Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Everolimus
A A H Pharmaceuticals Ltd
L01EG02
Everolimus
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500
Common Technical Document Everolimus, 2.5, 5, 10 mg Tablets M1.3.1_03.EVS.tab.001.03.Core Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EVEROLIMUS 2.5MG, 5MG AND 10MG TABLETS 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. - The full name of this medicine is Everolimus 2.5mg, 5mg and 10mg Tablets but within this leaflet it will be referred to as Everolimus Tablets. WHAT IS IN THIS LEAFLET 1. What Everolimus Tablets are and what they are used for 2. What you need to know before you take Everolimus Tablets 3. How to take Everolimus Tablets 4. Possible side effects 5. How to store Everolimus Tablets 6. Contents of the pack and other information 1. WHAT EVEROLIMUS TABLETS ARE AND WHAT THEY ARE USED FOR Everolimus Tablets are 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 Tablets are 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, bowel, lung or pancreas. It is given if the tumours are inoperable and do not overproduce specific hormones or other related natural substances. Everolimus whi Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Everolimus Sandoz 2.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg everolimus. Excipient(s) with known effect Each tablet contains 74 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to slightly yellow, elongated tablets approximately 10.1 x 4.1 mm with a bevelled edge and no score, engraved with “LCL” on one side and “NVR” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neuroendocrine tumours of pancreatic origin Everolimus 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 should be initiated and supervised by a physician experienced in the use of anticancer therapies. _ _ Posology For the different dose regimens Everolimus 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 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 DOSE ADJUSTMENT RECOMMENDATIONS ADVERSE REACTION SEVERITY 1 EVEROLIMUS DOSE ADJUSTMENT Grade 2 Consider interruption of therapy until symptoms improve to Grade ≤ 1. Re-initiate treatment at 5 mg daily. Discontinue treatm Đọc toàn bộ tài liệu