Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
adefovir dipivoxil
Gilead Sciences Ireland UC
J05AF08
adefovir dipivoxil
Nucleoside and nucleotide reverse transcriptase inhibitors
Hepatitis B, Chronic
Hepsera 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 fibrosis. Initiation of Hepsera 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);decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.
Revision: 27
Withdrawn
2003-03-06
23 B. PACKAGE LEAFLET Medicinal Product no longer authorised 24 PACKAGE LEAFLET: INFORMATION FOR THE USER HEPSERA 10 MG TABLETS adefovir dipivoxil 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 Hepsera is and what it is used for 2. What you need to know before you take Hepsera 3. How to take Hepsera 4. Possible side effects 5. How to store Hepsera 6. Contents of the pack and other information 1. WHAT HEPSERA IS AND WHAT IT IS USED FOR WHAT HEPSERA IS Hepsera contains the active substance adefovir dipivoxil and belongs to a group of medicines called antiviral medicines. WHAT IT IS USED FOR Hepsera is used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults. Infection with the hepatitis B virus leads to damage to the liver. Hepsera reduces the amount of the virus in your body, and has been shown to reduce liver damage. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HEPSERA DO NOT TAKE HEPSERA • IF YOU ARE ALLERGIC to adefovir, adefovir dipivoxil or any of the other ingredients of this medicine (listed in section 6). • TELL YOUR DOCTOR AT ONCE if you could be allergic to adefovir, adefovir dipivoxil or any of the other ingredients of Hepsera. WARNINGS AND PRECAUTIONS Talk to your doctor before using Hepsera. • TELL YOUR DOCTOR IF YOU HAVE HAD KIDNEY DISEASE , or if tests have shown problems with your kidneys. Hepsera can affect the way your kidneys work. The risk of this occurring is increased with long-term use of Hepsera. Your doctor should run tests to check your Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Hepsera 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of adefovir dipivoxil. Excipient(s) with known effect Each tablet contains 107.4 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. White to off-white, round, flat-faced, bevelled-edge tablets, 7 mm in diameter, debossed with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hepsera is indicated in adults for the treatment of chronic hepatitis B 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 fibrosis. Initiation of Hepsera 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). • decompensated liver disease in combination with a second agent without cross-resistance to Hepsera. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of chronic hepatitis B. Posology _Adults_ The recommended dose of Hepsera is 10 mg (one tablet) once daily taken orally with or without food. Higher doses must not be administered. The optimum duration of treatment is unknown. The relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis is not known. In patients with decompensated liver disease, adefovir should always be used in combination with a second agent, without cross-resistance to adefovir, to reduce the risk of resistance and to achieve rapid viral suppression. Medicinal Product no longer authorised 3 Patients should be monitored every six months for hepatitis B biochemic Đọc toàn bộ tài liệu