Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
AMIODARONE HYDROCHLORIDE
AVENTIS PHARMA - Indonesia
AMIODARONE HYDROCHLORIDE
50 MG/ML
CAIRAN INJEKSI
DUS, 6 AMPUL @ 3 ML
SANOFI-WINTHROP, FRANCE
2015-03-27
BASED ON AMIODARONE-CCDSV12 –CCDSV19 + CCDSV21 + EU SMPC CORDARONE AMIODARONE HCL 150 MG / 3 ML RANCANGAN LEAFLET QUALITATIVE AND QUANTITATIVE COMPOSITION : per ml /Inj. Amiodarone (INN) hydrochloride ...................................................................................................... 50 mg Excipient: polysorbate 80, benzyl alcohol, Water for injection preparation q.s …………...1 ml PHARMACEUTICAL FORM Ampoules containing 3 ml of solution for injection. CLINICAL PARTICULARS _THERAPEUTIC INDICATIONS _ Serious rhythm disorders when the oral route is not appropriate, namely - atrial rhythm disorders, with rapid ventricular rhythm; - Wolf-Parkinson-White syndrome tachycardia; - documented symptomatic and disabling ventricular rhythm disorders. PHARMACOLOGICAL PROPERTIES _PHARMACODYNAMIC PROPERTIES _ Antiarrhythmic properties - Prolongs phase 3 of the cardiac cell action potential without modifying its height or ascension rate (Vaughan Williams class III). Phase 3 of the action potential is prolonged by slowing the potassium current, without modifying the sodium or calcium current; - Bradycardiac effect by reducing sinus code automatically. This effect is not antagonized by atropine; - Non competitive alpha-and beta-adrenergic effect; - Slowed sinoatrial, atrial and nodal conduction, which is more pronounced the more rapid the rhythm; - No change in ventricular conduction. - Prolonged refractory periods and reduced myocardial excitability on atrial, nodal and ventricular levels; - Slowed conduction and prolonged refractory periods in the atrioventricular accessory channels. - No negative inotropic effect DISETUJUI OLEH BPOM: 31/08/2021 EREG10002212100101 BASED ON AMIODARONE-CCDSV12 –CCDSV19 + CCDSV21 + EU SMPC _PHARMACOKINETICS PROPERTIES _ The amiodarone injected diminishes very rapidly in the blood as the tissues become impregnated and drug flows to the receptor sites: the effects reach a maximum after approximately 15 minutes and decrease over a period of 4 hours. Amiodarone is mainly Izlasiet visu dokumentu