DOTAGRAF Solution for injection Ref.[28334] Active ingredients: Gadoteric acid

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Product name and form

Dotagraf 0.5 mmol/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless to yellow solution.

Contrast medium concentration	279,32 mg/ml 0,5 mmol/ml
Osmolality at 37°C	1,35 Osm/kg H₂O
Viscosity at 37°C	1,8 mPas
pH value	6,5-8,0

Qualitative and quantitative composition

1 ml solution for injection contains 279.32 mg gadoteric acid (as meglumine salt), equivalent to 0.5 mmol.

10 ml solution for injection contain 2793.2 mg gadoteric acid (as meglumine salt), equivalent to 5 mmol.

15 ml solution for injection contain 4189.8 mg gadoteric acid (as meglumine salt), equivalent to 7.5 mmol.

20 ml solution for injection contain 5586.4 mg gadoteric acid (as meglumine salt), equivalent to 10 mmol.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Gadoteric acid	Gadoteric acid has paramagnetic properties allowing MRI contrast enhancement. It has no specific pharmacodynamic activity and is biologically very inert.

List of Excipients
Meglumine 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA) Water for injections

Pack sizes and marketing

1 and 10 Type II single-use colourless glass vials of 10 ml and 20 ml (filled to 15 or 20 ml), sealed with a stopper of bromobutyl rubber and packed in unit carton box.

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Marketing authorization dates and numbers

PL 00010/0590

Date of first authorisation: 16 September 2016
Date of renewal of the authorisation: 02 December 2019

Drugs

Drug	Countries
DOTAGRAF	Austria, Cyprus, Estonia, Spain, Hong Kong, Croatia, Ireland, Lithuania, Malta, Poland, Romania, United Kingdom

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