- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
AdultsRapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory by-pass tracts (Wolff-Parkinson-White Syndrome).
Diagnostic IndicationsAid to diagnosis of broad or narrow complex supraventricular tachycardias. Although Adenosine 3mg/ml Solution for Injection 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 intra-cavitary electrophysiological investigations.
Paediatric populationRapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardia in children aged 0 to 18 years.
Paediatric populationDuring administration of Adenosine 3mg/ml Solution for Injection, cardio-respiratory resuscitation equipment must be available for immediate use if necessary. Adenosine 3mg/ml Solution for Injection is intended for use with continuous monitoring and ECG recording during administration.
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.
PaediatricsThe dosing recommended for the treatment of paroxysmal supraventricular tachycardia in the paediatric population is:- first bolus of 0.1mg/kg body weight (maximum dose of 6mg)- increments of 0.1mg/kg body weight as needed to achieve termination of supraventricular tachycardia (maximum dose of 12mg).
ElderlySee dosage recommendations for adults.
Diagnostic doseThe above ascending dosage schedule should be employed until sufficient diagnostic information has been obtained.
Method of administrationAdults and the elderly: Rapid intravenous injection only.Paediatrics: Adenosine 3mg/ml Solution for Injection 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.
Paediatric populationAdenosine 3mg/ml Solution for Injection may trigger atrial arrhythmias and thus might lead to ventricular acceleration in children with Wolff-Parkinson-White (WPW) syndrome (see section 5.1).The efficacy of intraosseus administration has not been established.
|Frequency||Applicable to Adenosine 6mg/2ml|
|Very common||- Bradycardia - Sinus pause, skipped beats - Atrial extrasystoles - Atrio-Ventricular block - Ventricular excitability disorders such as ventricular extrasystoles, non-sustained ventricular tachycardia|
|Uncommon||- Sinus tachycardia - Palpitations|
|Very rare||- Atrial fibrillation - Severe bradycardia not corrected by atropine and possibly requiring temporary pacing - Ventricular excitability disorders Including ventricular fibrillation and torsade de pointes (see section 4.4)|
|Not known||- Hypotension sometimes severe - Asystole /Cardiac arrest, sometimes fatal especially in patients with underlying ischemic heart disease /cardiac disorder (see section 4.4)|
|Nervous System disorders|
|Common||- Headache - Dizziness, light-headedness|
|Uncommon||- Head pressure|
|Very rare||- Transient and spontaneously rapidly reversible worsening of intracranial hypertension|
|Not known||- Loss of consciousness / syncope - Convulsions, especially in predisposed patients (see section 4.4)|
|Uncommon||- Blurred vision|
|Respiratory, thoracic and mediastinal disorders|
|Very common||- Dyspnea (or the urge to take a deep breath)|
|Very rare||- Bronchospasm (see section 4.4)|
|Not known||- Respiratory failure (see section 4.4) - Apnea / Respiratory arrest,|
|Cases of Respiratory failure, bronchospasm, apnea, and respiratory arrest with fatal outcome have been reported.|
|Uncommon||- Metallic taste|
|Not known||- Vomiting|
|Very common||- Flushing|
|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 reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
ATC Code: Other Cardiac Preparations C01EB10Endogenous nucleoside with peripheral vasodilator/antiarrhythmic effect. Antiarrhythmic drug. Adenosine is a purine nucleoside which is present in all cells of the body. Animal pharmacology studies have in several species shown that adenosine has a negative dromotropic effect on the atrioventricular (AV) node. In man Adenosine 3mg/ml Solution for Injection (adenosine), administered by rapid intravenous injection, slows conduction through the AV node. This action can interrupt re-entry circuits involving the AV node and restore normal sinus rhythm in patients with paroxysmal supraventricular tachycardias. Once the circuit has been interrupted, the tachycardia stops and normal sinus rhythm is re-established. One acute interruption of the circuit is usually sufficient to arrest the tachycardia. Since atrial fibrillation and atrial flutter do not involve the AV node as part of a re-entry circuit, adenosine will not terminate these arrhythmias. By transiently slowing AV conduction, atrial activity is easier to evaluate from ECG recordings and therefore the use of adenosine can aid the diagnosis of broad or narrow complex tachycardias. Adenosine may be useful during electrophysiological studies to determine the site of AV block or to determine in some cases of pre-excitation, whether conduction is occurring by an accessory pathway or via the AV node.
Paediatric populationNo controlled studies have been conducted in paediatric patients with adenosine for the conversion of paroxysmal supraventricular tachycardia (PSVT). However, the safety and efficacy of adenosine in children aged 0 to 18 years with PSVT is considered established based on extensive clinical use and literature data (open label studies, case reports, clinical guidelines).Literature review identified 14 studies where IV adenosine was used for acute termination of supraventricular tachycardia (SVT) in around a total of 450 paediatric patients aged 6 hours to 18 years. Studies were heterogenic in terms of age and dosing schedules. SVT was terminated in 72 to 100% of cases in most of the published studies. Dosages used varied from 37.5mcg/kg to 400mcg/kg. Several studies discussed a lack of response to starting doses less than 100mcg/kg.Depending on the child's clinical history, symptoms and ECG diagnosis, adenosine has been used in clinical practice under expert supervision in children with stable wide-QRS complex tachycardia and Wolff-Parkinson-White syndrome; however, the currently available data does not support a paediatric indication. In total, 6 cases of adenosine-induced arrhythmias (3 atrial fibrillation, 2 atrial flutter, 1 ventricular fibrillation) have been described in 6 children aged 0 to 16 years with manifest or concealed WPW syndrome, of which 3 spontaneously recovered and 3 needed amiodarone +/- cardioversion (see section 4.4).Adenosine has been used as an aid to diagnosis of broad or narrow complex supraventricular tachycardias in same doses as for treatment of supraventricular tachycardia. Although adenosine will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity. However, the currently available data does not support a paediatric indication for the use of adenosine for diagnostic purposes.
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