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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
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