Nchi: Malta
Lugha: Kiingereza
Chanzo: Malta Medicines Authority
AMIODARONE HYDROCHLORIDE
Ibigen S.r.L Via Fossignano, 2, 04011 Aprilia (LT), Italy
C01BD01
AMIODARONE HYDROCHLORIDE 150 mg
CONCENTRATE FOR SOLUTION FOR INFUSION OR INJECTION
AMIODARONE HYDROCHLORIDE 150 mg
POM
CARDIAC THERAPY
Authorised
2012-11-27
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER AMIODARONE IBIGEN 150MG/3ML CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION Amiodarone hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again - If you have any further questions, ask your doctor, pharmacist or nurse - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Amiodarone Ibigen is and what it is used for 2. What you need to know before you use Amiodarone Ibigen 3. How to use Amiodarone Ibigen 4. Possible side effects 5. How to store Amiodarone Ibigen 6. Contents of the pack and other information 1. WHAT AMIODARONE IBIGEN IS AND WHAT IT IS USED FOR Amiodarone Ibigen 150mg/3ml Concentrate for Solution for Injection/Infusion (called Amiodarone Ibigen in this leaflet) contains a medicine called amiodarone hydrochloride. This belongs to a group of medicines called anti-arrhythmics. It works by controlling the uneven beating of your heart (called ‘arrhythmias’). Having the injection helps your heartbeat to return to normal. Amiodarone Ibigen is normally only given in a hospital when a quick response is needed or when tablets cannot be given. Amiodarone Ibigen can be used to: • Treat uneven heartbeats where other medicines either have not worked or cannot be used • Treat an illness called Wolff-Parkinson-White Syndrome. This is where your heart beats unusually fast • Treat other types of fast or uneven heartbeats known as ‘atrial flutter’ or ‘atrial fibrillation’. Amiodarone Ibigen is used only when other medicines can not be used • Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone Ibigen is used only when other medicines cannot be used 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMIODARONE IBIGEN DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR, PHARMACI Soma hati kamili
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amiodarone Ibigen 150 mg/3 ml Concentrate for Solution for Injection/Infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 3 ml ampoule contains 150 mg amiodarone hydrochloride. Excipient with known effect Benzyl alcohol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for Solution for Injection/Infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment should be initiated and normally monitored only under hospital or specialist supervision. Amiodarone Ibigen 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 other types of tachyarrhythmias including supraventricular, nodal and ventricular tachycardias, atrial flutter and fibrillation, ventricular fibrillation, when other drugs cannot be used. Amiodarone Ibigen can be used where a rapid response is required or where oral administration is not possible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Amiodarone Ibigen should only be used when facilities exist for cardiac monitoring, defibrillation, and cardiac pacing (see section 6.6). Amiodarone Ibigen may be used prior to direct current (DC) cardioversion. Posology Adults _Infusion _ _Loading dose_ : The standard recommended dose is 5mg/kg bodyweight given by intravenous infusion over a period of 20 minutes to 2 hours. This should be administered as a dilute solution in 250 ml 5% dextrose. Page 2 of 19 This may be followed by repeat infusion up to 1200 mg (approximately 15 mg/kg bodyweight) in up to 500 ml 5% dextrose per 24 hours, the rate of infusion being adjusted on the basis of clinical response (see section 4.4). The therapeutic effect is visible in the first minutes, then decreased gradually, and should be followed by a maintenance infusion. _Maintenance dose: _ 10 - 20 mg per kg bw in physiological glucose solution ev Soma hati kamili