OPTIRAY Solution for injection or infusion Ref.[9473] Active ingredients: Ioversol

Source: Health Products Regulatory Authority (IE)  Revision Year: 2016  Publisher: Guerbet, BP 57400, 95943, Roissy CdG cedex, France

Product name and form

Optiray 350 mg I/ml Solution for injection or infusion.

Pharmaceutical Form

Solution for injection or infusion.

Clear, colourless to faint yellow solution.

Qualitative and quantitative composition

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
Trometamol hydrochloride
Sodium calcium edetate
Water for injections
Sodium hydroxide and/or hydrochloric acid (for pH: 6.0 to 7.4)

Pack sizes and marketing

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

Marketing authorization holder

Guerbet, BP 57400, 95943, Roissy CdG cedex, France

Marketing authorization dates and numbers

PA0686/007/006

Date of first authorisation: 22nd April 1993
Date of latest renewal: 22nd April 2008

Drugs

Drug Countries
OPTIRAY Austria, Brazil, Canada, Ecuador, Spain, Finland, France, Hong Kong, Ireland, Japan, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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