Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amiodarone hydrochloride
Bowmed Ibisqus Ltd
C01BD01
Amiodarone hydrochloride
50mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02030200; GTIN: 5060130130898
1. WHAT AMIODARONE IS AND WHAT IT IS USED FOR Amiodarone 150 mg/3 ml Concentrate for Solution for Injection/Infusion (called Amiodarone 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 is normally only given in a hospital when a quick response is needed or when tablets cannot be given. Amiodarone 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 is used only when other medicines cannot be used • Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone is used only when other medicines cannot be used 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMIODARONE DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR, PHARMACIST OR NURSE IF YOU: • are allergic to iodine, amiodarone, or any of the other ingredients of Amiodarone (listed in Section 6 below). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • have a slower than usual heartbeat (called ‘sinus bradycardia’) or an illness called ‘sino-atrial’ heart block • have any other problems with your heartbeat and do not have a pacemaker fitted • have or have previously had thyroid problems. Your doctor should test your thyroid before giving you this medicine • have severe breathing problems • have serious blood circulation problems • have very low blood pressure • are taking certain other medicines which could affect your heartbeat (see ‘Other medicines and Amiodarone’ below) • are pregnant or breast-feeding (see ‘Pregnancy and bre Přečtěte si celý dokument
OBJECT 1 AMIODARONE 150MG/3ML CONCENTRATE FOR SOLUTION FOR INJECTION AMPOULES Summary of Product Characteristics Updated 07-Dec-2017 | Bowmed Ibisqus Limited 1. Name of the medicinal product Amiodarone 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 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 • life-threatening ventricular arrhythmias, including persistent or non-persistent ventricular tachycardia or episodes of ventricular fibrillation, cardiopulmonary resuscitation in case of cardiac arrest related to ventricular fibrillation resistant to defibrillation; when other active substances cannot be used • all other types of tachyarrhythmias including supraventricular, nodal and ventricular tachycardias; atrial flutter and fibrillation. Amiodarone can be used where a rapid response is required or where oral administration is not possible. 4.2 Posology and method of administration Amiodarone should only be used when facilities exist for cardiac monitoring, defibrillation, and cardiac pacing. See section 6.6. Amiodarone 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. This may be followed by repeat infusion up to 1200 mg (approximately 15 mg/kg bodyweight) in up to 500 ml 5% dextr Přečtěte si celý dokument