Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ADENOSINE
Focus Pharmaceuticals Ltd
C01EB; C01EB10
ADENOSINE
3 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Other cardiac preparations; adenosine
Not marketed
2013-01-11
12mm 158 mm 350 mm 12mm FRONT 12mm 12mm 158 mm 350 mm 12mm BACK 12mm READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Adcus is and what it is used for 2. What you need to know before you are given Adcus 3. How you will be given Adcus 4. Possible side effects 5. How to store Adcus 6. Contents of the pack and other information 1.WHAT ADCUS IS AND WHAT IT IS USED FOR Adcus TM 3mg/ml Solution for Infusion (called Adcus throughout the rest of this leaflet) belongs to a group of medicines called coronary vasodilators. Adcus is given with other medicines, called radionuclides, during a diagnostic test, called myocardial perfusion imaging, to open up your heart’s blood vessels to allow your blood to flow more freely. Once in your blood, the radionuclide allows the doctor or nurse to see your heart and assess your heart condition. This medicine is for diagnostic use only and is used if you are incapable of exercise. You will usually be in hospital when you receive this medicine. 2.WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADCUS DO NOT HAVE ADCUS • if you are allergic to adenosine or any of the other ingredients of this medicine (listed in section 6); • if you have an irregular heart rhythm and do not currently have a pacemaker fitted; • if you have a disorder that affects the heart’s electrical activity (Long QT syndrome); • if you have very low blood pressure (severe hypotension); • if you have unstable angina (severe chest pain) that is not currently controlled by either treatment or medication; • if you have a type of heart failure where your heart does not pump out enough blood; • if you have asthma or any other severe breathing problems; • if you are taking Les hele dokumentet
Health Products Regulatory Authority 09 November 2018 CRN008HK6 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adenosine 3mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of solution contains 3mg of adenosine. Each vial contains 6mg of adenosine per 2ml of solution (3mg/ml). It also contains 3.54mg (0.15mmol) of sodium per 1ml of solution. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adenosine 3mg/ml Solution for Injection is indicated in adults and children aged 0 to 18 years. 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 Adenosine 3mg/ml Solution for Injection 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. Health Products Regulatory Authority 09 November 2018 CRN008HK6 Page 2 of 12 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adenosine 3mg/ml Solution for Injection is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use, if necessary. METHOD OF ADMINISTRATION 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 flus Les hele dokumentet