Land: Israel
Språk: engelsk
Kilde: Ministry of Health
AFATINIB AS DIMALEATE
BOEHRINGER INGELHEIM ISRAEL LTD.
L01XE13
FILM COATED TABLETS
AFATINIB AS DIMALEATE 40 MG
PER OS
Required
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY
AFATINIB
Giotrif as monotherapy is indicated for the treatment of: • EGFR TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);• locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.
2019-02-28
Giotrif Proposed Patient Information Film coated tablets 20mg, 30mg, 40mg, 50mg December 2019 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The dispensing of this medicine requires a physician’s prescription GIOTRIF ® 20 MG GIOTRIF ® 30 MG GIOTRIF ® 40 MG GIOTRIF ® 50 MG FILM-COATED TABLES Each film-coated tablet of Giotrif 20 mg contains 20 mg afatinib (as dimaleate). Each film-coated tablet of Giotrif 30 mg contains 30 mg afatinib (as dimaleate). Each film-coated tablet of Giotrif 40 mg contains 40 mg afatinib (as dimaleate). Each film-coated tablet of Giotrif 50 mg contains 50 mg afatinib (as dimaleate). Inactive ingredients and allergens in this medicine: See in Section 2 'Important information about some of the ingredients in this medicine' and Section 6 ‘Additional Information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, refer to your physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? This medicine is used as a monotherapy to treat: • Adult patients who have non-small cell lung cancer (NSCLC), identified by a mutation in the EGFR (Epidermal Growth Factor Receptor) gene, whose illness is in an advanced localized or metastatic stage and who have not yet been treated with tyrosine kinase inhibitors for EGF receptor. • Adult patients who have the squamous type of non-small cell lung cancer (NSCLC), whose illness in an advanced localized or metastatic stage and had progressed during or after chemotherapy. THERAPEUTIC GROUP: Antineoplastic, tyrosine kinase inhibitors. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient afatinib, or to any of the other ingredients that this medicine contains (see Se Les hele dokumentet
Giotrif Updated Prescribing Information Film coated tablets 20mg, 30mg, 40mg, 50mg December 2019 1 THE CONTENT OF THIS LEAFLET IS APPROVED BY THE MINISTRY OF HEALTH IN DECEMBER 2016 AND UPDATED ACCORDING TO MOH GUIDELINES IN DECEMBER 2019 GIOTRIF AFATINIB Film coated tablets PRESCRIBING INFORMATION 1. 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 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Giotrif 20 mg: One film-coated tablet contains 20 mg afatinib (as dimaleate). Giotrif 30 mg: One film-coated tablet contains 30 mg afatinib (as dimaleate). Giotrif 40 mg: One film-coated tablet contains 40 mg afatinib (as dimaleate). Giotrif 50 mg: One film-coated tablet contains 50 mg afatinib (as dimaleate). Excipient with known effect Giotrif 20 mg: One film-coated tablet contains 124 mg lactose (as monohydrate). Giotrif 30 mg: One film-coated tablet contains 186 mg lactose (as monohydrate). Giotrif 40 mg: One film-coated tablet contains 248 mg lactose (as monohydrate). Giotrif 50 mg: One film-coated tablet contains 310 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). GIOTRIF 20 mg: White to yellowish, round, biconvex and bevel-edged film-coated tablet debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 30 mg: Dark blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 40 mg: Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 50 mg: Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other. Giotrif Updated Prescribing Information Film coat Les hele dokumentet