microbubbles 8 microliters/mL powder and liquid for injection, dispersion sulfur hexafluoride
What SonoVue is and what it is used for
SonoVue is intended for diagnostic use only.
SonoVue is an ultrasound contrast agent that contains small bubbles filled with a gas called sulfur hexafluoride.
If you’re an adult, SonoVue is used to provide clearer ultrasound images of your heart, blood vessels, and/or liver and breast tissue.
SonoVue provides clearer images of the urinary tract in children.
What you need to know before you receive SonoVue
Do not use SonoVue
- if you are allergic to sulfur hexafluoride or any other ingredient in this medicine (listed in section 6),
- if you have a right-to-left heart shunt (abnormal blood passage in the heart),
- if you have severe pulmonary hypertension (increased pulmonary artery pressure > 90mmHg),
- if you have uncontrolled high blood pressure,
- if you have respiratory distress syndrome (a serious medical condition with extensive inflammation of the lungs),
- if you have been told not to take dobutamine (a medicine that stimulates the heart) because of your serious heart disease.
Warnings and precautions
Tell your doctor if in the last two days you have:
- had frequent or recurrent attacks of angina pectoris or chest pain, especially if you have a history of heart disease,
- had recent EKG changes.
Talk to your doctor before receiving SonoVue if:
- you have recently had a heart attack or undergone coronary artery surgery,
- you have angina, chest pain, or serious heart disease,
- you have a serious heart rhythm disorder,
- your heart disease has recently worsened,
- you have an acute inflammation of the lining of the heart ( endocarditis ),
- you have an implanted artificial heart valve,
- you have an acute general inflammation or infection,
- you have a disorder in the blood’s ability to clot
- you have a serious kidney or liver disease
If you receive SonoVue along with a drug, physical activity, or medical device that stimulates the heart to imagine the heart under stress, cardiac activity, blood pressure, and heart 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 an increased risk of serious reactions in patients who have previously had allergic reactions to PEG. Inform the doctor if you have previously had an allergic reaction to PEG-containing products.
You will be closely monitored for at least 30 minutes after injection of SonoVue, to monitor the risk of serious allergic reactions.
Children and young people
For patients under the age of 18, SonoVue can only be used for ultrasound of the urinary tract.
Other medicines and SonoVue
Tell your doctor if you are using, have recently used, or might be using other medicines. You must tell the doctor if you are taking beta-blockers (medicines for heart disease and high blood pressure or eye drops for glaucoma ).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before receiving this medicine.
It is not known whether SonoVue passes into breast milk. However, you should not breastfeed within two to three hours of the ultrasound examination.
Driving ability and use of machinery
SonoVue does not affect the ability to drive and use machines.
SonoVue contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is almost “sodium-free”.
How to get SonoVue
SonoVue is administered by a doctor or healthcare professional experienced in this type of examination.
For ultrasound of the heart or blood vessels and/or tissue in the liver and chest in adults, the dose administered into a vein must be calculated for you depending on which part of the body is to be examined. The recommended dose is 2 or 2.4 mL per patient. This dose may be repeated. If necessary, dose one can be repeated to 4.8 mL.
For ultrasound of the urinary tract in children, it is recommended that a dose of 1 mL per patient be administered into the bladder as follows:
After emptying the bladder, a saline solution is introduced into the bladder through a thin tube. SonoVue is then administered through the thin tube, followed by the administration of saline to continue filling the bladder. Filling and emptying the bladder with saline can be repeated if necessary.
If you have a serious lung or heart problem, you will be monitored closely during and for at least 30 minutes after an injection of SonoVue.
If you get too much SonoVue
You are not likely to get an overdose because SonoVue is given by a doctor. In case of an overdose, the doctor will take appropriate measures.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects of SonoVue are rare and usually not serious. However, some patients may experience serious side effects that may require treatment.
Inform your doctor immediately if you notice any of the following side effects – you may need medical treatment: swelling of the face, lips, mouth, and throat which makes it difficult to swallow or breathe; 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 users):
- Headache,
- numbness,
- Dizziness,
- Strange taste in the mouth,
- blushing,
- Chest discomfort,
- Nausea,
- abdominal pain,
- Rash,
- the feeling of warmth,
- A local reaction where the injection was given such as pain or abnormal sensation at the injection site,
- Elevated blood sugar.
Rare (may affect up to 1 in 1,000 users):
- blurred vision,
- Lowered blood pressure,
- itching,
- back pain,
- General pain,
- chest pains,
- Fatigue,
- Severe or less severe allergic reaction. This can mean flushing, decreased heart rate and blood pressure, shortness of breath, loss of consciousness, cardiac arrest/cardio-respiratory arrest, or a more serious reaction with difficulty breathing and dizziness.
Has been reported (occurring in an unknown number of users):
- Chest pain radiating to the neck or left arm, which may be a sign of a potentially serious allergic reaction called Kuoni’s syndrome,
- Pallor,
- In some cases of allergic reactions in patients with coronary artery disease (heart disease), insufficient oxygen supply to the heart and cardiac arrest were reported.
- Vomiting.
How to store SonoVue
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label. The expiration date is the last day of the specified month.
No special storage regulations.
Dispersion one of SonoVue should be given to you within 6 hours of its preparation.
Contents of the packaging and other information
Contents declaration
- The active ingredient is sulfur hexafluoride in the form of microbubbles
- Other ingredients are macrogol 4000, distearylphosphatidylcholine, sodium di palmityl phosphatidylglycerol, and palmitic acid.
The glass syringe contains sodium chloride solution 9 mg/mL (0.9%).
Appearance and package sizes of the medicine
SonoVue is a kit containing a glass vial with white powder, a glass syringe with solvent, and a transfer system.
Marketing Authorisation Holder
Bracco International BV
Strawinskylaan 3051
NL – 1077 ZX Amsterdam,
Holland
Manufacturer:
Bracco Imaging SpA
Via Ribes 5, Bioindustry Park
Colleretto Giacosa 10010 (TO)
Italy