מדינה: סינגפור
שפה: אנגלית
מקור: HSA (Health Sciences Authority)
Afatinib dimaleate 29.5600mg eqv Afatinib
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
L01XE13
20.0000mg
TABLET, FILM COATED
Afatinib dimaleate 29.5600mg eqv Afatinib 20.0000mg
ORAL
Prescription Only
Boehringer Ingelheim Pharma GmbH & Co. KG
ACTIVE
2013-12-17
1 0281-01 (SG) 20140828 Giotrif® Abcd COMPOSITION 1 film-coated tablet contains 50 mg, 40 mg, 30 mg, or 20 mg of afatinib (=free base) corresponding to 73.9 mg, 59.12 mg, 44.34 mg, or 29.56 mg 2-butenamide, _N_-[4-[3(-chloro-4-fluorophenyl)amino]-7-[[(_3S_)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]- 4-(dimethylamino)-,(_2E_)-, (_2Z_)-2-butenedioate (1:2) (= _AFATINIB DIMALEATE_) Excipients: _Tablet Core:_ lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone, magnesium stearate (E470b) _Film coating_: hypromellose 2910 (E464), macrogol 400, titanium dioxide (E171), talc (E553b), polysorbate 80 (E433), Colourant containing indigo carmine (E132) aluminium hydroxide (only used for 50 mg, 40 mg and 30 mg tablets) 20mg : white to slightly yellowish, round, biconvex, bevel-edged film-coated tablet debossed with the code T20 on one side and the Boehringer Ingelheim company symbol on the other side. 30mg: dark blue, round, biconvex,bevel-edged film-coated tabled debossed with the code T30 on one side and with the Boehringer Ingelheim company symbol on the other side. 40mg: light blue, round, biconvex, bevel-edged film-coated tablet debossed with the code T40 on one side and with the Boehringer Ingelheim company symbol on the other side. 50mg: dark blue, קרא את המסמך השלם
1 Giotrif® Abcd 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 One film-coated tablet contains 20 mg, 30 mg, 40 mg or 50 mg afatinib (as dimaleate). Excipient with known effect: GIOTRIF 20 mg: One film-coated tablet contains 118 mg lactose (as monohydrate). GIOTRIF 30 mg: One film-coated tablet contains 176 mg lactose (as monohydrate). GIOTRIF 40 mg: One film-coated tablet contains 235 mg lactose (as monohydrate). GIOTRIF 50 mg: One film-coated tablet contains 294 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. GIOTRIF 20mg: white to slightly yellowish, round, biconvex, bevel-edged film-coated tablet debossed with the code T20 on one side and the Boehringer Ingelheim company symbol on the other side. GIOTRIF 30mg: dark blue, round, biconvex, bevel-edged film-coated tabled debossed with the code T30 on one side and with the Boehringer Ingelheim company symbol on the other side. GIOTRIF 40mg: light blue, round, biconvex, bevel-edged film-coated tablet debossed with the code T40 on one side and with the Boehringer Ingelheim company symbol on the other side. GIOTRIF 50mg: dark blue, oval, biconvex, film-coated tablet debossed with the code T50 on one side and with the Boehringer Ingelheim company symbol on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • GIOTRIF is indicated for the first line treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation(s). • GIOTRIF as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy 2 4.2 DOSAGE AND ADMINISTRATION _ _ The recommended dose of GIOTRIF is 40 mg orally once daily. GIOTRIF should be taken without food. Food should not קרא את המסמך השלם