ENBREL (etanercept) Qualitative and Quantitative Composition

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Enbrel 25 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 25 mg of etanercept.

Enbrel 50 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 50 mg of etanercept.

Enbrel 25 mg powder and solvent for solution for injection 
Each vial contains 25 mg of etanercept.

Enbrel 25 mg solution for injection in pre-filled pen 
Each pre-filled pen contains 25 mg of etanercept

Enbrel 50 mg solution for injection in pre-filled pen 
Each pre-filled pen contains 50 mg of etanercept

Enbrel 10 mg powder and solvent for solution for injection for paediatric use.
Each vial contains 10 mg of etanercept. When reconstituted, the solution contains 10 mg/ml of etanercept.

Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. This Fc component contains the hinge, CH2 and CH3 regions, but not the CH1 region of IgG1. Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. The specific activity of etanercept is 1.7 x 106 units/mg.

For the full list of excipients, see section 6.1.