Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
Adtralza 150 mg solution for injection in pre-filled syringe.
Adtralza 300 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear to opalescent, colourless to pale yellow solution, pH 5.5 and osmolarity approximately 280 mOsm/L. |
Adtralza 150 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 150 mg of tralokinumab in 1 mL solution (150 mg/mL).
Adtralza 300 mg solution for injection in pre-filled pen: Each pre-filled pen contains 300 mg of tralokinumab in 2 mL solution (150 mg/mL).
Tralokinumab is produced in mouse myeloma cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tralokinumab |
Tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to the type 2 cytokine interleukin-13 (IL-13) and inhibits its interaction with the IL-13 receptors. Tralokinumab neutralises the biological activity of IL-13 by blocking its interaction with the IL-13Rα1/IL-4Rα receptor complex. IL-13 is a major driver of human type 2 inflammatory disease, such as atopic dermatitis and inhibiting the IL-13 pathway with tralokinumab in patients decreases many of the mediators of type 2 inflammation. |
| List of Excipients |
|---|
|
Sodium acetate trihydrate (E262) |
Adtralza 150 mg solution for injection in pre-filled syringe:
1 mL solution in a siliconised type-1 clear glass pre-filled syringe with 27 gauge ½ inch thin wall stainless steel staked needle, elastomer plunger stopper extended finger flange and needle guard.
Pack size:
Adtralza 300 mg solution for injection in pre-filled pen:
2 mL solution in a siliconised type-1 clear glass syringe in a pre-filled pen, with a 27 gauge ½ inch, thin wall stainless steel staked needle.
Pack size:
Not all pack sizes may be marketed.
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
Date of first authorisation: 17 June 2021
| Drug | Countries | |
|---|---|---|
| ADTRALZA | Estonia, Croatia, Ireland, Japan, Lithuania, Poland, Romania, United Kingdom |
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