Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

Exclusion Criteria

• •Subjects undergoing a change in chemotherapy within 48 hours prior to and up to 24 hours after gadobutrol injection
• •Any planned intervention during the study and up to 24 hours after gadobutrol injection (excluding lumbar puncture)
• •Subjects who received or will receive any investigational product within 48 hours before gadobutrol injection or during study participation
• •Subjects who received or will receive any other contrast agent within 48 hours prior to gadobutrol injection or up to 24 hours after gadobutrol injection
• •Subjects with contraindication for MRI such as iron metal implants (e.g. aneurysm clips)
• •History of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
• •Subject with renal insufficiency of any intensity, i.e. estimated Glomerular Filtration Rate \<80% of age adjusted normal value calculated based on the Schwartz formula