| Document Date: 2009-11-23 09:39:12
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City Ribavirin / / Company GlaxoSmithKline / / 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 / photophobia / advanced infection / Macular edema / HIV / chest pain / headache / Mycobacterium avium infection / MYOPATHY / seizures / Significant anemia / leukopenia / neutropenia and severe anemia / nausea / Stomatitis / anaphylaxis / Thrombocytopenia / rhinitis / hepatitis C / toxic epidermal necrolysis / muscle spasm / Stevens-Johnson syndrome / tremor / syncope / Symptomatic myopathy / fatigue / Obesity / Lymphadenopathy / residual opportunistic infections / liver cirrhosis / Granulocytopenia / Diarrhea / Hepatitis / sinusitis / Aplastic anemia / Constipation / hearing loss / liver disease / pruritus / Back pain / Hepatic decompensation / Gynecomastia / Immune reconstitution syndrome / abdominal pain / insomnia / congestive heart failure / central obesity / hemolytic anemia / Immune Reconstitution Syndrome Immune reconstitution syndrome / whole Fever / Cardiomyopathy / vasculitis / disease / Respiratory Cough / arthralgia / Dyspnea / chills / Dysphagia / hematuria / Carcinogenesis / Pneumocystis jirovecii pneumonia / Abnormal breath sounds/wheezing / neutropenia / vertigo / mouth ulcer / mania / HCV / erythema / fever / rhabdomyolysis / Amblyopia / vomiting / pain / Lactic acidosis / Patients With Renal Impairment End-Stage Renal Disease / urticaria / myositis / angioedema / allergic reactions / pancreatitis / digestive disorders / infection / dizziness / abdominal cramps / Patients With Severe Anemia / cough / depression / paresthesia / anemia / syndrome / pure red cell aplasia / tuberculosis / pancytopenia / / MedicalTreatment antiretroviral treatment / peritoneal dialysis / antiretroviral therapy / intravenous infusion / hemodialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Product COMBIVIR / zidovudine / TRIZIVIR / RETROVIR / EPIVIR / ganciclovir / ribavirin / didanosine / Stavudine / hepatic function / / Technology Pharmacokinetics / dialysis / / URL www.fda.gov/medwatch / /
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----------------------- WARNINGS AND PRECAUTIONS ---------------• Hematologic toxicity/bone marrow suppression including neutropenia and severe anemia have been associated with the use of zidovudine. (5.1) • Sympto