SONOVUE

This product should only be used by physicians experienced in diagnostic ultrasound imaging. Emergency equipment and personnel trained in its use must be readily available. Posology Intravenous use The recommended doses of SonoVue in adults are: • B-mode imaging of cardiac chambers, at rest or with stress: 2 mL.

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 dose recommendations for intravenous administration also apply to elderly patients.

Paediatric Patients The safety and efficacy of SonoVue in patients under 18 years of age has not been established for intravenous administration and use in echocardiography and vascular Doppler imaging. 6. Intravenous use SonoVue should be administered immediately after drawing into the syringe by injection into a peripheral vein.

9%) solution for injection. 9% sodium chloride solution) to approximately one third or half of its predicted total volume [(age in years + 2) x 30] mL. SonoVue is then administered through the urinary catheter. Administration of SonoVue is followed by completion of bladder filling with saline until patient has the urge to micturate or there is the first slight sign of back pressure to the infusion.

Ultrasound imaging of the bladder and kidneys is performed during filling and voiding of the bladder. Immediately following the first voiding, the bladder may be refilled with saline for a second cycle of voiding and imaging, without the need of a second SonoVue administration.

4) is recommended for imaging the bladder, ureters, and kidney during ultrasonography of the urinary tract with contrast.

Adult population-Intravenous use 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 < /100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data) Adverse Drug Reactions Frequency Category System Organ Class Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1000) Not known Cannot be estimated from available data Immune system disorders Hypersensitivity* Nervous system disorders Headache, paraesthesia, dizziness, dysgeusia Vasovagal reaction Eye disorders Vision blurred, Cardiac disorders Myocardial infarction** Myocardial ischemia** Kounis syndrome*** Vascular disorders Flushing Hypotension Gastrointestinal disorders Nausea, Abdominal pain Vomiting Skin and subcutaneous tissue disorders Rash Pruritus Musculoskeletal, connective tissue and bone disorders Back pain General disorders and administration site conditions Chest discomfort, injection site reaction, feeling hot 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. Paediatric population-Intravesical use 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 of suspected adverse reactions 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.

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8). 1). There may be increased risk of serious reactions in patients with prior hypersensitivity reaction(s) to PEG. 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 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. , 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. 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.

1). 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. e. essentially ‘sodium-free’.

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.