SONOVUE POWDER FOR DISPERSION FOR INJECTION 8 microlitresml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

SULFUR HEXAFLUORIDE

Available from:

DCH AURIGA SINGAPORE

ATC code:

V08DA05

Dosage:

8 microlitres/ml

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

SULFUR HEXAFLUORIDE 8 microlitres/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

BRACCO SUISSE SA

Authorization status:

ACTIVE

Authorization date:

2003-07-18

Patient Information leaflet

1. NAME OF THE MEDICINAL PRODUCT
SonoVue
®
, 8 microlitres / ml, powder and solvent for dispersion for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulphur hexafluoride microbubbles 8µl per ml
On reconstitution as directed, 1 ml of the resulting dispersion
contains 8 µl
sulphur hexafluoride in the microbubbles, equivalent to 45 µg.
For excipients, see 6.1
3. PHARMACEUTICAL FORM
Powder and solvent for dispersion for injection
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, 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
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_ _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.
DOPPLER OF MICROVASCULATURE
SonoVue
®
 improves display of the vascularity of liver and breast lesions
during
Doppler sonography, leading to more specific lesion characterisation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This product should only be used by physicians experienced in
diagnostic
ultrasound imaging.
The microbubble dispersion is prepared before use by injecting through
the
septum 5 ml of sodium chloride 0.9%w/v solution for injection to the
contents
of the vial. The vial is then shaken vigorously for a few seconds
until the lyophilisate
is completely dissolved. The desired volume of the dispersio

Summary of Product characteristics

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 of 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 used by physicians experienced in
diag