RAPISCAN Solution for injection Ref.[9309] Active ingredients: Regadenoson

Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: GE Healthcare AS, Nycoveien 1, NO-0485, Oslo, Norway

Product name and form

Rapiscan 400 microgram solution for injection.

Pharmaceutical Form
Solution for injection. Clear, colourless solution.

Qualitative and quantitative composition

Each 5 ml vial contains 400 micrograms regadenoson (80 micrograms/ml).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Regadenoson	Regadenoson is a low affinity agonist (Ki ≈ 1.3 μM) for the A_2A adenosine receptor, with at least 10-fold lower affinity for the A₁ adenosine receptor (Ki >16.5 μM), and very low, if any, affinity for the A_2B and A₃ adenosine receptors. Activation of the A_2A adenosine receptor produces coronary vasodilation and increases coronary blood flow (CBF).

List of Excipients
Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Propylene glycol Disodium edetate Water for injections

Pack sizes and marketing

5 ml solution in a single use Type 1 glass vial with (butyl) rubber stopper and aluminium over-seal.

Pack size of 1.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/10/643/001

Date of first authorisation: 06/09/2010
Date of latest renewal: 24/04/2015

Drugs

Drug	Countries
RAPISCAN	Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom

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