Kraj: Malta
Język: angielski
Źródło: Medicines Authority
EVEROLIMUS
Genthon BV Microweg 22, 6545 CM NIJMEGEN, Netherlands
L01EG02
EVEROLIMUS 5 mg
TABLET
EVEROLIMUS 5 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
2018-06-21
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EVEROLIMUS GENTHON 2.5 MG TABLETS EVEROLIMUS GENTHON 5 MG TABLETS EVEROLIMUS GENTHON 10 MG TABLETS Everolimus 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 any 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 Everolimus Genthon is and what it is used for 2. What you need to know before you take Everolimus Genthon 3. How to take Everolimus Genthon 4. Possible side effects 5. How to store Everolimus Genthon 6. Contents of the pack and other information 1 WHAT EVEROLIMUS GENTHON IS AND WHAT IT IS USED FOR Everolimus Genthon is an anticancer medicine containing the active substance everolimus. Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells. − Everolimus Genthon is used to treat adult patients with:hormone receptor-positive advanced breast cancer in postmenopausal women, in whom other treatments (so called “non-steroidal aromatase inhibitors”) no longer keep the disease under control. It is given together with a medicine called exemestane, a steroidal aromatase inhibitor, which is used for hormonal anticancer therapy. − advanced tumours called neuroendocrine tumours that originate from the stomach, bowels, lung or pancreas. It is given if the tumours are inoperable and do not overproduce specific hormones or other related natural substances. − advanced kidney cancer (advanced renal cell carcinoma), where other treatments (so-called “VEGF-targeted therapy”) have not helped stop your disease. Page 2 of 9 2 WHAT YOU NEED Przeczytaj cały dokument
Page 1 of 27 1. NAME OF THE MEDICINAL PRODUCT Everolimus Genthon 2.5 mg tablets Everolimus Genthon 5 mg tablets Everolimus Genthon 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Everolimus Genthon 2.5 mg tablets Each tablet contains 2.5 mg everolimus. Excipient with known effect Each tablet contains 74.3 mg lactose Everolimus Genthon 5 mg tablets Each tablet contains 5 mg everolimus. Excipient with known effect Each tablet contains 148.5 mg lactose Everolimus Genthon 10 mg tablets Each tablet contains 10 mg everolimus. Excipient with known effect Each tablet contains 297.0 mg lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 2.5 mg tablet: white to off white oval biconvex tablets (approximately 10 x 5 mm), debossed with E9VS on one side and 2.5 on the other side. 5 mg tablet: white to off white oval and biconvex tablets (approximately 13 x 6 mm), debossed with E9VS 5 on one side. 10 mg tablet: white to off white oval and biconvex tablets (approximately 16 x 8 mm), debossed with E9VS 10 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Page 2 of 27 Hormone receptor-positive advanced breast cancer Everolimus Genthon is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Everolimus Genthon is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Everolimus Genthon is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1). Renal cell carcinoma Przeczytaj cały dokument