Adenocor

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ADENOSINE

Available from:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC code:

C01EB10

INN (International Name):

ADENOSINE 3 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ADENOSINE 3 mg/ml

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Withdrawn

Authorization date:

2006-01-05

Patient Information leaflet

ADENOCOR 3MG/ML SOLUTION 
FOR INJECTION
Adenosine
The following information is extracted from the SPC.
TECHNICAL INFORMATION FOR THE ADMINISTRATION OF 
ADENOCOR 3MG/ML SOLUTION FOR INJECTION
1.  TRADE NAME OF MEDICINAL PRODUCT
Adenocor 3mg/ml Solution for injection
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 6mg of adenosine per 2ml 
(3mg/ml).
For the full list of excipients, see section 6.1
3.  PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution
4.2  POSOLOGY AND METHOD OF ADMINISTRATION
Adenocor 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.
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.
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.
The dosing recommended for the treatment o

Summary of Product characteristics

Page 1 of 9 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF MEDICINAL PRODUCT 

Adenocor 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each vial contains 6mg of adenosine per 2ml (3mg/ml). 

For excipients, see 6.1 

3. 
PHARMACEUTICAL FORM 

Solution for injection 

Clear, colourless solution 

4. 
CLINICAL PARTICULARS 

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). 

Paediatric population 
Rapid conversion to a normal sinus rhythm of paroxysmal
supraventricular tachycardia in 
children aged 0 to 18 years. 

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 condition helps diagnosis of atrial
activity. 

Sensitisation of
intra-cavitary electrophysiological investigations. 

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  b