Land: Malta
Språk: engelska
Källa: Medicines Authority
Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41, 60439 Frankfurt am Main, Germany
L04AA18
EVEROLIMUS 1 mg
TABLET
EVEROLIMUS 1 mg
POM
IMMUNOSUPPRESSANTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-02-21
PACKAGE LEAFLET: INFORMATION FOR THE USER EVEROLIMUS ASCEND 0.25 MG TABLETS EVEROLIMUS ASCEND 0.5 MG TABLETS EVEROLIMUS ASCEND 0.75 MG TABLETS EVEROLIMUS ASCEND 1 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 Ascend is and what it is used for 2. What you need to know before you take Everolimus Ascend 3. How to take Everolimus Ascend 4. Possible side effects 5. How to store Everolimus Ascend 6. Contents of the pack and other information 1. WHAT EVEROLIMUS ASCEND IS AND WHAT IT IS USED FOR The active substance is Everolimus. Everolimus Ascend belongs to a group of medicines called immunosuppressants. It is used in adults to prevent the body’s immune system from rejecting a transplanted kidney, heart or liver. Everolimus Ascend is used together with other medicines, such as ciclosporin for kidney and heart transplantation, tacrolimus for liver transplantation, and corticosteroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EVEROLIMUS ASCEND DO NOT TAKE EVEROLIMUS ASCEND • if you are allergic (hypersensitive) to everolimus or any of the other ingredients of this medicine (listed in section 6). • if you are allergic (hypersensitive) to sirolimus. IF ANY OF THE ABOVE APPLIES TO YOU, TELL YOUR DOCTOR AND DO NOT TAKE EVEROLIMUS ASCEND. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE TAKING EVEROLIMUS ASCEND: • Medicines that suppress the immune system like Everolimus Ascend reduce your body´s ability to fight against infections. It is advisable to c Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Everolimus Ascend 0.25 mg tablets Everolimus Ascend 0.5 mg tablets Everolimus Ascend 0.75 mg tablets Everolimus Ascend 1 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.25/0.5/0.75/1 mg everolimus. Excipient(s) with known effect: Each tablet contains 2.225/4.450/6.675/8.900 mg lactose monohydrate and 37.167/74.334/111.501/148.668 mg lactose anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Tablets are white to off white, round shaped tablets. 0.25 mg: debossed with "EVR" on one side and "25" on other side. 0.5 mg: debossed with "EVR" on one side and "50" on other side. 0.75 mg: debossed with "EVR" on one side and "75" on other side. 1 mg: debossed with "EVR" on one side and "100" on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kidney and heart transplantation Everolimus Ascend is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. In kidney and heart transplantation, Everolimus Ascend should be used in combination with ciclosporin for microemulsion and corticosteroids. Liver transplantation Everolimus Ascend is indicated for the prophylaxis of organ rejection in adult patients receiving a hepatic transplant. In liver transplantation, Everolimus Ascend should be used in combination with tacrolimus and corticosteroids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Everolimus Ascend should only be initiated and maintained by physicians who are experienced in immunosuppressive therapy following organ transplantation and who have access to everolimus whole blood concentration monitoring. Posology _Adults _ An initial dose regimen of 0.75 mg twice daily in co-administration with ciclosporin is recommended for the general kidney and heart transplant population, administered as soon as possible after transplantation. The dose of 1.0 mg twice daily in Läs hela dokumentet