Country: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
ERLOTINIB HYDROCHLORIDE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
L01XE03
ERLOTINIB HYDROCHLORIDE 100 mg
FILM-COATED TABLET
ERLOTINIB HYDROCHLORIDE 100 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2017-05-31
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ERLOTINIB ACTAVIS 25 MG FILM-COATED TABLETS ERLOTINIB ACTAVIS 100 MG FILM-COATED TABLETS ERLOTINIB ACTAVIS 150 MG FILM-COATED TABLETS erlotinib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Erlotinib Actavis is and what it is used for 2. What you need to know before you take Erlotinib Actavis 3. How to take Erlotinib Actavis 4. Possible side effects 5. How to store Erlotinib Actavis 6. Contents of the pack and other information 1. WHAT ERLOTINIB ACTAVIS IS AND WHAT IT IS USED FOR Erlotinib Actavis contains the active substance erlotinib. Erlotinib Actavis is a medicine used to treat 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. Erlotinib Actavis 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERLOTINIB ACTAVIS DO NOT TAKE ERLOTINIB ACTAVIS: - if you are allergic to erlotinib or any o সম্পূর্ণ নথি পড়ুন
Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Erlotinib Actavis 25 mg film-coated tablets Erlotinib Actavis 100 mg film-coated tablets Erlotinib Actavis 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride). One film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride). One film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride). Excipients with known effect: Each 25 mg film-coated tablet contains 20.94 mg lactose anhydrous. Each 100 mg film-coated tablet contains 83.77 mg lactose anhydrous. Each 150 mg film-coated tablet contains 125.65 mg lactose anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Erlotinib Actavis 25 mg film-coated tablets: White, round, biconvex film-coated tablets of 6 mm with uniform appearance and intact edges, engraved with A105 on one side. Erlotinib Actavis 100 mg film-coated tablets: White, round, biconvex film-coated tablets of 10 mm with uniform appearance and intact edges, engraved with A116 on one side. Erlotinib Actavis 150 mg film-coated tablets: White, round, biconvex film-coated tablets of 11 mm with uniform appearance and intact edges, engraved with A127 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-Small Cell Lung Cancer (NSCLC) Erlotinib Actavis is indicated for the first-line treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with EGFR activating mutations. Erlotinib Actavis is is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy. Erlotinib Actavis is is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. When prescribing Erlotinib Actavis, factors associated with prolonged sur সম্পূর্ণ নথি পড়ুন