국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
AMIODARONE HYDROCHLORIDE
PCO Manufacturing
200 Milligram
Tablets
2004-03-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cordarone X 200 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg amiodarone hydrochloride. Excipient: Lactose Monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from the Netherlands and Hungary:_ Round, white tablet with a breakline, ‘200’ and a logo on one side, plain on the other side. The breakline is only to facilitate breaking for ease of swallowing and not to be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral Cordarone X is indicated only for the treatment of severe rhythm disorders not responding to other therapies or when other treatments cannot be used. Tachyarrhythmias associated with Wolff-Parkinson-White syndrome. Atrial flutter and fibrillation when other drugs cannot be used. All types of tachyarrhythmias of paroxysmal nature including; supraventricular, nodal and ventricular tachycardias, ventricular fibrillation: when other drugs cannot be used. Cordarone is indicated for the prevention of ventricular arrhythmias in high-risk patients following myocardial infarction or in patients with clinical signs of congestive cardiac failure and/or LVEF less than 40% who are receiving appropriate cardiac failure treatment which includes ACE-inhibitors. The minimum effective dose must be used and treatment must be initiated and used only under hospital/specialist supervision. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cordarone X 200 Tablets are for oral administration. _ADULTS_ It is particularly important that the minimum effective dose be used. In all cases the patient's management must be jud 전체 문서 읽기