ADENOSCAN Solution for infusion Ref.[27893] Active ingredients: Adenine Deoxy Nucleoside

Adenoscan is intended for use in hospitals with monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary.

It should be administered following the same procedure as for exercise testing where facilities for cardiac monitoring and cardio-respiratory resuscitation are available. During administration of Adenoscan continuous ECG control is necessary as life-threatening arrhythmia might occur. Heart rate and blood pressure should be monitored every minute.

Posology

Adults

1. Adenoscan should be administered undiluted as a continuous peripheral intravenous infusion at a dose of 140 µg/kg/min for six minutes using an infusion pump. Separate venous sites for Adenoscan and radionuclide administration are recommended to avoid an adenosine bolus effect.
2. After three minutes of Adenoscan infusion, the radionuclide is injected to ensure sufficient time for peak coronary blood flow to occur. The optimal vasodilator protocol is achieved with six minutes of Adenoscan infusion.
3. To avoid an adenosine bolus effect, blood pressure should be measured in the arm opposite to the Adenoscan infusion.

The table below is given as a guide for adjustment of the infusion rate of undiluted Adenoscan, in line with bodyweight (total dose 0.84 mg/kg).

Paediatric population

The safety and efficacy of adenosine in children aged 0–18 years old have not been established. Currently available data are described in section 5.1 but no recommendation on a posology can be made.

Elderly

See dosage recommendations for adults.

Overdosage would cause severe hypotension, bradycardia or asystole. The half-life of adenosine in blood is very short, and side effects of Adenoscan (when they occur) would quickly resolve when the infusion is discontinued. Administration of IV aminophylline or theophylline may be needed.

The shelf life of the unopened product is 3 years.

The medicinal product should be used immediately after opening.

Do not refrigerate (see section 6.3).

Type I glass vials with chlorobutyl rubber stoppers, packs with 6 vials.

See section 4.2.

The product is for single use only.

The product should be inspected visually for particulate matter and colouration prior to administration. Where the visual appearance of the product may have changed, the vial should be discarded.

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