FDA Expands Pediatric Age Range for MultiHance Contrast Agent
Bracco Diagnostics announced that the Food and Drug Administration (FDA) has approved an expanded age range for MultiHance (gadobenate dimeglumine) contrast agent to include magnetic resonance imaging (MRI) of the central nervous system (CNS) in pediatric patients aged <2 years (including term neonates), to visualize lesions with abnormal blood-brain barrier of abnormal vascularity of the brain, spine, and associated tissues.
The FDA's approval was supported by data specifically gathered in patients aged <2 years. The 0.1mmol/kg dose significantly improved the visualization and morphologic assessment of CNS lesions as seen in older pediatric patients and adults. For neonates and infants, the lower 0.05mmol/kg dose was shown to be effective at improving the visualization of lesions in the brain and spine.
MultiHance injection, a gadolinium-based contrast agent, is already intended for use in MRI of the CNS in adults to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues. It is also approved for use in magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
MultiHance is available as a 529mg/mL strength solution for intravenous (IV) injection in single-dose vials.
For more information call (800) 257-5181 or visit Bracco.com.