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

Treatment with Rapiscan is restricted to use in a medical facility where cardiac monitoring and resuscitation equipment are available.

Posology

The recommended dose is a single injection of 400 micrograms regadenoson (5 ml) into a peripheral vein, with no dose adjustment necessary for body weight.

Patients should avoid consumption of any products containing methylxanthines (e.g. caffeine) as well as any medicinal products containing theophylline for at least 12 hours before Rapiscan administration (see section 4.5).

When possible, dipyridamole should be withheld for at least two days prior to Rapiscan administration (see section 4.5).

Aminophylline may be used to attenuate severe and/or persistent adverse reactions to regadenoson but should not be used solely for the purpose of terminating a seizure induced by Rapiscan (see section 4.4).

Regadenoson causes a rapid increase in heart rate (see sections 4.4 and 5.1). Patients should remain sitting or lying down and be monitored at frequent intervals after the injection until the ECG parameters, heart rate and blood pressure have returned to pre-dose levels.

Repeated use

For use in radionuclide MPI: This product is to be administered only once within a 24 hour period. Safety and tolerability of repeated use of this product within 24 hours has not been characterised.

For use in FFR: This product is to be administered no more than twice, no less than10 minutes apart, during any 24 hour period. When administered twice 10 minutes apart in a 24-hour period, full safety data for the second injection of Rapiscan are not available.

Paediatric population

The safety and efficacy of regadenoson in children below the age of 18 years have not yet been established.

No data are available.

Elderly

No dose adjustment is necessary (see section 5.2).

Hepatic impairment

No dose adjustment is necessary (see section 5.2).

Renal impairment

No dose adjustment is necessary (see section 5.2).

Method of administration

For intravenous use.

Radionuclide myocardial perfusion imaging (MPI):

• Rapiscan should be administered as a rapid, 10-second injection into a peripheral vein using a 22-gauge or larger catheter or needle.
• 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
• The radiopharmaceutical for the myocardial perfusion imaging agent should be administered 10-20 seconds after the sodium chloride 9 mg/ml (0.9%) solution for injection. The radiopharmaceutical may be injected directly into the same catheter as Rapiscan.

Fractional flow reserve (FFR):

• Rapiscan should be administered as a rapid 10-second injection into a peripheral vein, using a 22-gauge or larger catheter or needle
• 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
• FFR should be measured as the lowest value of Pd/Pa achieved during steady state hyperemia.

In a study of healthy volunteers, symptoms of flushing, dizziness and increased heart rate were assessed as intolerable at regadenoson doses greater than 0.02 mg/kg.

Treatment

Aminophylline may be used to attenuate severe or persistent adverse reactions to regadenoson. Administration of aminophylline, solely for the purpose of terminating a regadenoson-induced seizure is not recommended (see section 4.4).

Shelf life: 4 years.

This medicinal product does not require any special storage conditions.

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

Pack size of 1.

This medicinal product should be inspected visually for particulate matter and discolouration prior to administration.

Any unused product or waste material should be disposed of in accordance with local requirements.