Study to evaluate the product flow, breakdown and elimination of DOTAREM from the blood and its safety and efficacy in children aged > 2 years

Update Il y a 4 ans
Reference: EUCTR2013-003215-21

Woman and Man

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Extract

To evaluate pharmacokinetics profile in plasma of DOTAREM following single intravenous injection in pediatric subjects aged up to 23 months (inclusive)


Inclusion criteria

  • Pediatric subject aged <2 years (term newborn infants to toddlers 23 months of age inclusive) scheduled to undergo routine gadolinium-enhanced Magnetic Resonance Imaging of any body region