LUMINITY Gas and solvent for dispersion for injection/infusion Ref.[27908] Active ingredients: Perflutren

Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Lantheus EU Limited, Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare V14 FW97, Ireland

Product name and form

Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion.

Pharmaceutical Form
Gas and solvent for dispersion for injection/infusion. Colourless, uniformly clear to translucent liquid.

Qualitative and quantitative composition

Each ml contains a maximum of 6.4 × 10⁹ perflutren-containing lipid microspheres, with a mean diameter range of 1.1-2.5 micrometres (μm). The approximate amount of perflutren gas in each ml is 150 microlitres (μl).

Excipient(s) with known effect: Each ml contains 2.679 mg 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
1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC) 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA) N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE) Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Sodium chloride Propylene glycol Glycerol Water for injections

Pack sizes and marketing

1.5 ml liquid in clear borosilicate Type I glass vial, closed with a chlorobutyl elastomeric lyophilisation stopper, and sealed with an aluminium crimp seal having a plastic flip-off button.

Pack sizes of 1 or 4 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Lantheus EU Limited, Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare V14 FW97, Ireland

Marketing authorization dates and numbers

EU/1/06/361/001 – 002

Date of first authorisation: 20 September 2006
Date of latest renewal: 15 July 2016

Drugs

Drug	Countries
LUMINITY	Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom

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