Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Primovist 0.25 mmol/ml, solution for injection, pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection, prefilled syringe. Clear, colourless to pale yellow liquid free from visible particles. |
Each ml contains 0.25 mmol gadoxetate disodium (Gd-EOB-DTPA disodium), equivalent to 181.43 mg gadoxetate disodium.
1 prefilled syringe with 5.0 ml contains 907 mg gadoxetate disodium,
1 prefilled syringe with 7.5 ml contains 1361 mg gadoxetate disodium,
1 prefilled syringe with 10.0 ml contains 1814 mg gadoxetate disodium.
Excipients with known effect: 11.7 mg sodium/ml.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Gadoxetic acid |
Gadoxetic acid is a paramagnetic contrast agent for magnetic resonance imaging. The contrast-enhancing effect is mediated by gadoxetate (Gd EOB DTPA), an ionic complex consisting of gadolinium (III) and the ligand ethoxybenzyl-diethylenetriamine-pentaacetic acid (EOB-DTPA). |
| List of Excipients |
|---|
|
Caloxetate trisodium |
Glass syringes: 10 ml prefilled syringes consisting of a colourless siliconized PhEur type I glass barrel, a siliconized chlorobutyl elastomer plunger stopper, a chlorobutyl elastomer rubber tip cap, a polysulfone Luer Lock adapter and a polypropylene safety cap.
Plastic syringes: 10 ml prefilled syringes consisting of a colourless cycloolefin polymer plastic barrel with a thermoplastic elastomer tip seal, closed with a siliconized bromobutyl plunger.
Package sizes:
1, 5 and 10 × 5 ml (in 10 ml prefilled syringe)
1, 5 and 10 × 7.5 ml (in 10 ml prefilled syringe) (glass only)
1, 5 and 10 × 10 ml (in 10 ml prefilled syringe)
Not all pack sizes may be marketed.
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
PL 00010/0555
Date of first authorisation: 10 November 2004
Date of renewal of the authorisation: 26 March 2014
| Drug | Countries | |
|---|---|---|
| PRIMOVIST | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Japan, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
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