Active ingredients: Alemtuzumab
MabCampath 30 mg/ml concentrate for solution for infusion.
Concentrate for solution for infusion.
Colourless to slightly yellow concentrate.
One ml contains 30 mg of alemtuzumab.
Each vial contains 30 mg of alemtuzumab.
Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52). The antibody is produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium.
For a full list of excipients, see section 6.1.
Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52) expressed primarily on the surface of normal and malignant peripheral blood B and T cell lymphocytes. Alemtuzumab acts through antibody-dependent cellular cytolysis and complement-mediated lysis following cell surface binding to CD52, a cell surface antigen present at high levels on T (CD3+) and B (CD19+) lymphocytes, and at lower levels on natural killer cells, monocytes, and macrophages.
Potassium dihydrogen phosphate
Dibasic sodium phosphate
Water for injections
Clear type I glass vial, closed with a rubber stopper, containing 1 ml of concentrate.
Pack size: carton of 3 vials.
Genzyme Europe BV
1411 DD Naarden
Date of first authorisation: 06/07/2001
Date of latest renewal: 10/07/2011