Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands, bioepis.mi@medinformation.co.uk
Aybintio 25 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to pale brown liquid. |
Each ml of concentrate contains 25 mg of bevacizumab*.
Each 4 ml vial contains 100 mg of bevacizumab.
Each 16 ml vial contains 400 mg of bevacizumab.
For dilution and other handling recommendations, see section 6.6.
* Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Bevacizumab |
Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells. Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth. |
| List of Excipients |
|---|
|
Trehalose dihydrate |
4 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab.
16 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 400 mg of bevacizumab.
Pack of 1 vial.
Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands, bioepis.mi@medinformation.co.uk
EU/1/20/1454/001 – 100 mg/4 ml vial
EU/1/20/1454/002 – 400 mg/16 ml vial
Date of first authorisation: 19 August 2020
| Drug | Countries | |
|---|---|---|
| AYBINTIO | Austria, Estonia, Spain, France, Croatia, Ireland, Lithuania, Poland, United Kingdom |
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