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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Optiray 300 mg I/ml Solution for injection or infusion
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 or infusion.
Clear, colourless to pale faint yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Optiray 300 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 intraarterial and intravenous digital subtraction angiography (IA-
DSA). Optiray 300 is also indicated for use in computed tomography (CT) of the head and body. Optiray 300 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
Renal Arteriographie
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
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 increased to the maximum.
Children:
Recommended dosage
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