Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX ISUMMARY OF PRODUCT OF THE MEDICINAL PRODUCT humira 20 mg solution for injection in pre-filled AND QUANTITATIVE COMPOSITION Each ml single dose pre-filled syringe contains 20 mg of adalimumab. Adalimumab is a recombinant human monoclonal antibody producedin Chinese Hamster Ovary the full list of excipients, see section FORM Solution for injection.(injection)Clear, colourless solution. indications Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritisHumira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2years 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 ).
Humira has not been studied in these patient populations. No dose recommendations can be made. Method of administration Humira is administered by subcutaneous injection. Full instructions for use are provided in the package leaflet. Humira is available in other strengths and presentations. 4.3 Contraindications
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