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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

icient period of time for elimination of the drug from the body prior to any re-administration (5.1). _________________________________________________________

Contraindicated in patients with a history of clinically important hypersensitivity reactions to DOTAREM.

The possibility of serious or life-threatening anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, should be considered.

In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging. Screen all patients for renal impairment by obtaining a history and/or laboratory tests. Consider follow-up renal function assessments for patients with a history of renal dysfunction.

The most common adverse reactions associated with Dotarem® in clinical studies were nausea, headache, injection site pain, injection site coldness, and burning sensation.

For more information about Dotarem®, including full Boxed WARNING, please see the Full Prescribing Information and Brief Summary attached to this press release.

Winthrop is a 591-bed teaching hospital in Mineola, NY, that was recently ranked as one of the best hospitals for 2013-14 in the New York Metro Area by U.S. News & World Report. The hospital performs about 1,000 MRIs per month in adult and pediatric patients, with at least two-thirds of the cases involving contrast agents. More information about the Radiology Department can be found here.

“In the past, before the availability of Dotarem, we would not use contrast agents in patients with impaired renal function,” said Dr. Orlando Ortiz, Chairman
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