SonoVue 8 microlitres / ml powder and solvent for dispersion forinjection

ATC Code
SonoVue 8 microlitres / ml powder and solvent for dispersion forinjection

Bracco International BV

Narcotic Psychotropic
No No
Pharmacological group Ultrasound contrast media


All to know


Bracco International BV

What is it?

SonoVue is a medicine that contains the active substance sulphur hexafluoride (a gas). It is available as a kit including one vial of gas and powder and one pre-filled syringe containing 5 ml of solvent. When made up into a solution, SonoVue contains sulphur hexafluoride gas as ?microbubbles? in suspension in a liquid.

What is it used for?

SonoVue is for diagnostic use only. It is a contrast agent (it helps make internal body structures visible during imaging tests). SonoVue is used in tests that measure how ultrasound travels within the body because it improves the ability of the blood to create an echo. It is only used when the results of the test without a contrast agent are inconclusive. SonoVue is used in:

echocardiography a diagnostic test where an image of the heart is obtained. It is used to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, in patients with suspected or confirmed coronary artery disease.

Doppler a diagnostic test that measures the speed of blood flow. SonoVue can be used in Doppler tests for large blood vessels, such as those in the head, those leading to the head or the main vein to the liver, or for smaller blood vessels such as those in lesions areas of disease in the breast or liver.

The medicine can only be obtained with a prescription.


How is it used?

SonoVue should only be used by doctors who have experience in diagnostic ultrasound imaging. It is injected intravenously (into a vein) before the test is carried out, as a 2 or 2.4 ml dose depending on which test is being carried out. The dose can be repeated.

How does it work?

The active substance in SonoVue, sodium hexafluoride, is a gas that is not soluble in the blood. When SonoVue is made up into a suspension, the gas is trapped in tiny bubbles called microbubbles. After injection, the microbubbles travel in the blood, where they reflect ultrasound waves more than the surrounding tissues. This helps to enhance the results of tests that rely on measuring ultrasound, such as echocardiography and Doppler tests. The gas is removed naturally from the body through the lungs.

How has it been studied?

SonoVue has been studied in a total of 895 patients in six main studies. These included three studies of echocardiography and three studies of Doppler.

The echocardiography studies involved a total of 317 patients, and compared SonoVue with another contrast agent and placebo (a dummy treatment).

The Doppler studies involved 361 patients who were being tested for abnormalities in large blood vessels, and 217 patients being tested for abnormalities in smaller vessels. In these studies, SonoVue was not compared with any other medicine, but the results of the test with SonoVue were compared with the ?gold standard?, such as angiography (X-rays of blood vessels). The main measure of effectiveness was how clear the images obtained in the test were.

What benefits has it shown during the studies?

In the echocardiography studies, SonoVue was more effective than the comparator and than placebo in improving the clarity of the image obtained of the left ventricle and left ventricle border.

In the Doppler studies, using SonoVue to measure blood flow in large blood vessels improved the quality of the scan when testing the cerebral arteries (in the head), the carotids (in the neck) and the portal vein (leading to the liver), but not the renal arteries (leading to the kidneys). For the smaller vessels, SonoVue led to better quality scans when looking at the blood flow in breast and liver lesions. However, this was not observed for lesions in the pancreas, kidney, ovary or prostate gland.

What is the risk associated?

The most common side effects with SonoVue (seen in between 1 and 10 patients in 100) are headache, paraesthesia (unusual sensations like pins and needles), dizziness, dysgeusia (taste disturbances), flushing (reddening of the skin), pharyngitis (sore throat), nausea (feeling sick), pruritus (itching), rash, pain, including back and chest pain, chest discomfort, fatigue (tiredness), reactions at the injection site, feeling hot and raised blood sugar levels. For the full list of all side effects reported with SonoVue, see the package leaflet.

SonoVue should not be used in people who may be hypersensitive (allergic) to sulphur hexafluoride or any of the other ingredients. SonoVue must also not be used in the following patients:

patients with recent acute coronary syndrome symptoms involving the heart or unstable ischaemic cardiac disease reduced blood supply to the heart


patients known to have right-to-left shunts abnormal movement of blood within the heart, severe pulmonary hypertension high blood pressure in the pulmonary artery, the blood vessel that leads from the heart to the lungs, uncontrolled hypertension high blood pressure or adult respiratory distress syndrome severe fluid build-up in both lungs

pregnant or breast-feeding women.

Why has it been approved?

The CHMP decided that SonoVue?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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