Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Adenosine
Sanofi-Aventis Ireland Limited T/A SANOFI
C01EB; C01EB10
Adenosine
3 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Other cardiac preparations; adenosine
Marketed
1994-06-16
PACKAGE LEAFLET: INFORMATION FOR THE USER ADENOCOR® 3MG/ML SOLUTION FOR INJECTION ADENOSINE SANOFI Is this leaflet hard to see or read? Phone 01 4035600 for help READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE. • Keep this leaflet. You may need to read it again • If you have any further questions after reading this leaflet, ask your doctor • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist IN THIS LEAFLET: 1. What Adenocor is and what it is used for 2. What you need to know before you are given Adenocor 3. How Adenocor is given 4. Possible side effects 5. How to store Adenocor 6. Contents of the pack and other information 1. WHAT ADENOCOR IS AND WHAT IT IS USED FOR Adenocor contains a medicine called adenosine. This belongs to a group of medicines called ‘antiarrythmics’. Adenocor works by slowing down electrical impulses between the upper and lower chambers of the heart. This slows the fast or uneven heartbeats called ‘arrythmias’. ADENOCOR IS USED: ADULTS • During a test. This is to help doctors find out what type of arrythmia (uneven heartbeat) you have • To bring your heart beat back to normal if you have a type of arrythmia called ‘paroxysmal supraventricular tachycardia (SVT)’ or ‘Wolf-Parkinson-White Syndrome Children: • To bring your childs heart back to normal if your child has a type of heart rhythm trouble called 'paroxysmal supraventricular tachycardia' (PSVT). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADENOCOR Do not have this medicine and tell your doctor if: • You are allergic (hypersensitive) to adenosine or any of the other ingredients of Adenocor (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 • You have problems with your heart rhythm and do not have a pacemaker • You have asthma • You have been told you have ‘Long QT syndrome’ Прочетете целия документ
Health Products Regulatory Authority 12 October 2023 CRN00DRW1 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adenocor 3 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 6mg of adenosine per 2ml (3mg/ml). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory by-pass tracts (Wolff-Parkinson-White Syndrome). DIAGNOSTIC INDICATIONS Aid to diagnosis of broad or narrow complex supraventricular tachycardias. Although Adenocor will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity. Sensitisation of intra-cavitary electrophysiological investigations. Paediatric population Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardia in children aged 0 to 18 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adenocor is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use. It should be administered by rapid IV bolus injection according to the ascending dosage schedule below. To be certain the solution reaches the systemic circulation administer either directly into a vein or into an IV line. If given into an IV line it should be injected as proximally as possible, and followed by a rapid saline flush. Adenocor should only be used when facilities exist for cardiac monitoring. Patients who develop high-level AV block at a particular dose should not be given further dosage increments. THERAPEUTIC DOSE Adult: Initial dose: 3mg given as a rapid intravenous bolus (injection over 2 seconds). Second dose: If the first dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 6mg Прочетете целия документ