Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder:
Macrogol 4000
Distearoylphosphatidylcholine
Dipalmitoylphosphatidylglycerol Sodium
Palmitic acid
Solvent:
Sodium chloride 9 mg/mL (0.9%) solution for injection.

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Once reconstituted, the product should be used immediately, 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.
6.4   Special precautions for storage

Store below 25°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5   Nature and contents of container
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.

6.6   Special precautions for disposal

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.

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.