Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Guerbet, 15, rue des Vanesses, 93420, Villepinte, France
Optimark 500 micromol/ml solution for injection in pre-filled syringe.
Optimark 500 micromol/ml solution for injection in vial.
| Pharmaceutical Form |
|---|
|
Pre-filled syringe: Solution for injection in pre-filled syringe. Vial: Solution for injection in vial. Clear, colourless to pale yellow solution. pH: 6.0–7.5. |
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Each 10 ml syringe contains 3309 mg gadoversetamide equivalent to 5 millimol.
Each 15 ml syringe contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Each 20 ml syringe contains 6618 mg gadoversetamide equivalent to 10 millimol.
Each 30 ml syringe contains 9927 mg gadoversetamide equivalent to 15 millimol.
Excipient(s) with known effect:
20 ml of the solution contain 28.75 mg sodium.
30 ml of the solution contain 43.13 mg sodium.
For the full list of excipients, see section 6.1.
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Each 10 ml vial contains 3309 mg gadoversetamide equivalent to 5 millimol.
Each 15 ml vial contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Each 20 ml vial contains 6618 mg gadoversetamide equivalent to 10 millimol.
Excipient(s) with known effect:
20 ml of the solution contain 28.75 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Gadoversetamide |
Gadoversetamide is a chelate containing gadolinium – which has paramagnetic properties and is responsible for the contrast enhancement effect in MRI – and the ligand versetamide. Gadoversetamide after intravenous administration, equilibrates rapidly within the extracellular fluid/space and is eliminated primarily by glomerular filtration. |
| List of Excipients |
|---|
|
Versetamide |
Optimark is filled in pre-filled syringes made of polypropylene. Syringe tip cap and piston are made of bromobutyl rubber.
Pack sizes:
1 × 10 ml 10 × 10 ml
1 × 15 ml 10 × 15 ml
1 × 20 ml 10 × 20 ml
1 × 30 ml 10 × 30 ml
Not all pack-sizes may be marketed.
Optimark is filled in vials made of colourless highly resistant borosilicate glass (EP Type I). The vials are fitted with bromobutyl rubber closures, aluminium cap seals, and plastic flip caps.
Pack sizes:
1 × 10 ml 10 × 10 ml
1 × 15 ml 10 × 15 ml
1 × 20 ml 10 × 20 ml
Not all pack-sizes may be marketed.
Guerbet, 15, rue des Vanesses, 93420, Villepinte, France
Pre-filled syringe:
1 × 10 ml: EU/1/07/398/007
10 × 10 ml: EU/1/07/398/008
1 × 15 ml: EU/1/07/398/009
10 × 15 ml: EU/1/07/398/010
1 × 20 ml: EU/1/07/398/011
10 × 20 ml: EU/1/07/398/012
10 × 30 ml EU/1/07/398/014
Vial:
1 × 10 ml: EU/1/07/398/001
10 × 10 ml: EU/1/07/398/002
1 × 15 ml: EU/1/07/398/003
10 × 15 ml: EU/1/07/398/004
1 × 20 ml: EU/1/07/398/005
10 × 20 ml: EU/1/07/398/006
Date of first authorisation: 23 July 2007
Date of latest renewal: 15 June 2012
| Drug | Countries | |
|---|---|---|
| OPTIMARK | Austria, Brazil, Estonia, Lithuania, South Africa |
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