ADENOSINE

Adenosine 3 mg/ml solution for injection is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use. Method of administration It should be administered by rapid IV bolus injection according to the ascending dosage schedule below.

To be certain the solution reaches the systemic circulation administer either directly into a vein or into an IV line. If given into an IV line it should be injected as proximally as possible, and followed by a rapid saline flush. Adenosine 3 mg/ml solution for injection should only be used when facilities exist for cardiac monitoring.

Patients who develop high-level AV block at a particular dose should not be given further dosage increments.

Posology Adult:

Initial dose: 3mg given as a rapid intravenous bolus (over 2 seconds).

Second dose:

If the first dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 6mg should be given also as a rapid intravenous bolus.

Third dose:

If the second dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes. 12mg should be given also as a rapid intravenous bolus. Additional or higher doses are not recommended. Paediatric population During administration of adenosine cardio-respiratory resuscitation equipment must be available for immediate use if necessary.

Adenosine is intended for use with continuous monitoring and ECG recording during administration. 1 mg/kg body weight as needed to achieve termination of supraventricular tachycardia (maximum dose of 12mg). Method of administration 3/11 Version 06 Adenosine should be administered by rapid intravenous (IV) bolus injection into a vein or into an IV line.

If given into an IV line it should be injected through as proximally as possible, and followed by a rapid saline flush. If administered through a peripheral vein, a large bore cannula should be used. 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. Elderly See dosage recommendations for adults. Diagnostic dose The above ascending dosage schedule should be employed until sufficient diagnostic information has been obtained.

Adverse events are ranked under the heading of the frequency:

Very common (>1/10), Common (>1/100, <1/10), Uncommon (>1/1000, <1/100), Rare (>1/10000, <1/1000), Very rare (<1/10000), Not known (cannot be estimated from available data). These side effects are generally mild, of short duration (usually less than 1 minute) and well tolerated by the patient.

However severe reactions can occur. Methylxanthines, such as IV aminophylline or theophylline have been used to terminate persistent side effects (50-125 mg by slow intravenous injection). 4) Eye disorders Uncommon - Blurred vision Immune system disorders: Not known: - anaphylactic reaction (including angioedema and skin reactions such as urticaria and rash).

4) - Arteriospasm coronary which may lead to myocardial infarction. 4) - Apnea / Respiratory arrest, Cases of Respiratory failure, bronchospasm, apnea, and respiratory arrest with fatal outcome have been reported. Gastrointestinal disorders Common - Nausea Uncommon - Metallic taste Not known - Vomiting General disorders and Administration Site conditions Very common -Chest pressure/pain, feeling of thoracic constriction/oppression Common Burning sensation Uncommon - Sweating - Feeling of general discomfort / weakness / pain Very rare - Injection site reactions Reporting of suspected adverse reactions Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product.

uk/yellowcard. 9/11 Version 06

Special warnings:

Due to the possibility of transient cardiac arrhythmias arising during conversion of the supraventricular tachycardia to normal sinus rhythm, administration should be carried out in a hospital setting with monitoring and cardio- respiratory resuscitation equipment available for immediate use if necessary.

During administration, continuous ECG monitoring is necessary as life-threatening arrhythmia might occur. 2). 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 4/11 Version 06 pericardial effusion, autonomic dysfunction or stenotic carotid artery disease with cerebrovascular insufficiency.

Adenosine should be used with caution in patients with recent myocardial infarction, severe 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.

Rare 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, especially in patients with prolonged QT intervals.

In patients with recent heart transplantation (less than 1 year) an increased sensitivity of the heart to adenosine has been observed. Since neither the kidney nor the liver are involved in the degradation of exogenous adenosine, Adenosine 3 mg/ml solution for injection's efficacy should be unaffected by hepatic or renal insufficiency.

1. - Sick sinus syndrome, second or third degree Atrio-Ventricular (AV) block (except in patients with a functioning artificial pacemaker). g asthma bronchiale) - Long QT syndrome - Severe hypotension - Decompensated states of heart failure