SonoVue Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: 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 9mg/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 must be discarded in accordance with local requirements.