Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Bracco UK Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ, United Kingdom
MultiHance, 0.5 M solution for injection.
| Pharmaceutical Form |
|---|
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Solution for injection. Clear aqueous solution filled into colourless glass vials. Osmolality at 37°C: 1.97 osmol/kg. |
1 ml of solution for injection contains: gadobenic acid 334 mg (0.5M) as the dimeglumine salt.
[Gadobenate dimeglumine 529 mg = gadobenic acid 334 mg + meglumine 195 mg].
5 ml of solution for injection contain: gadobenic acid 1670 mg (2.5 mmol) as dimeglumine salt. [gadobenate dimeglumine 2645 mg = gadobenic acid 1670 mg + meglumine 975 mg]
10 ml of solution for injection contain: gadobenic acid 3340 mg (5 mmol) as dimeglumine salt. [gadobenate dimeglumine 5290 mg = gadobenic acid 3340 mg + meglumine 1950 mg]
15 ml of solution for injection contain: gadobenic acid 5010 mg (7.5 mmol) as dimeglumine salt. [gadobenate dimeglumine 7935 = gadobenic acid 5010 mg + meglumine 2925 mg]
20 ml of solution for injection contain: gadobenic acid 6680 mg (10 mmol) as dimeglumine salt. [gadobenate dimeglumine 10580 mg = gadobenic acid 6680 mg + meglumine 3900 mg]
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Gadobenic acid |
Gadobenic acid is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) of the liver. |
| List of Excipients |
|---|
|
Water for injections |
5 mL, 10 mL, 15 mL and 20 mL of a clear aqueous solution filled into single dose colourless type I glass vials with elastomeric closures, aluminium sealing crimps and polypropylene caps.
Kit with administration devices: 15 and 20 mL vial, syringe for magnetic resonance automatic injector ((65 mL syringe (polyethelene terephthalate/polycarbonate), 115 mL syringe (polyethelene terephthalate/polycarbonate), connector (PVC/polycarbonate/polypropylene/silicone), 2 spikes (ABS)), 20 G secured catheter.
Not all pack sizes may be marketed.
Bracco UK Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ, United Kingdom
PL 18920/0039
Date of first authorisation: 22 July 1997
Date of last renewal: 21 July 2012
| Drug | Countries | |
|---|---|---|
| MULTIHANCE | Austria, Brazil, Canada, Spain, Finland, France, Hong Kong, Croatia, Ireland, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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