Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2017 Publisher: GE Healthcare, 8 Tangihua Street, PO Box 106911, Auckland 1010, Ph 0800 659465, Fax (09) 353-6701
VISIPAQUE.
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VISIPAQUE injectable solution is provided as a ready-to-use sterile, pyrogen-free, colourless to pale yellow solution, in concentrations of 270 and 320 mg of organically bound iodine per ml (550 and 652 mg of iodixanol per ml, respectively). All solutions of iodixanol are hypotonic to blood. Sodium chloride and calcium chloride have been added resulting in an isotonic solution for injection. VISIPAQUE (270 mg I/ml) contains 0.07 mg calcium chloride dihydrate per ml and 1.87 mg sodium chloride per ml, and VISIPAQUE (320 mg I/ml) contains 0.04 mg calcium chloride dihydrate per ml and 1.10 mg sodium chloride per ml providing for both concentrations a sodium/calcium ratio equivalent to blood. In addition, each millilitre contains 1.2 mg trometamol and 0.1 mg sodium calcium edetate; the pH is adjusted between 6.8 and 7.7 with hydrochloric acid and/or sodium hydroxide at 22ºC. All solutions are terminally sterilised by autoclaving and contain no preservatives. Physical Properties of VISIPAQUEThe two concentrations of VISIPAQUE, 270 mg I/ml and 320 mg I/ml have the following physical properties:
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Iodixanol Injection 270 mg I/ml, 320 mg I/ml.
| Active Ingredient | Description | |
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| Iodixanol |
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| List of Excipients |
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Trometamol The pH of the product is 6.8-7.6. |
VISIPAQUE (iodixanol) injection 270 mg l/ml:
20 ml glass vial, boxes of 10
50 ml glass or polypropylene bottles, boxes of 10
75 ml polypropylene bottles, boxes of 10
100 ml glass or polypropylene bottles, boxes of 10
150 ml polypropylene bottles, boxes of 10
200 ml glass or polypropylene bottles, boxes of 6 or 10
500 ml glass or polypropylene bottles, boxes of 6
VISIPAQUE (iodixanol) injection 320 mg l/ml:
20 ml glass vial, boxes of 10
50 ml glass or polypropylene bottles, boxes of 10
75 ml polypropylene bottles, boxes of 10
100 ml glass or polypropylene bottles, boxes of 10
150 ml polypropylene bottles, boxes of 10
200 ml glass or polypropylene bottles, boxes of 6 or 10
500 ml glass or polypropylene bottles, boxes of 6
Not all presentations are marketed.
GE Healthcare, 8 Tangihua Street, PO Box 106911, Auckland 1010, Ph 0800 659465, Fax (09) 353-6701
9 March 1995
| Drug | Countries | |
|---|---|---|
| VISIPAQUE | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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