ADENOSINE

Adenosine 30 mg/10 ml solution for infusion 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 Adenosine 30 mg/10 ml solution for infusion continuous ECG control is necessary as life- threatening arrhythmia might occur. Heart rate and blood pressure should be monitored every minute. Each vial is intended for single use.

The solution should be examined visually for particulate matter and discoloration prior to administration. Only clear and colourless solution should be used. Adults: 1. Adenosine 30 mg/10 ml solution for infusion 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 Adenosine 30 mg/10 ml solution for infusion and radionuclide administration are recommended to avoid an adenosine bolus effect. 2. After three minutes of Adenosine 30 mg/10 ml solution for 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 Adenosine 30 mg/10 ml solution for infusion 3. To avoid an adenosine bolus effect, blood pressure should be measured in the arm opposite to the Adenosine 30 mg/10 ml solution for infusion.

84 mg/kg). 7 Paediatric population: The safety and efficacy of adenosine in children aged 0-18 years old have not been established. 1 but no recommendation on a posology can be made.

Elderly:

See dosage recommendations for adults.

Adenosine is intended for use in a hospital setting with monitoring and cardio- respiratory resuscitation equipment available for immediate use if necessary. 2). Because it has the potential to cause significant hypotension, Adenosine 30 mg/10 ml solution for infusion should be used with caution in patients with left main coronary stenosis, uncorrected hypovolemia, stenotic valvular heart disease, left to right shunt, pericarditis or pericardial effusion, autonomic dysfunction or stenotic carotid artery disease with cerebrovascular insufficiency.

Adenosine 30 mg/10 ml solution for infusion should be discontinued in any patient who develops persistent or symptomatic hypotension. Adenosine 30 mg/10 ml solution for infusion should be used with caution in patients with recent myocardial infarction or severe heart failure.

Adenosine 30 mg/10 ml solution for infusion should be used with caution in patients with minor conduction defects (first degree AV block, bundle branch block) that could be transiently aggravated during infusion. Adenosine may trigger convulsions in patients who are susceptible to convulsions.

Adenosine 30 mg/10 ml solution for infusion should be used with caution in patients with atrial fibrillation or flutter and especially in those with an accessory by- pass tract since particularly the latter may develop increased conduction down the anomalous pathway.

Rare cases of severe bradycardia have been reported. Some occurred in early post- transplant patients; in the other cases occult sino-atrial disease was present. The occurrence of severe bradycardia should be taken as a warning of underlying disease and should lead to treatment discontinuation.

Severe bradycardia would favour the occurrence of torsades de pointes, especially in patients with prolonged QT intervals. But to date, no case of torsades de pointes has been reported when adenosine is continuously infused. The occurrence of respiratory failure (potentially fatal), asystole/cardiac arrest (potentially fatal), angina, severe bradycardia or severe hypotension should also lead to treatment discontinuation.

Adenosine 30 mg/10 ml solution for infusion is contra-indicated in patients suffering from: - Hypersensitivity to the adenosine or to any of the excipients. g. 5).