Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bracco Imaging SPA, Via Egidio Folli, 50, 20134 Milan, Italy
Vueway 0.5mmol/mL solution for injection.
| Pharmaceutical Form | ||||||||
|---|---|---|---|---|---|---|---|---|
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Solution for injection. Clear, colourless to pale yellow solution.
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1 mL of solution contains 485.1 mg gadopiclenol (equivalent to 0.5 mmol of gadopiclenol and to 78.6 mg of gadolinium).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Gadopiclenol |
Gadopiclenol is a paramagnetic agent for Magnetic Resonance Imaging (MRI). The contrast-enhancing effect is mediated by gadopiclenol which is a macrocyclic non-ionic complex of gadolinium, the active moiety which enhances the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues. |
| List of Excipients |
|---|
|
Tetraxetan |
3 mL solution for injection in a 10 mL vial (glass type I) with elastomeric stopper in pack size of 1.
7.5 mL solution for injection in a 10 mL vial (glass type I) with elastomeric stopper in pack sizes of 1 or 25.
10 mL solution for injection in a 10 mL vial (glass type I) with elastomeric stopper in pack sizes of 1 or 25.
15 mL solution for injection in a 20 mL vial (glass type I) with elastomeric stopper in pack sizes of 1 or 25.
30 mL solution for injection in a 50 mL vial (glass type I) with elastomeric stopper in pack size of 1.
50 mL solution for injection in a 50 mL vial (glass type I) with elastomeric stopper in pack size of 1.
100 mL solution for injection in a 100 mL vial (glass type I) with elastomeric stopper in pack size of 1.
7.5 mL, 10 mL or 15 mL of solution for injection in a 15 mL plastic (polypropylene) pre-filled syringe, graduated every 0.5 mL, without a needle, with an elastomeric (bromobutyl) plunger stopper and capped with an elastomeric (bromobutyl) tip cap. Pack size of 1 or a multipack containing 10 (10 packs of 1) prefilled syringes.
7.5 mL, 10 mL or 15 mL of solution for injection in 15 a mL plastic (polypropylene) pre-filled syringe, graduated every 0.5 mL, with an elastomeric (bromobutyl) plunger stopper and capped with an elastomeric (bromobutyl) tip cap with administration set for manual injection (one extension line and one catheter) in pack size of 1.
7.5 mL, 10 mL or 15 mL of solution for injection in 15 mL plastic (polypropylene) pre-filled syringe, graduated every 0.5 mL, with an elastomeric (bromobutyl) plunger stopper and capped with an elastomeric (bromobutyl) tip cap with administration set for Optistar Elite injector (one extension line, one catheter and one empty 60 mL plastic syringe) in pack size of 1.
7.5 mL, 10 mL or 15 mL of solution for injection in 15 mL plastic (polypropylene) pre-filled syringe, graduated every 0.5 mL, with an elastomeric (bromobutyl) plunger stopper and capped with an elastomeric (bromobutyl) tip cap with administration set for Medrad Spectris Solaris EP injector (one extension line, one catheter and one empty 115 mL plastic syringe) in pack size of 1.
Not all pack sizes may be marketed.
Bracco Imaging SPA, Via Egidio Folli, 50, 20134 Milan, Italy
EU/1/23/1773/001-025
| Drug | Countries | |
|---|---|---|
| VUEWAY | Austria, Estonia, France, Croatia, Lithuania |
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