Source: Health Products Regulatory Authority (IE) Revision Year: 2015 Publisher: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18
Ultravist 300mg/ml Solution for Injection (20ml).
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Solution for injection. Clear, colourless to pale yellow aqueous solution. The physico-chemical properties of Ultravist at the concentrations listed below are:
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Ultravist 300: 1 ml contains 623mg iopromide, equivalent to 300 mg iodine.
One 20 ml vial of Ultravist 300 contains 12.46 g iopromide.
This medicinal product contains 12.3 micrograms sodium per ml.
For a full list of excipients see Section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Iopromide |
The contrast-giving substance in the iopromide formulations is iopromide, a non-ionic water-soluble derivative of triiodinated isophthalic acid in which the firmly bound iodine absorbs the X-rays. Injection of iopromide opacifies those vessels or body cavities in the path of flow of the contrast agent, permitting radio-graphic visualization of the internal structures until significant dilution occurs. |
| List of Excipients |
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Sodium calcium edetate |
Vials: Glass type I
Stopper: Stopper type I, chlorobutyl-elastomer
Presentation:
Ultravist 300: Vials of 20 ml. Cartons contain 10 vials of 20 ml.
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18
PA 1410/011/002
Date of first authorisation: 24 September 1986
Date of last renewal: 24 September 2006
| Drug | Countries | |
|---|---|---|
| ULTRAVIST | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Israel, Lithuania, Malta, Nigeria, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United States, South Africa |
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