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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

h 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.

5.4 Extravasation and Injection Site Reactions
Ensure catheter and venous patency before the injection of DOTAREM. Extravasation into tissues during DOTAREM administration may result in tissue irritation [see Nonclinical Toxicology (13.2)].

6 ADVERSE REACTIONS
GBCAs have been associated with a risk for NSF [see Warnings and Precautions (5.1)]. NSF has not been reported in patients with a clear history of exposure to DOTAREM alone. For hypersensitivity reactions and acute kidney injury see Warnings and Precautions (5.2) and (5.3).

6.1 Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The data described below reflect DOTAREM exposure in 2813 patients, representing 2672 adults and 141 pediatric patients. Overall, 55% of the patients were men. In clinical trials where ethnicity was recorded the ethnic distribution was 74% Caucasian, 12% Asian, 4% Black, and 10% others.

The average age was 53 years (range from 0.1 to 97 years).
Overall, 3.9% of patients reported at least one adverse reaction, primarily occurring immediately or several days following DOTAREM administration. Most adverse reactions were mild or moderate in severity and transient in nature.

Table 1 lists adverse reactions that occurred in grea
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