Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ERLOTINIB HYDROCHLORIDE
RANBAXY (MALAYSIA) SDN. BHD.
ERLOTINIB HYDROCHLORIDE
30 Tablets
Sun Pharmaceutical Industries Ltd.
TARLONIB Page 1 _Consumer Medication Information Leafleat (RiMUP)_ TARLONIB _ _ (ERLOTINIB TABLETS 25, 100, 150 MG ) _ _ WHAT IS IN THIS LEAFLET 1. What TARLONIB is used for 2. How TARLONIB works 3. Before you use TARLONIB 4. How to use TARLONIB 5. While you are using TARLONIB 6. Side Effects 7. Storage and Disposal of TARLONIB 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision This leaflet answers some common questions about TARLONIB It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking TARLONIB against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TARLONIB IS USED FOR TARLONIB is used to treat the cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR). TARLONIB 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 or as therapy if your disease remains largely unchanged after initial chemotherapy, provided your cancer cells have specific EGFR mutations. It can also be prescribed if previous chemotherapy has not helped to stop your disease. This medicine can also be prescribed to you in combination with another treatment called gemcitabine if you have cancer of the pancreas at a metastatic stage. HOW TARLONIB WORKS TARLONIB contains the active substance erlotinib. TARLONIB is used to treat the cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR). This protein is known to be involved in the growth and spread of cancer cells. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TARLONIB HAS BEEN PRESCRIBED FOR YOU. This product is available as 25 mg, 100 mg and 150 mg strengths. BEFO Læs hele dokumentet
1 _For the Use of a Registered Medical Practitioner only_ PRESCRIBING INFORMATION TARLONIB 25, 100 AND 150 (ERLOTINIB TABLETS 25 MG, 100 MG AND 150 MG) COMPOSITION TARLONIB 25 Each film-coated tablet contains Erlotinib (as erlotinib hydrochloride)….. 25 mg TARLONIB 100 Each film-coated tablet contains Erlotinib (as erlotinib hydrochloride)….. 100 mg TARLONIB 150 Each film-coated tablet contains Erlotinib (as erlotinib hydrochloride)….. 150 mg Excipients_: _ Lactose Monohydrate, Microcrystalline cellulose, Sodium starch glycolate, Sodium lauryl sulphate, Magnesium stearate, Microcrystalline cellulose, Opadry. PRODUCT DESCRIPTION TARLONIB 25 are are white to off white round biconvex film coated tablets debossed with "RL" on one side and "11" on other side. TARLONIB 100 are White to off white round biconvex film coated tablets debossed with "RL" on one side and "12" on other side. TARLONIB 150 are White to off white round biconvex film coated tablets debossed with "RL" on one side and "13" on other side. 2 PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES PHARMACODYNAMICS Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR also known as HER1) tyrosine kinase inhibitor. Erlotinib potently inhibits the intracellular phosphorylation of EGFR. EGFR is expressed on the cell surface of normal cells and cancer cells. It is reported that the inhibition of EGFR phosphotyrosine results in cell stasis and/or death. EGFR mutations may lead to constitutive activation of anti-apoptotic and proliferation signaling pathways. The potent effectiveness of erlotinib in blocking EGFR-mediated signalling in these EGFR mutation positive tumours is attributed to the tight binding of erlotinib to the ATP-binding site in the mutated kinase domain of the EGFR. Due to the blocking of downstream-signaling, the proliferation of cells is stopped, and cell death is induced through the intrinsic apoptotic pathway. Tumour regression has been reported in mouse models of enforced expression of these E Læs hele dokumentet