Sonovue 8 microliters/ml powder and solvent for injectable dispersion

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

SonoVue 8 microlitres/ml powder and solvent for injectable dispersion

Sulfur hexafluoride

Contents of the Package Leaflet

1. What SonoVue is and what it is used for

2. What you need to know before using SonoVue

3. How to use SonoVue

4. Possible side effects

5. How to store SonoVue

6. Contents of the pack and other information

1. What SonoVue is and what it is used for

SonoVue is indicated for diagnostic use only.

SonoVue is an ultrasound contrast agent containing microbubbles filled with a gas called sulfur hexafluoride.

If you are an adult, SonoVue helps obtain clearer ultrasound images of the heart, blood vessels, and/or liver and breast tissues.

SonoVue helps obtain clearer images of the urinary tract in children.

2. What you need to know before using SonoVue

Do not use SonoVue:

• If you are allergic to sulfur hexafluoride or to any of the other ingredients of this medicine (listed in section 6).
• If your doctor has told you that you have a right-to-left cardiac shunt.
• If you have severe pulmonary hypertension (pulmonary arterial pressure > 90 mm Hg).
• If you have uncontrolled hypertension.
• If you have severe acute respiratory distress syndrome (a serious condition characterized by widespread inflammation in the lungs).
• If you have been advised not to take dobutamine (a medicine that stimulates the heart) due to severe heart disease.

Warnings and precautions

Consult your doctor if within the last 2 days you have experienced:

• Frequent and/or recurrent episodes of angina or chest pain, especially if you have a history of heart disease,
• Recent changes in your electrocardiogram.

Consult your doctor before receiving SonoVue if:

• You have recently had a myocardial infarction or have recently undergone coronary intervention,
• You suffer from angina pectoris, chest pain, or severe heart disease,
• You have serious cardiac arrhythmias,
• Your heart condition has recently worsened,
• You have acute inflammation of the heart lining (endocarditis),
• You have artificial heart valves implanted,
• You have acute systemic inflammation or infection,
• You have known blood clotting disorders,
• You have severe kidney or liver disease.

If SonoVue is administered together with a medicine, exercise, or device used to stimulate the heart to visualize cardiac function under stress, your cardiac activity, blood pressure, and heart rate will be monitored.

SonoVue contains macrogol, an ingredient also known as polyethylene glycol (PEG). Cases of severe allergic reactions have been reported. There may be an increased risk of severe reactions in patients with previous allergic reactions to PEG. Inform your doctor if you have had prior allergic reactions to products containing PEG.

To monitor the risk of severe allergic reactions, close medical supervision is required for at least 30 minutes after administration of SonoVue.

Children and adolescents

For patients under 18 years of age, SonoVue may only be used for ultrasound of the urinary tract.

Use of SonoVue with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Specifically, inform your doctor if you are taking beta-blockers (medicines used to treat heart conditions and hypertension, or administered as eye drops to treat glaucoma).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is unknown whether SonoVue passes into breast milk. However, breastfeeding should be interrupted for two to three hours after echocardiography.

Driving and using machines

SonoVue does not affect the ability to drive or operate machinery.

SonoVue contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially “sodium-free”.

3. How to use SonoVue

SonoVue will be administered by qualified medical or healthcare personnel trained in this type of examination.

For cardiac ultrasound or ultrasound of its blood vessels and/or liver and breast tissues in adults: the dose administered intravenously will be determined according to the body area being examined. The recommended dose is 2 or 2.4 ml per patient. This dose may be repeated if necessary, up to a maximum total dose of 4.8 ml.

For urinary tract ultrasound in children: the recommended dose is 1 ml per patient, to be administered into the bladder as follows:

After emptying the bladder, a saline solution will be introduced into the bladder through a thin tube. Then, SonoVue will be administered through the same thin tube, followed by additional saline solution to continue filling the bladder. The process of filling and emptying the bladder with saline solution may be repeated if necessary.

If you have a serious heart or lung condition, medical personnel will monitor you closely during and for at least 30 minutes after the injection of SonoVue.

If you receive more SonoVue than you should

An overdose is unlikely since SonoVue is administered by a physician. However, if an overdose occurs, the doctor will take appropriate measures.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Most of the side effects with SonoVue are rare and are usually not serious. However, some patients may experience serious adverse effects and may require treatment.

Tell your doctor immediately if you notice any of the following adverse effects, as you may require medical treatment: swelling of the face, lips, mouth or throat which may make swallowing or breathing difficult; skin rash; hives; swelling of the hands, feet or ankles.

The following are adverse effects reported with the use of SonoVue:

Uncommon adverse effects (may affect up to 1 in 100 people):

• Headache,

• Numbness,

• Dizziness,

• Altered taste,

• Flushing,

• Chest discomfort,

• Feeling unwell (nausea),

• Abdominal pain,

• Skin rash,

• Feeling of warmth,

• Local reactions at the injection site, such as: pain or an unusual sensation at the injection site.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Blurred vision,

• Decrease in blood pressure,

• Itching,

• Back pain,

• Generalised pain,

• Chest pain,

• Fatigue,

• Severe and less severe allergic reactions (including skin redness, decreased heart rate, decreased blood pressure, shortness of breath, loss of consciousness, cardiac arrest/respiratory arrest or more severe reaction accompanied by difficulty breathing and dizziness).

Frequency not known (cannot be estimated from available data):

• Chest pain spreading to the neck or left arm, as this may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

• Fainting,

• In some cases of allergic reactions in patients with coronary artery disease, cases of inadequate oxygen supply to the heart or cardiac arrest have been reported,

• Vomiting.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SonoVue

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

The SonoVue dispersion must be administered within 6 hours of preparation.

6. Contents of the pack and other information

Contents of SonoVue

• The active substance is sulfur hexafluoride in the form of microbubbles.
• The other components are: macrogol 4000, distearoylphosphatidylcholine, sodium dipalmitoylphosphatidylglycerol, palmitic acid.

The glass syringe contains a sodium chloride injectable solution of 9 mg/ml (0.9%).

Appearance of the product and pack size

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

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

Bracco International B.V.

Argonstraat 3

6422 PH Heerlen

The Netherlands

Manufacturer:

Bracco Imaging S.p.A.

Via Ribes 5, Bioindustry Park

Colleretto Giacosa-10010 (TO)

Italy

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency’s website: http://www.ema.europa.eu.

This information is intended only for healthcare professionals:

If SonoVue is not used immediately after reconstitution, the dispersion should be resuspended by shaking before withdrawal into the syringe.

The medicine is intended for a single examination only. Any unused volume remaining after an examination must be discarded.

Reconstitution instructions:

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

After reconstitution, SonoVue is a homogeneous, milky-white dispersion.

Do not use if the resulting liquid is transparent and/or if solid particles of the lyophilisate are visible in the suspension.

The injectable dispersion SonoVue must be administered within six hours of preparation.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.