| Document Date: 2014-11-18 14:01:05
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City Reference / / Company SUSPECTED ADVERSE REACTIONS / Schering Corporation / / Event Product Issues / / Facility Laboratory ALT / / IndustryTerm therapy for melanoma / healthcare / treatment of melanoma / / MedicalCondition ventricular tachycardia / interstitial pneumonitis / macular edema / retinal hemorrhages / III melanoma / headache / bundle-branch block / retinal detachment / rheumatoid arthritis / hallucinations / nausea / thrombotic thrombocytopenic purpura / cirrhosis / stomatitis / anaphylaxis / thrombocytopenia / toxic epidermal necrolysis / hyperthyroidism / peripheral neuropathy / sarcoidosis / Stevens-Johnson syndrome / melanoma / fatigue / angina pectoris / injury / encephalopathy / erythema multiforme / interstitial nephritis / hypersensitivity / hepatitis / memory loss / end-stage renal disease / lupus / Infections / serious depression / Hepatic decompensation / blindness / hypotension / Nutrition Disorders / arrhythmia / anovulation / endocrine disorders / papilledema / pneumonia / CHC / pulmonary infiltrates / cardiomyopathy / disease / Nervous System Disorders / severe fatigue / Hypothyroidism / chills / Carcinogenesis / hyperglycemia / optic neuritis / ESRD / neutropenia / stroke / vertigo / mania / thyroiditis / cotton wool spots / bipolar disorders / psychoses / myocardial infarction / diabetes mellitus / Hepatic Failure / urticaria / angioedema / pancreatitis / serious neuropsychiatric disorders / increased ALT / Autoimmune hepatitis / Cough / thrombosis / Retinal disorders / depression / idiopathic thrombocytopenic purpura / Fertility Carcinogenesis / bronchiolitis obliterans / chronic hepatitis C / disorders / unstable cardiac disease / / MedicalTreatment hemodialysis / dialysis / adjuvant therapy / / Organization FDA / Independent Review Committee / / / Position General / / Product acetaminophen / polyethylene glycol / peginterferon / Sterile Water for Injection / estradiol / tolbutamide / ribavirin / Intron A / renal function / / Technology alpha / antibodies / Pharmacokinetics / recombinant DNA / 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 SYLATRON safely and effectively. See full prescribing information for SYLATRON. SYLATRON™ (peginterferon alfa-2b)