ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

1 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).

2 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 patients aged less than arthritisHumira is indicated for the treatment of active enthesitis-related arthritis in patients, 6years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section ).Paediatric plaque psoriasisHumira 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 Crohn's disease humira is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6years of age)

3 Who have had an inadequate response to conventional therapy including primary nutrition therapyand a corticosteroidand/or an immunomodulator, or who are intolerant to or have contraindications for such UveitisHumira is indicated for the treatment of paediatricchronic non-infectiousanterior 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 and method of administration 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 oftreatment with humira (see section ).

4 Patients treated with humira should be given the Patient Reminder 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. During treatment with humira , other concomitant therapies ( , corticosteroids and/or immunomodulatory agents) should be populationJuvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritis from 2 years of ageThe recommended dose of humira for patients with polyarticular juvenile idiopathic arthritisfrom 2years of age is based on body weight (Table 1). humira isadministered every other week via subcutaneous 1. humira Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient WeightDosing Regimen10 kg to < 30 kg20 mg every other week 30 kg40 mg every other weekAvailable data suggest that clinical response is usually achieved within 12weeks of therapy should be carefully reconsidered in a patient not responding within this time is no relevant use of humira in patients agedless than2 years for this may be available in other strengths and/or presentations depending on the individual treatment arthritisThe recommended dose of humira for patients with enthesitis-related arthritis from 6 years of ageis based on body weight (Table 2).

5 humira is administered every other week via subcutaneous humira Dose for Patients with Enthesitis-Related Arthritis Patient WeightDosing Regimen15 kg to < 30 kg20 mg every other week 30 kg40 mg every other weekHumira has not been studied in patients with enthesitis-related arthritis aged less than may be available in other strengths and/or presentations depending on the individual treatment plaque psoriasisThe recommended humira dose for patients with plaque psoriasis from 4 to 17years of age is based on body weight (Table 3). humira is administered via subcutaneous 3. humira Dose for Paediatric Patients with Plaque Psoriasis Patient WeightDosing Regimen15 kg to < 30 kgInitial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose 30 kgInitial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial doseContinued therapy beyond 16weeks should be carefully considered in a patient not responding within this time retreatment with humira is indicated.

6 The above guidance on dose and treatment duration should be safetyof humira in paediatric patients with plaque psoriasis has been assessed for a mean of 13 is no relevant use of humira in children aged less than 4years for this may be available in other strengths and/or presentations depending on the individual treatment Crohn's diseaseThe recommended dose of humira for patients with Crohn s disease from 6to 17 years of age is based on body weight(Table 4). humira is administered via subcutaneous 4. humira Dose for Paediatric Patients with Crohn s diseasePatient WeightInduction DoseMaintenance DoseStartingatWeek 4< 40 kg 40 mg at week 0 and 20 mg at week 2In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: 80 mg at week 0 and 40 mg at week 220 mg every other week 40 kg 80 mg at week 0 and 40 mg at week 2In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used.

7 160 mg at week 0 and 80 mg at week 240 mg every other weekPatients who experience insufficient response may benefit from an increase in dosage: < 40 kg: 20 mg every week 40 kg: 40 mg every weekor 80 mg every other weekContinued therapy should be carefully considered in a subject not responding by week is no relevant use of humira in children aged less than6 years for this may be available in other strengths and/or presentations depending on the individual treatment UveitisThe recommended dose of humira for paediatric patients with uveitisfrom 2years of age is based on body weight(Table 5). humira is administered via subcutaneous paediatric uveitis, there is no experience in the treatment with humira without concomitant treatment with humira Dose for Paediatric Patients with UveitisPatient WeightDosing Regimen< 30 kg20 mg every other week in combination with methotrexate 30 kg40 mg every other week in combination with methotrexateWhen humira therapy is initiated, a loading dose of 40mg for patients < 30kg or 80mg for patients 30 kg may be administered one week prior to the start of maintenance clinical data are available on the use of a humira loading dose in children <6 years of age (see section ).

8 6 There is no relevant use of humira in children aged less than 2years in this is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section ). humira may be available in other strengths and/or presentations depending on the individual treatment and/or hepatic impairmentHumira has not been studied in these patient populations. No dose recommendations can be of administrationHumira is administered by subcutaneous injection. Full instructions for use are provided in the package is available in other strengths and Hypersensitivity to theactive substance or to any of the excipients listed in section Active tuberculosis or other severe infections such as sepsis and opportunistic infections (see section ).

9 Moderate to severe heart failure (NYHA class III/IV) (see section ). warnings and precautions for useTraceabilityIn order to improve traceability of biological medicinal products, the nameand the batch number of the administered PRODUCT should be clearly taking TNF-antagonists are more susceptible to serious infections. Impaired lung function may increase the risk for developing infections. Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with humira . Because the elimination of adalimumab may take up to four months, monitoring should be continued throughout this with humira should not be initiated in patients with active infections including chronic or localised infections untilinfections are controlled.

10 In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with humira should be considered prior to initiating therapy (see Other opportunistic infections).Patients who develop a new infection while undergoing treatment with humira should be monitored closely and undergo a complete diagnostic evaluation. Administration of humira should be discontinued if a patient develops a new serious infection or sepsis and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled. Physicians should exercise caution when considering the use of humira in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive infectionsSerious infections, including sepsis,due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infectionssuch as listeriosis, legionellosis and pneumocystishave been reported in patients receiving humira .