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First Adult Injection in US of Dotarem® (gadoterate meglumine) Performed at Winthrop-University Hospital in New York
Date:9/5/2013

Princeton, NJ (PRWEB) September 05, 2013

Guerbet announced today that Winthrop-University Hospital in Mineola, NY recently performed the first US adult injection of Dotarem® (gadoterate meglumine), the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) approved by the US Food and Drug Administration. The procedure was performed in an adult with borderline renal function. It follows the first pediatric injection of Dotarem at Cincinnati Children’s Hospital Medical Center.

Dotarem is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Important Safety Information

___________________________________________________
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
See full prescribing information for complete boxed warning

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.

  • The risk for NSF appears highest among patients with:
-- Chronic, severe kidney disease (GFR less than 30 mL/min/1.73m2), or
-- Acute kidney injury.

  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age greater than 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing (5.1).
  • For patients at highest risk for NSF, do not exceed the recommended DOTAREM dose and allow a suff
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