Source: European Medicines Agency (EU) Revision Year: 2009 Publisher: Serono Europe Ltd., 56 Marsh Wall, London E14 9TP, United Kingdom
Raptiva 100 mg/ml powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. The powder is a white to off white cake. The solvent is a clear, colourless liquid. The pH of the reconstituted solution is 5.9-6.5. |
Each vial contains a retrievable amount of 125 mg of efalizumab.
Reconstitution with the solvent yields a solution containing efalizumab at 100 mg/ml.
Efalizumab is a recombinant humanized monoclonal antibody produced in genetically engineered Chinese Hamster Ovary (CHO) cells. Efalizumab is an IgG1 kappa immunoglobulin, containing human constant region sequences and murine light- and heavy-chain complementary determining region sequences.
Excipients: 2.5 mg polysorbate 20, 3.55 mg histidine, 5.70 mg histidine hydrochloride monohydrate, 102.7 mg sucrose.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Efalizumab |
Efalizumab is a recombinant humanized monoclonal antibody that binds specifically to the CD11a subunit of LFA-1 (lymphocyte function-associated antigen-1), a leukocyte cell surface protein. By this mechanism, efalizumab inhibits the binding of LFA-1 to ICAM-1, which interferes with T lymphocytes adhesion to other cell types. By preventing LFA-1/ICAM binding, efalizumab may alleviate signs and symptoms of psoriasis by inhibiting several stages in the immunologic cascade. |
| List of Excipients |
|---|
|
Powder for solution for injection: Polysorbate 20 Solvent: Water for injections |
Powder: Colourless type I glass vial with a butyl rubber stopper, and aluminium seal fitted with a flip-off plastic cap.
Solvent: Type I glass pre-filled syringe.
Raptiva is available in:
Packs of 1 vial of powder, 1 pre-filled syringe of solvent, 1 EasyMIX adapter for reconstitution and 1 needle for injection.
Packs of 4 vials of powder, 4 pre-filled syringes of solvent, 4 EasyMIX adapters for reconstitution and 4 needles for injection.
Packs of 12 vials of powder, 12 pre-filled syringes of solvent, 12 EasyMIX adapters for reconstitution and 12 needles for injection.
Not all pack sizes may be marketed.
Serono Europe Ltd., 56 Marsh Wall, London E14 9TP, United Kingdom
EU/1/04/291/001
EU/1/04/291/002
EU/1/04/291/003
Date of first authorisation: 20 September 2004
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