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
OMNIPAQUE.
| Pharmaceutical Form | ||||||||||||||||||||
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180 mg, bottles containing 388 mg iohexol per ml, equivalent to 180 mg iodine per ml. OMNIPAQUE solutions are colourless. The osmolality and viscosity values are as follows:
* at 37ºC, 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. |
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 |
|---|
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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. |
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.
GE Healthcare, 300 Great South Road, PO Box 17122, Greenlane, Auckland 1130
Ph (09) 523-5896
Fax (09) 522-7342
Date of first approval: 8 August 1985
| Drug | Countries | |
|---|---|---|
| OMNIPAQUE | Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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