Australia - English - 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 - English - 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 - English - 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

United States - English - NLM (National Library of Medicine)

safecor health, llc - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 20 mg - omeprazole delayed-release capsules, usp are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy.   omeprazole delayed-release capsules, usp, in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults.   omeprazole delayed-release capsules, usp, in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults.   eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [seeclinical studies (14.1) and dosage and administration (2)].   among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared w

Israel - English - 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 - English - 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 - English - 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 - English - 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.

United States - English - NLM (National Library of Medicine)

safecor health, llc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)] . quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies (14.2)] . quetiapine fumarate tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week mo

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

inova pharmaceuticals australia pty ltd - flecainide acetate -