Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ERLOTINIB HYDROCHLORIDE
ROCHE (MALAYSIA) SDN. BHD.
ERLOTINIB HYDROCHLORIDE
30Tablet Tablets
Delpharm Milano s.r.l
_ _ _ _ _Consumer Medication Information Leaflet (RiMUP) _ _ _ TARCEVA ® _Contains active ingredient Erlotinib(25mg, 100mg, 150mg) _ _ _ 1 WHAT IS IN THIS LEAFLET 1. What Tarceva is used for 2. How Tarceva works 3. Before you use Tarceva 4. How to use Tarceva 5. While you are using it 6. Side effects 7. Storage and disposal of Tarceva 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number 1. WHAT TARCEVA IS USED FOR Tarceva contains the active ingredient erlotinib. Tarceva is indicated for adults. This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage. It can be prescribed as initial therapy if your cancer cells have specific EGFR mutations. It can also be prescribed if your disease remains largely unchanged after initial chemotherapy, or if previous chemotherapy has not helped to stop your disease. Tarceva is also used in combination with gemcitabine for the treatment of pancreatic cancer. This medicine is available only with a doctor's prescription. 2. HOW TARCEVA WORKS As a targeted cancer treatment, Tarceva targets a specific protein on the surface of the cancer cells called EGFR/ HER1 (epidermal growth factor receptor 1). It slows or blocks the activity of EGFR and may cause the cancer cells to die, with potentially less damage to normal cells. However, the way Tarceva works to treat cancer is not fully known. 3. BEFORE YOU USE TARCEVA - _WHEN YOU MUST NOT USE IT _ DO NOT TAKE TARCEVA IF: 1. you have had an allergic reaction to Tarceva or any ingredients listed at the end of this leaflet 2. the package is torn or shows_ _ signs of tampering. 3. the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well. If you are not sure if you should be taking Tarceva, talk to your doctor. _ _ _USE IN CHILDREN _ Do not give Tarceva to children. Safety and effectiveness in patients less than 18 years of age have not been established. - _BEFORE YOU Прочитать полный документ
PACK INSERT FOR MALAYSIA Tarceva ® Erlotinib 1. DESCRIPTION 1.1 Therapeutic / Pharmacologic Class of Drug Antineoplastic agent. ATC code L01EB02 1.2 Type of Dosage Form Tarceva film-coated tablets 25 mg, 100 mg, 150 mg. Film-coated white to yellowish, round, biconvex tablets, with ‘T25 or T100 or T150’ engraved on one side according to tablet strength. 1.3 Route of Administration Oral. 1.4 Qualitative and Quantitative Composition Active ingredient: erlotinib hydrochloride. One film-coated tablet of each strength contains erlotinib hydrochloride, corresponding to 25 mg, 100 mg and 150 mg of erlotinib. List of excipient Tablet core Lactose monohydrate Ph. Eur./USP/JP Cellulose, microcrystalline Ph. Eur./USP/JP Sodium starch glycolate Ph. Eur./USP/JPE Sodium laurilsulfate Ph. Eur./USP/JP Magnesium stearate Ph. Eur./USP/JP Tablet coat Hydroxypropyl cellulose Ph. Eur./USP/JP Titanium dioxide Ph. Eur./USP/JP Polyethylene glycol Ph. Eur./ NF/JP Hydroxypropyl methylcellulose Ph. Eur./USP/JP 2. CLINICAL PARTICULARS 2.1 Therapeutic Indication(s) 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 (NSCLC) with EGFR activating mutations. Tarceva is indicated for maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations who have not progressed after first- line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. Pancreatic Cancer Tarceva in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer 2.2 Dosage and Administration 2.2.1 Standard Dosage Non-small cell lung cancer EGFR mutation testing should be performed prior to initiation of Tarceva as first-line or maintenance therapy in patients with locallyadvanced or metastatic NSCLC. The recommended daily dose of Прочитать полный документ