CADEN SOLUTION FOR INJECTION 6 MG / 2 ML [SIN16391P]

Product Info

CADEN SOLUTION FOR INJECTION 6 MG / 2 ML

[SIN16391P]

4.1 Therapeutic indications

Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory by-pass tracts (Wolff-Parkinson-White Syndrome).

Diagnostic indications
Aid to diagnosis of broad or narrow complex supraventricular tachycardias. Although Caden will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of atrioventricular (AV) conduction helps diagnosis of atrial activity.
Sensitisation of intra-cavitary electrophysiological investigations.

4.2 Posology and method of administration

Caden is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use.

It should be administered by rapid intravenous 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 intravenous line.

If given into an intravenous line it should be injected as proximally as possible and followed by a rapid saline flush.

Caden 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.

Therapeutic dose

Adults
Initial dose: 3 mg 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, 6 mg 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, 12 mg should be given also as a rapid intravenous bolus.

Additional or higher doses are not recommended.

Paediatric population
The safety and efficacy of adenosine in children aged 0–18 years old have not been established. No data are available. No controlled paediatric study has been undertaken. The level of evidence does not allow a recommended posology.

Elderly
See dosage recommendations for adults.

Diagnostic dose
The above ascending dosage schedule should be employed until sufficient diagnostic information has been obtained.

Method of administration
Rapid intravenous injection only.

4.3 Contraindications

Caden is contraindicated for patients presenting:

• Known hypersensitivity to the adenosine or any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Sick sinus syndrome, second or third degree Atrio-Ventricular (AV) block (except in patients with a functioning artificial pacemaker)

• Chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma, bronchiale)

• Long QT syndrome

• Severe hypotension

• Decompensated states of heart failure