Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Guerbet, BP 57400, 95943, Roissy CdG cedex, France
This medicinal product is for diagnostic use only.
Optiray 350 is a non-ionic X-ray contrast medium that is indicated in adults for use in coronary, peripheral, visceral, and renal arteriography, aortography and left ventriculography. Optiray 350 is also indicated in adults for use in computed tomography (CT) of the head and body, intravenous urography, venography, and in intraarterial and intravenous digital subtraction angiography (IA-DSA and IV-DSA).
Recommended dosage schedule:
| Procedure | Dosage* | Maximum Total Dose |
|---|---|---|
| Peripheral Arteriography | 10-90 ml | 250 ml |
| Venography | 50-100 ml | 250 ml |
| Left Ventriculography | 30-50 ml | 250 ml |
| Coronary Arteriography | 1-10 ml | 250 ml |
| Visceral Arteriography | 12-60 ml | 250 ml |
| Aortography | 10-80 ml | 250 ml |
| 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 |
| Intraarterial Digital Subtraction Angiography | 5-80 ml | 250 ml |
| Intravenous Digital Subtraction Angiography | 30-50 ml | 250 ml |
* Repeated as necessary
Dosage as for adults. Where poor demonstration is to be expected, the dosage can be increased to the maximum.
The safety and efficacy of Optiray 350 in children have not been established. The medicinal product should therefore not be used in children aged up to 18 years, until further data becomes available. For cerebral, peripheral and visceral angiography and for intravenous urography Optiray 300 may be used in children.
It is recommended that intravascularly administered iodinated contrast agents are warmed up to body temperature prior to injection. As with all radiopaque contrast agents, the lowest dose necessary to obtain adequate visualisation should be used.
Appropriate resuscitation equipment should be available.
As with all iodinated X-ray contrast media, overdoses of Optiray are potentially fatal and may affect the respiratory and cardiovascular system. Treatment should be symptomatic. Dialysis can be used to remove Optiray from the blood.
Shelf life: 3 years.
Chemical and physical in-use stability has been demonstrated for 24 hours up to 37°C.
After use, discard the remaining solution.
Keep the container in the outer carton in order to protect from light. Protect from X-rays. Do not store above 30°C. Optiray can be stored for one month at 37°C in a contrast medium warmer with circulating air. Do not freeze. Discard the solution in case of discolouration or particulate matter
Uncoloured vials and bottles composed of Type I Ph. Eur. glass. Vials are fitted with 20 mm latex-free bromobutyl rubber closures and aluminium cap seals. Bottles are fitted with 32 mm latex-free bromobutyl rubber closures and aluminium cap seals.
Pack sizes:
10 × 30 ml vial
10 × 50 ml bottle
10 × 100 ml bottle
10 × 200 ml bottle
Not all pack sizes may be marketed
ike all parenteral products, the vials and bottles of Optiray should be inspected visually for integrity of the container. Optiray vials and bottles are intended for single use only. Discard any unused solution immediately.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
