OFEV

Pays: Indonésie

Langue: indonésien

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

Unités en paquet:

DUS, 6 ALUBLISTER @ 10 KAPSUL LUNAK

Date de l'autorisation:

2022-10-11

Résumé des caractéristiques du produit

Red font: Proposed CCDS 0286-11,15
OFEV
NINTEDANIB
COMPOSITION
OFEV
_ _
100 MG SOFT CAPSULES
1 capsule contains 100 mg of nintedanib (= free base)
corresponding to 120.4 mg 1_H_-Indole-6-carboxylic acid,
2,3-dihydro-3-[[[4-[methyl[(4-methyl-
1-piperazinyl)acetyl]
amino]phenyl]
amino]phenylmethylene]-2-oxo-,
methyl
ester,
(3_Z_)-,
ethanesulfonate (1:1) (=_ _nintedanib esilate)._ _
OFEV 150 MG SOFT CAPSULES
1 capsule contains 150 mg of nintedanib (= free base)
corresponding to 180.6 mg 1_H_-Indole-6-carboxylic acid,
2,3-dihydro-3-[[[4-[methyl[(4-methyl-
1-piperazinyl)acetyl]
amino]phenyl]amino]phenylmethylene]-2-oxo-,
methyl
ester,
(3_Z_)-,
ethanesulfonate (1:1) (= nintedanib esilate)._ _
EXCIPIENTS ***
Capsule fill:
Medium chain triglycerides, hard fat, soya lecithin (E322)
Capsule shell:
Gelatine, glycerol 85 %, titanium dioxide (E171), iron oxide red
(E172), iron
oxide yellow (E172), black ink (Opacode
®
)
Black ink:
Shellac glaze, iron oxide black (E172), propylene glycol (E1520)_ _
DISETUJUI BPOOM: 15/02/2022
ID: EREG10036412000481, EREG10036412000482
Red font: Proposed CCDS 0286-11,15
INDICATIONS/ USAGE
OFEV is indicated for the treatment of Idiopathic Pulmonary Fibrosis
(IPF).
Ofev is indicated for slowing the rate of decline in pulmonary
function in patients with systemic
sclerosis-associated interstitial lung disease (SSc-ILD).
Ofev is indicated in adults for the treatment of other chronic
fibrosing interstitial lung diseases
(ILDs) with a progressive phenotype (also known as progressive
fibrosing ILD).
DOSAGE AND ADMINISTRATION/ RECOMMENDED INTAKE
Treatment with Ofev should be initiated by physicians experienced in
the diagnosis
and treatment for which OFEV is indicated.
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose is 150 mg nintedanib twice daily administered
approximately
12 hours apart. The 100 mg twice daily dose is only recommended to be
used in
patients who do not tolerate the 150 mg twice daily dose.
If a dose is missed, administration should resume at the next
scheduled time at the