Sonovue

/ Dexcel

The recommended doses of Sulphur hexafluoride are: B-mode imaging of cardiac chambers, at rest or with stress: 2 ml. Vascular Doppler imaging: 2.4 ml. During a single examination, a second injection of the recommended dose can be made when deemed necessary by the physician.
Elderly Patients: The dosage recommendations also apply to elderly patients. Of the total number of 6179 adult patients in clinical studies of Sulphur hexafluoride, 39% were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly or younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Paediatric Patients: The safety and effectiveness of Sulphur hexafluoride in patients under 18 years old has not been established and the product should not be used in these patients.

This medicinal product is for diagnostic use only. For use with ultrasound imaging to enhance  the echogenicity of the blood, which results in an improved signal to noise ratio. Should only be used in patients where study without contrast enhancement is inconclusive.
Echocardiography: The drug is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.
Doppler of macrovasculature: The drug increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries by improving the Doppler signal to noise ratio. Sulphur hexafluoride increases the quality of the Doppler flow image and the duration of clinically-useful signal enhancement in portal vein assessment.
Doppler of microvasculature: Sulphur hexafluoride improves display of the vascularity of liver and breast lesions during Doppler sonography, leading to more specific lesion characterization.

Hypersensitivity to the active substance(s) or to any of the excipients. Patients known or suspected right-to-left, bi-directional or transient right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome. In combination with dobutamine in patients with conditions suggesting cardiovascular instability where dobutamine is contraindicated.

ECG monitoring should be performed in high-risk patients as clinically indicated. It should be emphasised that stress echocardiography, which can mimic an ischaemic episode, could potentially increase the risk of Sulphur hexafluoride utilisation. Therefore, if Sulphur hexafluoride  is to be used in conjunction with stress echocardiography patients must have a stable condition verified by absence of chest pain or ECG modification during the two preceding days. Moreover, ECG and blood pressure monitoring should be performed during Sulphur hexafluoride -enhanced echocardiography with a pharmacological stress (e.g. with dobutamine).
Serious cardiopulmonary reactions, including fatalities have occurred uncommonly during or shortly following administration of ultrasound contrast agents, including Sulphur hexafluoride. These reactions typically occurred within 30 minutes of administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions.
Use extreme caution when considering the administration of Sulphur hexafluoride in patients with recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), worsening or unstable congestive heart failure, acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders because in these patients allergy like and/or vasodilatory reactions may lead to life threatening conditions. Sulphur hexafluoride  should only be administered to such patients after careful risk/benefit assessment and a closely monitoring of vital signs should be performed during and after administration. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to Sulphur hexafluoride  administration and monitor all patients for acute reactions.
The reported reactions that may follow the administration of ultrasound contrast agents include: fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, and ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing, loss of consciousness, and convulsions.
Anaphylactoid reactions such as skin erythema, rash, urticaria, flushing, throat tightness, dyspnea, or anaphylactic shock have uncommonly been observed following the injection of Sulphur hexafluoride. These reactions may occur in patients with no history of prior exposure to sulfur hexafluoride lipid containing microspheres. In the event of an anaphylactic reaction, beta blockers (including eye drop preparations) may aggravate the reaction. Patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions.
Caution is advised when Sulphur hexafluoride is administered to patients with clinically significant pulmonary disease, including severe chronic obstructive pulmonary disease.
It is recommended to keep the patient under close medical supervision during and for at least 30 minutes following the administration of Sulphur hexafluoride.
Numbers of patients with the following conditions who were exposed to Sulphur hexafluoride in the clinical trials were limited, and therefore, caution is advisable when administering the product to patients with: acute endocarditis, prosthetic valves, acute systemic inflammation and/or sepsis, hyperactive coagulation states and/or recent thromboembolism, and end-stage renal or hepatic disease. Sulphur hexafluoride is not suitable for use in ventilated patients, and those with unstable neurological diseases.
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No interaction studies have been performed. There was no apparent relationship with respect to occurrence of adverse events in the clinical studies for patients receiving various categories of the most common concomitant medications.
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Pregnancy: No clinical data on exposed pregnancies are available.
Lactation: It is not known if sulphur hexafluoride is excreted in human milk. However, based on its rapid elimination from the body via the expired air, it is considered that the breastfeeding can be resumed two to three hours after administration of sulphur hexafluoride.
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