SONOVUE (sulphur hexafluoride), contrast agent

High clinical benefit in urinary tract ultrasonography in children (0-18 years) for detecting vesicoureteral reflux and minor clinical added value in the current diagnostic strategy, which includes retrograde urethrocystography techniques, with administration of contrast agents.

• SONOVUE has been granted marketing authorisation for urinary tract ultrasonography in children from birth to 18 years, with a view to detecting vesicoureteral reflux.

• The efficacy data are based upon 4 clinical studies and one pooled analysis of these 4 studies, comparing urinary tract ultrasonography (UTU) with SONOVUE with retrograde mictional urethrocystography (RMU) to detect vesicoureteral reflux in children. In total, in the 4 studies, approximately 60% additional vesicoureteral reflux diagnoses were made with UTU (329 diagnoses) compared to RMU (195 diagnoses) and 28 cases of vesicoureteral reflux diagnosed with RMU were not observed with UTU.

• The safety profile of SONOVUE is consistent with that already known in its other indications, and is favourable compared to RMU due to the lack of exposure to ionising radiation.