Regulatory Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INJECTION
4.2 Posology and Method of Administration Adenocor is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use. 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. Adenocor 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** Adult: 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, 12mg 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.
INTRAVENOUS
Medical Information
4.1 Therapeutic Indications Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). Diagnostic Indications Aid to diagnosis of broad or narrow complex supraventricular tachycardias. Although Adenocor will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity. Sensitisation of intracavitary electrophysiological investigations.
4.3 Contraindications Adenocor is contraindicated for patients presenting: - Known hypersensitivity to adenosine or to any of the excipients - Sick sinus syndrome, second or third degree Atrioventricular (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
C01EB10
adenosine
Manufacturer Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Famar Health Care Services Madrid, S.A.U.
CENEXI HSC
Active Ingredients
Documents
Package Inserts
ADENOCOR INJECTION PI.pdf
Approved: July 14, 2021