Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
ISOSORBIDE DINITRATE
SCHWARZ PHARMA Limited
ISOSORBIDE DINITRATE
0.1 %w/v
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
Isoket 1 mg/ml Concentrate for solution for injection or infusion Isosorbide Dinitrate 10 ml ampoule PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. In this leaflet, Isoket 1 mg/ml concentrate for solution for injection or infusion will be called Isoket. IN THIS LEAFLET: 1. WHAT ISOKET IS FOR 2. BEFORE YOU USE ISOKET 3. HOW TO USE ISOKET 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ISOKET 6. FURTHER INFORMATION. 1. WHAT ISOKET IS 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 normally feels like a tight pain in the chest, neck or arm area. It is also used sometimes during surgical procedures on the heart. 2. BEFORE YOU USE ISOKET DO NOT USE ISOKET IF: You are allergic to isosorbide dinitrate, other nitrates or any of the other ingredients of Isoket (see 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 pre Прочетете целия документ
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 a 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 Dosage 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. Children The safety and efficacy of Isoket has not yet been established in children. Elderly There’s no evidence that dose adjustment in elderly patients is needed. 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 Прочетете целия документ