Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Everolimus
TAD Pharma GmbH
L01XE; L01XE10
Everolimus
5 milligram(s)
Tablet
Protein kinase inhibitors; everolimus
Not marketed
2019-11-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EVEROLIMUS TAD 2.5 MG TABLETS EVEROLIMUS TAD 5 MG TABLETS EVEROLIMUS TAD 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 TAD is and what it is used for 2. What you need to know before you take Everolimus TAD 3. How to take Everolimus TAD 4. Possible side effects 5. How to store Everolimus TAD 6. Contents of the pack and other information 1. WHAT EVEROLIMUS TAD IS AND WHAT IT IS USED FOR Everolimus TAD 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 TAD is used to treat adult patients with: - advanced tumours called neuroendocrine tumours that originate from the pancreas. 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 TAD Everolimus TAD 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 TAD or why it has been prescribed for you, ask your doctor. DO NOT TAKE EVEROLIMUS TAD - 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 in section 6). If you think you may be allergi Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 20 July 2023 CRN00DQ95 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Everolimus TAD 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg everolimus. Excipient with known effect Each tablet contains 147.88 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off white oval and biconvex tablets (approximately 13 x 6 mm), debossed with E9VS 5 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neuroendocrine tumours of pancreatic origin Everolimus TAD is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Everolimus TAD should be initiated and supervised by a physician experienced in the use of anticancer therapies. Posology For the different dose regimens Everolimus TAD is available as 2.5 mg, 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 TAD 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 TAD dose adjustment recommendations ADVERSE REACTION SEVERITY 1 EVEROLIMUS TAD DOSE ADJUSTMENT Non-infectious pneumonitis Grade 2 Consider interruption of therapy until symptoms improve to Grade ≤1. Re-i Lesen Sie das vollständige Dokument