Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dipyridamole
Boehringer Ingelheim Ltd
B01AC07
Dipyridamole
5mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02090000; GTIN: 5012816012424
PACKAGE LEAFLET: INFORMATION FOR THE USER PERSANTIN ® AMPOULES 10 MG/2 ML SOLUTION FOR INFUSION (dipyridamole) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • 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 gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What PERSANTIN Ampoules are and what they are used for 2. Before you receive PERSANTIN Ampoules 3. How PERSANTIN Ampoules will be given 4. Possible side effects 5. How to store PERSANTIN Ampoules 6. Further information 1. WHAT PERSANTIN AMPOULES ARE AND WHAT THEY ARE USED FOR The name of your injection is PERSANTIN Ampoules 10 mg / 2 ml Solution for Infusion (called PERSANTIN Ampoules in this leaflet). • It contains a medicine called dipyridamole. This belongs to a group of medicines called ‘coronary vasodilators’ • It works by opening up (dilating) the blood vessels in the heart PERSANTIN Ampoules are used instead of exercise during scans to assess heart conditions. 2. BEFORE YOU RECEIVE PERSANTIN AMPOULES YOU SHOULD NOT BE GIVEN PERSANTIN AMPOULES IF: • You are allergic (hypersensitive) to dipyridamole or any of the other ingredients of PERSANTIN Ampoules (listed in Section 6 below) • You have heart problems such as a recent heart attack (within the last 4 weeks), angina (chest pain) at rest, irregular heart beat, heart block (this usually causes a slow heart beat), heart failure or a problem affecting the heart valves • You have low blood pressure or have recently fainted (within the last 4 weeks) for no apparent reason • You have had a stroke or something called a ‘transient ischaemic attack’ (a temporary stroke that lasts less than 24 hours) • You have breathing probl Olvassa el a teljes dokumentumot
PERSANTIN AMPOULES 10 MG/2 ML SOLUTION FOR INFUSION Summary of Product Characteristics Updated 02-Mar-2015 | Boehringer Ingelheim Limited 1. Name of the medicinal product Persantin Ampoules 10 mg / 2 ml Solution for Infusion 2. Qualitative and quantitative composition Dipyridamole 5 mg/ml. Each 2 ml ampoule contains 10 mg dipyridamole. For excipients, see 6.1. 3. Pharmaceutical form Solution for infusion. 2ml glass ampoules containing a clear, yellow-coloured solution. 4. Clinical particulars 4.1 Therapeutic indications _Adults:_ As an alternative to exercise stress in thallium-201 myocardial imaging, particularly in patients unable to exercise or in those for whom exercise may be contraindicated. _Children:_ As an alternative to exercise stress in myocardial perfusion imaging, particularly in children unable to exercise or in those for whom exercise may be contraindicated. More specifically, this may include children with Kawasaki disease complicated by coronary artery involvement, or those with congenitally abnormal coronary circulations. 4.2 Posology and method of administration The dose of intravenous PERSANTIN as an adjunct to thallium myocardial perfusion imaging should be adjusted according to the weight of the patient. The recommended dose is 0.142 mg/kg/minute (0.567 mg/kg total) infused over 4 minutes. Thallium-201 should be injected within 3-5 minutes following the 4-minute infusion of PERSANTIN. 4.3 Contraindications Hypersensitivity to any of the components of the product. Patients with dysrhythmias, second- or third degree atrioventricular block or with sick sinus syndrome should not receive intravenous PERSANTIN (unless they have a functioning pacemaker). Patients with baseline hypotension (systolic blood pressure < 90 mmHg), recent unexplained syncope (within 4 weeks) or with recent transient ischaemic attacks are not suitable candidates for dipyridamole testing. Patients with severe coronary artery disease, including unstable angina and recent myocardial infarction (within 4 weeks), left ventricu Olvassa el a teljes dokumentumot