Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Alexion Europe SAS, 103-105 rue Anatole France, 92300, Levallois-Perret, FRANCE
Soliris 300 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion. Clear, colorless, pH 7.0 solution. |
Eculizumab is a humanised monoclonal (IgG2/4Îș) antibody produced in NS0 cell line by recombinant DNA technology.
One vial of 30 ml contains 300 mg of eculizumab (10 mg/ml).
After dilution, the final concentration of the solution to be infused is 5 mg/ml.
Excipients with known effect: Sodium (5 mmol per vial)
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Eculizumab |
Eculizumab is a monoclonal antibody, a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. Eculizumab preserves the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes. |
| List of Excipients |
|---|
|
Sodium phosphate, monobasic |
30 ml of concentrate in a vial (Type I glass) with a stopper (butyl, siliconised), and a seal (aluminium) with flip-off cap (polypropylene).
Pack size of one vial.
Alexion Europe SAS, 103-105 rue Anatole France, 92300, Levallois-Perret, FRANCE
EU/1/07/393/001
Date of first authorisation: 20 June 2007
Date of latest renewal: 18 June 2012
| Drug | Countries | |
|---|---|---|
| SOLIRIS | Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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