ADALIMUMAB KAMADA

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

ADALIMUMAB

Dostopno od:

KAMADA LTD, ISRAEL

Farmacevtska oblika:

SOLUTION FOR INJECTION

Sestava:

ADALIMUMAB 100 MG/ML

Pot uporabe:

S.C

Tip zastaranja:

Required

Izdeluje:

ALVOTECH HF, ICELAND

Terapevtske indikacije:

Rheumatoid arthritisAdalimumab Kamada 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.Adalimumab Kamada 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.Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritisAdalimumab Kamada in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years, weighing > 30 Kg,who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab Kamada can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate . Adalimumab has not been studied in patients aged less than 2 years.Enthesitis-related arthritisAdalimumab Kamada is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, weighing > 30 Kg, who have had an inadequate response to, or who are intolerant of, conventional therapy .Axial spondyloarthritisAnkylosing spondylitis (AS): Adalimumab Kamada 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: Adalimumab Kamada 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 Adalimumab Kamada 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 and to improve physical function.Psoriasis Adalimumab Kamada is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.Paediatric plaque psoriasisAdalimumab Kamada is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age, weighing > 30 Kg, who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.Hidradenitis suppurativa (HS)Adalimumab Kamada is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age, weighing > 30 Kg, with an inadequate response to conventional systemic HS therapy .Crohn’s diseaseAdalimumab Kamada 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. Adalimumab Kamada 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.Paediatric Crohn's disease Adalimumab Kamada is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age, weighing > 40 Kg) who have had an inadequate response to conventional therapy including primary nutrition therapy and corticosteroid, and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.Ulcerative colitisAdalimumab Kamada 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.Paediatric ulcerative colitisAdalimumab Kamada is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.Uveitis Adalimumab Kamada 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 corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.Paediatric Uveitis Adalimumab Kamada is indicated for the treatment of chronic non-infectious uveitis in paediatric patients from 2 years of age, weighing > 30 Kg, who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Datum dovoljenje:

2023-02-08