Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
IOVERSOL
Covidien (UK) Commerical Limited
300
Solution for Injection
2012-01-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Optiray 300 mg I/ml PFS Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ioversol 636 mg/ml (equivalent to Iodine content of 300 mg/ml). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale faint yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Optiray 300 PFS is a non-ionic X-ray contrast medium that is indicated for use in cerebral, peripheral, visceral, and renal arteriography, venography, intravenous urography and in intra-arterial and intravenous digital subtraction angiography (IA- DSA and IV-DSA). Optiray 300 PFS is also indicated for use in computed tomography (CT) of the head and body. Optiray 300 PFS may also be used in children for cerebral, peripheral and visceral arteriography and for intravenous urography. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult: Recommended dosage schedule: Procedure Dosage* Maximum Total Dose Cerebral Arteriography - Carotid or vertebral artery 2-12 ml 200 ml - Aortic arch 20-50 ml 200 ml Peripheral Arteriography 10-90 ml 250 ml Venography 50-100 ml 250 ml Visceral Arteriography 12-60 ml 250 ml Procedure Dosage* Maximum Total Dose Renal Arteriography 6-15 ml 250 ml Intravenous Urography 50-75 ml 150 ml Head Computed Tomography 50-150 ml 150 ml Body Computed Tomography 25-150 ml 150 ml Intra-arterial Digital Subtraction Angiography 5-80 ml 250 ml Intra-venous Digital Subtraction Angiography 30-50 ml 250 ml IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/02/2012_ _CRN 2111302_ _page number: 1_ * Repeated as necessary Elderly: Dosage as for adults. Where poor demonstration is to be expected, the dosage can be i Lees het volledige document