TARCEVA Film-coated tablets (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Tarceva 25 mg film-coated tablets. Tarceva 100 mg film-coated tablets. Tarceva 150 mg film-coated tablets.
Qualitative and quantitative composition
Tarceva 25 mg film coated tablets: Each film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride). Tarceva 100 mg film-coated tablets: Each film-coated tablet contains 100 mg erlotinib ...
Pharmaceutical form
Film-coated tablet. Tarceva 25 mg film coated tablets: White to yellowish, round, biconvex tablets with T 25 engraved on one side. Tarceva 100 mg film-coated tablets: White to yellowish, round, biconvex ...
Therapeutic indications
Non-Small Cell Lung Cancer (NSCLC) Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations. ...
Posology and method of administration
Tarceva treatment should be supervised by a physician experienced in the use of anti-cancer therapies. Patients with Non-Small Cell Lung Cancer EGFR mutation testing should be performed in accordance with ...
Contraindications
Hypersensitivity to erlotinib or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Assessment of EGFR mutation status When considering the use of Tarceva as a first line or maintenance treatment for locally advanced or metastatic NSCLC, it is important that the EGFR mutation status of ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Erlotinib and other CYP substrates Erlotinib is a potent inhibitor of CYP1A1, and a moderate inhibitor of CYP3A4 and CYP2C8, as well as a strong ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data for the use of erlotinib in pregnant women. Studies in animals have shown no evidence of teratogenicity or abnormal parturition. However, an adverse effect on the pregnancy ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed; however erlotinib is not associated with impairment of mental ability.
Undesirable effects
Safety evaluation of Tarceva is based on the data from more than 1500 patients treated with at least one 150 mg dose of Tarceva monotherapy and more than 300 patients who received Tarceva 100 or 150 mg ...
Overdose
Symptoms Single oral doses of Tarceva up to 1000 mg erlotinib in healthy subjects, and up to 1600 mg in cancer patients have been tolerated. Repeated twice daily doses of 200 mg in healthy subjects were ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agent protein kinase inhibitor ATC code: L01XE03 Mechanism of action Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type ...
Pharmacokinetic properties
Absorption After oral administration, erlotinib peak plasma levels are obtained in approximately 4 hours after oral dosing. A study in normal healthy volunteers provided an estimate of the absolute bioavailability ...
Preclinical safety data
Chronic dosing effects observed in at least one animal species or study included effects on the cornea (atrophy, ulceration), skin (follicular degeneration and inflammation, redness, and alopecia), ovary ...
List of excipients
Tablet core: Lactose monohydrate Cellulose, microcrystalline (E460) Sodium starch glycolate Type A Sodium laurilsulfate Magnesium stearate (E470b) Tablet coat: Hydroxypropyl cellulose (E463) Titanium dioxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC blister sealed with aluminium foil containing 30 tablets.
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Marketing authorization number(s)
EU/1/05/311/001 EU/1/05/311/002 EU/1/05/311/003
Date of first authorization / renewal of the authorization
Date of first authorization: 19 September 2005 Date of latest renewal: 2 July 2010
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