MRI IN CHILDREN GIVEN GADODIAMIDE INJECTION - SAFETY AND EFFICACY IN CNS AND BODY INDICATIONS

The safety and efficacy of the MRI contrast medium gadodiamide injecti on (OMNISCAN(R)) in children is summarised. Four open and three double -blind, multinational, multicentre comparative trials have been undert aken. Overall, 353 patients (15 days to 18 years, plus one 21 years) r eceived gadodiamide injection, and 128 (2-18 years) received godopente tate dimeglumine (Magnevist(R)), intravenously at 0.1 mmol/kg body wei ght, to aid the identification of CNS and body lesions. adverse events were reported in 13 (4%) patients given gadodiamide injection and 8 ( 6%) given gadopentetate dimeglumine; few patients reported injection-a ssociated discomfort. The post-contrast scan gave more diagnostic info rmation in 223 (63%) patients given gadodiamide injection (CNS and bod y indications). In the comparative trials, the post-contrast scan gave more diagnostic information for 91 (65%) and 82 (64%) patients given gadodiamide injection and gadopentetate dimeglumine, respectively (CNS indications only). Gadodiamide injection (0.1 mmol/kg body weight) wa s safe and effective in infants. children and adolescents.