Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
ISOSORBIDE DINITRATE
UCB Pharma Limited
0.1 %w/v
Concentrate for Soln for Inf
2010-08-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isoket 1mg/ml Concentrate for solution for Injection or Infusion, 50ml bottle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre contains 1mg isosorbide dinitrate. Each 50ml bottle contains 50mg isosorbide dinitrate. 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 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 2mg and 12mg per hour is usually satisfactory. However, dosages up to 20mg per hour administered should be adjusted to the patient response. _INTRA-CORONARY ROUTE_ The usual dose is 1mg given as a bolus injection prior to balloon inflation. Further doses may be given not exceeding 5mg within a 30 minute period. Children The safety and efficacy of Isoket has not yet been established in children. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 03/10/2011_ _CRN 2106140_ _page number: 1_ _ADMINISTRATION_ Isoket is a concentrated solution and must be diluted prior Prečítajte si celý dokument