| Document Date: 2012-06-06 10:30:21
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City Ribavirin / Reference / / Event Product Issues / / Facility Laboratory Abnormalities / / IndustryTerm immune systems / HCV therapy / Prevention of HIV / Treatment of HIV / therapy of HIV / combination products / therapy for HIV / / MedicalCondition inflammatory response / advanced infection / Macular edema / HIV / chest pain / headache / Mycobacterium avium infection / myopathy / significant anemia / leukopenia / neutropenia and severe anemia / nausea / Stomatitis / anaphylaxis / Thrombocytopenia / hepatitis C / muscle spasm / Stevens-Johnson syndrome / tremor / syncope / Symptomatic myopathy / fatigue / Obesity / Lymphadenopathy / residual opportunistic infections / liver cirrhosis / Granulocytopenia / Diarrhea / Graves’ disease / Hepatitis / Aplastic anemia / Neutropenia Significant anemia / Constipation / liver disease / Back pain / Hepatic decompensation / Gynecomastia / Immune reconstitution syndrome / abdominal pain / Autoimmune disorders / insomnia / congestive heart failure / central obesity / hemolytic anemia / Immune Reconstitution Syndrome Immune reconstitution syndrome / whole Fever / Cardiomyopathy / vasculitis / disease / Respiratory Cough / arthralgia / chills / Dysphagia / hematuria / Guillain-Barré syndrome / Carcinogenesis / Pneumocystis jirovecii pneumonia / Abnormal breath sounds/wheezing / neutropenia / mouth ulcer / HCV / erythema / fever / rhabdomyolysis / vomiting / pain / lactic acidosis / Patients With Renal Impairment End-Stage Renal Disease / myositis / angioedema / allergic reactions / pancreatitis / digestive disorders / infection / abdominal cramps / Patients With Severe Anemia / cough / anemia / Syndrome / pure red cell aplasia / polymyositis / tuberculosis / pancytopenia / / MedicalTreatment antiretroviral treatment / peritoneal dialysis / antiretroviral therapy / intravenous infusion / blood transfusions / hemodialysis / / Organization FDA / / Person Pediatric Patients / / / Product COMBIVIR / zidovudine / TRIZIVIR / abacavir sulfate / RETROVIR / EPIVIR / Oral Suspension / ribavirin / lamivudine / didanosine / Stavudine / hepatic function / / Technology Pharmacokinetics / dialysis / / URL www.fda.gov/medwatch / /
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-------------------------------CONTRAINDICATIONS-----------------------Hypersensitivity to zidovudine (e.g., anaphylaxis, Stevens-Johnson syndrome[removed]HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not inclu