MULTIHANCE Solution for injection Ref.[9501] Active ingredients: Gadobenic acid

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

Product name and form

MultiHance, 0.5 M solution for injection.

Pharmaceutical Form

Solution for injection.

Clear aqueous solution filled into colourless glass vials.

Osmolality at 37°C: 1.97 osmol/kg.
Viscosity at 37°C: 5.3 mPa.s.

Qualitative and quantitative composition

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

Pack sizes and marketing

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.

Marketing authorization holder

Bracco UK Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ, United Kingdom

Marketing authorization dates and numbers

PL 18920/0039

Date of first authorisation: 22 July 1997
Date of last renewal: 21 July 2012

Drugs

Drug Countries
MULTIHANCE Austria, Brazil, Canada, Spain, Finland, France, Hong Kong, Ireland, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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