Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Adalimumab
FRESENIUS KABI MALAYSIA SDN. BHD
Adalimumab
0.8 ml; 0.8 ml
FRESENIUS KABI AUSTRIA GMBH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ IDACIO ® SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Adalimumab (40mg) WHAT IS IN THIS LEAFLET 1. What Idacio® is used for 2. How Idacio® works 3. Before you use Idacio® 4. How to use Idacio® 5. While you are using Idacio® 6. Possible side effects 7. Storage and Disposal of Idacio® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision - If you have a severe infection, including active tuberculosis. - If you have moderate or severe heart failure. - It is important to tell your doctor if you have had or have any of the above. _ _ _ _ - _Pregnancy and lactation _ Do not take Idacio® if you are pregnant, trying to get pregnant or think you may be pregnant. _Taking other medicines_ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. You should not take Idacio® with medicines containing the active substance, anakinra or abatacept. If you have questions, please ask your doctor. WHAT IDACIO® IS USED FOR In adult, Idacio® is intended for treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. In children, Idacio® is prescribed for polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, Crohn’s disease, plaque psoriasis, hidradenitis suppurativa,uveitis and ulcerative colitis. HOW IDACIO® WORKS It is a medicine that decreases the inflammation process of certain diseases. The active ingredient, adalimumab, is a human monoclonal antibody produced by cultured cells. Monoclonal antibodies are proteins that recognise and bind to other unique proteins. Adalimumab binds to a specific protein (tumour necrosis factor or TNF), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, psoriati Přečtěte si celý dokument
1 IDACIO ® Adalimumab PRODUCT NAME IDACIO solution for injection in pre-filled syringe 40mg/0.8ml IDACIO solution for injection in pre-filled pen 40mg/0.8ml IDACIO solution for injection for paediatric use 40mg/0.8ml TRADE NAME IDACIO ® IDACIO (adalimumab) is a biosimilar medicine to the reference product Humira ® . CLINICAL PHARMACOLOGY GENERAL Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of rheumatoid arthritis, including juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis patients and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in hidradenitis suppurativa (HS) lesions. The relationship between these pharmacodynamic activities and the mechanism(s) by which adalimumab exerts its clinical effects is unknown. Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC 50 of 1-2 X 10 -10 M). PHARMACODYNAMICS After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed compared to baseline in patients with RA. A decrease in CRP levels was also observed in patients with JIA, Crohn’s disease, ulcerative colitis and hidradenitis suppurativa as well as a significant reduction in the expression of the TNF and inflammatory markers such as human leucocyte antigen (HLA-DR) and myeloperoxidase (MPO) in the colon of patients with Crohn’s disease. Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that pr Přečtěte si celý dokument