Երկիր: Ինդոնեզիա
Լեզու: ինդոնեզերեն
Աղբյուրը: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BARICITINIB
PYRIDAM FARMA TBK - Indonesia
BARICITINIB
2.000 MG
TABLET SALUT SELAPUT
DUS, 4 BLISTER @ 7 TABLET SALUT SELAPUT
LILLY DEL CARIBE, INC. - United States of America
2021-12-20
Unamity_ID_New Indication_leaflet for doctor_proposedTC-V4 Page 1 of 30 UNAMITY BARICITINIB 2 MG FILM-COATED TABLETS BARICITINIB 4 MG FILM-COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Unamity 2 mg film-coated tablets Unamity 4 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Unamity 2 mg film-coated tablets Each film-coated tablet contains 2 mg baricitinib Unamity 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). Unamity 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. Unamity 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 one or more disease-modifying anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate. 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). DISETUJUI OLEH BPOM: 03/07/2023 EREG10019312200200 EREG10019312200201 Unamity_ID_New Indication_leaflet for doctor_proposedTC-V4 Page 2 of 30 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 fo Կարդացեք ամբողջական փաստաթուղթը