Bracco Imaging has changed the labeling for its SonoVue ultrasound contrast agent in the European Union.
Following an evaluation by the Committee on Human Medicinal Products (CHMP) of the European Medicines Agency of the benefits and risks of SonoVue use in critically ill patients, the contraindication for the use of SonoVue in patients with recent acute coronary syndrome or clinically unstable ischemic cardiac disease has been removed, Bracco said.
SonoVue can now be utilized, even if with extreme caution, in patients with conditions such as evolving or ongoing myocardial infarction, typical angina at rest within the last seven days, significant worsening of cardiac symptoms within the last seven days, recent coronary artery intervention, other factors suggesting clinical instability, acute cardiac failure, class III/IV cardiac failure, or severe rhythm disorders, Bracco said.
However, the CHMP has also recommended avoiding the use of SonoVue in combination with dobutamine in those patients for which the use of this pharmacological stressor is contraindicated. In a new contraindication added to the labeling for SonoVue, the agent "should not be used in combination with dobutamine in patients with conditions suggesting cardiovascular instability where dobutamine is contraindicated."