SonoVue
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
05-06-2023
Valmisteyhteenveto
(SPC)
05-06-2023
Julkisesta arviointikertomuksesta
(PAR)
24-08-2017
Aktiivinen ainesosa:
sulphur hexafluoride
Saatavilla:
Bracco International B.V.
ATC-koodi:
V08DA04
INN (Kansainvälinen yleisnimi):
sulphur hexafluoride
Terapeuttinen ryhmä:
Contrast media
Terapeuttinen alue:
Ultrasonography; Echocardiography
Käyttöaiheet:
This medicinal product is for diagnostic use only.SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio.SonoVue should only be used in patients where study without contrast enhancement is inconclusive.EchocardiographySonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.Doppler of macrovasculatureSonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio.SonoVue increases the quality of the Doppler flow image and the duration of clinically useful signal enhancement in portal vein assessment in adult patients.Doppler of microvasculatureSonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients leading to more specific lesion characterisation.Ultrasonography of excretory urinary tractSonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux. For the limitation in the interpretation of a negative urosonography.
Tuoteyhteenveto:
Revision: 20
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2001-03-26
Pakkausseloste
19
B.
PACKAGE LEAFLET
20
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
widespread inflammation in 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 h
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
SonoVue 8 microlitres/mL powder and solvent for dispersion for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of the dispersion contains 8 µL sulphur hexafluoride
microbubbles, equivalent to
45 micrograms.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder and solvent for dispersion for injection.
White powder
Clear, colourless solvent
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
SonoVue is for use with ultrasound imaging to enhance the echogenicity
of the blood, or of fluids in
the urinary tract which results in an improved signal to noise ratio.
SonoVue should only be used in patients where study without contrast
enhancement is inconclusive.
Echocardiography
SonoVue is a transpulmonary echocardiographic contrast agent for use
in adult patients with suspected
or established cardiovascular disease to provide opacification of
cardiac chambers and enhance left
ventricular endocardial border delineation.
Doppler of macrovasculature
SonoVue increases the accuracy in detection or exclusion of
abnormalities in cerebral arteries and
extracranial carotid or peripheral arteries in adult patients by
improving the Doppler signal to noise
ratio.
SonoVue increases the quality of the Doppler flow image and the
duration of clinically-useful signal
enhancement in portal vein assessment in adult patients.
Doppler of microvasculature
SonoVue improves display of the vascularity of liver and breast
lesions during Doppler sonography in
adult patients leading to more specific lesion characterisation.
Ultrasonography of excretory urinary tract
SonoVue is indicated for use in ultrasonography of the excretory tract
in paediatric patients from
newborn to 18 years to detect vesicoureteral reflux. For the
limitation in the interpretation of a
negative urosonography, see section 4.4. and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This product should only be u
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