Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Everolimus (stabilised with bht)
Novartis Ireland Limited
L04AA; L04AA18
Everolimus (stabilised with bht)
0.5 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Selective immunosuppressants; everolimus
Not marketed
2014-12-12
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CERTICAN ® 0.25 MG TABLETS CERTICAN ® 0.5 MG TABLETS CERTICAN ® 0.75 MG TABLETS CERTICAN ® 1.0 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 Certican is and what it is used for 2. What you need to know before you take Certican 3. How to take Certican 4. Possible side effects 5. How to store Certican 6. Contents of the pack and other information 1. WHAT CERTICAN IS AND WHAT IT IS USED FOR The active substance of Certican is everolimus. Everolimus 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. Certican 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 CERTICAN DO NOT TAKE CERTICAN • 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 CERTICAN. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE TAKING CERTICAN: • Medicines that suppress the immune system like Certican reduce your body´s ability to fight against infections. It is advisable to consult your doctor or transplant centre if you have a fever or generally feel unwell, or have local symptoms such Lestu allt skjalið
Health Products Regulatory Authority 26 September 2023 CRN00DCTN Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Certican 0.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg everolimus. Excipient(s) with known effect: Each tablet contains 4 mg lactose monohydrate and 74 mg Anhydrous lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Tablets are white to yellowish, marbled, round, flat with a bevelled edge. 0.5 mg (diameter of 7 mm): engraved with “CH” on one side and “NVR” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kidney and heart transplantation Certican is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological riskreceiving an allogeneic renal or cardiac transplant. In kidney and heart transplantation, Certican should be used in combination with ciclosporin for microemulsion and corticosteroids. Liver transplantation Certican is indicated for the prophylaxis of organ rejection in adult patients receiving a hepatic transplant. In liver transplantation, Certican should be used in combination with tacrolimus and corticosteroids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Certican 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 co-administration with tacrolimus is recommended for the hepatic transplant population with the initial dose approximately 4 weeks after transplantation. Patients receiving Certican may require dose adjustments based on blood concentrations achieved, tolerability, individual response, cha Lestu allt skjalið