מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Isosorbide dinitrate
Merus Labs Luxco II S.à.R.L.
C01DA; C01DA08
Isosorbide dinitrate
1 milligram(s)/millilitre
Concentrate for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Organic nitrates; isosorbide dinitrate
Marketed
1982-12-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Isoket 1 mg/ml Concentrate for solution for injection or infusion Isosorbide dinitrate 10 ml ampoule READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 possible side effects not listed in this leaflet. See section 4. • In this leaflet, Isoket 1 mg/ml concentrate for solution for injection or infusion will be called Isoket. WHAT IS IN THIS LEAFLET: 1. What Isoket is and what it is used for 2. What you need to know before you use Isoket 3. How to use Isoket 4. Possible side effects 5. How to store Isoket 6. Contents of the pack and other information 1. WHAT ISOKET IS AND WHAT IT IS USED FOR Isoket belongs to a group of medicines called organic nitrates. Organic nitrates work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it. Isoket is used to treat heart failure (heart problems that can cause shortness of breath or ankle swelling) and angina pectoris. Angina usually feels like a tight pain in the chest, neck or arm area. It is also used sometimes during surgical procedures on the heart. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ISOKET DO NOT USE ISOKET IF: • You are allergic to isosorbide dinitrate, other nitrates or any of the other ingredients of this medicine (listed in section 6) • You suffer from anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness) • You have had a brain haemorrhage (bleeding) • You have had a head injury (head trauma) or raised intracranial pressure (high pressure within your skull) • You have a low blood volume (hypovolaemia) • You have very low blood pressure • Your blood has stopped circulating around your body properly (circulatory failure) • You ha קרא את המסמך השלם
Health Products Regulatory Authority 27 March 2023 CRN00DG89 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isoket 1mg/ml Concentrate for solution for injection or infusion, 10 ml Ampoule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 1mg isosorbide dinitrate. Each 10 ml ampoule contains 10mg isosorbide dinitrate. Each ml of concentrated solution contains 3.54mg sodium (as sodium chloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for injection or infusion (sterile concentrate). Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intravenous Isoket is indicated in the treatment of unresponsive left ventricular failure secondary to acute myocardial infarction, unresponsive left ventricular failure of various aetiology and severe or unstable angina pectoris. Intra-coronary Isoket is indicated during percutaneous transluminal coronary angioplasty to facilitate prolongation of balloon inflation and to prevent or relieve coronary spasm. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults, including the elderly. Intravenous route A dose of between 2 mg and 12 mg per hour is usually satisfactory. However, dosages up to 20 mg per hour administered should be adjusted to the patient response. Intra-coronary Route The usual dose is 1 mg given as a bolus injection prior to balloon inflation. Further doses may be given not exceeding 5 mg within a 30 minute period. Older People There's no evidence that dose adjustment in elderly patients in needed. Paediatric Population The safety and efficacy of Isoket has not yet been established in children. Method of administration Isoket is a concentrated solution and must be diluted prior to use. The diluted solution should never be injected directly in the form of a bolus except via the intra- coronary route prior to balloon inflation. A dilution of 50% is advocated for intracoronary administration. Isoket can be administered as an intravenous admixture w קרא את המסמך השלם