Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Sanofi Belgium, Leonardo Da Vincilaan 19, B-1831, Diegem, Belgium
LEMTRADA 12 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). A clear, colourless to slightly yellow concentrate with pH 7.0–7.4. |
Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml).
Alemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant DNA technology.
Excipients with known effect:
This medicine contains less than 1 mmol potassium (39 mg) per infusion, i.e. it is essentially ‘potassium-free’.
This medicine contains less than 1 mmol sodium (23 mg) per infusion, i.e. it is essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Alemtuzumab |
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. |
| List of Excipients |
|---|
|
Disodium phosphate dihydrate (E339) |
LEMTRADA is supplied in a clear, 2 ml glass vial, with a butyl rubber stopper and aluminium seal with a plastic flip-off cap.
Pack size: carton with 1 vial
Sanofi Belgium, Leonardo Da Vincilaan 19, B-1831, Diegem, Belgium
EU/1/13/869/001
Date of first authorisation: 12 September 2013
Date of latest renewal: 2 July 2018
| Drug | Countries | |
|---|---|---|
| LEMTRADA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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