OPTISON Dispersion for injection Ref.[9485] Active ingredients: Perflutren

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: GE Healthcare AS, Nycoveien 1, NO-0485, Oslo, Norway

Product name and form

OPTISON 0.19 mg/ml dispersion for injection.

Pharmaceutical Form

Dispersion for injection.

Clear solution with white microsphere layer on top.

Qualitative and quantitative composition

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
Sodium chloride
N-acetyltryptophan
Caprylic acid
Sodium hydroxide (pH adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

GE Healthcare AS, Nycoveien 1, NO-0485, Oslo, Norway

Marketing authorization dates and numbers

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

Drugs

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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