Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
AMIODARONE
Clonmel Healthcare Ltd
50 Mg/Ml
Concentrate for Soln for Inj
2008-09-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amiodarone 50mg/ml Concentrate for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 50 mg of amiodarone hydrochloride Each 3 ml ampoule contains 150 mg amiodarone hydrochloride. Excipient: 60.6 mg of benzyl alcohol/ampoule of 3 ml sterile concentrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for injection or infusion (Sterile concentrate) Clear, pale, yellow solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amiodarone 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. All types of tachyarrhythmias including supraventricular, nodal and ventricular tachycardias; atrial flutter and fibrillation; ventricular fibrillation; when other drugs have been proven ineffective or caused unacceptable side effects or when invasive anti-arrhythmic procedure is contraindicated or not effective. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Routes of administration: Intravenous use Treatment should be initiated and normally monitored only under hospital or specialist supervision. Amiodarone can be used where a rapid response is required or where oral administration is not possible. Infusion: The standard recommended loading dose is 5 mg/kg bodyweight in 250 ml of 5% dextrose infused within 20 minutes to 2 hours. This may be repeated 2 to 3 times during the following 24 hours (up to 1200 mg/24 hours [approximately 15 mg/kg bodyweight] in up to 500 ml 5% dextrose) and the rate of infusion is to be controlled according to the clinical response. (See section 4.4). Injection: In extreme clin Läs hela dokumentet