Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
CINQAERO 10 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to slightly hazy opalescent, colourless to slightly yellow solution with pH 5.5. Proteinaceous particles might be present. |
Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL).
Each vial of 2.5 mL contains 25 mg of reslizumab.
Each vial of 10 mL contains 100 mg of reslizumab.
Reslizumab is a humanised monoclonal antibody produced in mouse myeloma cells (NS0) by recombinant DNA technology.
Excipient with known effect:
Each vial of 2.5 mL contains 0.05 mmol (1.15 mg) of sodium.
Each vial of 10 mL contains 0.20 mmol (4.6 mg) of sodium.
For the full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Reslizumab |
Reslizumab is a humanised monoclonal antibody (IgG4, Îș) against the human interleukin-5 (IL-5). Reslizumab binds specifically to IL-5 and interferes with IL-5 binding to its cell-surface receptor. IL-5 is a key cytokine responsible for the differentiation, maturation, recruitment and activation of human eosinophils. Reslizumab binds human IL-5 with picomolar affinity blocking its biological function; consequently survival and activity of eosinophils are reduced. |
| List of Excipients |
|---|
|
Sodium acetate trihydrate |
2.5 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a white plastic flip-off cap.
10 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a blue plastic flip-off cap.
Pack sizes:
Not all pack sizes may be marketed.
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
EU/1/16/1125/001 – 1 vial of 10 mL
EU/1/16/1125/002 – 1 vial of 2.5 mL
EU/1/16/1125/003 – 2 vials of 10 mL
EU/1/16/1125/004 – 2 vials of 2.5 mL
Date of first authorisation: 16 August 2016
| Drug | Countries | |
|---|---|---|
| CINQAERO | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, United Kingdom |
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