국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
regadenoson
GE Healthcare AS
C01EB21
regadenoson
Cardiac therapy
Myocardial Perfusion Imaging
This medicinal product is for diagnostic use only.Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress.
Revision: 15
Authorised
2010-09-06
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER RAPISCAN 400 MICROGRAM SOLUTION FOR INJECTION Regadenoson 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 pharmacist. If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Rapiscan is and what it is used for 2. What you need to know before you are given Rapiscan 3. How Rapiscan is given 4. Possible side effects 5. How to store Rapiscan 6. Contents of the pack and other information 1. WHAT RAPISCAN IS AND WHAT IT IS USED FOR Rapiscan contains the active substance regadenoson _. _ This belongs to a group of medicines called ‘coronary vasodilators’ _. _ It makes the heart arteries expand and heart rate increase. This makes more blood flow to the muscles of the heart. This medicine is for diagnostic use only. Rapiscan is used in a type of heart scan in adults called ‘myocardial perfusion imaging’. The scan uses a diagnostic agent _ _ to create images. These images show how well blood flows to the muscles of the heart. Usually, exercise on a treadmill is used to put the heart under stress before a scan. During the exercise, a small amount of the diagnostic agent is injected into the body, often into a vein in the hand. Images are then taken of the heart. The doctor can then see if the heart muscles are getting enough blood flow when it is under stress. If you are unable to exercise enough to reach sufficient stress to the heart, Rapiscan will be injected to provide a stress of similar amplitude to the heart to increase the blood flow. Rapiscan is also used during catheterisation and imaging arteries of the heart (invasive coronary angiography) to expand the arteries of the heart to measure the difference in pressure, caused by a narrowing wit 전체 문서 읽기
1 ANNEX 1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rapiscan 400 microgram solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 400 micrograms regadenoson in 5ml solution (80 micrograms/ml). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use in adults as a pharmacological stress agent for: • myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. • the measurement of fractional flow reserve (FFR) of a single coronary artery stenosis during invasive coronary angiography, when repeated FFR measurements are not anticipated (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Rapiscan is restricted to use in a medical facility where cardiac monitoring and resuscitation equipment are available. Posology The recommended dose is a single injection of 400 micrograms regadenoson (5 ml) into a peripheral vein, with no dose adjustment necessary for body weight. Patients should avoid consumption of any products containing methylxanthines (e.g. caffeine) as well as any medicinal products containing theophylline for at least 12 hours before Rapiscan administration (see section 4.5). When possible, dipyridamole should be withheld for at least two days prior to Rapiscan administration (see section 4.5). Aminophylline may be used to attenuate severe and/or persistent adverse reactions to regadenoson but should not be used solely for the purpose of terminating a seizure induced by Rapiscan (see section 4.4). Regadenoson causes a rapid increase in heart rate (see sections 4.4 and 5.1). Patients should remain sitting or lying down and be monitored at frequent intervals after the injection until the ECG parameters, heart rate and blood pressure have returned to pre-dose levels. 3 전체 문서 읽기