Revised SPC: Diafer (iron (III) isomaltoside 1000) 50mg/ml solution for injection

Sections 4.4+4.8 advise there have been reports of hypersensitivity reactions progressing to Kounis syndrome (acute allergic coronary arteriospasm that can result in MI). Section 4.6 recommends foetal monitoring during administration to pregnant women (due to foetal bradycardia).