Država: Armenija
Jezik: engleski
Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
etanercept
Wyeth Pharmaceuticals
etanercept
50mg/ml
solution for s/c injection
Prescription
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 187 1. NAME OF THE MEDICINAL PRODUCT Enbrel 50 mg solution for injection in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe 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. 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, CH 2 and CH 3 regions, but not the CH 1 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 10 6 units/mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear, and colourless or pale yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS R h eumatoid arthritis Enbrel 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. Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Enbrel, 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 Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who Pročitajte cijeli dokument