Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
lamivudine
GlaxoSmithKline (Ireland) Limited
J05AF05
lamivudine
Antivirals for systemic use
Hepatitis B, Chronic
Zeffix is indicated for the treatment of chronic hepatitis B in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate;, decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.
Revision: 29
Authorised
1999-07-29
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZEFFIX 100 MG FILM-COATED TABLETS lamivudine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have 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 Zeffix is and what it is used for 2. What you need to know before you take Zeffix 3. How to take Zeffix 4. Possible side effects 5. How to store Zeffix 6. Contents of the pack and other information 1. WHAT ZEFFIX IS AND WHAT IT IS USED FOR The active ingredient in Zeffix is lamivudine. ZEFFIX IS USED TO TREAT LONG TERM (CHRONIC) HEPATITIS B INFECTION IN ADULTS. Zeffix is an antiviral medicine that suppresses the hepatitis B virus and belongs to a group of medicines called _nucleoside analogue reverse transcriptase inhibitors (NRTIs)_ . Hepatitis B is a virus which infects the liver, causes long term (chronic) infection, and can lead to liver damage. Zeffix can be used in people whose liver is damaged, but still functions normally (compensated liver disease) and in combination with other medicines in people whose liver is damaged and does not function normally (decompensated liver disease). Treatment with Zeffix can reduce the amount of hepatitis B virus in your body. This should lead to a reduction in liver damage and an improvement in your liver function. Not everyone responds to treatment with Zeffix in the same way. Your doctor will monitor the effectiveness of your treatment with regular blood tests. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEFFIX Your healthcare provider should offer you counselling and testing for HIV infection before you start treatment with lamivudine for hepatiti Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zeffix 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg lamivudine For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Butterscotch coloured, film-coated, capsule shaped, biconvex, approximate dimensions 11mm x 5mm and engraved “GX CG5” on one face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zeffix is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and/or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see section 5.1). decompensated liver disease in combination with a second agent without cross-resistance to lamivudine (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy with Zeffix should be initiated by a physician experienced in the management of chronic hepatitis B. Posology _Adults_ The recommended dosage of Zeffix is 100 mg once daily. In patients with decompensated liver disease, lamivudine should always be used in combination with a second agent, without cross-resistance to lamivudine, to reduce the risk of resistance and to achieve rapid viral suppression. _Duration of treatment_ The optimal duration of treatment is unknown. • In patients with HBeAg positive chronic hepatitis B (CHB) without cirrhosis, treatment should be administered for at least 6-12 months after HBeAg seroconversion (HBeAg and HBV DNA loss with HBeAb detection) is confirmed, to limit the risk of virological relapse, or until HBsAg seroconversion or there is loss of efficacy (see section 4.4). Serum ALT and HBV DNA levels 3 should be followed regularly after treatment disco Pročitajte cijeli dokument