देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Baricitinib
ZUELLIG PHARMA SDN BHD
Baricitinib
7 Tablets; 4 x 7 Tablets
LILLY DEL CARIBE INC
Consumer Medication Information Leaflet (RiMUP) OLUMIANT FILM-COATED TABLETS Baricitinib (2 mg, 4 mg) 1 What is in this leaflet 1. What Olumiant is used for 2. How Olumiant works 3. Before you use Olumiant 4. How to use Olumiant 5. While you are using Olumiant 6. Side effects 7. Storage and Disposal of Olumiant 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number What Olumiant is used for Rheumatoid arthritis Olumiant is used to treat adults with moderate to severe rheumatoid arthritis, an inflammatory disease of the joints, if previous therapy did not work well enough or was not tolerated. Olumiant can be used alone or together with some other medicines, such as methotrexate. Atopic dermatitis Olumiant is used to treat adults with moderate to severe atopic dermatitis, also known as atopic eczema. Olumiant may be used with eczema medicines that you apply to the skin or it may be used on its own. Alopecia areata Olumiant is used to treat adults with severe alopecia areata, an autoimmune disease characterized by inflammatory, nonscarring hair loss on the scalp, face and sometimes on other areas of the body that can be recurrent and progressive. How Olumiant works Olumiant contains the active substance baricitinib. It belongs to a group of medicines called Janus kinase inhibitors, which help to reduce inflammation. Rheumatoid arthritis Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase’, which is involved in inflammation. By reducing the activity of this enzyme, Olumiant helps to reduce pain, stiffness and swelling in your joints, tiredness, and helps to slow damage to the bone and cartilage in the joints. These effects can help you to do normal daily activities and so improve the health-related quality of life for patients with rheumatoid arthritis. Atopic dermatitis Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase’, which is involved in inflammation. By reducing the activity of t पूरा दस्तावेज़ पढ़ें
Olumiant 2mg_4mg PI_EUSPC_20June2022_31Mar2023 1. NAME OF THE MEDICINAL PRODUCT Olumiant 2 mg film-coated tablets Olumiant 4 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olumiant 2 mg film-coated tablets Each film-coated tablet contains 2 mg baricitinib. Olumiant 4 mg film-coated tablets Each film-coated tablet contains 4 mg baricitinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Olumiant 2 mg film-coated tablets Light pink, 9 x 7.5 mm oblong tablets, debossed with “Lilly” on one side and “2” on the other. Olumiant 4 mg film-coated tablets Medium pink, 8.5 mm round tablets, debossed with “Lilly” on one side and “4” on the other. The tablets contain a recessed area on each side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Rheumatoid arthritis Baricitinib 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. Baricitinib may be used as monotherapy or in combination with methotrexate (see sections 4.4, 4.5 and 5.1 for available data on different combinations). Atopic Dermatitis Baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. Alopecia areata Baricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1). Olumiant 2mg_4mg PI_EUSPC_20June2022_31Mar2023 4.2 Posology and method of administration Treatment should be initiated by physicians experienced in the diagnosis and treatment of the conditions for which this medicinal product is indicated. Posology Rheumatoid arthritis The recommended dose of baricitinib is 4 mg once daily. A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily may al पूरा दस्तावेज़ पढ़ें