Shandong Kexing bioproducts Co., Ltd

[Drug name] Generic name: Adalimumab Solution for Injection Trade name: An Jian Ning English name: Adalimumab Solution for Injection Chinese Pinyin: Adamu Dankang Zhusheye [Ingredients] Active ingredient: Adalimumab 40mg. Molecular weight: About 148kD Excipients: Citric acid Sodium citrate Sodium dihydrogen phosphate Disodium hydrogen phosphate Sucrose Polysorbate 80 Sodium hydroxide [Appearance] It should be a colorless or slightly yellow clear solution with slight opalescence. [Indications] Rheumatoid Arthritis This product can be used in combination with methotrexate, is indicate for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response  to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been  inadequate. This product has been shown to reduce the rate of progression of joint damage as  2 / 37measured by X-ray and to improve physical function, when given in combination with methotrexate. Ankylosing spondylitis This product is indicated for the treatment of adults with severe active ankylosing spondylitis who  have had an inadequate response to conventional therapy Psoriasis This product is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult  patients who are candidates for systemic therapy. Crohn’s Disease This product is indicated for treatment of moderately to severely active Crohn’s disease, in adult  patients who have not responded despite a full and adequate course of therapy with a  corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical  contraindications for such therapies. Uveitis This product 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. Juvenile idiopathic arthritis This product in combination with methotrexate is indicated for the treatment of active  polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an  inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). This product can be given as monotherapy in case of intolerance to methotrexate or when continued  treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section [Clinical  trial]).  Adalimumab has not been studied in patients aged less than 2 years. Paediatric plaque psoriasis This product is indicated for the treatment of severe chronic plaque psoriasis in children and  adolescents from 4 years of age who have had an inadequate response to or are inappropriate  candidates for topical therapy and phototherapies. This product should only be given to patients who will be closely monitored and regularly  followed up by a physician. Paediatric Crohn’s disease 3 / 37This product is indicated to reduce signs and symptoms and to induce and maintain clinical  remission in paediatric patients (from 6 years of age) with moderate-to-severe active Crohn's  disease who have an inadequate response to corticosteroid and/or an immunomodulator (e.g.  azathioprine, 6-mercaptopurine, methotrexate). This product is indicated for the treatment of moderately to severely active Crohn's disease in  paediatric patients (from 6 years of age) who have had an inadequate response to conventional  therapy including a corticosteroid and/or an immunomodulator (e.g. azathioprine,  6-mercaptopurine, methotrexate), or who are intolerant to or have contraindications for such  therapies. [Strength] 0.8ml: 40mg