Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Adalimumab
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
Adalimumab
1 Capsules; 1 Units; 2 Units
Sandoz GmbH, Biochemiestrasse
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ HYRIMOZ SOLUTION FOR INJECTION IN PRE-FILLED PEN Adalimumab (40mg/0.8ml) _ _ _ _ _1 _ _ _ WHAT IS IN THIS LEAFLET 1. What Hyrimoz is used for 2. How Hyrimoz works 3. Before you use Hyrimoz 4. How to use Hyrimoz 5. While you are using it 6. Side effects 7. Storage and Disposal of Hyrimoz 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT HYRIMOZ IS USED FOR Hyrimoz is intended for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis aged above 2 years old, axial spondyloarthritis (ankylosing spondylitis and Non- radiographic axial spondyloarthritis), psoriatic arthritis, enthesitis-related arthritis in children aged 6 years and above, psoriasis in adults and children aged 4 years and above, Crohn’s disease in adults and children aged 6 years and above, ulcerative colitis in adults and children aged 6 years and above, hidradenitis suppurativa in adults and adolescents, and uveitis in adults and children aged 2 years and above. HOW HYRIMOZ WORKS It is a medicine that decreases the inflammation process of these 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 TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, axial spondyloarthritis (ankylosing spondylitis and Non-radiographic axial spondyloarthritis), psoriatic arthritis, psoriasis, ulcerative colitis, hidradenitis suppurativa , Crohn’s disease, Uveitis and Enthesitis-Related Arthritis. BEFORE YOU USE HYRIMOZ - _When you must not use it _ • If you are allergic (hypersensitive) to adalimumab or any of the other ingredients of Hyrimoz. • If you have a severe infection, including active tuberculosis. It is important that you tell Prečítajte si celý dokument
1 1. NAME OF THE MEDICINAL PRODUCT Hyrimoz 40mg/0.8ml Solution for Injection in Pre-Filled Pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.8 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 to slightly opalescent, colourless to slightly yellowish solution. Hyrimoz is a biosimilar medicinal product of Humira. Hyrimoz is not interchangeable or automatically substitutable with Humira. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RHEUMATOID ARTHRITIS Hyrimoz is indicated for reducing signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Hyrimoz can be used alone or in combination with methotrexate or other disease modifying antirheumatic drugs (DMARDs). PSORIATIC ARTHRITIS Hyrimoz is indicated for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis. Hyrimoz can be used alone or in combination with disease modifying anti-rheumatic drugs. AXIAL SPONDYLOARTHRITIS ANKYLOSING SPONDYLITIS Hyrimoz is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS (AXIAL SPONDYLOARTHRITIS WITHOUT RADIOGRAPHIC EVIDENCE OF AS) Hyrimoz is indicated for reducing signs and symptoms in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. PLAQUE PSORIASIS Hyrimoz is indicated for the treatment of adult patients with moderat Prečítajte si celý dokument