Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
IOVERSOL
Covidien (UK) Commerical Limited
240
Solution for Inj/Inf
2012-01-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Optiray 240 mg I/ml Solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ioversol 509 mg/ml (equivalent to Iodine content of 240 mg/ml) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion. Clear, colourless to pale faint yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Optiray 240 is a non-ionic X-ray contrast medium that is indicated for use in cerebral arteriography, venography, intravenous urography and with the intra-arterial digital subtraction angiography (IA-DSA) to provide contrast enhancement and facilitate visualisation of the vascular system. Optiray 240 is also indicated for use in computed tomography (CT) of the head and body. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Recommended dosage schedule * Repeated as necessary Children: Safety and effectiveness of Optiray 240 in children have not yet been established. Elderly: Dosage as for adults. Where poor demonstration is to be expected, the dosage can be increased to the maximum. It is recommended that intravascularly administered iodinated contrast agents are warmed to body temperatures prior to injection. As with all radiopaque contrast agents, the lowest dose necessary to obtain adequate visualisation should be used. Discard if the solution is markedly discoloured or is not clear of particulate matter. Procedure Dosage* Maximum Total Dose Cerebral Arteriography - Carotid or vertebral artery 2-12 ml 200 ml - Aortic arch 20-50 ml 200 ml Venography 50-100 ml 250 ml Intravenous Urography 65-100 ml 200 ml Head Computed Tomography 65-200 ml 200 ml Body Computed Tomography 35-200 ml 200 ml Intra-arterial Digital Subtraction Angiography 5-80 ml 250 ml IRISH MEDICINES BOARD _ Aqra d-dokument sħiħ