| Document Date: 2013-05-23 16:04:28
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City Gadolinium / Reference / / Company Intravenous Injection Only Mallinckrodt Inc. / Mallinckrodt Inc. / Ames / / Event FDA Phase / Product Issues / / Facility LABORATORY TEST INTERACTIONS Interference / / IndustryTerm magnetic resonance imaging / aqueous solution / / MedicalCondition NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents / hemolytic anemias / chronic / severe kidney disease / neoplasms / lymphoma / seizures / cysts / sickle cell anemia / heart disease / SPECIAL POPULATIONS Renal Insufficiency / mature post-operative scars / CNS disorders / injury / chronic kidney disease / hypersensitivity / liver disease / Hepatic Insufficiency / asthma / hemoglobinopathies / hypertension / kidney disease / CARCINOGENESIS / chronic / diabetes / itching / allergy / abscesses / chronic hypertension / renal insufficiency / diabetes mellitus / diseases / infection / anemia / disorders / fibrosis / / MedicalTreatment chemotherapy / emergency treatment / surgery / radiation / relaxation / Hemodialysis / dialysis / / Organization National Science Foundation / FDA / CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION / / / Position counsel / physician / / Product For Intravenous Injection / Palm Pre Plus Smartphone / calcium chloride / OptiMARK / Gadoversetamide Injection / elimination / gadoversetamide / OptiMARK™ Injection / hepatic function / renal function / / Technology radiation / tomography / MRI / PHARMACOKINETICS / magnetic resonance imaging / chemotherapy / spectroscopy / PHARMACODYNAMICS / dialysis / / URL www.fda.gov/medwatch / /
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OptiMARK™ 0.5 mmol/mL (Gadoversetamide Injection) PRESCRIBING INFORMATION Rx only Mallinckrodt Inc. May 2013