SONOVUE POWDER FOR DISPERSION FOR INJECTION 8 MICROLITRES/ML [SIN12349P]

Product Info

SONOVUE POWDER FOR DISPERSION FOR INJECTION 8 MICROLITRES/ML

[SIN12349P]

4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio.
SonoVue should only be used in patients where study without contrast enhancement is inconclusive.

Echocardiography
SonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.

Doppler of macrovasculature
SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio.
SonoVue increases the quality of the Doppler flow image and the duration of clinically-useful signal enhancement in portal vein assessment in adult patients.

Doppler of microvasculature
SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients, leading to more specific lesion characterisation.

Ultrasonography of excretory urinary tract
SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux. For the limitation in the interpretation of a negative urosonography, see section 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2 Posology and method of administration
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.
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 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.

Intravesical use
In paediatric patients the recommended dose of SonoVue is 1mL

Method of administration
For instructions on reconstitution of the medicinal product before administration see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Intravenous use
SonoVue should be administered immediately after drawing into the syringe by injection into a peripheral vein. Every injection should be followed by a flush with 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.

Intravesical use
After introduction of a sterile 6F–8F urinary catheter into the bladder under sterile conditions, the bladder is emptied of urine and then filled with saline (normal sterile 0.9% 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. A low mechanical index (≤ 0.4) is recommended for imaging the bladder, ureters, and kidney during ultrasonography of the urinary tract with contrast.

4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
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.