国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Adenosine
Sanofi
C01EB10
Adenosine
3mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02030200; GTIN: 5000283600787
PACKAGE LEAFLET: INFORMATION FOR THE USER ADENOSCAN® 30 MG/10 ML SOLUTION FOR INFUSION Adenosine If this leaflet is hard to see or read Phone 01483 505515 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, ask your doctor or nurse. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. IN THIS LEAFLET: 1. What Adenoscan is and what it is used for 2. Before you are given Adenoscan 3. How Adenoscan is given 4. Possible side effects 5. How to store Adenoscan 6. Further information 1. WHAT ADENOSCAN IS AND WHAT IT IS USED FOR Adenoscan contains a medicine called adenosine. This belongs to a group of medicines called ‘coronary vasodilatators’. This medicine is for diagnostic use only. Adenoscan is used before a test called “myocardial perfusion imaging” to look at your heart. During this test you are given a medicine called a “radiopharmaceutical”. Adenoscan 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 procedure is used if you are not capable of exercise or if an exercise stress test is not possible. 2. BEFORE YOU ARE GIVEN ADENOSCAN DO NOT HAVE THIS MEDICINE AND TELL YOUR DOCTOR IF: You are allergic (hypersensitive) to adenosine or any of the other ingredients of Adenoscan (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 very low blood pressure (severe hypotension) You have unstable angina which is not controlled by treatment with medicine You have asthma or any other severe breathing problem You are taking a medicine called dipyridamole used to thin the blood. You have a ty 阅读完整的文件
OBJECT 1 ADENOSCAN Summary of Product Characteristics Updated 06-Feb-2014 | SANOFI 1. Name of the medicinal product ADENOSCAN ® 30 mg/10 ml, solution for infusion 2. Qualitative and quantitative composition Each 10 ml vial of Adenoscan ® contains 30 mg of adenosine (3 mg/ml) Excipient: each vial contains 90 mg of sodium chloride (9 mg/ml). For a full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for infusion. Adenoscan® is a sterile clear, colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Intravenous (IV) Adenoscan ® 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 Adenoscan ® 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 Adenoscan ® continuous ECG control is necessary as life-threatening arrhythmia might occur. Heart rate and blood pressure should be monitored every minute. ADULTS : 1. Adenoscan ® 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 Adenoscan ® and radionuclide administration are recommended to avoid an adenosine bolus effect. 2. After three minutes of Adenoscan ® 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 Adenoscan ® infusion. 3. To avoid an adenosine bolus effect, blood pressure should be measured in the arm opposite to the Adenoscan ® infusion. The table below is given as a guide for adjustment of the infusion rate of undiluted Adenoscan ® , i 阅读完整的文件