Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Isosorbide dinitrate
Merus Labs Luxco II S.à.R.L.
C01DA; C01DA08
Isosorbide dinitrate
0.1 percent weight/volume
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Organic nitrates; isosorbide dinitrate
Not marketed
1984-11-13
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 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. Paediatric population The safety and efficacy of Isoket has not yet been established in children. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Přečtěte si celý dokument