Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
ADENOSINE
Wockhardt UK Limited
C01EB; C01EB10
ADENOSINE
30 milligram/ 10 millilitre
Solution for infusion
Product subject to prescription which may not be renewed (A)
Other cardiac preparations; adenosine
Marketed
2013-10-04
PACKAGE LEAFLET: INFORMATION FOR THE USER ADENOSINE 30MG/10ML SOLUTION FOR INFUSION (Referred to as Adenosine Infusion in the remainder of the leaflet) Read all of this leaflet carefully before you start to take this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or nurse This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. IN THIS LEAFLET: 1. What Adenosine Infusion and what it is used for 2. Before you are given Adenosine Infusion 3. How you will be given Adenosine Infusion 4. Possible side effects 5. How to store Adenosine Infusion 6. Further information 1. WHAT ADENOSINE INFUSION IS AND WHAADENOSINE INFUSION IS AND WHAT IT ISUSED FOR 1. WHAT ADENOSINE INFUSION IS AND WHAT IT IS USED FOR The name of your medicine is Adenosine Infusion. The active ingredient in your medicine is adenosine. Adenosine belongs to a group of medicines called coronary vasodilators. This medicine is for diagnostic use only. Adenosine Infusion is given before a test called “myocardial perfusion imaging” to look at your heart. During this test you are given a medicine called a “radiopharmaceutical”. Adenosine Infusion works by opening up your heart’s blood vessels and allowing blood to flow more freely. This allows the radiopharmaceutical medicine to get into your heart. The doctor can see your heart and assess your heart condition. This is used if you are not capable of exercise or if an exercise stress test is not possible. 2. BEFORE YOU ARE GIVEN ADENOSINE INFUSION YOU SHOULD NOT BE GIVEN ADENOSINE INFUSION IF YOU are allergic (hypersensitive) to adenosine or to any of the other ingredients in this medicine (see section 6. Further information) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling Leggi il documento completo
Health Products Regulatory Authority 05 March 2019 CRN008T5V Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adenosine 30mg/10ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 30mg of adenosine per 10ml (3mg/ml). Excipient: each vial contains approximately 36 mg of sodium per vial (10ml). For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. A clear, colourless solution free from visible particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intravenous (IV) adenosine infusion is a coronary vasodilator for use in conjunction with radionuclide myocardial perfusion imaging in patients who cannot exercise adequately or for whom exercise is inappropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adenosine infusion is intended for use in hospitals with monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary. It should be administered following the same procedure as for exercise testing where facilities for cardiac monitoring and cardio-respiratory resuscitation are available. During administration of adenosine infusion continuous ECG control is necessary as life-threatening arrhythmia might occur. Heart rate and blood pressure should be monitored every minute. Posology: Adults: 1. Adenosine infusion should be administered undiluted as a continuous peripheral intravenous infusion at a dose of 140 µg/kg/min for six minutes using an infusion pump. Separate venous sites for adenosine infusion and radionuclide administration are recommended to avoid an adenosine bolus effect. 2. After three minutes of adenosine infusion, the radionuclide is injected to ensure sufficient time for peak coronary blood flow to occur. The optimal vasodilator protocol is achieved with six minutes of adenosine infusion. 3. To avoid an adenosine bolus effect, blood pressure should be measured in the arm opposite to the adenosine infusion. The table below is given as a guide for adjustment of Leggi il documento completo