ประเทศ: อินโดนีเซีย
ภาษา: อินโดนีเชีย
แหล่งที่มา: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BAYER INDONESIA - Indonesia -
20.00 MG
TABLET SALUT SELAPUT
FINERENONE
DUS, 1 BLISTER @ 14 TABLET SALUT SELAPUT
Obat
BAYER AG - Federal Republic of Germany
Berlakus/d 16-03-2028
2023-03-16
1 1. NAME OF THE MEDICINAL PRODUCT Firialta 10 mg film-coated tablets Firialta 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Firialta 10 mg film-coated tablets Each film-coated tablet contains 10 mg of finerenone. _Excipient with known effect _ Each film-coated tablet contains 45 mg of lactose (as monohydrate), see section 4.4. Firialta 20 mg film-coated tablets Each film-coated tablet contains 20 mg of finerenone. _Excipient with known effect _ Each film-coated tablet contains 40 mg of lactose (as monohydrate), see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Firialta 10 mg film-coated tablets Pink, oval-oblong film-coated tablet with a length of 10 mm and a width of 5 mm, marked ‘10’ on one side and ‘FI’ on the other side. Firialta 20 mg film-coated tablets Yellow, oval-oblong film-coated tablet with a length of 10 mm and a width of 5 mm, marked ‘20’ on one side and ‘FI’ on the other side. FIRIALTA ® FILM-COATED TABLET DISETUJUI OLEB BPOM: 20 FEBRUARI 2023 ID: EREG10036612200103; EREG10036612200104; EREG10036612200105; EREG10036612200106; EREG10036612200107; EREG10036612200108 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Firialta is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended target dose is 20 mg finerenone once daily. The maximum recommended dose is 20 mg finerenone once daily. _Initiation of treatment _ Serum potassium and estimated glomerular filtration rate (eGFR) have to be measured to determine if finerenone treatment can be initiated and to determine the starting dose. If serum potassium ≤ 4.8 mmol/L, finerenone treatment can be initiated. For monitoring of serum potassium, see below ‘Continuation of treatment.’ If serum potassium > 4.8 to 5.0 mmol/L, initiation of finerenone treatment may be considered with additional serum potassium monitoring อ่านเอกสารฉบับเต็ม