Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
AMIODARONE HYDROCHLORIDE
Stragen UK Limited
C01BD01
AMIODARONE HYDROCHLORIDE
50 Mg/Ml
Concentrate for Soln for Inj
Product subject to prescription which may not be renewed (A)
amiodarone
Not Marketed
2007-12-19
05368 PACKAGE LEAFLET: INFORMATION FOR THE USER AMIODARONE 50MG/ML 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Amiodarone is and what it is used for 2. What you need to know before you are given Amiodarone 3. How Amiodarone is given 4. Possible side effects 5. How to store Amiodarone 6. Contents of the pack and other information 1. WHAT AMIODARONE IS AND WHAT IT IS USED FOR Amiodarone is used to treat certain heart conditions, for example, when the heart is beating much too rapidly. Amiodarone is used when the patient is not responding to other treatments or when other treatments cannot be used. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMIODARONE DO NOT USE AMIODARONE - if you are allergic to amiodarone hydrochloride, iodine or the other ingredients of this medicine (listed in section 6) - if you have a heart condition causing a very slow heart rate (such as heart block or sinus bradycardia), any other heart condition causing very fast or irregular pulse or dizziness - if you have or have had thyroid problems - if you have severe breathing problems, severe blood circulatory problems or very low blood pressure - if you suffer from low blood pressure, heart failure or cardiomyopathy (weakness of the heart muscle) you must not receive Amiodarone as a single injection but only as a slow infusion - if you are taking certain drugs which may cause a heart condition called Torsades de Pointes (heart rhythm disturbance), such as: other antiarrhythmic heart medicines e.g. quinidine, disopyramide, procainamide, sotalol, bretylium some antibiotic injections e.g. erythromycin, c Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amiodarone 50 mg/ml Concentrate for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 50 mg of amiodarone hydrochloride Each 3 ml ampoule contains 150 mg amiodarone hydrochloride. Excipient with known effect: 60.6 mg of benzyl alcohol/ampoule of 3 ml sterile concentrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for injection/infusion (Sterile concentrate). The product is a 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 clinical emergency the drug may, at the discretion of the clinician, be given as a slow injection of 150-300 mg in 10-20 ml 5% dextrose over a minimum of 3 minutes. The solution is prepared by drawin Læs hele dokumentet