Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Ceft Biopharma s.r.o., Trtinova 260/1, Cakovice, 196 00 Praha 9, Czech Republic
Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations for infusion.
| Pharmaceutical Form |
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Kit for radiopharmaceutical preparations for infusion. Ibritumomab tiuxetan vial: Clear colourless solution. Sodium acetate vial: Clear colourless solution. Formulation buffer vial: Clear yellow to amber coloured solution. |
Zevalin is supplied as a kit for the preparation of yttrium-90 radiolabelled ibritumomab tiuxetan. The kit contains one ibritumomab tiuxetan vial, one sodium acetate vial, one formulation buffer vial, and one empty reaction vial. The radionuclide is not part of the kit.
One ibritumomab tiuxetan vial contains 3.2 mg ibritumomab tiuxetan* in 2 ml solution (1.6 mg per ml).
* murine IgG1 monoclonal antibody produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line and conjugated to the chelating agent MX-DTPA.
The final formulation after radiolabelling contains 2.08 mg ibritumomab tiuxetan [90Y] in a total volume of 10 ml.
Excipients: This medicinal product can contain up to 28 mg sodium per dose, depending on the radioactivity concentration. To be taken into consideration by patients on a controlled sodium diet.
For the full list of excipients, see section 6.1.
| List of Excipients |
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Ibritumomab tiuxetan vial: Sodium chloride Sodium acetate vial: Sodium acetate Formulation buffer vial: Disodium phosphate dodecahydrate |
Zevalin is supplied as a kit for the preparation of yttrium-90 (90Y) radiolabelled ibritumomab tiuxetan.
Zevalin contains 1 of each of the following:
Ibritumomab tiuxetan vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl) containing 2 ml solution.
Sodium acetate vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl) containing 2 ml solution.
Formulation buffer vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl) containing 10 ml solution.
Reaction vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl)
Pack size of 1 kit.
Ceft Biopharma s.r.o., Trtinova 260/1, Cakovice, 196 00 Praha 9, Czech Republic
EU/1/03/264/001
Date of first authorisation: 16 January 2004
Date of latest renewal: 16 January 2009
| Drug | Countries | |
|---|---|---|
| ZEVALIN | Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Poland, United Kingdom, South Africa |
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