Australia - engelsk - Department of Health (Therapeutic Goods Administration)

inova pharmaceuticals (australia) pty ltd - flecainide acetate, quantity: 10 mg/ml - injection, solution - excipient ingredients: glacial acetic acid; sodium acetate; water for injections - supraventricular arrhythmias: (a) due to pre-excitation syndromes, eg wolff-parkinson-white and lown-ganong-levine syndromes. (b) due to dual av nodal pathways in patients with debilitating symptoms. (c) 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. 2. 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 requir

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

inova pharmaceuticals (australia) pty ltd - flecainide acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; hydrogenated vegetable oil; magnesium stearate; croscarmellose sodium; pregelatinised maize starch - supraventricular arrhythmias: (a) due to pre-excitation syndromes, eg wolff-parkinson-white and lown-ganong-levine syndromes. (b) due to dual av nodal pathways in patients with debilitating symptoms. (c) 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. 2. 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 requir

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

inova pharmaceuticals (australia) pty ltd - flecainide acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hydrogenated vegetable oil; magnesium stearate; pregelatinised maize starch - supraventricular arrhythmias: (a) due to pre-excitation syndromes, eg wolff-parkinson-white and lown-ganong-levine syndromes. (b) due to dual av nodal pathways in patients with debilitating symptoms. (c) 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. 2. 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 requir

Israel - engelsk - Ministry of Health

megapharm ltd - flecainide acetate - solution for injection - flecainide acetate 10 mg/ml - flecainide - flecainide - serious sustained life threatening ventricular arrhthymias that have not respoded to other drugs.

Israel - engelsk - Ministry of Health

megapharm ltd - flecainide acetate - tablets - flecainide acetate 50 mg - flecainide - flecainide - serious sustained life threatening supraventricular arrhythmias that have not responded to other drugs. paroxysmal atrial fibrillation and atrial flutter

Israel - engelsk - Ministry of Health

megapharm ltd - flecainide acetate - tablets - flecainide acetate 100 mg - flecainide - flecainide - serious sustained life threatening ventricular arrhytmias that have not responsed to other drugs. paroxymal atrial flutter.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

inova pharmaceuticals (new zealand) limited - flecainide acetate 10 mg/ml;   - solution for injection - 10 mg/ml - active: flecainide acetate 10 mg/ml   excipient: glacial acetic acid sodium acetate trihydrate water for injection - tambocor injection is indicated in patients without structural heart disease when rapid control or short-term prophylaxis of the arrhythmias below is the main clinical requirement, including: · ventricular tachyarrhythmias where these are resistant to other treatment; · av nodal reciprocating tachycardia, arrhythmias associated with wolff-parkinson-white syndrome and similar conditions with accessory pathways; · paroxysmal atrial fibrillation in patients with disabling symptoms. arrhythmias of recent onset will respond more readily.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

inova pharmaceuticals australia pty ltd - flecainide acetate -

Irland - engelsk - HPRA (Health Products Regulatory Authority)

meda health sales ireland limited - flecainide acetate - solution for inj/inf - 10 mg/ml - antiarrhythmics, class ic

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - flecainide acetate - solution for injection - 10mg/1ml