib. However, in phase I clinical trials, a limited number of patients were treated with daily doses of up to 1000 mg. An increase of frequency ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors ATC code: L01XE02 Mechanism of action and pharmacodynamic effects The epidermal growth factor (EGF) and its receptor (EGFR [HER1; ...
Pharmacokinetic properties
Absorption Following oral administration of gefitinib, absorption is moderately slow and peak plasma concentrations of gefitinib typically occur at 3 to 7 hours after administration. Mean absolute bioavailability ...
Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows: Corneal epithelia ...
List of excipients
Tablet core: Lactose monohydrate Microcrystalline cellulose (E460) Croscarmellose sodium Povidone (K29-32) (E1201) Sodium laurilsulfate Magnesium stearate Tablet coating: Hypromellose (E464) Macrogol 300 ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 4 years.
Special precautions for storage
Store in the original package in order to protect from moisture.
Nature and contents of container
PVC/Aluminium perforated blister containing 10 tablets or PVC/Aluminium non-perforated blister containing 10 tablets. Three blisters are combined with an aluminium foil laminate over-wrap in a carton. ...
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
AstraZeneca AB, SE-151 85, Södertälje, Sweden
Marketing authorization number(s)
EU/1/09/526/001 EU/1/09/526/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 24/06/2009 Date of latest renewal: 23/04/2014
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