País: Cingapura
Língua: inglês
Origem: HSA (Health Sciences Authority)
Perampanel (Anhydrous basis)
EISAI (SINGAPORE) PTE. LTD.
N03AX22
8.0 mg
TABLET, FILM COATED
Perampanel (Anhydrous basis) 8.0 mg
ORAL
Prescription Only
Eisai Manufacturing Ltd.
ACTIVE
2014-09-12
An ti- epileptic drug F Y COMPA® Film- coa ted Tablets 2mg , 4mg , 6mg , 8mg , 10mg , 12mg per ampanel 1. NAME OF THE MEDICINAL PR ODUC T 2 mg , 4 mg , 6 mg , 8 mg , 10 mg , 12 mg film- coa ted tablets 2. QU ANTIT A TIVE C OMPOSITION E ac h fi lm -c o at e d t ab le t co n ta in s 2 , 4 , 6 , 8 , 1 0 , o r 1 2 m g p e ra m p an e l. T h e c o m p le te q u a n ti ta ti ve c o m p o si ti o n c a n b e f o u n d in S e ct io n 6 . 3. PHARMA CEUTIC AL FORM Film- coa ted tablet (tablet): 2 mg tablet: Or ange , r ound , bic on v ex tablet, debossed with Є275 on one side and ‘2’ on the other side 4 mg tablet: R ed , r ound , bic on v ex tablet, debossed with Є277 on one side and ‘4’ on the other side 6 m g t a b le t: P in k , r o u n d , b ic o n ve x ta b le t, d e b o ss e d w it h Є 2 9 4 o n one side and ‘6’ on the other side 8 m g t ab le t: P u rp le , r o u n d , b ic o n ve x ta b le t, d e b o ss e d w it h Є 2 9 5 o n one side and ‘8’ on the other side 1 0 m g t ab le t: G re e n , r o u n d , b ic o n ve x ta b le t, d e b o ss e d w it h Є 2 9 6 o n one side and ‘10’ on the other side 1 2 m g t a b le t: B lu e , r o u n d , b ic o n ve x ta b le t, d e b o ss e d w it h Є 2 9 7 o n one side and ‘12’ on the other side 4. CLINIC AL P ARTICUL ARS 4.1 T HER APEUTIC INDIC A TIONS F Y C O M PA is in d ic at e d fo r th e a d ju n ct iv e t re at m e n t o f p ar ti al -o n se t se iz u re s w it h o r w it h o u t se co n d a ri ly g e n e ra liz e d s e iz u re s in p a ti e n ts w it h e p ile p sy a g e d 1 2 y e a rs a n d o ld e r. 4.2 P OSOLOGY AND METHOD OF ADMINISTR A TION D osing C onsider ations C onc omitant CY P3A Enz yme -Inducing AED s Signific antly Reduc e Both P lasma L ev els and E ffic ac y C ar b am az e p in e , o xc ar b az e p in e a n d p h e n y Leia o documento completo
Anti-epileptic drug Fycompa ® Film-coated Tablets 2mg, 4mg, 8mg1. 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, 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 FYCOMPA is indicated for: - treatment of partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 years of age and older. - adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in patients from 7 years of age and older with idiopathic generalized epilepsy (see section 5.1). 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. The physician should prescribe the most appropriate formulation and strength according to weight and dose. Alternate formulations of perampanel are available, including oral suspension _Partial Onset Seizures _ [Monotherapy] The following table summarises the recommended posology for adults, adolescents, and children from 4 years of age. More details are provided below the table. TABLE 1: RECOMMENDED POSOLOGY FOR ADULTS, ADOLESCENTS AND CHILDREN FROM 4 YEARS OF AGE Adult/adolescent (12 years and older) Children (4 – 11 years); weighing: ≥ 30 kg 20 - < 30 kg < 20 kg Recommended starting dose 2 mg/day 2 mg/day 1 mg/day 1 mg/day Titration (incremental steps) 2 mg/day (no more frequently than intervals of 2 mg/day (no more frequentl Leia o documento completo