SonoVue 8 microlitres / ml powder and solvent for dispersion forinjection

SonoVue is a contrast agent for ultrasound scans of blood vessels and tissues of the body.

SonoVue is a dispersion containing millions of tiny bubbles (microbubbles). Each of these bubbles is smaller than a red blood cell. The bubbles act as a reflector of the ultrasound beam and provide a better echo than the tissues of the body.

SonoVue is a contrast agent that reflects ultrasound waves differently from the tissues of the body and improves the picture from the scan. This helps your doctor to identify the part of your body or blood vessel and to see any abnormalities. SonoVue can be used for scans of the chambers of the heart, scans of large blood vessels and scans to assess lesions in the breast and the liver.
This medicine is for diagnostic use only.

Do not use SonoVue:

If you are allergic (hypersensitive) to sulphur hexafluoride or any of the other ingredients of SonoVue or if you have:

• had a myocardial infarction and you still suffer from frequent and/or repeated angina or chest pain,
• had a recent coronary artery intervention,
• recent changes in your electrocardiogram,
• frequent and/or repeated angina or chest pain in the past 7 days,
• heart failure,
• severe heart rhythm disorders,
• right-to-left shunts of the heart,
• severe increase in pulmonary artery blood pressure,
• uncontrolled hypertension,
• adult respiratory distress syndrome.

If you have had an allergic reaction in the past to SonoVue or any other ultrasound contrast agent tell your doctor.

If you have to undergo echocardiography during stress, tell your doctor if in the past 2 days you have:

• had frequent and/or repeated angina or chest pain, especially if you have history of heart disease,
• recent electrocardiography changes.

Take special care with SonoVue:

• during SonoVue-enhanced echocardiography examination with a pharmacological stress, when ECG and blood pressure should be carefully monitored,
• in case you have severe lung disease and shortage of breath,
• in case you have a neurological illness which is unstable, respiratory ventilation, acute endocarditis, artificial heart valves, acute systemic inflammation and/or sepsis, hyperactive coagulation states and/or recent thromboembolism, advanced kidney or liver diseases.

Taking other medicines:
There are no reports of reactions between SonoVue and other medicines. However, please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast- feeding
SonoVue has not been studied in pregnant women. Danger to a developing baby is not expected. If you are pregnant, or think that you might be pregnant tell your doctor.
If you are breast feeding tell your doctor. It is not known if SonoVue passes into breast milk. Your doctor will advise you if you should stop feeding for a short time after your ultrasound examination.

Ask your doctor for advice before taking any medicine.

After reconstitution, SonoVue is a homogeneous white milky dispersion. If solid parts are seen or the dispersion is not homogeneous, the product will be discarded.
If SonoVue is not used immediately after reconstitution the dispersion will be shaken again before being drawn up into a syringe.
SonoVue is injected into a vein, usually in your arm. The amount that you will be given depends on which part of your body is being scanned. The usual dose is 2 or 2.4 ml of the dispersion. This dose might be repeated. The medical staff supervising your scan will administer the injection of SonoVue to you. The dose is the same in adult and elderly patients, however SonoVue should not be given to patients under 18 years old.
You will be monitored for 30 minutes after your examination.

The product is for a single examination only. Any unused liquid remaining at the end of an examination must be discarded.
If you have any further questions on the use of this product, ask your doctor.

Like all medicines, SonoVue can cause side effects, although not everybody gets them.

Most of the side effects are mild to moderate. However , some patients may experience serious side effects and may require treatment .

Tell your doctor straight away if you notice any of the following serious side effects ? you may need urgent medical treatment:

• Signs of a severe allergic reaction such as swelling of the face, lips, mouth or throat which may make it difficult to swallow or breathe; skin rash; hives; swelling of the hands, feet or ankles.

Side effects may occur with certain frequencies, which are defined as follows:

• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• rare: affects less than 1 user in 10,000
• known: frequency cannot be estimated from the available data.

The following side effects have been observed with SonoVue:
Uncommon:

• Headache
• Numbness
• Dizziness
• Strange taste in the mouth
• Flushing
• Irritation in the throat
• Feeling sick ( nausea)
• Itching; skin rash
• Back pain
• Feeling hot
• Chest pain or discomfort
• Fatigue
• Local reactions where the injection was given such as: pain or an unusual sensation at the injection site
• Pain in general
• Increase in blood sugar levels

Rare:

• Difficulty in sleeping
• Pain or pressure in the forehead, cheeks, nose and between the eyes
• Blurred vision
• Abdominal pain

Not known:

• Loss of consciousness
• Severe and less severe allergic reaction

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Keep out of the reach and sight of children
Do not use after the expiry date stated on the label.
This medicinal product does not require any special storage conditions.
SonoVue dispersion should be administered to you within six hours of its preparation.

What SonoVue contains

The active substance is sulphur hexafluoride in the form of microbubbles.
The other ingredients are: macrogol 4000, distearoylphosphatidylcholine,
dipalmitoylphosphatidylglycerol sodium, palmitic acid.
The glass syringe contains sodium chloride 9 mg/ml (0.9%) solution for injection.

What SonoVue looks like and content of the pack

SonoVue is a kit which includes a glass vial containing white powder, a glass syringe containing the solvent and a transfer system.

Marketing Authorisation Holder:

Bracco International B.V.
Strawinskylaan 3051
NL - 1077 ZX Amsterdam
The Netherlands

Manufacturer:

Bracco Imaging S.p.A.
Via Ribes 5, Biondustry Park
Colleretto Giacosa - 10010 (TO)
Italy

This leaflet was last approved on

The following information is intended for medical or healthcare professionals only: Presentation 02 (with separate MiniSpike transfer system (CE 0123))

1 2 34 56 7 8v1.0-082000 BRG 200

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 Flipcap glass 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 (white milky liquid).

7. Invert the system and carefully withdraw SonoVue into the syringe.

8. Unscrew the syringe from the system.