Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
adalimumab
AbbVie Deutschland GmbH Co. KG
L04AB04
adalimumab
Immunosuppressants
Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Arthritis, Rheumatoid
Please refer to the product information document.
Revision: 89
Authorised
2003-09-08
317 B. PACKAGE LEAFLET 318 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HUMIRA 20 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE adalimumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION. Keep this leaflet. You may need to read it again. Your doctor will also give you a PATIENT REMINDER CARD, which contains important safety information that you need to be aware of before your child begins using Humira and during treatment with Humira. Keep this PATIENT REMINDER CARD with you or your child. If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child. If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Humira is and what it is used for 2. What you need to know before your child uses Humira 3. How to use Humira 4. Possible side effects 5 How to store Humira 6. Contents of the pack and other information 7. Injecting Humira 1. WHAT HUMIRA IS AND WHAT IT IS USED FOR Humira contains the active substance adalimumab. Humira is intended for the treatment of the inflammatory diseases described below: Polyarticular juvenile idiopathic arthritis Enthesitis-related arthritis Paediatric plaque psoriasis Paediatric Crohn’s disease Paediatric uveitis The active ingredient in Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target. The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Humira decreases the process of inflammation in these diseases. Polyarticular juvenile idiopathic arthritis Poly Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Humira 20 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.2 ml single dose pre-filled syringe contains 20 mg of adalimumab. Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. (injection) Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 5.1). Humira has not been studied in patients aged less than 2 years. _Enthesitis-related arthritis_ 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 therapy (see section 5.1). 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 are intolerant to or have contraindications for such therapies. 3 Paediatric Uveitis Humira is i Прочетете целия документ