Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216, Ingelheim am Rhein, Germany
Praxbind 2.5 g/50 mL solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Clear to slightly opalescent, colourless to slightly yellow solution. |
Each mL of solution for injection/infusion contains 50 mg idarucizumab.
Each vial contains 2.5 g idarucizumab in 50 mL.
Idarucizumab is produced by recombinant DNA technology in Chinese Hamster Ovary cells.
Excipients with known effect: Each 50 mL vial contains 2 g sorbitol and 25 mg sodium (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Idarucizumab |
Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity, approximately 300-fold more potent than the binding affinity of dabigatran for thrombin. The idarucizumab-dabigatran complex is characterised by a rapid on-rate and extremely slow off-rate resulting in a very stable complex. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises their anticoagulant effect. |
| List of Excipients |
|---|
|
Sodium acetate trihydrate |
50 mL solution in a glass vial (type I glass), with a butyl rubber stopper, an aluminium cap and a label with integrated hanger.
Pack size of 2 vials.
Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216, Ingelheim am Rhein, Germany
EU/1/15/1056/001
Date of first authorisation: 20 November 2015
| Drug | Countries | |
|---|---|---|
| PRAXBIND | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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