| Document Date: 2014-03-28 10:14:04
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Company ES E -R AG / GE / US Inc. / Galen US Inc. / ve co / uld co / ontr co / Ames / / Country United States / / Event Product Issues / / Facility store SYNERA / Handling Store / / IndustryTerm magnetic resonance imaging / similar products / oil / imaging / healthcare professional / / MedicalCondition double vision / tremors / severe hepatic disease / allergic reaction / headache / seizures / unconsciousness / coma / nausea / hepatic dysfunction / numbness / drowsiness / bradycardia / burns / hypersensitivity / cardiac arrest / idiopathic methemoglobinemia / pruritus / hypotension / light-headedness / thermal injury / bronchospasm / disease / shock / skin hurts / Carcinogenesis / corneal irritation / skin irritation / erythema / potential irritation / vomiting / pain / blister / severe eye irritation / urticaria / pseudocholinesterase deficiency / angioedema / Allergic Reactions / respiratory depression / infection / irritation / contact dermatitis / vesiculobullous rash / dizziness / deficiency / depression / Fertility Carcinogenesis / rash / paresthesia / methemoglobinemia / tinnitus / / MedicalTreatment cannulation / Vaccinations / Dialysis / / Organization Single Dermal Administration / FDA / / / Position Major / / Product acetaminophen / sodium chloride / primaquine / lidocaine and tetracaine / nitroglycerin / nitrofurantoin / dapsone / phenytoin / Oucher / epinephrine / lidocaine / SYNERA / skin / / PublishedMedium Magnetic Resonance Imaging / / Technology alpha / Pharmacokinetics / magnetic resonance imaging / Dialysis / / URL www.fda.gov/medwatch / /
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(lidocaine and tetracaine) Topical Patch idiopathic methemoglobinemia, and infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents. • Very young patients or patients with