1. NAME OF THE MEDICINAL PRODUCT Erelzi 25 mg solution for injection in pre-filled syringe Erelzi 50 mg solution for injection in pre-filled syringe Erelzi 50 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Erelzi 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept. Erelzi 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept. Erelzi 50 mg solution for injection in pre-filled pen Each pre-filled pen contains 50 mg 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. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) Solution for injection (injection) in pre-filled pen (SensoReady pen) The solution is clear or slightly opalescent, colourless to slightly yellowish. 4.
CLINICAL PARTICULARS 4.1 Therapeutic indications Rheumatoid arthritis Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis 2