FIRIALTA

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

제공처:

BAYER INDONESIA - Indonesia -

복용량:

20.00 MG

약제 형태:

TABLET SALUT SELAPUT

구성:

FINERENONE

패키지 단위:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

수업:

Obat

Manufactured by:

BAYER AG - Federal Republic of Germany

승인 상태:

Berlakus/d 16-03-2028

승인 날짜:

2023-03-16

제품 특성 요약

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