Страна: Нидерландия
Език: нидерландски
Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EVEROLIMUS 2,5 mg/stuk
Zentiva a.s. U. Kabelovny 130 10237 PRAGUE (TSJECHIË)
L01XE10
EVEROLIMUS 2,5 mg/stuk
Tablet
BUTYLHYDROXYTOLUEEN (E 321) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b)
Oraal gebruik
Everolimus
1900-01-01
04/2022 PRAC PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EVEROLIMUS ZENTIVA 2,5 MG, TABLETTEN EVEROLIMUS ZENTIVA 5 MG, TABLETTEN EVEROLIMUS ZENTIVA 10 MG, TABLETTEN 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 Zentiva is and what it is used for 2. What you need to know before you take Everolimus Zentiva 3. How to take Everolimus Zentiva 4. Possible side effects 5. How to store Everolimus Zentiva 6. Contents of the pack and other information 1. WHAT EVEROLIMUS ZENTIVA IS AND WHAT IT IS USED FOR Everolimus Zentiva 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 Zentiva 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. 2. WHAT YOU NE Прочетете целия документ
10/2022 Renewal R/001 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Everolimus Zentiva 2,5 mg, tabletten Everolimus Zentiva 5 mg, tabletten Everolimus Zentiva 10 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Everolimus Zentiva 2,5 mg, tabletten Each tablet contains 2.5 mg everolimus. Excipient with known effect Each tablet contains 74.3 mg lactose. Everolimus Zentiva 5 mg, tabletten Each tablet contains 5 mg everolimus. Excipient with known effect Each tablet contains 148.5 mg lactose. Everolimus Zentiva 10 mg, tabletten 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. Everolimus Zentiva 2.5 mg tablets White to off white oval biconvex tablets (approximately 10×5 mm), debossed with E9VS on one side and 2.5 on the other side. Everolimus Zentiva 5 mg tablets White to off white oval and biconvex tablets (approximately 13×6 mm), debossed with E9VS 5 on one side. Everolimus Zentiva 10 mg tablets White to off white oval and biconvex tablets (approximately 16×8 mm), debossed with E9VS 10 on one side. 10/2022 Renewal R/001 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone receptor-positive advanced breast cancer Everolimus Zentiva 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 Zentiva 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 Zentiva is indicated for the treatment of unresectable or metastatic, well- differentiated (Grade 1 or Grade 2) non-functional neuroendocrine Прочетете целия документ