VECTIBIX Concentrate for solution for infusion Ref.[8859] Active ingredients: Panitumumab

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands

Product name and form

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.

Qualitative and quantitative composition

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
Sodium acetate trihydrate
Acetic acid, glacial (for pH-adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands

Marketing authorization dates and numbers

EU/1/07/423/001
EU/1/07/423/003

Date of first authorisation: 3 December 2007

Date of latest renewal: 15 January 2015

Drugs

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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