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Abstract #4576

Pharmacokinetics and Safety of Gadobenate Dimeglumine in Patients from 2 to 5 Years of Age

Gianpaolo Pirovano1, Mieczyslaw Pasowicz2, Miles A. Kirchin3, Ningyan Shen4, John R. Parker5, Alberto Spinazzi1

1Medical Affairs, Bracco Diagnostics Inc., Princeton, NJ, United States; 2Radiology, John Paul II Hospital, Kracow, Poland; 3Medical Communications, Bracco Imaging, Milan, Italy; 4Biometrics, Bracco Diagnostics Inc., Princeton, NJ, United States; 5Medical Communications, Bracco Diagnostics Inc., Princeton, NJ, United States

15 subjects aged 2-5 years were enrolled in a pharmacokinetic study and received 0.1 mmol/kg bw gadobenate dimeglumine. Pharmacokinetic parameters were calculated from the blood Gd concentration-time data using compartmental and noncompartmental techniques. At 6 hours after gadobenate dimeglumine administration, all subjects residual Gd in blood was close to 1.0 g/mL, indicating that Gd was successfully cleared from the blood. No differences in whole blood or urinary pharmacokinetic parameters were observed between pediatric subjects 2 to 5 years when compared to adult subjects studied in previously.