| Document Date: 2014-09-18 02:20:04
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City Reference / / Company SUSPECTED ADVERSE REACTIONS / Schering Corporation / Merck & Co. Inc. / / Country United States / / Event Product Recall / FDA Phase / Product Issues / / Facility Laboratory Tests PegIntron / Laboratory Evaluations / Laboratory Parameters / / IndustryTerm renal insufficiency receiving interferon alpha products / food / / MedicalCondition interstitial pneumonitis / macular edema / HIV / HBV / HCV genotype 1 / sterility / rheumatoid arthritis / hallucinations / thrombotic thrombocytopenic purpura / cirrhosis / Pulmonary Disorders Dyspnea / anaphylaxis / toxic epidermal necrolysis / cirrhotic CHC / Endocrine Disorders PegIntron / StevensJohnson syndrome / thalassemia major / Pulmonary / acute hypersensitivity / psoriasis / cardiac arrest / bloody diarrhea / renal dysfunction / Pulmonary Disorders / Hepatic decompensation / birth defects / HCV genotype / Abdominal pain / severe renal dysfunction / autoimmune disorders / papilledema / pneumonia / pulmonary infiltrates / cardiomyopathy / respiratory failure / Hypothyroidism / nonfatal pancreatitis / Carcinogenesis / hyperglycemia / Cerebrovascular Disorders / neutropenia / stroke / mania / diabetes / ophthalmologic disorders / HCV / cotton wool spots / fever / vomiting / psychiatric disorders / Psychoses / Pancreatitis / above disorders / infection / depression / bronchiolitis obliterans / HCV-RNA / infectious disorders / bronchoconstriction / disorders / drug addiction / cardiac disease N/A / sickle-cell anemia / serous retinal detachment / systemic lupus erythematosus / retinal hemorrhages / hemorrhagic/ischemic colitis / headache / substance use disorders / nausea / compensated liver disease / Known hypersensitivity / hyperthyroidism / Colitis / Stevens-Johnson syndrome / Peripheral neuropathy / sarcoidosis / injection-site erythema / fatigue / angina pectoris / encephalopathy / injection-site inflammation / vein thrombosis / moderate renal dysfunction / renal insufficiency receiving interferon alpha products / Dental/periodontal disorders / interstitial nephritis / tachycardia / Hypersensitivity / aplastic anemia / pulmonary function impairment / HCV genotype 2 / hypotension / Hemoglobinopathies / arrhythmia / periodontal disorders / Hemolytic anemia / CHC / potential pancreatitis / Hypertriglyceridemia / chronic obstructive pulmonary disease / optic neuritis / cardiovascular disease / arrhythmic disorder / thyroiditis / pulmonary hypertension / clinical depression / pulmonary disease / psychiatric disorder / bipolar disorders / renal insufficiency / myocardial infarction / diabetes mellitus / injection site inflammation / Hepatic Failure / urticaria / angioedema / rigors / fetal death / cardiac disease / Dental and Periodontal Disorders / Autoimmune hepatitis / idiopathic thrombocytopenic purpura / chronic hepatitis B / anemia / Chronic Hepatitis C / unstable cardiac disease / / MedicalTreatment highly active antiretroviral therapy / contraception / HAART / hemodialysis / Organ transplant / / Organization DOSAGE AND ADMINISTRATION / FDA / PegIntron administration / / / Product Peginterferon / phenytoin / Daily Dose Capsules / Copegus / RIBAVIRIN / Pegasys / REBETOL / Didanosine / Adverse Reactions Application Site Injection / PegIntron / Sterile Water for Injection / INTRON A / renal function / / Technology drug screening / Geriatrics / genotype / alpha / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PegIntron safely and effectively. See full prescribing information for PegIntron. PegIntron® (Peginterferon alfa-2b