Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
telbivudine
Novartis Europharm Limited
J05AF11
telbivudine
Nucleoside and nucleotide reverse transcriptase inhibitors
Hepatitis B, Chronic
Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.Initiation of Sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
Revision: 20
Withdrawn
2007-04-24
47 B. PACKAGE LEAFLET Medicinal product no longer authorised 48 PACKAGE LEAFLET: INFORMATION FOR THE USER SEBIVO 600 MG FILM-COATED TABLETS Telbivudine 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 Sebivo is and what it is used for 2. What you need to know before you take Sebivo 3. How to take Sebivo 4. Possible side effects 5. How to store Sebivo 6. Contents of the pack and other information 1. WHAT SEBIVO IS AND WHAT IT IS USED FOR Sebivo contains the active substance telbivudine. Sebivo belongs to a group of medicines called antiviral medicines, which are used to treat infections caused by viruses. Sebivo is used to treat adults with chronic hepatitis B. Starting treatment with Sebivo should only be considered when it is not possible or appropriate to use an alternative medicine to which the hepatitis B virus is less likely to develop resistance. Your doctor will decide which treatment is most appropriate for you. Hepatitis B is caused by infection with the hepatitis B virus, which multiplies in the liver and causes liver damage. Treatment with Sebivo reduces the amount of hepatitis B virus in the body by blocking its growth, resulting in less liver damage and improved liver function. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SEBIVO DO NOT TAKE SEBIVO - if you are allergic to telbivudine or any of the other ingredients of this medicine (listed in section 6). - if you are being treated with pegylated or standard interferon alfa (see “Taking other medicines”). If this applies to you, DO NO Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Sebivo 600 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg telbivudine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White to slightly yellowish, oval film-coated tablet, imprinted with “LDT” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. Initiation of Sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. See section 5.1 for details of the study and specific patient characteristics on which this indication is based. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy must be initiated by a physician experienced in the management of chronic hepatitis B infection. Posology _Adults _ The recommended dose of Sebivo is 600 mg (one tablet) once daily. Sebivo oral solution may be considered for patients who have difficulties swallowing tablets. _Monitoring during treatment _ On-treatment response at week 24 has been shown to be predictive of longer-term response (see Table 7 in section 5.1). HBV DNA levels should be monitored at 24 weeks of treatment to assure complete viral suppression (HBV DNA less than 300 copies/ml). For patients with detectable HBV DNA after 24 weeks of therapy, treatment modification should be considered. HBV DNA should be monitored every 6 months to assure continued response. If patients test positive for HBV DNA at any time after their initial response, treatment modification should be considered. Optimal therapy should be guided by resistance testing. Medicinal product no Przeczytaj cały dokument