| Document Date: 2014-11-17 14:53:23
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City Oslo / Gadolinium / Reference / / Company General Electric Company / GE Healthcare Inc. / / Event Product Issues / FDA Phase / / Facility Laboratory Test Findings / Store OMNISCAN / Pharmacy Bulk Package / Laboratory Test Findings Asymptomatic / / IndustryTerm diagnostic magnetic resonance imaging / magnetic resonance imaging / resonance imaging / rubber / aqueous solution / resuscitation equipment / / MedicalCondition Nephrogenic Systemic Fibrosis Gadolinium-based contrast agents / chronic / severe kidney disease / neoplasms / chest pain / dry mouth/vomiting / headache / Autonomic Nervous System Disorders / cardiac failure / sterility / cysts / rash / erythematous rash / impaired renal insufficiency / coma / ischemic heart disease / nausea / Peripheral Nervous System Disorders / Rhinitis / muscle weakness / hypersensitivity disorders / systemic fibrosis / tremor / syncope / chronic / moderate kidney disease / severe infection / fatigue / injury / multiple sclerosis / rare arrhythmia / ataxia / abnormal coordination / hypersensitivity / anaphylactic reactions / diarrhea / skin and appendage disorders / allergic respiratory disorders / deep thrombophlebitis / mature postoperative scars / neurologic deficits / Pruritus / paresis / liver disease / NEPHROGENIC SYSTEMIC FIBROSIS / asthma / arrhythmia / Musculoskeletal System Disorders / Abdominal pain / Cardiovascular Disorders / hypertension / Convulsions / flushing / Nervous System Disorders / Arthralgia / dyspnea / Carcinogenesis / acute kidney injury / chronic / mild kidney disease / Vestibular Disorders / migraine / diabetes / Other Disorders / itching / fever / allergy / abscesses / chronic hypertension / serious hypersensitivity / melena / pain / renal insufficiency / myocardial infarction / Gastrointestinal System Disorders / concomitant disease / diabetes mellitus / Application Site Disorders / urticaria / rigors / liver and biliary system disorders / Respiratory System Disorders / prior hypersensitivity / dizziness / renal failure / paresthesia / Acute Renal Failure / Tinnitus / Whole-General Disorders / fibrosis / Disorders / Urinary System Disorders / Acute reversible renal failure / / MedicalTreatment surgery / relaxation / resuscitation / Hemodialysis / drug therapy / dialysis / / Organization National Science Foundation / DOSAGE AND ADMINISTRATION / FDA / OMNISCAN administration / / / Position physician / Whole-General / / Product OMNISCAN / sodium chloride / Monogram / elimination / NOT / Norway OMNISCAN / Visualization / NOT FOR INTRATHECAL / renal function / / Technology MRI / Pharmacokinetics / magnetic resonance imaging / Pharmacodynamics / 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 OMNISCAN safely and effectively. See full prescribing information for OMNISCAN. OMNISCANTM (gadodiamide) Injection f