Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Adalimumab
AbbVie Ltd
L04AB04
Adalimumab
100mg/1ml
Solution for injection
Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 8054083010038
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HUMIRA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE adalimumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − Your doctor will also give you a PATIENT ALERT CARD, which contains important safety information that you need to be aware of before you begin using Humira and during treatment with Humira. Keep this PATIENT ALERT CARD with you. − If you have any questions, ask your doctor or pharmacist. − This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. − If you get 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 you use Humira 3. How to use Humira 4. Possible side effects 5 How to store Humira 6. Contents of the pack and other information 7. Instructions for use 1. WHAT HUMIRA IS AND WHAT IT IS USED FOR Humira contains the active substance adalimumab. Humira is used to treat • Rheumatoid arthritis • Polyarticular juvenile idiopathic arthritis • Enthesitis-related arthritis • Ankylosing spondylitis • Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis • Psoriatic arthritis • Plaque psoriasis • Hidradenitis suppurativa • Crohn’s disease • Ulcerative colitis • Non-infectious 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 Lestu allt skjalið
OBJECT 1 HUMIRA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Summary of Product Characteristics Updated 05-Jul-2018 | AbbVie Limited 1. Name of the medicinal product Humira 40 mg solution for injection in pre-filled syringe Humira 40 mg solution for injection in pre-filled pen 2. Qualitative and quantitative composition Humira 40 mg solution for injection in pre-filled syringe Each 0.4 ml single dose pre-filled syringe contains 40 mg of adalimumab. Humira 40 mg solution for injection in pre-filled syringe with automatic needle guard Each 0.4 ml single dose pre-filled syringe contains 40 mg of adalimumab. Humira 40 mg solution for injection in pre-filled pen Each 0.4 ml single dose pre-filled pen contains 40 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 Rheumatoid arthritis Humira in combination with methotrexate, is indicated for: ▪ the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. ▪ the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. 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-rheum Lestu allt skjalið