Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bracco International B.V., Strawinskylaan 3051, NL 1077 ZX, Amsterdam, The Netherlands
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Intravenous use of SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome.
SonoVue must not be used in combination with dobutamine in patients with conditions suggesting cardiovascular instability where dobutamine is contraindicated.
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).
ECG monitoring should be performed in high-risk patients as clinically indicated. It is recommended to keep the patient under close medical supervision during and for at least 30 minutes following the administration of SonoVue.
Use extreme caution when considering the administration of Sonvue 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).
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.
False negative cases can occur with voiding ultrasonography with SonoVue and have not been clarified (see section 5.1).
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.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
No interaction studies have been performed.
No clinical data on exposed pregnancies are available. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3 Preclinical safety data). As a precautionary measure, it is preferable to avoid the use of SonoVue during pregnancy.
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 SonoVue.
No clinical data are available. Animal studies do not indicate harmful effects on fertility.
SonoVue has no or negligible influence on the ability to drive and use machines.
The safety of SonoVue after intravenous administration was evaluated in 4653 adult patients who participated in 58 clinical trials. The undesirable effects reported with SonoVue after intravenous administration were, in general, non-serious, transient and resolved spontaneously without residual effects. In clinical trials, the most commonly reported adverse reactions after intravenous administration are: headache, injection site reaction, and nausea.
The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data).
Rare: Hypersensitivity*
Uncommon: Headache, paraesthesia, dizziness, dysgeusia
Not known: Vasovagal reaction
Rare: Vision blurred
Not known: Myocardial infarction**, Myocardial ischemia**, Kounis syndrome***
Uncommon: Flushing
Rare: Hypotension
Uncommon: Nausea, Abdominal pain
Not known: Vomiting
Uncommon: Rash
Rare: Pruritus
Rare: Back pain
Uncommon: Chest discomfort, injection site reaction, feeling hot
Rare: Chest pain, pain, fatigue
* Cases suggestive of hypersensitivity may include: skin erythema, bradycardia, hypotension, dyspnoea, loss of consciousness, cardiac/cardio-respiratory arrest, anaphylactic reaction, anaphylactic shock.
** In some of the cases of hypersensitivity, in patients with underlying coronary artery disease, myocardial ischemia and/or myocardial infarctions were also reported.
*** Allergic acute coronary syndrome
In very rare cases, fatal outcomes have been reported in temporal association with the use of SonoVue. In all these patients there was a high underlying risk for major cardiac complications, which could have led to the fatal outcome.
The safety of SonoVue after intravesical administration was based on evaluation of published literature involving use of SonoVue in over 6000 paediatric patients (age range 2 days to 18 years). No adverse reactions were reported.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
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