Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Upadacitinib Hemihydrate
ABBVIE SDN BHD
Upadacitinib Hemihydrate
28 Tablets
Abbvie Ireland NL B.V
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ RINVOQ ® 15 mg Extended-Release Film Coated Tablets Upadacitinib (15 mg) _________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What RINVOQ ® is used for 2. How RINVOQ ® works 3. Before you use RINVOQ ® 4. How to use RINVOQ ® 5. While you are using it 6. Side effects 7. Storage and Disposal of RINVOQ ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT RINVOQ ® IS USED FOR RINVOQ ® is used to treat adults with: - moderately to severely active rheumatoid arthritis. Rheumatoid arthritis is a disease that causes inflamed joints. - active psoriatic arthritis. Psoriatic arthritis is a disease that causes inflamed joints and psoriasis. - active ankylosing spondylitis. Ankylosing spondylitis is a disease that primarily causes inflammation in the spine. RINVOQ ® is used to treat adults and adolescents 12 years and older with moderate to severe atopic dermatitis, also known as atopic eczema. RINVOQ ® may be used with eczema medicines that you apply to the skin or it may be used on its own. HOW RINVOQ ® WORKS RINVOQ ® works by reducing the activity of an enzyme in the body called ‘Janus kinase’. Rheumatoid arthritis RINVOQ ® can help to reduce pain, stiffness and swelling in your joints, reduce tiredness, and it can slow down damage to the bone and cartilage in your joints. These effects can ease your normal daily activities and so improve your quality of life. Psoriatic arthritis RINVOQ ® can help to reduce pain, stiffness, and swelling in and around your joints, pain and stiffness in your spine, psoriatic skin rash, and tiredness, and it can slow down damage to the bone and cartilage in your joints. These effects can ease your normal daily activities and so improve your quality of life. Atopic Dermatitis Taking RINVOQ ® can improve the condition of your skin and reduce itching and flares. RINVOQ ® can help improve symptoms of Přečtěte si celý dokument
1 RINVOQ®15 mg extended-release film coated tablets QUALITATIVE AND QUANTITATIVE COMPOSITION Each extended-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg of upadacitinib. For the full list of excipients, see LIST OF EXCIPIENTS section. PHARMACEUTICAL FORM Extended-release tablet. RINVOQ® 15 mg extended-release film coated tablets Purple 14 x 8 mm, oblong biconvex extended-release tablets imprinted on one side with ‘a15’. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Rheumatoid arthritis RINVOQ® is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ® may be used as monotherapy or in combination with methotrexate. Psoriatic arthritis RINVOQ® is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ® may be used as monotherapy or in combination with methotrexate. Atopic dermatitis RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Ankylosing Spondylitis (AS, radiographic axial spondyloarthritis) RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. POSOLOGY AND METHOD OF ADMINISTRATION Treatment with upadacitinib should be initiated and supervised by physicians experienced in the diagnosis and treatment of conditions for which upadacitinib is indicated. Posology Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis 2 The recommended dose of upadacitinib is 15 mg once daily. Consideration should be given to discontinuing treatment in patients with ankylosing spondylitis who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may subsequently Přečtěte si celý dokument