Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Guerbet, BP 57400, 95943, Roissy CdG cedex, France
Optiray 350 mg I/ml Solution for injection or infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection or infusion. Clear, colourless to faint yellow solution. |
1 ml solution contains 741 mg ioversol equivalent to 350 mg Iodine.
Osmolality: 780 mosmoles/kg
Viscosity: 14.3 mPa·s (at 25°C)
Viscosity: 9 mPa·s (at 37°C)
Contains Iodine per ml: 350 mg
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ioversol |
Ioversol is a non-ionic X-ray contrast medium. Intravascular injection of ioversol opacifies those vessels in the path of the flow of the contrast medium, permitting radiographic visualisation of the internal structures until significant haemodilution occurs. |
| List of Excipients |
|---|
|
Trometamol |
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
Guerbet, BP 57400, 95943, Roissy CdG cedex, France
PA0686/007/006
Date of first authorisation: 22nd April 1993
Date of latest renewal: 22nd April 2008
| Drug | Countries | |
|---|---|---|
| OPTIRAY | Austria, Brazil, Canada, Ecuador, Spain, Finland, France, Hong Kong, Croatia, Ireland, Japan, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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