Ország: Indonézia
Nyelv: indonéz
Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PIRFENIDONE
BOEHRINGER INGELHEIM INDONESIA - Indonesia
PIRFENIDONE
267 MG
KAPSUL
DUS, 14 BLISTER @ 18 KAPSUL
CATALENT PHARM SOLUTION - USA
2018-08-02
_Draft_Esbriet_PI_MAT_CDS10.0_EN_v2_ _ _ Page 1 of 16 ESBRIET ® Pirfenidone 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Pirfenidone belongs to the chemical class of pyridine derivative. ATC code: L04AX05. 1.2 TYPE OF DOSAGE FORM Hard capsule. Two piece capsules with a white to off-white opaque cap and a white opaque body imprinted with "PFD 267 mg" in brown ink and containing a white to pale yellow powder. 1.3 ROUTE OF ADMINISTRATION For oral use. 1.4 STERILE/RADIOACTIVE STATEMENT Not applicable. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient: _pirfenidone_. _ _ _ Esbriet (pirfenidone) 267 mg capsules. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION Esbriet is indicated to slow the progression of idiopathic pulmonary fibrosis (IPF) in adult patients with mild to moderate IPF. The studies beyond 48 weeks of treatment showed inconsistent efficacy result. 2.2 DOSAGE AND ADMINISTRATION METHOD OF ADMINISTRATION Esbriet is to be swallowed whole with water and taken with food to reduce the possibility of nausea and dizziness (see sections_ 2.6 Undesirable Effects_ and_ 3.2 Pharmacokinetic Properties_). TESTING PRIOR TO ESBRIET ADMINISTRATION Conduct liver function tests prior to initiating treatment with Esbriet. DISETUJUI OLEH BPOM : 08/06/2021 EREG100364VR12000346 _Draft_Esbriet_PI_MAT_CDS10.0_EN_v2_ _ _ Page 2 of 16 POSOLOGY _Adults _ The recommended daily dose of Esbriet for patients with IPF is three 267 mg capsules three times a day with food for a total of 2403 mg/day. Upon initiating treatment, the dose should be titrated to the recommended daily dose of nine capsules per day over a 14 day period as follows: Days 1 to 7: one capsule, three times a day (801 mg/day) Days 8 to 14: two capsules, three times a day (1602 mg/day) Day 15 onward: three capsules, three times a day (2403 mg/day) Doses above 2403 mg/day are not recommended for any patient (see section _2.7 Overdose)._ Patients who miss 14 consecutive days or more of Esbriet treatment should re-initiate therapy Olvassa el a teljes dokumentumot