ADENOSINE-CLARIS, ADSINE (AFT Pharmaceuticals Pty Ltd)
Product name
ADENOSINE-CLARIS, ADSINE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
141 working days (255)
Active ingredients
adenosine
Registration type
New generic medicine
Indication
Adenosine (solution for infusion) is a coronary vasodilator for use in conjunction with radionuclide myocardial perfusion imaging in patients unable to exercise adequately.
Adenosine 6 mg/2 mL solution for injection is indicated for:
- 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 QRS complex supraventricular tachycardias. Although adenosine 6 mg/2 mL is not effective in converting atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity;
- In this respect, adenosine should be used as an adjunct to, but not a replacement for, clinical and ECG observations. It should be used only when, despite all diagnostic attempts, doubt still persists;
- Improved diagnostic sensitivity of intracavity electrophysiological investigations.