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post in: Lifestyle, News Date:11 Oct 2017, 07:00 views:2535
Name of the medicinal product. Humira 40 mg/0.8 ml solution for injection for paediatric use.
Qualitative and quantitative composition, each.8 ml single dose vial contains 40 mg of adalimumab. Adalimumab is a recombinant hours human monoclonal antibody expressed in Chinese Hamster Ovary cells. For the full list of excipients, see section.1.
Pharmaceutical form, solution for injection.
Juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, humira 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). Humira 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.1).
Humira has not been studied in patients aged less than 2 years. Humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional allergy therapy (see section.1). Paediatric plaque psoriasis, humira 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.
Paediatric Crohn's disease, humira 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 primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who. Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections.1 and.2). Paediatric Uveitis, humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated.
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira (see section.4). Patients treated with Humira should be given the special alert card. After proper training in injection technique, patients may self-inject with Humira if their physician determines that it is appropriate and with medical follow-up as necessary.
Posology, paediatric population, juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis from 2 to 12 years of age. The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 2-12 years, is 24 mg/m body surface area up to a maximum single dose of 20 mg adalimumab (for patients aged 2- 4) and up to a maximum single dose of 40mg.
The volume for injection is selected based on the patients' height and weight (Table 1).