Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: CIS bio international, B.P.32, F-91192 Gif-sur-Yvette Cedex, France
Scintimun 1 mg kit for radiopharmaceutical preparation.
| Pharmaceutical Form |
|---|
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Kit for radiopharmaceutical preparation. Scintimun: white powder. Solvent for Scintimun: white powder. |
Each vial of Scintimun contains 1 mg of besilesomab.
Besilesomab is an anti-granulocyte monoclonal antibody (BW 250/183), produced in murine cells.
The radionuclide is not part of the kit.
Excipients with known effect: Each vial of Scintimun contains 2 mg of sorbitol.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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Besilesomab is a murine immunoglobulin of IgG1 isotype that specifically binds to NCA-95 (non specific cross-reacting antigen 95), an epitope expressed at the cell membrane of granulocytes and granulocyte precursors. Besilesomab cross-reacts with tumours expressing carcinoembryonic antigen (CEA). |
| List of Excipients |
|---|
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Scintimun vial: Sodium dihydrogen phosphate, anhydrous Solvent for Scintimun vial: 1, 1, 3, 3-propane tetraphosphonic acid, tetrasodium salt, dihydrate (PTP) |
Scintimun vial: 15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and aluminium crimped capsule (green) containing 5.02 mg of powder.
Solvent for Scintimun: 15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and crimped aluminium capsule (yellow) containing 2.82 mg of powder.
Pack sizes:
Kit of one multidose vial of Scintimun and one vial of solvent.
Kit of two multidose vials of Scintimun and two vials of solvent.
Not all pack sizes may be marketed.
CIS bio international, B.P.32, F-91192 Gif-sur-Yvette Cedex, France
EU/1/09/602/001
EU/1/09/602/002
Date of first authorisation: 11 January 2010
Date of latest renewal: 26 August 2014
| Drug | Countries | |
|---|---|---|
| SCINTIMUN | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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