Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2017 Publisher: Manufactured by: Guerbet, 16-24 rue Jean Chaptal, 93600 Aulnay-sous-Bois, FRANCE, www.guerbet.com Distributed in NZ by: Obex Medical Limited, P O Box 26511, Epsom, AUCKLAND, Telephone: (09) 630 3456, Toll ...
Dotarem (bottles and pre-filled syringes) 0.5 mmol/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection in bottles and prefilled syringes. Clear, colourless to pale yellow solution. Osmolality: 1350 mOsm.kg -1 Viscosity at 20°C: 3.2 mPa.s Viscosity at 37°C: 2.0 mPa.s pH: 6.5 to 8.0 |
Per 100 mL of solution:
Gadoteric acid* 27.932 g
corresponding to DOTA 20.246 g
corresponding to gadolinium oxide 9.062 g
* Gadoteric acid: complex gadolinium of 1, 4, 7, 10 tetraazacyclododecane-N,N',N'‘,N’'' tetraacetic acid.
Contrast agent concentration: 0.5 mmol/mL
For a 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 |
Bottles: Single bottles containing 5 mL, 10 mL, 15 mL, 20 mL, 60 mL and 100 mL, closed by an elastomeric stopper.
Pre-filled syringes: Single disposable syringes containing 10 mL, 15 mL and 20 mL with latex-free elastometric seals.
Not all pack sizes may be marketed.
Manufactured by: Guerbet, 16-24 rue Jean Chaptal, 93600 Aulnay-sous-Bois, FRANCE, www.guerbet.com
Distributed in NZ by: Obex Medical Limited, P O Box 26511, Epsom, AUCKLAND, Telephone: (09) 630 3456, Toll Free: 0800 656 239, Fax: (09) 630 9009, www.obex.co.nz
Date of first approval: 06 November 1997
| Drug | Countries | |
|---|---|---|
| DOTAREM | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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