| Document Date: 2012-10-15 15:53:23
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City Reference / / Company Bristol-Myers Squibb / Alteon Inc. / / Event FDA Phase / / Facility Laboratory Abnormalities Frequencies / / IndustryTerm HIV treatment / hepatitis B therapy / treatment for HIV / / MedicalCondition HIV infection / Decompensated Liver Disease Study AI463048 / HIV / headache / HBV / HBeAg-negative chronic HBV infection / recurrent viremia / hepatocellular carcinoma / Hematuria / Carcinogenesis / Hyperglycemia / chronic HBV infection / nausea / cirrhosis / Glycosuria / compensated liver disease / hepatic encephalopathy / hepatitis B / upper respiratory infection / viremia / fatigue / Lactic acidosis / virus infection / gastrointestinal hemorrhage / SEVERE ACUTE EXACERBATIONS OF HEPATITIS B / Obesity / hepatic failure / Decompensated liver disease / histologically active disease / infection / Hepatitis / dizziness / renal failure / liver disease / hepatorenal syndrome / hepatic decompensation / chronic hepatitis B / / MedicalTreatment continuous ambulatory peritoneal dialysis / hemodialysis / highly active antiretroviral therapy / Liver transplant / HAART / CAPD / / Organization DOSAGE AND ADMINISTRATION / FDA / / Person Fatigue Nervous / / / Position General / / Product Lamivudine / BARACLUDE / BARACLUDE (entecavir) Oral / or / / Technology Pharmacokinetics / dialysis / / URL www.fda.gov/medwatch / /
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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.