Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ERLOTINIB HYDROCHLORIDE
CIPLA MALAYSIA SDN BHD
ERLOTINIB HYDROCHLORIDE
1 x 10 Tablets
CIPLA LTD
ERLOCIP FILM COATED TABLET _CONSUMER MEDICATION INFORMATION (RIMUP)_ Erlotinib (25 mg, 100 mg and 150 mg) ____________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Erlocip is used for 2. How Erlocip works 3. Before you take Erlocip 4. How to take Erlocip 5. While you are using Erlocip 6. Side effects 7. Storage and Disposal of Erlocip 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT ERLOCIP IS USED FOR Erlocip contains the active ingredient erlotinib. Erlocip 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. Erlocip is also used in combination with gemcitabine for the treatment of pancreatic cancer. This medicine is available only with a doctor's prescription. HOW ERLOCIP WORKS As a targeted cancer treatment, Erlocip 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 Erlocip works to treat cancer is not fully known. BEFORE YOU TAKE ERLOCIP - _When you must not take it _ Do not take Erlocip if: 1. you have had an allergic reaction to Erlocip 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 Erlocip, talk to your doctor. Use in children DO NOT GIVE ERLOCIP TO CHILDREN. Safety and effectiveness in patients less than 18 years of Citiți documentul complet
_For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only OR for_ _Specialist Use only_ ERLOCIP 25 / 100 / 150 FILM COATED TABLET ERLOTINIB HYDROCHLORIDE 25 / 100 / 150 COMPOSITION Erlocip 25 Each film coated tablet contains Erlotinib hydrochloride equivalent to Erlotinib……25 mg Colour: Titanium dioxide Erlocip 100 Each film coated tablet contains Erlotinib hydrochloride equivalent to Erlotinib……100 mg Colour: Titanium dioxide Erlocip 150 Each film coated tablet contains Erlotinib hydrochloride equivalent to Erlotinib……150 mg Colour: Titanium dioxide DOSAGE FORM Film Coated Tablet PRODUCT DESCRIPTION Erlocip 25 White, round, biconvex, film coated tablet debossed with "C1" on one side and plain on the other side. Erlocip 100 White, round, biconvex, film coated tablet debossed with "C2" on one side and plain on the other side. Erlocip 150 White, round, biconvex, film coated tablet debossed with ‘C3’ on one side and plain on other side. PHARMACOLOGY _ _ _PHARMACODYNAMICS _ Mechanism of action Erlotinib potently inhibits the intracellular phosphorylation of HER1/EGFR receptor. HER1/EGFR receptor is expressed on the cell surface of normal cells and cancer cells. In non- clinical models, inhibition of EGFR phosphotyrosine results in cell stasis and/or death. _PHARMACOKINETICS_ Exposure Following a 150 mg oral dose of erlotinib, at steady state, the median time to reach maximum plasma concentrations is approximately 4 hours with median maximum plasma concentrations achieved of 1,995 ng/ml. Prior to the next dose at 24 hours, the median minimum plasma concentrations are 1,238 ng/ml. Median AUC achieved during the dosing interval at steady state are 41.300 mcg*hr/ml. Absorption Oral erlotinib is well absorbed and has an extended absorption phase, with mean peak plasma levels occurring at 4 hours after oral dosing,provided an estimate of bioavailability of 59%. The exposure after an oral dose may be increased by food. Following absorption, erlotinib is highly bound in blood, with Citiți documentul complet