OMNIPAQUE Solution Ref.[9483] Active ingredients: Iohexol

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: GE Healthcare, 300 Great South Road, PO Box 17122, Greenlane, Auckland 1130 Ph (09) 523-5896 Fax (09) 522-7342

Product name and form

OMNIPAQUE.

Pharmaceutical Form

180 mg, bottles containing 388 mg iohexol per ml, equivalent to 180 mg iodine per ml.
240 mg, bottles containing 518 mg iohexol per ml, equivalent to 240 mg Iodine per ml.
300 mg, bottles containing 647 mg iohexol per ml, equivalent to 300 mg iodine per ml.
350 mg, bottles containing 755 mg iohexol per ml, equivalent to 350 mg iodine per ml.

OMNIPAQUE solutions are colourless.

The osmolality and viscosity values are as follows:

Concentration (mg I/ml) Osmolality* (mol/kg) Viscosity (mPa s) 20ยบCViscosity (mPa s) 37ยบC
1800.363.22.0
2400.515.63.3
3000.6411.66.1
3500.7823.310.6

* at 37ยบC, in aqueous solutions of iohexol.

OMNIPAQUE is isotonic to blood (300 mOsm/kg) and cerebrospinal fluid (CSF) at a concentration of 140 mg I/ml. The density of OMNIPAQUE at the available concentrations is hyperbaric to CSF.

Qualitative and quantitative composition

Iohexol 180, 240, 300 and 350 mg iodine per ml.

Active Ingredient Description
Iohexol

Iohexol is an effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality.

List of Excipients

Each millilitre of iohexol solution also contains 1.2 mg of tromethamine USP and 0.l mg of edetate calcium disodium USP with the pH adjusted between 6.8 and 7.6 with hydrochloric acid or sodium hydroxide. Solutions are sterilised by autoclaving and contain no preservatives.

Pack sizes and marketing

180 mg I/ml:

10 ml: Packs of 10 glass or polypropylene bottles.

240 mg I/ml:

20 ml: Packs of 6 or 25 glass bottles and 10 polypropylene bottles.
50 ml: Packs of 10 glass or polypropylene bottles.
500 ml: Packs of 6 bottles.

300 mg I/ml:

10 ml: Packs of 10 glass or polypropylene bottles.
20 ml: Packs of 6 or 25 glass bottles and 10 polypropylene bottles.
50 ml: Packs of 10 glass or polypropylene bottles.
75 ml: Packs of 10 glass or polypropylene bottles.
100 ml: Packs of 10 glass or polypropylene bottles.
150 ml: Packs of 10 polypropylene bottles.
200 ml: Packs of 10 polypropylene bottles.
500 ml: Packs of 6 glass or polypropylene bottles.

350 mg I/ml:

20 ml: Packs of 6 or 25 glass bottles and 10 polypropylene bottles.
50 ml: Packs of 10 glass or polypropylene bottles.
75 ml: Packs of 10 glass or polypropylene bottles.
100 ml: Packs of 10 glass or polypropylene bottles.
150 ml: Packs of 10 polypropylene bottles.
200 ml: Packs of 6 glass or 6 and 10 polypropylene bottles Packs of.
500 ml: 6 glass or 6 and 10 polypropylene bottles.

Not all presentations are marketed.

Marketing authorization holder

GE Healthcare, 300 Great South Road, PO Box 17122, Greenlane, Auckland 1130

Ph (09) 523-5896
Fax (09) 522-7342

Marketing authorization dates and numbers

Date of first approval: 8 August 1985

Drugs

Drug Countries
OMNIPAQUE Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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