Product Information for the Patient

SonoVue 8 microliters/ml powder and solvent for injection

Sulfur hexafluoride

1. How to use SonoVue
2. Possible adverse effects
3. Storage of SonoVue

1. Contents of the container and additional information

SonoVue is indicated solely for diagnostic use.

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

If you are an adult, SonoVue helps you 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.

No use SonoVue:

• If you are allergic to sulfur hexafluoride or any of the other components of this medication (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 a syndrome ofdistressrespiratory in adults (a serious disease characterized by widespread inflammation in the lungs).
• If you have been advised not to take dobutamine (a medication that stimulates the heart) due to severe heart disease.

Warnings and precautions

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

• Episodes of angina or frequent and/or repeated chest pain (toracic), 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 have angina, chest pain, or severe heart disease,

• You have severe arrhythmias,
• Your heart disease has worsened recently,

• You have acute endocarditis (inflammation of the heart membrane),
• You have artificial heart valves implanted,
• You have acute generalized inflammation or infection,

• You have known blood clotting problems,
• You have severe kidney or liver disease,

If you receive SonoVue in combination with a medication, exercise, or device that stimulates the heart to visualize its activity under stress, your heart activity, blood pressure, and heart rhythm will be monitored.

Children and adolescents

SonoVue can only be used for ultrasound of the urinary tract in patients under 18 years old.

Use of SonoVue with other medications

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

Specifically, inform your doctor if you are taking beta blockers (medications for treating heart disease and hypertension or administered as eye drops for treating glaucoma).

Pregnancy and breastfeeding

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

The passage of SonoVue into breast milk is unknown. However, breastfeeding should be interrupted for two or three hours after the echocardiogram.

Driving and operating machines

SonoVue does not affect the ability to drive and operate machines.

SonoVue contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

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

For heart or blood vessel ultrasound and/or liver and breast tissue in adults: the dose to be administered via a vein will be calculated based on the body part being examined. The recommended dose is 2 or 2.4 ml per patient. This dose may be repeated as needed up to a maximum 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 your bladder, a saline solution will be introduced into your bladder through a thin tube. SonoVue will then be administered through the thin tube, followed by the saline solution to continue filling the bladder. Filling and emptying the bladder with saline solution may be repeated if necessary.

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

If you use more SonoVue than you should

It is unlikely that an overdose will occur, as SonoVue is administered by a medical professional. If an overdose does occur, the doctor will take the necessary measures.

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

The majority of SonoVue side effects are rare and not usually serious. However, some patients may experience severe side effects and may need treatment.

Inform your doctor immediatelyif you notice any of the following side effects,

because you may need medical treatment:swelling of the face, lips, mouth, or throat that maymake it difficult to swallow or breathe; skin rash; urticaria; swelling of the hands, feet, or ankles.

The following side effects have been reported with the use of SonoVue:

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

• Headache,
• Numbness,
• Dizziness,

• Strange taste in the mouth,
• Redness,

• Uncomfortable feeling in the chest,
• Feeling of discomfort (nausea),
• Abdominal pain,

• Skin rash,
• Sensation of heat,

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

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

• Blurred vision,

• Decreased blood pressure,
• Itching,
• Back pain,

• General pain,
• Chest pain,

• Fatigue,

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

Unknown frequency(cannot be estimated from available data):

• Chest pain, which extends to the neck or left arm, as it could be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Fainting,

• In some cases of allergic reactions in patients with angiocardiopathy, cases of lack of oxygen supply to the heart or cardiac arrest have been reported,
• Vomiting.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

SonoVue dispersion should be administered within 6 hours of preparation.

Contents of SonoVue

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

The glass syringe contains an injectable solution of sodium chloride 9 mg/ml (0.9%).Appearance of the product and size of the packaging

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Bracco International B.V.

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Responsible for manufacturing:

Bracco Imaging S.p.A.

Via Ribes 5, Bioindustry Park

Colleretto Giacosa-10010 (TO)

Italy

Date of the last review of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

If SonoVue is not used immediately after reconstitution, the dispersion should be shaken again before extracting it with the syringe.

The medicine is only for a single examination. Any remaining unused volume at the end of an examination should be discarded.

Reconstitution instructions:

1. Connect the plunger to the syringe, screwing it clockwise.
2. Open the blister of the MiniSpike transfer system and remove the stopper from the syringe.

1. Open the stopper of the transfer system and connect the syringe by screwing it clockwise.
2. Remove the protective disc from the vial. Slide the vial into the transparent sheet of the transfer system and press firmly to secure the vial in place.
3. Empty the contents of the syringe into the vial by pushing the plunger.

1. Shake vigorously for 20 seconds to mix the contents of the vial to obtain a homogeneous white milky liquid.
2. Invert the system and carefully extract SonoVue into the syringe.

1. Back off the syringe from the transfer system.

After reconstitution, SonoVue is a homogeneous white milky dispersion.

Do not use if the obtained liquid is transparent and/or if solid parts of the lyophilizate are observed in the suspension.

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

Medicines should not be thrown away through the drains. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. In this way, you will help protect the environment.