Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Amiodarone hydrochloride
Sanofi-Aventis Ireland Limited T/A SANOFI
C01BD; C01BD01
Amiodarone hydrochloride
150mg/3 millilitre(s)
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Antiarrhythmics, class III; amiodarone
Marketed
1984-02-20
PACKAGE LEAFLET: INFORMATION FOR THE USER CORDARONE® X INTRAVENOUS 150MG/3ML, CONCENTRATE FOR SOLUTION FOR INFUSION OR SLOW INJECTION amiodarone hydrochloride Is this leaflet hard to see or read? Phone 01 4035600 for help READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START HAVING THIS MEDICINE • Keep this leaflet. You may need to read it again • If you have any further questions, ask your doctor, nurse or pharmacist • This medicine has been prescribed for you. Do not pass it on to oth- ers. It may harm them, even if their symptoms are the same as yours • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: 1. What Cordarone X is and what it is used for 2. What you need to know before you take Cordarone X 3. How Cordarone X is given 4. Possible side effects 5. How to store Cordarone X 6. Further information 1. WHAT CORDARONE X IS AND WHAT IT IS USED FOR Cordarone X Intravenous 150mg/3ml concentrate for solution for infu- sion or slow injection (called Cordarone X 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 ‘arrhyth- mias’). Having the injection helps your heartbeat to return to normal. Cordarone X is normally only given in a hospital when a quick response is needed or when tablets cannot be given. Cordarone X 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’. Cordarone X is used only when other medicines can not be used • Treat fast heartbeats which may happen suddenly and may be uneven. Cordarone X is used only when other medicines cannot be used 2. WHAT YOU NEED TO KNOW BEFORE Lestu allt skjalið
Health Products Regulatory Authority 10 June 2022 CRN00CZ71 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cordarone X Intravenous, 150mg/3ml, Concentrate for solution for infusion or slow injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 3 ml ampoule contains 150mg Amiodarone Hydrochloride (50mg/ml). Excipients: contains benzyl alcohol 20mg/ml (60mg per 3ml ampoule). _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Concentrate for Solution for infusion or slow injection (sterile concentrate). Colourless glass ampoule containing a clear, pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment should be initiated and normally monitored only under hospital or specialist supervision. Cordarone X Intravenous 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 including supraventricular, nodal and ventricular tachycardias, ventricular fibrillation, when other drugs cannot be used. Intravenous Cordarone can be used where a rapid response is required or where oral administration is not possible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cordarone X Intravenous should only be used when facilities exist for cardiac monitoring, defibrillation and cardiac pacing. Cordarone X Intravenous may be used prior to DC cardioversion. 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 250ml 5% dextrose. This may be followed by repeat infusions up to 1200mg, (approximately 15mg/kg bodyweight) in up to 500ml 5% dextrose per 24 hours, the rate of infusion being adjusted on the basis of clinical response. (_See Section 4.4_). In extreme clinical emergency the drug may, at the discretion Lestu allt skjalið