SonoVue 8microlitresml powder and solvent for dispersion for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulfur hexafluoride

Available from:

Bracco UK Ltd

INN (International Name):

Sulfur hexafluoride

Dosage:

8microlitre/1ml

Pharmaceutical form:

Powder and solvent for dispersion for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF:

Summary of Product characteristics

OBJECT 1
SONOVUE 8 MICROLITRES/ML, POWDER AND SOLVENT FOR
DISPERSION FOR INJECTION
Summary of Product Characteristics Updated 18-Sep-2017 | Bracco UK
Limited
1. Name of the medicinal product
SonoVue 8 microlitres/mL powder and solvent for dispersion for
injection
2. Qualitative and quantitative composition
Each mLof 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
ur