PaÃs: Jordà nia
Idioma: anglès
Font: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)
Entecavir 0.5 mg
مستودع أدوية الشرق شخشير - ORIENT DRUG STORE CO
J05AF10
Entecavir 0.5 mg
0.5 mg
30
ASTRAZENECA PHARMACEUTICALS LP/USA (امريكا)
1 HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BARACLUDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BARACLUDE. BARACLUDE  (ENTECAVIR) TABLETS, FOR ORAL USE BARACLUDE  (ENTECAVIR) ORAL SOLUTION INITIAL U.S. APPROVAL: 2005 WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, AND LACTIC ACIDOSIS AND HEPATOMEGALY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _  SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO HAVE DISCONTINUED ANTI-HEPATITIS B THERAPY, INCLUDING ENTECAVIR. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY FOR AT LEAST SEVERAL MONTHS AFTER DISCONTINUATION. INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED. (5.1)  BARACLUDE IS NOT RECOMMENDED FOR PATIENTS CO-INFECTED WITH HUMAN IMMUNODEFICIENCY VIRUS (HIV) AND HEPATITIS B VIRUS (HBV) WHO ARE NOT ALSO RECEIVING HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART), BECAUSE OF THE POTENTIAL FOR THE DEVELOPMENT OF RESISTANCE TO HIV NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS. (5.2)  LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUE INHIBITORS. (5.3) ---------------------------INDICATIONS AND USAGE---------------------------- BARACLUDE is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (1) ------------------------DOSAGE AND ADMINISTRATION----------------------  Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily. (2.2)  Nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric patients at least 2 years of age and weighin Llegiu el document complet