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Erelzi
Therapeutic indications
Rheumatoid arthritis
Erelzi is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless contraindicated) has been inadequate.
Erelzi can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.
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
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 have proved intolerant of, methotrexate.
Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Etanercept has not been studied in children aged less than 2 years
Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Axial spondyloarthritis
Ankylosing spondylitis (AS)
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Non-radiographic axial spondyloarthritis
Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs).
Plaque psoriasis
Treatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Paediatric plaque psoriasis
Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Hyrimoz®
adalimumab biosimilar by Sandoz Therapeutic indications Rheumatoid arthritis
Hyrimoz in combination with methotrexate, is indicated for:
• the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Axial spondyloarthritis
Ankylosing spondylitis (AS)
Hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS
Hyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS, but with objective signs of inflammation by radiological and/or laboratory tests including MRI and serum CRP levels , who have had an inadequate response to, or are intolerant to, non - steroidal anti-inflammatory drugs.
Psoriatic arthritis
Hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Psoriasis
Hyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Hidradenitis suppurativa (HS)
Hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Crohn’s disease
Hyrimoz is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Hyrimoz is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Ulcerative colitis
Hyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Uveitis
Hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of 3 corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Intestinal Behcet’s disease
Hyrimoz is indicated for the treatment of intestinal Behcet’s disease in patients who have had an inadequate response to conventional therapy.