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(Approval lapsed) TAMBOCOR flecainide 10mg/mL injection solution ampoule (Germany)
Section 19A approved medicine
(Approval lapsed) TAMBOCOR flecainide 10mg/mL injection solution ampoule (Germany)
Section 19A approval holder
Medsurge Healthcare Pty Ltd ABN 92 124 728 892
Phone
1300 788 261
Approved until
Status
Expired
Medicines in short supply/unavailable
TAMBOCOR flecainide acetate 150mg/15mL injection ampoule - ARTG 10592
Indication(s)
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Supraventricular arrhythmias:
- due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown-Ganong-Levine syndromes
- due to dual AV nodal pathways in patients with debilitating symptoms
-
paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.
Although TAMBOCOR may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. In these patients, particularly in the presence of impaired left ventricular function, TAMBOCOR should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate. Use of TAMBOCOR in chronic atrial fibrillation has not been adequately studied and is not recommended.
-
Life threatening ventricular arrhythmias not controlled by other drugs.
Intravenous TAMBOCOR is indicated when rapid control or short-term prophylaxis of the above arrhythmias is the main clinical requirement. All use of the injection should be in hospitals only.
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