Gadobutrol was well tolerated with high safety margins between the single diagnostic dose of 0.1 mmol/kg in humans and the doses showing effects in animal studies.
No findings were observed in any of the preclinical studies with Magnevist in healthy rats and dogs which could be characterized as similar to the types of morphologic lesions that have subsequently been identified as consistent with NSF. This preclinical assessment is in contrast to the reported clinical evidence of rare NSF cases in patients with severe kidney impairment after Magnevist administration. The differences between the preclinical models and their predictive limitations with regard to the clinical situation of renally impaired patients are discussed.
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