Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bracco International B.V., Strawinskylaan 3051, NL 1077 ZX, Amsterdam, The Netherlands
SonoVue 8 microlitres/mL powder and solvent for dispersion for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for dispersion for injection. White powder. |
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.
| Active Ingredient | Description | |
|---|---|---|
| Sulfur hexafluoride |
Sulphur hexafluoride is an inert, innocuous gas, poorly soluble in aqueous solutions. Sulphur hexafluoride 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. |
| List of Excipients |
|---|
|
Powder: Macrogol 4000 Solvent: Sodium chloride 9 mg/mL (0.9%) solution for injection. |
Type I colourless glass vial containing 25 mg of dry, lyophilised powder in an atmosphere of sulphur hexafluoride closed with a grey butyl rubber stopper and sealed with an aluminium crimp seal with a flip-off disc. A transfer system (MiniSpike).
Type I clear glass pre-filled syringe containing 5 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Bracco International B.V., Strawinskylaan 3051, NL – 1077 ZX, Amsterdam, The Netherlands
EU/1/01/177/002
Date of first authorisation: 26 March 2001
Date of latest renewal: 24 April 2006
| Drug | Countries | |
|---|---|---|
| SONOVUE | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, Singapore, United Kingdom |
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