Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Fresenius Kabi Deutschland GmbH, Else-Kroener-Strasse 1, 61352 Bad Homburg v.d.Hoehe, Germany
Tyenne 20 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear and colourless to pale yellow solution. |
Each mL concentrate contains 20 mg tocilizumab*.
Each vial contains 80 mg of tocilizumab* in 4 mL (20 mg/mL).
Each vial contains 200 mg of tocilizumab* in 10 mL (20 mg/mL).
Each vial contains 400 mg of tocilizumab* in 20 mL (20 mg/mL).
* humanised IgG1 monoclonal antibody against the human interleukin-6 (IL-6) receptor produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tocilizumab |
Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R). IL-6 is involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, induction of hepatic acute phase protein synthesis and stimulation of haemopoiesis. IL-6 has been implicated in the pathogenesis of diseases including inflammatory diseases, osteoporosis and neoplasia. |
| List of Excipients |
|---|
|
L-arginine |
Tyenne is supplied in a vial (type I glass) with a stopper (bromobutyl rubber) containing 4 mL, 10 mL or 20 mL concentrate. Each pack contains 1 vial and multipacks contain 4 (4 packs of 1) vials.
Not all pack sizes may be marketed.
Fresenius Kabi Deutschland GmbH, Else-Kroener-Strasse 1, 61352 Bad Homburg v.d.Hoehe, Germany
EU/1/23/1754/001
EU/1/23/1754/002
EU/1/23/1754/003
EU/1/23/1754/004
EU/1/23/1754/005
EU/1/23/1754/006
| Drug | Countries | |
|---|---|---|
| TYENNE | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, United Kingdom, United States |
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