KERENDIA FILM-COATED TABLET 10MG

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Finerenone

Disponible desde:

BAYER (SOUTH EAST ASIA) PTE LTD

Código ATC:

Pending

formulario farmacéutico:

TABLET, FILM COATED

Composición:

Finerenone 10mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricado por:

Bayer AG

Estado de Autorización:

ACTIVE

Fecha de autorización:

2021-11-25

Ficha técnica

Kerendia_SG_CCDS2&3_v1
1. NAME OF THE MEDICINAL PRODUCT
Kerendia 10 mg film-coated tablets
Kerendia 20 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
KERENDIA 10
MG FILM-COATED TABLET
Each film-coated tablet contains 10 mg finerenone.
KERENDIA 20
MG FILM-COATED TABLET
Each film-coated tablet contains 20 mg finerenone.
3. PHARMACEUTICAL FORM
Film-coated tablet
KERENDIA 10
MG FILM-COATED TABLET
Pink, oval-oblong tablet with a length of 10 mm and a width of 5 mm,
marked ´10´ on one side and
´FI´ on the other side
KERENDIA 20
MG FILM-COATED TABLET
Pale-yellow, oval-oblong tablet with a length of 10 mm and a width of
5 mm, marked ´20´ on one side
and ´FI´ on the other side
4. CLINICAL PARTICULARS
4.1 INDICATION(S)
Kerendia, in addition to standard of care, is indicated to reduce the
risk of sustained eGFR decline,
end-stage kidney disease, cardiovascular death, non-fatal myocardial
infarction and hospitalization for
heart failure in adults with chronic kidney disease and albuminuria
associated with type 2 diabetes.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
4.2.1 METHOD OF ADMINISTRATION
Oral use
Tablets may be taken with a glass of water and with or without food
_(see section ‘Pharmacokinetic _
_properties’)_
.
Avoid taking Kerendia with grapefruit or grapefruit juice
_(see section _
´Special warnings and
precautions for use´
_and_
_’_
4.5 Interaction with other medicinal products and other forms of
interaction
_’)_
.
For patients who are unable to swallow whole tablets, Kerendia tablet
may be crushed and mixed with
water or soft foods, such as applesauce, immediately prior to use and
administered orally
_(see section _
_‘Pharmacokinetic properties’)_
.
4.2.2 DOSAGE REGIMEN
The recommended target dose of Kerendia is 20 mg once daily.
4.2.2.1 INITIATION OF TREATMENT
Initiation of Kerendia treatment is recommended when serum potassium
≤ 4.8 mmol/L.
For monitoring of serum potassium, see ‘Continuation of
treatment.’
Kerendia_SG_CCDS2&3_v1
If serum potassium > 4.8 to 5.0 mmol/