Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
ADENOSINE
Fresenius Kabi Limited
C01EB10
ADENOSINE
3 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Other cardiac preparations
Authorised
2015-08-28
PACKAGE LEAFLET: INFORMATION FOR THE USER ADENOSINE 3 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 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 Adenosine is and what it is used for 2. What you need to know before you use Adenosine 3. How to use Adenosine 4. Possible side effects 5. How to store Adenosine 6. Contents of the pack and other information 1. WHAT ADENOSINE IS AND WHAT IT IS USED FOR Adenosine contains a medicine called adenosine. This belongs to a group of medicines called ’antiarrhythmics’. Adenosine works by slowing down electrical impulses between the upper and lower chambers of the heart. This slows the fast or uneven heartbeats called ’arrhythmias’. Adenosine is used in adults: • During a test. This is to help doctors find out what type of arrhythmia (uneven heartbeat) you have • To bring your heart beat back to normal if you have a type of arrhythmia called ‘paroxysmal supraventricular tachycardia (SVT)’ or ‘Wolff- Parkinson-White Syndrome’. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADENOSINE DO NOT USE ADENOSINE IF: - you are allergic to adenosine or any of the other ingredients of this medicine (listed in section 6). 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 (second or third degree atrioventricular block, sick sinus syndrome) - Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adenosine 3 mg/ml solution for injection in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 3 mg of adenosine. Each 1 ml single dose pre-filled syringe contains 3 mg of adenosine. Each 2 ml single dose pre-filled syringe contains 6 mg of adenosine. Each 4 ml single dose pre-filled syringe contains 12 mg of adenosine. Each 1 ml of solution contains 3.54 mg (0.15 mmoL) of sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection in pre-filled syringe Clear, colourless solution. pH: 5.5 – 7.5 Osmolality: 270 – 330 mOsm/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _For adults only:_ 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 Adenosine 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adenosine is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use. Adenosine 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. Posology _Adult:_ Initial dose: 3mg given as a rapid intravenous bolus (over 2 seconds). Second dose: If the first dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 6mg should be given also as a rapid intravenous bolus. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Prečítajte si celý dokument