Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Magnevist 2 mmol/l solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to pale yellow or brownish-yellow solution. |
1 ml aqueous solution contains 1.876 mg gadopentetic acid, dimeglumine salt as active ingredient (equivalent to 0.002 mmol gadopentetic acid, dimeglumine, containing 0.32 mg gadolinium).
Excipient with known effect: sodium chloride.
Magnevist 2 mmol/l contains 3.4 mg sodium per ml.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Gadopentetate dimeglumine |
Gadopentetic acid is a paramagnetic contrast agent for magnetic resonance imaging. |
| List of Excipients |
|---|
|
Pentetic acid |
Colourless Type I, glass pre-filled syringe with chlorinated butyl rubber stopper and combined luer lock adapter, tip cap (chlorobutyl rubber), safety cap.
Pack size: syringe containing 20 ml of Magnevist solution; individual syringe is blister packaged, with one syringe per carton.
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
PL 00010/0544
Date of First Authorisation: 01 May 2008
Date of Renewal of the Authorisation: 23 February 2009
| Drug | Countries | |
|---|---|---|
| MAGNEVIST | Austria, Canada, Cyprus, Estonia, Lithuania, Poland, Singapore, United Kingdom, United States, South Africa |
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