CIMZIA Israel - English - Ministry of Health

cimzia

neopharm ltd, israel - certolizumab pegol - solution for injection - certolizumab pegol 200 mg/ml - certolizumab pegol - rheumatoid arthritis:cimzia, in combination with methotrexate (mtx), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis (ra) in adult patients when the response to disease-modifying antirheumatic drugs (dmards) including methotrexate, has been inadequate. cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. cimzia 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:cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: ankylosing spondylitis (as): adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). axial spondyloarthritis without radiographic evidence of as adults with severe active axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri), who have had an inadequate response to, or are intolerant to nsaids. crohn's disease :cimzia is indicated for reducing signs and symptoms of crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.plaque psoriasis:cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who arecandidates for systemic therapy.

HUMIRA adalimumab 80 mg/0.8 mL injection solution pre-filled syringe Australia - English - Department of Health (Therapeutic Goods Administration)

humira adalimumab 80 mg/0.8 ml injection solution pre-filled syringe

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: polysorbate 80; water for injections; mannitol - rheumatoid arthritis: humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis: humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis: humira is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis: humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn's disease in adults and children (6 years and older): humira is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; - who have had an inadequate response to conventional therapies or, - who have lost response to or are intolerant of infliximab.,ulcerative colitis: humira is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see clinical trials).,psoriasis in adults and children: humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age): humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis: humira is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

HUMIRA adalimumab (rch) 20 mg/0.2 mL solution for injection pre- filled syringe Australia - English - Department of Health (Therapeutic Goods Administration)

humira adalimumab (rch) 20 mg/0.2 ml solution for injection pre- filled syringe

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: mannitol; water for injections; polysorbate 80 - rheumatoid arthritis: humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. humira can be used alone or in combination with methotrexate. juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis: - humira is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis: - humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and older):- humira is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; - who have had an inadequate response to conventional therapies or, - who have lost response to or are intolerant to infliximab.,ulcerative colitis: - humira is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see clinical trials).,psoriasis in adults and children:- humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age):- humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis:- humira is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

HUMIRA adalimumab 80 mg/0.8 mL injection solution pre-filled pen Australia - English - Department of Health (Therapeutic Goods Administration)

humira adalimumab 80 mg/0.8 ml injection solution pre-filled pen

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: polysorbate 80; water for injections; mannitol - rheumatoid arthritis: humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis: humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis: humira is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis: humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn's disease in adults and children (6 years and older): humira is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; - who have had an inadequate response to conventional therapies or, - who have lost response to or are intolerant of infliximab.,ulcerative colitis: humira is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see clinical trials).,psoriasis in adults and children: humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age): humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis: humira is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

HUMIRA adalimumab 40 mg/0.4 mL solution for injection pre-filled pen Australia - English - Department of Health (Therapeutic Goods Administration)

humira adalimumab 40 mg/0.4 ml solution for injection pre-filled pen

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: mannitol; polysorbate 80; water for injections - rheumatoid arthritis humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. humira can be used alone or in combination with methotrexate.,,juvenile idiopathic arthritis humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying antirheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis humira is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis humira is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (?6 years) humira is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; - who have had an inadequate response to conventional therapies or, - who have lost response to or are intolerant of infliximab.,ulcerative colitis humira is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see clinical trials).,psoriasis in adults and children humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age) humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis: humira is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

HUMIRA adalimumab 40 mg/0.4 mL solution for injection pre-filled syringe Australia - English - Department of Health (Therapeutic Goods Administration)

humira adalimumab 40 mg/0.4 ml solution for injection pre-filled syringe

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: mannitol; polysorbate 80; water for injections - rheumatoid arthritis humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying antirheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis humira is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis humira is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (?6 years) humira is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; - who have had an inadequate response to conventional therapies or, - who have lost response to or are intolerant of infliximab.,,ulcerative colitis humira is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see clinical trials).,psoriasis in adults and children humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age) humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis humira is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

AMGEVITA adalimumab (rch) 20mg/0.4mL injection solution syringe Australia - English - Department of Health (Therapeutic Goods Administration)

amgevita adalimumab (rch) 20mg/0.4ml injection solution syringe

amgen australia pty ltd - adalimumab, quantity: 20 mg - injection, solution - excipient ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide - rheumatoid arthritis,amgevita is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. amgevita can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis amgevita is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis amgevita is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis amgevita is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and old) amgevita is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant of infliximab.,ulcerative colitis amgevita is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.,psoriasis in adults and children amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis amgevita is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

AMGEVITA adalimumab (rch) 40mg/0.8mL injection solution syringe Australia - English - Department of Health (Therapeutic Goods Administration)

amgevita adalimumab (rch) 40mg/0.8ml injection solution syringe

amgen australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide - rheumatoid arthritis,amgevita is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. amgevita can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis amgevita is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis amgevita is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis amgevita is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and older) amgevita is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant of infliximab.,ulcerative colitis amgevita is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.,psoriasis in adults and children amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis amgevita is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

AMGEVITA adalimumab (rch) 40mg/0.8mL injection solution syringe within a pen injector Australia - English - Department of Health (Therapeutic Goods Administration)

amgevita adalimumab (rch) 40mg/0.8ml injection solution syringe within a pen injector

amgen australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide - rheumatoid arthritis,amgevita is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. amgevita can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis amgevita is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis amgevita is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis amgevita is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and old) amgevita is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant of infliximab.,ulcerative colitis amgevita is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.,psoriasis in adults and children amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis amgevita is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

HADLIMA Israel - English - Ministry of Health

hadlima

samsung bioepis il ltd, israel - adalimumab - solution for injection - adalimumab 50 mg/ml - adalimumab - rheumatoid arthritishadlima 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.hadlima 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 spondyloarthritisankylosing spondylitis (as):hadlima 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:hadlima 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 arthritishadlima 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 to improve physical function.psoriasishadlima is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.hidradenitis suppurativa (hs)hadlima is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hs therapy.crohn’s diseasehadlima 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. hadlima 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 colitishadlima 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.uveitishadlima 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 corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.intestinal behcet's diseasehadlima is indicated for the treatment of intestinal behcet’s disease in adult patients who have had an inadequate response to conventional therapy.