Addition of text to section 4.4:
Because it has the potential to cause significant hypotension, adenosine 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 should be used with caution in patients with recent myocardial
infarction, heart failure, or in patients with minor conduction defects (first degree A-V block, bundle branch block) that could be transiently aggravated during infusion. Adenosine 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.
Some cases of severe bradycardia have been reported. Some occurred in early post heart 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 could potentially favour the occurrence of torsades de pointes.
In patients with recent heart transplantation (less than 1 year) an increased sensitivity of the heart to adenosine has been observed.
Update section 4.8 of the SPC in line with MedDRA organ/class system
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