SonoVue - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

SonoVue 8 microlitres/mL powder and solvent for dispersion for injection sulphur hexafluoride

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• – If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What SonoVue is and what it is used for

• 2. What you need to know before you are given SonoVue

• 3. How SonoVue is given

• 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 for diagnostic use only.

SonoVue is an ultrasound contrast agent that contains tiny bubbles filled with a gas called sulphur hexafluoride.

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

SonoVue helps to obtain clearer pictures of the urinary tract in children.

2. What you need to know before you are given SonoVue

Do not use SonoVue:

• – If you are allergic to sulphur hexafluoride or any of the other ingredients of this medicine (listed in section 6).

• – If you have been told you have a right-to-left heart shunt.

• – If you have severe pulmonary hypertension (pulmonary artery pressure > 90mmHg).

• – If you have uncontrolled hypertension.

• – If you have adult respiratory distress syndrome (a severe, medical condition characterized by widespreadin the lungs).

• – If you have been told not to take dobutamine (medicine that stimulates the heart) due to your severe heart disease.

Warnings and precautions

Please 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,

• – had recent electrocardiography changes.

Talk to your doctor before you are given SonoVue if:

• – you had a recent myocardial infarction or a recent surgery on your coronary arteries,

• – you suffer from angina or chest pain or severe cardiac disease,

• – you suffer from severe heart rhythm disorders,

• – your cardiac disease has worsened recently,

• – you have an acute inflammation of the cardiac envelope (endocarditis),

• – you have artificial heart valves,

• – you have an acute general inflammation or infection,

• – you have known blood clotting problem,

• – you have severe kidney or liver diseases,

If you are given SonoVue together with a medicine, exercise or a device that stimulates the heart in order to visualise your heart under stress work, your heart activity, your blood pressure and rhythm will be monitored.

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

A close medical supervision during at least 30 minutes is necessary following the administration of SonoVue to monitor the risk of serious allergic reactions.

Children and adolescents

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

Other medicines and SonoVue

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

In particular, please tell your doctor if you are taking beta-blockers (medicines for heart disease and hypertension or for glaucoma in eye drops).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

It is not known if SonoVue passes into breast milk. However, you must stop breastfeeding for two to three hours after your ultrasound examination.

Driving and using machines

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

SonoVue contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

• 3. How SonoVue is given

SonoVue is given to you by medical or healthcare professionals who are experienced in this type of examination.

For ultrasound scan of heart or your blood vessels and/or tissues of the liver and breast in adults, the dose to be administered into a vein will be calculated for you depending on which part of your body is being examined. The recommended dose is 2 or 2.4 mL per patient. This dose might be repeated if needed up to 4.8 mL.

For ultrasound scan of urinary tract 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 via a thin tube. SonoVue will then be administered through the thin tube and will be followed by administration of saline to continue filling the bladder. The filling and emptying of the bladder with saline solution may be repeated if needed.

If you have a serious pulmonary or cardiac condition, you will be under close medical supervision during and for at least 30 minutes after the injection of SonoVue.

If you are given more SonoVue than you should

Overdose is not likely to happen since SonoVue is given by a doctor. In the case of overdose, the doctor will take appropriate action.

4. Possible side effects

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

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

Tell your doctor straight away if you notice any of the following side effects, you may need medical treatment: 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.

The following side effects have been reported with SonoVue:

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

• – Headache

• – Numbness

• – Dizziness

• – Strange taste in the mouth

• – Redness

• – Chest discomfort

• – Feeling sick (nausea)

• – Abdominal pain

• – skin rash

• – Feeling hot

• – Local reactions where the injection was given such as: pain or an unusual sensation at the injection site

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

• – Blurred vision

• – Decrease in blood pressure

• – Itching

• – Back pain

• – Pain in general

• – Chest pain

• – Fatigue

• – Severe and less severe allergic reaction (including redness of the skin, decrease in heart rate, decrease in blood pressure, breathlessness, loss of consciousness, cardiac/cardio-respiratory arrest or more severe reaction with difficulties in breathing and dizziness)

Not known (frequency cannot be estimated from the available data):

• – Chest pain, radiating to the neck or the left arm, which can be a sign of a potentially serious allergic reaction called Kounis syndrome

• – Faintness

• – In some of the cases of allergic reactions, in patients with cardiac blood vessel disease, lack of oxygen supply of the heart or cardiac arrest were reported

• – Vomiting

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store SonoVue

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

SonoVue dispersion should be administered to you within six hours of its preparation.

6. Contents of the pack and other information

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 contents 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 and Manufacturer:

Marketing authorisation holder

Bracco International B.V.

Strawinskylaan 3051

NL – 1077 ZX Amsterdam

The Netherlands

Manufacturer:

Bracco Imaging S.p.A.

Via Ribes 5, Bioindustry Park

Colleretto Giacosa – 10010 (TO)

Italy

This leaflet was last revised on

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

The following information is intended for healthcare professionals only:

If SonoVue is not used immediately after reconstitution the dispersion will be shaken again before being drawn up into a syringe.

The product is for a single examination only. Any unused liquid remaining at the end of an examination must be discarded.

Reconstitution instructions:

v1.0–08/2000 ©BRG 2000

• 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 system.

Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for sulfur hexafluoride, the scientific conclusions of CHMP are as follows:

In view of available data on PEG allergy from the literature, spontaneous reports including in some cases a close temporal relationship and in view of a plausible mechanism of action, the PRAC considers that the warning section should be amended to highlight the role of PEG in the occurrence of rare but serious hypersensitivity reactions and to strengthen the existing wording about hypersensitivity reactions.

The PRAC concluded that the product information of products containing sulfur hexafluoride should be amended accordingly.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for sulfur hexafluoride the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing sulfur hexafluoride is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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