XENETIX Solution for injection Ref.[8834] Active ingredients: Iobitriol

Revision Year: 2014  Publisher: GUERBET, BP 57400 F-95943 Roissy CDG Cedex, France Manufacturing site address: GUERBET, 16-24 rue Jean Chaptal, 93600 Aulnay-sous-Bois, France

Product name and form

XENETIX, solution for injection.

Pharmaceutical Form

Solution for injection.

Qualitative and quantitative composition

Xenetix 250 (250mg iodine/ml):

Per 100ml of solution:

Iobitridol: 54.84g (548.4mg/ml)
Corresponding mass of iodine: 25g (250mg/ml)
Viscosity at 20°C: 6 mPa.s
Viscosity at 37°C: 4 mPa.s
Osmolality: 585 mOsm/kg H2O

Xenetix 300 (300mg iodine/ml):

Per 100ml of solution:

Iobitridol: 65.81g (658.1mg/ml)
Corresponding mass of iodine: 30g (300mg/ml)
Viscosity at 20°C: 11mPa.s
Viscosity at 37°C: 6mPa.s
Osmolality: 695mOsm/kg H2O

Xenetix 350 (350mg iodine/ml):

Per 100ml of solution:

Iobitridol: 76.78g (767.8mg/ml)
Corresponding mass of iodine: 35g (350mg/ml)
Viscosity at 20°C: 21mPa.s
Viscosity at 37°C: 10mPa.s
Osmolality: 915mOsm/kg H2O

Excipient with known effect: sodium (up to 3.5 mg per 100 mL).

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Iobitriol

Iobitriol is a urographic and angiographic water-soluble nonionic contrast agent.

List of Excipients

Sodium calcium edetate
Trometamol
Trometamol hydrochloride
Sodium hydroxide or hydrochloric acid
Water for injection

Pack sizes and marketing

Marketing authorization holder

GUERBET, BP 57400 – F-95943 Roissy CDG Cedex, France

Manufacturing site address: GUERBET, 16-24 rue Jean Chaptal, 93600 – Aulnay-sous-Bois, France

Drugs

Drug Countries
XENETIX Austria, Ecuador, Spain, France, Hong Kong, Croatia, Ireland, Romania, Singapore, Tunisia, South Africa

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