Safety assessment of gadoversetamide (OptiMARK®) administered by power injector
✍ Scribed by Nancy Abdou; Alicia M. Napoli; Michael R. Hynes; John C. Allen Jr.; James H. Wible Jr.
- Publisher
- John Wiley and Sons
- Year
- 2003
- Tongue
- English
- Weight
- 141 KB
- Volume
- 19
- Category
- Article
- ISSN
- 1053-1807
No coin nor oath required. For personal study only.
✦ Synopsis
Abstract
Purpose
To evaluate the safety of OptiMARK® (gadoversetamide injection) administered via power injector.
Materials and Methods
The study population included 144 healthy volunteers aged 18 years or older randomly assigned to one of seven treatment groups (N = 20/group). The safety assessment was based on changes in physical examination, vital signs, electrocardiograms (ECGs), standard clinical laboratory tests, and adverse events (AEs) through a 24‐hour postinjection period.
Results
OptiMARK caused no serious AEs or unexpected changes in physical examinations or laboratory parameters. The changes observed in vital signs and ECG intervals did not vary with changes in injection rate and were not significantly (P < 0.05) different from those elicited by saline administration at the same rates.
Conclusion
This study demonstrated the safety of OptiMARK when administered via a power injector at rates of 2, 4, and 6 mL/second. J. Magn. Reson. Imaging 2004;19:133–140. © 2003 Wiley‐Liss, Inc.