Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
FLECAINIDE ACETATE
MEGAPHARM LTD
C01BC04
SOLUTION FOR INJECTION
FLECAINIDE ACETATE 10 MG/ML
I.V
Required
CENEXI , FRANCE
FLECAINIDE
FLECAINIDE
Serious sustained life threatening ventricular arrhthymias that have not respoded to other drugs.
2022-07-31
העדוה לע הרמחה ( עדימ ןולעב )תוחיטב אפורל ךיראת 11/05/2015 םש רישכת תילגנאב רפסמו םושירה TAMBOCOR INJECTION 106-41-23294-00 םש לעב םושירה םראפאגמ מ"עב ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה ןולעב אפורל קרפ ןולעב טסקט יחכונ טסקט שדח POSOLOGY AND METHOD OF ADMINISTRATION CHILDREN: Tambocor is not recommended in children under 12 CHILDREN: Tambocor is not recommended in children under 12, as there is insufficient evidence of its use in this age group. CONTRAINDICATIONS Tambocor is contra-indicated in cardiac failure and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics or asymptomatic non-sustained ventricular tachycardia. It is also contra-indicated in patients with long standing atrial fibrillation in whom there has been no attempt to convert to sinus rhythm, and in patients with haemodynamically significant valvular heart disease. Unless pacing rescue is available, Tambocor should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrioventricular block, bundle branch block or distal block. Hypersensitivity to flecainide or to any of the excipients. Tambocor is contra-indicated in cardiac failure and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics or asymptomatic non-sustained ventricular tachycardia. Flecainide is contra-indicated in the presence of cardiogenic shock. It is also contra-indicated in patients with long standing atrial fibrillation in whom there has been no attempt to convert to sinus rhythm, and in patients with haemodynamically significant valvular heart disease. Known Brugada syndrome. Unless pacing rescue is available, Tambocor should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrioventricular block, bundl Perskaitykite visą dokumentą
1 from 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tambocor Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL solution for injection contains 10 mg flecainide acetate. One ampoule containing 15 mL solution for injection contains 150 mg flecainide acetate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Clear, colourless solution for injection or infusion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Serious sustained life threatening ventricular arrhthymias that have not responded to other drugs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION In an emergency or for rapid effect, or as a slow intravenous infusion when prolonged administration is required. a) Bolus injection: Administer 2 mg/kg over not less than ten minutes, or in divided doses. Alternatively dilute with 5% dextrose and give as a mini-infusion. Continuous ECG monitoring is recommended. Stop the injection when the arrhythmia is controlled. For sustained ventricular tachycardia, or people with a history of cardiac failure (who may become decompensated during administration) give the initial dose over 30 minutes and monitor the ECG carefully. The maximum recommended bolus dose is 150 mg. b) Intravenous infusion: The recommended procedure is to start with a slow injection of 2 mg/kg over 30 minutes, then continue intravenous infusion at the following rates: First hour: 1.5 mg/kg per hour. Second and later hours: 0.1 - 0.25 mg/kg per hour. The maximum recommended infusion duration is 24 hours; if exceeded, and in patients receiving high doses, monitor plasma levels. The maximum cumulative dose over the first 24 hours should not exceed 600 mg. In severe renal impairment (creatinine clearance < 35 ml/min/1.73 sq.m.) reduce the above dosage recommendations by half. Oral maintenance dosing should be started as soon as possible after stopping the infusion. CHILDREN: Tambocor is not recommended in children under 12, as there is insufficient evidence of its use in this age group. ELDERLY PATIENTS: Perskaitykite visą dokumentą