البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
Maribavir
Takeda Pharmaceuticals International AG Ireland Branch
J05AX10
maribavir
Antivirals for systemic use
Cytomegalovirus Infections
LIVTENCITY is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).Consideration should be given to official guidance on the appropriate use of antiviral agents.
Revision: 4
Authorised
2022-11-09
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LIVTENCITY 200 MG FILM-COATED TABLETS maribavir This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What LIVTENCITY is and what it is used for 2. What you need to know before you take LIVTENCITY 3. How to take LIVTENCITY 4. Possible side effects 5. How to store LIVTENCITY 6. Contents of the pack and other information 1. WHAT LIVTENCITY IS AND WHAT IT IS USED FOR LIVTENCITY is an antiviral medicine that contains the active substance maribavir. It is a medicine used to treat adults who have had an organ or bone marrow transplant and developed a CMV (‘cytomegalovirus’) infection that did not go away or came back again after taking another antiviral medicine. CMV is a virus that a lot of people have without symptoms and normally just stays in the body without causing any harm. However, if your immune system is weakened after you get an organ or bone marrow transplant, you may be at higher risk of becoming ill from CMV. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIVTENCITY DO NOT TAKE LIVTENCITY if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). if you take either of these medicines: o ganciclovir (used to manage CMV infection) o اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT LIVTENCITY 200 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg maribavir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Blue, oval shaped convex tablet of 15.5 mm, debossed with “SHP” on one side and “620” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LIVTENCITY is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT). Consideration should be given to official guidance on the appropriate use of antiviral agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION LIVTENCITY should be initiated by a physician experienced in the management of patients who have undergone solid organ transplant or haematopoietic stem cell transplant. Posology The recommended dose of LIVTENCITY is 400 mg (two 200 mg tablets) twice daily resulting in a daily dose of 800 mg for 8 weeks. Treatment duration may need to be individualised based on the clinical characteristics of each patient. 3 Co-administration with CYP3A inducers Co-administration of LIVTENCITY with the strong cytochrome P450 3A (CYP3A) inducers rifampicin, rifabutin or St. John’s wort is not recommended due to potential for a decrease in efficacy of maribavir. If co-administration of LIVTENCITY with other strong or moderate CYP3A inducers (e,g., carbamazepine, efavirenz, phenobarbital and phenytoin) cannot be avoided, the LIVTENCITY dose should be i اقرأ الوثيقة كاملة