Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
ISOSORBIDE DINITRATE
UCB Pharma Limited
ISOSORBIDE DINITRATE
0.05 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
Isoket 0.5 mg/ml solution for infusion or injection Isosorbide Dinitrate 50 ml bottle 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 0.5 mg/ml solution for infusion or injection 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 pressu Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isoket 0.5 mg/ml Solution for Infusion or Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Isosorbide dinitrate 0.05% w/v, equivalent to 25 mg/50 ml (500 micrograms/ml). Each millilitre also contains 3.54mg sodium (as sodium chloride) Each 50ml bottle contains 177mg sodium (as sodium chloride) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion or injection 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 aetiologies 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 Adults, including the elderly _INTRAVENOUS ROUTE:_ Isoket 0.5 mg/ml (undiluted) is intended for intravenous administration by slow infusion via a syringe pump. Alternatively it can be administered as an admixture with a suitable vehicle such as Sodium Chloride Injection B.P. or Dextrose Injection B.P. A dose of between 2 mg and 12 mg per hour is usually satisfactory. However, dosages up to 20 mg per hour may be required. In all cases the dose administered should be adjusted to the patient response. _INTRA-CORONARY ROUTE:_ Isoket 0.5 mg/ml can be injected directly by this route according to the proposed dosage schedule. 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. IRISH MEDICINES BOARD ______ Baca dokumen lengkap