Product Information
Registration Status: ActiveSIN12349P
SONOVUE POWDER FOR DISPERSION FOR INJECTION 8 MICROLITRES/ML is approved to be sold in Singapore with effective from 2003-07-18. It is marketed by DCH AURIGA SINGAPORE, with the registration number of SIN12349P.
This product contains Sulfur Hexafluoride 8 microlitres/ml in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for INTRAVENOUS use.
This product is manufactured by BRACCO SUISSE SA in SWITZERLAND, andVetter Pharma-Fetigung GmbH & Co.KG (Solvent manufacturer) in GERMANY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Sulfur hexafluoride is an ultrasound contrast agent indicated for use •in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms •in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
Indication
Echocardiography: Sulfur hexafluoride is indicated for use in adult patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricularendocardial border. Ultrasonography of the Liver: Sulfur hexafluoride is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions.
Mechanism of Action
Within the blood, the acoustic impedance of Lumason microspheres is lower than that of the surrounding non-aqueous tissue. Therefore, an ultrasound beam is reflected from the interface between the microspheres and the surrounding tissue. The reflected ultrasound signal provides a visual image that shows a contrast between the blood and the surrounding tissues.
Pharmacokinetics
- Absorption
- The pharmacokinetic of the SF6 gas component of Lumason was evaluated in 12 healthy adult subjects (7 men and 5 women). After intravenous bolus injections of 0.03 mL/kg and 0.3 mL/kg of Lumason, corresponding to approximately 1 and 10 times the recommended doses, concentrations of SF6 in blood peaked within 1 to 2 minutes for both doses.
- Distribution
- In a study of healthy subjects, the mean values for the apparent steady-state volume of distribution of SF6 were 341 L and 710 L for Lumason doses of 0.03 mL/kg and 0.3 mL/kg, respectively. Preferential distribution to the lung is likely responsible for these values.
- Metabolism
- SF6 undergoes little or no biotransformation; 88% of an administered dose is recovered unchanged in expired air.
- Elimination
Active Ingredient/Synonyms
hexafluoridosulfur | Sulfur fluoride | sulfur(6+) fluoride | sulfur(VI) fluoride | Sulphur hexafluoride | Sulfur hexafluoride |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.