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.
Disodium edetate
Polysorbate 80
Potassium chloride
Potassium dihydrogen phosphate
Sodium chloride
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
Gooimeer 10
1411 DD Naarden
Netherlands
EU/1/01/193/002
Date of first authorisation: 06/07/2001
Date of latest renewal: 10/07/2011