País: Singapur
Idioma: anglès
Font: HSA (Health Sciences Authority)
Perampanel (Anhydrous basis)
EISAI (SINGAPORE) PTE. LTD.
N03AX22
10.0 mg
TABLET, FILM COATED
ORAL
Prescription Only
Eisai Manufacturing Ltd.
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 Llegiu el document complet