An
observational post-marketing study was conducted in 10 countries to
prospectively collect safety data in adults and children who were scheduled to
undergo routine Magnetic Resonance Imaging (MRI) with administration of
gadoterate meglumine (Dotarem®). The incidence of Nephrogenic Systemic Fibrosis
(NSF) in routine practice was assessed through specific follow-up of patients
with moderate to severe renal impairment. Final results in a large pediatric
sub-population of over 1,600 children showed a very good safety profile of
gadoterate meglumine with only one adverse event reported in a child and no
suspicion of NSF reported.
