SAFETY OF PROHANCE IN SPECIAL POPULATIONS

The safety profile of ProHance in special populations was evaluated by analyzing data extracted from the database of phase I-III studies whi ch included data on 2,656 ProHance injections of which 119 in pediatri c patients, 814 in elderly patients and 30 in patients with varying de grees of renal impairment (moderate, severe or end stage requiring hem odialysis). ProHance was administered at doses ranging from 0.1 mmol/k g to 0.3 mmol/kg and was found to be safe in all patient populations i rrespective of age and of pre-existing renal impairment. There appeare d to be no correlation between incidence of adverse events and dose le vel in these special populations and the higher dose level of 0.3 mmol /kg could be safely administered also to patients with end stage renal disease requiring hemodialysis, from whom the contrast medium was rap idly and efficiently dialysed.