Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Everolimus
A A H Pharmaceuticals Ltd
L01EG02
Everolimus
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) No Yes Details EVEROLIMUS 2.5MG AND 5MG TABLETS PIL - UK Black BBBA6289 NM 19/09/2019 19/11/2019 NM 200x320 9pt Synthon 19/09/2019 03/10/2019 2 Version 2 01.11.2017 EVEROLIMUS 2.5MG, 5MG AND 10MG TABLETS PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 patien Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Everolimus Ethypharm 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg everolimus. Excipient with known effect: Each tablet contains 149 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white oblong tablet, 12.5 x 5.0 mm engraved with a “E” on one side and with a “5” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Hormone receptor-positive advanced breast cancer _ Everolimus Ethypharm 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 Ethypharm 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 Ethypharm 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 Ethypharm 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 Ethypharm should be initiated and supervised by a physician experienced in the use of anticancer therapies. POSOLOGY For the different dose regimens Everolimus Ethypharm 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 to Preberite celoten dokument