Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: GE Healthcare AS, Nycoveien 1, NO-0485, Oslo, Norway
OPTISON 0.19 mg/ml dispersion for injection.
| Pharmaceutical Form |
|---|
|
Dispersion for injection. Clear solution with white microsphere layer on top. |
OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in human albumin solution, 1%.
Concentration: Perflutren-containing microspheres, 5-8 × 108/ml with a mean diameter range of 2.5-4.5 Ξm.
The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg.
Excipient with known effect: Each ml contains 0.15 mmol (3.45 mg) of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Perflutren |
When used in conjunction with diagnostic ultrasound, perflutren provides opacification of cardiac chambers, improvement in delineation of endocardial borders, enhancement of the Doppler signal, and visualisation of wall motion and blood flow within the heart. |
| List of Excipients |
|---|
|
Human albumin |
3 ml type I glass vial, closed with bromobutyl rubber stopper, and sealed with aluminium cap with coloured plastic flip-off top.
OPTISON is supplied as: 1 vial of 3 ml or 5 vials of 3 ml.
Not all pack sizes may be marketed.
GE Healthcare AS, Nycoveien 1, NO-0485, Oslo, Norway
1 × 3 ml presentation: EU/1/98/065/001
5 × 3 ml presentation: EU/1/98/065/002
Date of first authorisation: 18 May 1998
Date of latest renewal: 12 June 2008
| Drug | Countries | |
|---|---|---|
| OPTISON | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom, United States, South Africa |
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