Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Vectibix 20 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Colourless, pH 5.6 to 6.0 solution that may contain translucent to white, visible amorphous, proteinaceous panitumumab particles. |
Each mL of concentrate contains 20 mg panitumumab.
Each vial contains either 100 mg of panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL.
When prepared according to the instructions given in section 6.6, the final panitumumab concentration should not exceed 10 mg/mL.
Panitumumab is a fully human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Excipient with known effect: Each mL of concentrate contains 0.150 mmol sodium, which is 3.45 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Panitumumab |
Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity and specificity to the human EGFR. Panitumumab binds to the ligand binding domain of EGFR and inhibits receptor autophosphorylation induced by all known EGFR ligands. Binding of panitumumab to EGFR results in internalisation of the receptor, inhibition of cell growth, induction of apoptosis, and decreased interleukin 8 and vascular endothelial growth factor production. |
| List of Excipients |
|---|
|
Sodium chloride |
Type I glass vial with an elastomeric stopper, aluminium seal and flip-off plastic cap. One vial contains either 100 mg of panitumumab in 5 mL, or 400 mg panitumumab in 20 mL of concentrate for solution for infusion.
Pack of 1 vial.
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
EU/1/07/423/001
EU/1/07/423/003
Date of first authorisation: 3 December 2007
Date of latest renewal: 15 January 2015
| Drug | Countries | |
|---|---|---|
| VECTIBIX | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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