ADENOCOR INJECTION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Adenosine

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

Adenosine

Units in package:

6Units Units

Manufactured by:

Famar Health Care Services Madrid S.A.U.

Summary of Product characteristics

ADENOCOR ® INJECTION
Adenosine
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 6mg of adenosine
per 2ml (3mg/ml). For excipients, see List of Excipients
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution
CLINICAL PARTICULARS
Therapeutic indications
R a p i d c o n v e r s i o n t o a n o r m a l s i n u s r h y t h m o f p a r o x y s m a l sup ra ven t ricula r tachyca rd ia s,
in clud ing tho se asso cia ted with accessory by -pass 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 i ntra -cavitary electrophysiological investigations.
Posology and method of administration
Adenocor is intended for hospital use only with mo nitoring 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 b e 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 incremen ts.
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