| Document Date: 2009-07-24 02:07:51
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Company Bristol-Myers Squibb / Alteon Inc. / / Event FDA Phase / / Facility Laboratory Abnormalities Frequencies / laboratory BARACLUDE / / IndustryTerm HIV treatment / hepatitis B therapy / treatment for HIV / Healthcare providers / / MedicalCondition HIV infection / OF HEPATITIS B / HIV / headache / HBV / HBeAg-negative chronic HBV infection / recurrent viremia / Skin disorders / hepatocellular carcinoma / Hematuria / Carcinogenesis / subcutaneous tissue disorders / nausea / cirrhosis / Glycosuria / compensated liver disease / Alopecia / hepatitis B / viremia / fatigue / Lactic acidosis / virus infection / SEVERE ACUTE EXACERBATIONS OF HEPATITIS B / Obesity / histologically active disease / infection / Immune system disorders / Hepatitis / dizziness / liver disease / rash / chronic hepatitis B / mg/dL Hyperglycemia / / MedicalTreatment continuous ambulatory peritoneal dialysis / hemodialysis / highly active antiretroviral therapy / HAART / CAPD / / Organization DOSAGE AND ADMINISTRATION / FDA / / Person Fatigue Nervous / / / Position General / / Product tenofovir disoproxil fumarate / 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. ®