This is a summary of the European public assessment report (EPAR) for SonoVue. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use SonoVue. For practical information about using SonoVue, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication This medicinal product is for diagnostic use only. SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio. SonoVue should only be used in patients where study without contrast enhancement is inconclusive. Echocardiography SonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation. Doppler of macrovasculature SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio. SonoVue increases the quality of the Doppler flow image and the duration of clinically useful signal enhancement in portal vein assessment in adult patients. Doppler of microvasculature SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients leading to more specific lesion characterisation. Ultrasonography of excretory urinary tract SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux. For the limitation in the interpretation of a negative urosonography.
Therapeutic Area (MeSH)
ATC Code
V08DA05
ATC Item
sulfur hexafluoride, phospholipid microspheres
Pharmacotherapeutic Group
Contrast media
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| sulphur hexafluoride | N/A | 六氟化硫微泡 |
EMA Name
SonoVue
Medicine Name
SonoVue
Aliases
N/ANo risk management plan link.
