Country: Ինդոնեզիա
language: ինդոնեզերեն
source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PERAMPANEL
EISAI INDONESIA - Indonesia
PERAMPANEL
4 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 14 TABLET
EISAI INDONESIA - Indonesia
2019-09-06
PT Eisai Indonesia | Product Information FYCOMPA 1 1. NAME OF THE MEDICINAL PRODUCT Fycompa 2 mg, 4 mg, 8 mg film-coated tablets 2. QUANTITATIVE COMPOSITION Each film-coated tablet contains 2, 4, or 8 mg perampanel. The complete quantitative composition can be found in Section 6. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet): *) 2 mg tablet: Orange, round, biconvex tablet, debossed with Є275 on one side and '2' on the other side *) 4 mg tablet: Red, round, biconvex tablet, debossed with Є277 on one side and '4' on the other side *) 8 mg tablet: Purple, round, biconvex tablet, debossed with Є295 on one side and '8' on the other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Fycompa must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability. Perampanel should be taken orally once daily at bedtime. Treatment with Fycompa should be initiated with a dose of 2 mg/day. The dose may be increased based on individual clinical response and tolerability to a maintenance dose of 4 mg/day to 8 mg/day and if necessary up to 12 mg/day. Adult / Adolescent (12 years of age and older) and Children (4-11 years), weighing 30 kg or more Recommended starting 2 mg/day dose Titration (incremental 2 mg/day steps) (no more frequently than weekly intervals) Fycompa is indicated for the adjunctive treatment of partial-onset seizures (POS) with Fycompa is indicated for the adjunctive treatment of primary generalised tonic- clonic seizures (PGTC) i n patients from 7 years of age and older weighing 30 kg or more with idiopathic generalised epilepsy (IGE). _Partial-Onset Seizures: 4 years of age and older, weighing 30 kg or more_ DISETUJUI OLEH BPOM: 22/12/2023 ID: EREG17180812200009 EREG17180812200010 EREG17180812200011 PT Eisai Indonesia | Product Information FYCOMPA 2 Recommended 4 – 8 mg/day maintenance dose Titration (incremental 2 mg/day steps) (no more frequently than weekly intervals) Recommended maxi read_full_document