Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use

Hypersensitivity reactions
Serious hypersensitivity reactions have been observed during or shortly following SonoVue administration in patients with no prior exposure to sulphur hexafluoride microbubbles products, including patients with prior hypersensitivity reaction(s) to macrogol, also known as polyethylene glycol (PEG) (see section 4.8).

SonoVue contains PEG (see section 6.1). There may be increased risk of serious reactions in patients with prior hypersensitivity reaction(s) to PEG.
It is recommended to keep all patients under close medical supervision during and for at least 30 minutes following the administration of SonoVue to monitor the risk of serious hypersensitivity reactions (see section 4.2).

Use caution when treating anaphylaxis with epinephrine in patients on beta blockers since response may be poor or promote undesired alpha-adrenergic and vagotonic effects (hypertension, bradycardia).

Intravenous use

Patients with unstable cardiopulmonary status
ECG monitoring should be performed in high-risk patients as clinically indicated and a close medical supervision is recommended.

Use extreme caution when considering the administration of SonoVue 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), 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. SonoVue 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.

It should be emphasised that stress echocardiography not only can induce an ischaemic episode but also the stressors may induce predictable, dose-dependent effects on the cardiovascular system (e.g., increase in heart rate, blood pressure and ventricular ectopic activity for dobutamine, or decrease in blood pressure for adenosine and dipyridamole) as well as unpredictable, hypersensitivity reactions.
Therefore, if SonoVue 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 SonoVue-enhanced echocardiography with a pharmacological stress (e.g. with dobutamine).

Other concomitant diseases
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, as the numbers of patients with those conditions who were exposed to SonoVue in the clinical trials were limited.

Technical recommendation
In animal studies, the application of echo-contrast agents revealed biological adverse reactions (e.g.
endothelial cell injury, capillary rupture) by interaction with the ultrasound beam. Although these biological side effects have not been reported in humans, the use of a low mechanical index is recommended.

Excipients
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially "sodium- free".

Effects on Driving

4.7    Effects on ability to drive and use machines
SonoVue has no or negligible influence on the ability to drive and use machines.