SONOVUE Powder and solvent for dispersion for injection Ref.[9487] Active ingredients: Sulfur hexafluoride

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 1 mL.

Method of administration

For instructions on reconstitution of the medicinal product before administration see section 6.6.

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.

Since there have been no cases of overdose reported to date, neither signs nor symptoms of overdose have been identified. In a Phase I study doses up to 52 mL of SonoVue were administered to normal volunteers without serious adverse events being reported. In the event of overdose occurring, the patient should be observed and treated symptomatically.

2 years.

Once reconstituted, chemical and physical stability has been demonstrated for 6 hours. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user.

The medicinal product does not require any special storage conditions.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Type I colourless glass vial containing 25 mg of dry, lyophilised powder in an atmosphere of sulphur hexafluoride closed with a grey butyl rubber stopper and sealed with an aluminium crimp seal with a flip-off disc. A transfer system (MiniSpike).

Type I clear glass pre-filled syringe containing 5 mL sodium chloride 9 mg/mL (0.9%) solution for injection.

Before use examine the product to ensure that the container and closure have not been damaged.

SonoVue must be prepared before use by injecting through the septum 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to the contents of the vial. The vial is then shaken vigorously for twenty seconds after which the desired volume of the dispersion can be drawn into a syringe as follows:

1. Connect the plunger rod by screwing it clockwise into the syringe.
2. Open the MiniSpike transfer system blister and remove syringe tip cap.
3. Open the transfer system cap and connect the syringe to the transfer system by screwing it in clockwise.
4. Remove the protective disk from the vial. Slide the vial into the transparent sleeve of the transfer system and press firmly to lock the vial in place.
5. Empty the contents of the syringe into the vial by pushing on the plunger rod.
6. Shake vigorously for 20 seconds to mix all the contents in the vial to obtain a white milky homogeneous liquid.
7. Invert the system and carefully withdraw SonoVue into the syringe.
8. Unscrew the syringe from the transfer system.

Do not use if the liquid obtained is clear and/or if solid parts of the lyophilisate are seen in the suspension.

SonoVue should be administered immediately by injection into a peripheral vein for use in echocardiography and in vascular Doppler imaging in adults or by intravesical administration for use in ultrasonography of the excretory urinary tract in paediatric patients.

If SonoVue is not used immediately after reconstitution the microbubble dispersion should be shaken again before being drawn up into a syringe. Chemical and physical stability of the microbubble dispersion has been demonstrated for 6 hours.

The vial is for a single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.