SONOVUE POWDER FOR DISPERSION FOR INJECTION 8 microlitres/ml

INJECTION, POWDER, FOR SOLUTION

**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.