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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

linkClick(this.href)" rel="nofollow">Guerbet website. The company assumes no liability whatsoever to update these forward-looking-statements or to conform them to future events or developments.
Dotarem® is registered in U.S. Patent and Trademark Office by Guerbet and is available by prescription only.
[1] Data on file as of January 1, 2013.
[2] In MRI volume. ECMIG 2011.

DOTAREM® (gadoterate meglumine) injection, for intravenous use
Initial U.S. Approval: 2013

BRIEF SUMMARY OF PRESCRIBING INFORMATION
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
____________________________________
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. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

  • 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 (e.g. age greater than 60 years, hypertension, 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 sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.1)].
______________________________

1    INDICATIONS AND USAGE
DOTAREM is a gadolini
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