Negara: Singapura
Bahasa: Inggris
Sumber: HSA (Health Sciences Authority)
Erlotinib hydrochloride eqv. to Erlotinib
ROCHE SINGAPORE PTE. LTD.
L01XE03
25mg
TABLET, FILM COATED
ORAL
Prescription Only
Kremers Urban Pharmaceuticals Inc.
2006-02-10
TARCEVA TM Erlotinib hydrochloride ANTINEOPLASTIC AGENT. 1. P HARMACEUTICAL F ORM Tarceva film-coated tablets 25mg, 100mg, 150mg Tarceva tablet 25mg: Round, biconvex face and straight sides, white film-coated, with ‘T 25’ engraved on one side. Tarceva tablet 100mg: Round, biconvex face and straight sides, white film-coated, with ‘T 100’ engraved on one side. Tarceva tablet 150mg: Round, biconvex face and straight sides, white film-coated, with ‘T 150’ engraved on one side. Qualitative and Quantitative Composition _Active ingredient:_ erlotinib. One film-coated tablet of each strength contains erlotinib hydrochloride, corresponding to 25mg, 100mg and 150mg of erlotinib. For excipients, see section 5.1. 2. C LINICAL P ARTICULARS 2.1 THERAPEUTIC INDICATIONS NON-SMALL CELL LUNG CANCER: Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations. Tarceva is also indicated as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after 4 cycles of standard platinum-based first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)- negative tumours. PANCREATIC CANCER: Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer. 2.2 DOSAGE AND METHOD Baca dokumen lengkapnya