SONOVUE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SULPHUR HEXAFLUORIDE

Available from:

DEXCEL LTD, ISRAEL

ATC code:

V08DA05

Pharmaceutical form:

POWDER AND SOLVENT FOR DISPERSION FOR INJECTION

Composition:

SULPHUR HEXAFLUORIDE 8 MCL/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BRACCO IMAGING S.P.A., ITALY

Therapeutic area:

SULFUR HEXAFLUORIDE

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.

Authorization date:

2019-11-30

Patient Information leaflet

לע העדוה
( הרמחה עדימ ןולעב )תוחיטב
אפורל
ןכדועמ(
.102.50
) ךיראת
03.11.2015 םושירה רפסמו תילגנאב רישכת םש
)
00
-
34004
-
03
-
153
(
SONOVUE
םושירה לעב םש
.
DEXCEL LTD
ה טורפל דעוימ הז ספוט
דבלב תורמחה
! תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
דח טסקט
ש
INDICATIONS
CONTRAINDICATI
ONS
4. CLINICAL PARTICULARS
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s)
or to any of the excipients listed in section
6.1.
SonoVue is contraindicated in patients
known or suspected right-to-left, bi-
directional or transient right-to-left
shunts, severe pulmonary hypertension
(pulmonary artery pressure >90 mmHg),
uncontrolled systemic hypertension, and
in patients with adult respiratory distress
syndrome.
SonoVue should not be used in
combination with dobutamine in
patients with conditions suggesting
cardiovascular instability where
dobutamine is contraindicated.
The safety and efficacy of SonoVue
have not been established in pregnant
and lactating women therefore,
SonoVue should not be administered
during pregnancy and lactation (see
Section 4.6).
4. CLINICAL PARTICULARS
4.3 CONTRAINDICATIONS
Hypersensitivity to the active
substance(s) or to any of the excipients
listed in section 6.1.
SonoVue is contraindicated in
patients known or suspected
right-to-left, bi-directional or
transient right-to-left shunts, severe
pulmonary hypertension (pulmonary
artery pressure >90 mmHg),
uncontrolled systemic hypertension,
and in patients with adult respiratory
distress syndrome.
SonoVue should not be used in
combination with dobutamine in
patients with conditions suggesting
cardiovascular instability where
dobutamine is contraindicated.
The safety and efficacy of SonoVue
have not been established in pregnant
and lactating women therefore,
SonoVue should not be administered
during pregnancy and lactation (see
Section 4.6).
POSOLOGY,
DOSAGE&
ADMINISTRATION
SPECIAL
WARNING AND
SPECIAL
PRECAU

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SonoVue
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, 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.
Emergency equipment and personnel trained in its use must be readily
available.
Posology
_ _
_Intravenous use_
The recommended doses of SonoVue in adults are:

B-mode imaging of cardiac chambers, at rest or with stress: 2 mL.

Vascular Doppler imaging: 2.4 mL.
During a single examination, a second injection of the recommended
dose can be made when deemed
necessary by the physician.
_E