Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
erlotinib
Roche Registration GmbH
L01EB02
erlotinib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms
Non-small cell lung cancer (NSCLC)Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after 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.In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.When prescribing Tarceva, factors associated with prolonged survival should be taken into account.No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours.Pancreatic cancerTarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
Revision: 32
Authorised
2005-09-19
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE USER TARCEVA 25 MG FILM-COATED TABLETS TARCEVA 100 MG FILM-COATED TABLETS TARCEVA 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 Tarceva is and what it is used for 2. What you need to know before you take Tarceva 3. How to take Tarceva 4. Possible side effects 5. How to store Tarceva 6. Contents of the pack and other information 1. WHAT TARCEVA IS AND WHAT IT IS USED FOR Tarceva contains the active substance erlotinib. Tarceva 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. 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 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 TARCEVA DO NOT TAKE TARCEVA • if you are allergic to erlotinib or any of the ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS: • if you are taking ot Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 2 1. NAME OF THE MEDICINAL PRODUCT Tarceva 25 mg film-coated tablets Tarceva 100 mg film-coated tablets Tarceva 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tarceva 25 mg film coated tablets Each film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride). Tarceva 100 mg film-coated tablets Each film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride). Tarceva 150 mg film-coated tablets Each film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride). Excipients with known effect _Tarceva 25 mg film coated tablets _ Each 25 mg film-coated tablet contains 27.43 mg Lactose monohydrate. _Tarceva 100 mg film-coated tablets _ Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate. _Tarceva 150 mg film-coated tablets _ Each 150 mg film-coated tablet contains 103.82 mg Lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Tarceva 25 mg film coated tablets White to yellowish, round, biconvex tablets with ‘T 25’ engraved on one side. Tarceva 100 mg film-coated tablets White to yellowish, round, biconvex tablets with ‘T 100’ engraved on one side. Tarceva 150 mg film-coated tablets White to yellowish, round, biconvex tablets with ‘T 150’ engraved on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-Small Cell Lung Cancer (NSCLC) 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 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. 3 Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is Pročitajte cijeli dokument