Dear Healthcare Professional Letter on the revised contraindications and warnings and precautions for the use of SonoVue (sulphur hexafluoride)
09.12.2014
Bracco International BV, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform health care professionals on the revised contraindications and warnings and precautions for the use of SonoVue (sulphur hexafluoride).
Summary
- Rare but severe arrhythmias, sometimes fatal, have been reported in patients with cardiovascular instability during stress echocardiography procedure with SonoVue used in combination with dobutamine.
- Therefore, in patients with conditions suggesting cardiovascular instability (e.g. recent acute coronary syndrome or clinically unstable ischaemia), SonoVue should not be used in combination with dobutamine.
- When administered alone in patients with cardiovascular instability, Sonovue should be used with extreme caution and only be administered after careful risk/benefit assessment; a close monitoring of vital signs should be performed during and after administration, because in these patients allergy-like and/or vasodilatory reactions may lead to life-threatening conditions.
Additional information
In the European Union, SonoVue is approved for use in:echocardiography, and doppler of macrovasculature, and doppler of microvasculature.
In view of the frequent use of the direct-acting inotropic agent dobutamine for stress echocardiographic procedures and the risk of serious adverse cardiac reactions when used in combination with SonoVue in patients with cardiovascular instability, the European Health Authorities have decided to add a contraindication for the use of this combination in patients with conditions suggesting cardiovascular instability. In addition, based on the results of literature and clinical experience the existing contraindication in patients with recent acute coronary syndrome or clinically unstable ischemic cardiac disease was removed and replaced by a warning.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
