Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Everolimus
Rowex Ltd
L01EG02; L01XE; L01XE10
Everolimus
10 milligram(s)
Tablet
everolimus; Protein kinase inhibitors; everolimus
Not marketed
2019-09-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EVEROLIMUS ROWEX 2.5 MG TABLETS EVEROLIMUS ROWEX 5 MG TABLETS EVEROLIMUS ROWEX 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 Rowex is and what it is used for 2. What you need to know before you take Everolimus Rowex 3. How to take Everolimus Rowex 4. Possible side effects 5. How to store Everolimus Rowex 6. Contents of the pack and other information 1. WHAT EVEROLIMUS ROWEX IS AND WHAT IT IS USED FOR _ _ Everolimus Rowex 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 Rowex 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 NEED TO KNOW BEFORE YOU TAKE EVEROLIMUS ROWEX Přečtěte si celý dokument
Health Products Regulatory Authority 16 January 2023 CRN00D8C2 Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Everolimus Rowex 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of everolimus. Excipient with known effect Each tablet contains 296.8 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to slightly yellow, elongated tablets approximately 15.1 x 6.0 mm with a bevelled edge and no score, engraved with "UHE" on one side and "NVR" on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone receptor-positive advanced breast cancer Everolimus Rowex 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 Rowex 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 Rowex 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 Everolimus Rowex is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Everolimus Rowex should be initiated and supervised by a physician experienced in the use of anticancer therapies. Posology For the different dose regimens Everolimus Rowex is available as 2.5 mg, 5 mg and 10 mg tablets. The recommended dose is 10 mg everolimus once daily. Treatm Přečtěte si celý dokument