Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Everolimus
Teva B.V.
L01XE; L01XE01
Everolimus
10 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Protein kinase inhibitors; imatinib
Not marketed
2017-06-30
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EVEROLIMUS TEVA 2.5 MG TABLETS EVEROLIMUS TEVA 5 MG TABLETS EVEROLIMUS TEVA 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 Teva is and what it is used for 2. What you need to know before you take Everolimus Teva 3. How to take Everolimus Teva 4. Possible side effects 5. How to store Everolimus Teva 6. Contents of the pack and other information 1. WHAT EVEROLIMUS TEVA IS AND WHAT IT IS USED FOR Everolimus Teva 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 Teva is used to treat adult patients with: ADVANCED TUMOURS called neuroendocrine tumours that originate from the stomach, bowels, lung. It is given if the tumours are inoperable and do not overproduce specific hormones or other related natural substances. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EVEROLIMUS TEVA Everolimus Teva will only be prescribed for you by a doctor with experience in cancer treatment. Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. If you have any questions about Everolimus Teva or why it has been prescribed for you, ask your doctor. DO NOT TAKE EVEROLIMUS TEVA: IF YOU ARE ALLERGIC to everolimus, to related substances such as sirolimus or temsirolimus, or to any of the other ingredients of this medicine (listed i Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Everolimus Teva 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg everolimus. Excipient with known effect: Each tablet contains 297 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, oblong, flat, bevelled edge tablets, approximately 15mm long and 6mm wide, marked with “EV” on one side and “10” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neuroendocrine tumours of gastrointestinal or lung origin Everolimus Teva 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Everolimus Teva should be initiated and supervised by a physician experienced in the use of anticancer therapies. Posology For the different dose regimens, Everolimus Teva is available as 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets. The recommended dose is 10 mg everolimus once daily. Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. If a dose is missed, the patient should not take an additional dose, but take the next prescribed dose as usual. _Dose adjustment due to adverse reactions_ Management of severe and/or intolerable suspected adverse reactions may require dose reduction and/or temporary interruption of Everolimus Teva therapy. For adverse reactions of Grade 1, dose adjustment is usually not required. If dose reduction is required, the recommended dose is 5 mg daily and must not be lower than 5 mg daily. Table 1 summarises the dose adjustment recommendations for specific adverse reactions (see also section 4.4). TABLE 1 EVEROLIMUS TEVA DOSE ADJUSTMENT RECOMMENDATIONS ADVERSE REACTION SEVERITY 1 EVEROLIMUS TEVA DOSE ADJUSTMENT H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R Läs hela dokumentet