Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
ReoPro 2 mg/mL solution for injection or infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection or infusion. ReoPro is a colourless and clear liquid. |
ReoPro 2 mg/mL contains 10 mg abciximab in 5 mL water for injection.
Abciximab is the Fab fragment of a chimeric IgG1 monoclonal antibody manufactured from a recombinant cell line cultured by continuous perfusion.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Abciximab |
Abciximab is the Fab fragment of the chimeric monoclonal antibody 7E3. It is directed against the glycoprotein (GP) IIb/IIIa (αIIbβ3) receptor located on the surface of human platelets. Abciximab inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor, and other adhesive molecules to GPIIb/IIIa receptor sites on activated platelets. |
| List of Excipients |
|---|
|
Water for injection |
ReoPro is supplied as a 5 mL solution in a type I borosilicate glass vial with a Teflon-coated rubber stopper and an aluminium crimp protected by a plastic cap in a pack size of one.
Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
PL 08563/0015
Date of first authorisation: 23 March 1995
Date of last renewal of the authorisation: 22 March 2010
| Drug | Countries | |
|---|---|---|
| REOPRO | Brazil |
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