Țară: Taiwan
Limbă: chineză
Sursă: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
brexpiprazole
台灣大塚製藥股份有限公司 台北市中山區復興北路378號11樓 (14001297)
N05AX16
膜衣錠
brexpiprazole (2816300100) MG
塑膠瓶裝(HDPE);;裸錠大桶裝
製 劑
須由醫師處方使用
Sharp Packaging Services, LLC 7451 KEEBLER WAY , ALLENTOWN , PENNSYLVANIA 18106 , USA US
brexpiprazole
思覺失調症
有效日期: 2028/03/27; 英文品名: REXULTI® (brexpiprazole) tablets 4 mg
2018-03-27
® REXULTI ® (BREXPIPRAZOLE) TABLETS 0.25 027363 0.5 027364 1 027365 2 027366 3 027367 4 027368 REXULTI [ (5.1)] 1 Ɣ [ (14.1)] 2 2.1 REXULTI 1 4 1 [ (12.3)] REXULTI 2 4 5 7 2 8 4 4 2.2 &KLOG3XJKVFRUH 3 [ (8.6) (12.3)] 2.3 ( [CLcr] <60 / ) 3 [ (8.7) (12.3)] 2.4 CYP2D6 (POOR METABOLIZERS) CYP P450 (CYP) 2D6 CYP3A4 CYP2D6 CYP3A4 ( 1) REXULTI CYP3A4 1~2 REXULTI [ (7.1) (12.3)] 1CYP2D6 (POOR METABOLIZERS) CYP3A4 CYP2D6 / CYP3A4 REXULTI REXULTI CYP2D6 CYP2D6 CYP2D6 / CYP3A4 CYP2D6 / CYP3A4 CYP2D6 CYP3A4 / CYP2D6 / CYP3A4 CYP3A4 CYP3A4 1~2 3 REXULTI 6 ( 2) 2REXULTI / 0.25 BRX0.25 0.5 BRX0.5 1 BRX1 2 BRX2 3 BRX3 4 BRX4 4 brexpiprazole REXULTI (anaphylaxis) 5 5.1 17 ( 10 ) 1.6~1.7 10 4.5% 2.6% ( ) ( : ) REXULTI [ (5.2)] 5.2 risperidonearipiprazole olanzapine ( ) (transient ischemic attack) REXULTI [ (5.1)] 5.3 (NMS) REXULTI (NMS) ( ) (NMS) REXULTI 5.4 (TARDIVE DYSKINESIA) ( ) REXULTI : (1) (2) REXULTI REXULTI 5.5 REXULTI / REXULTI 6 (<100 mg/dL) PJG/ <126 mg/dL) REXULTI REXULTI 8% 17% 10% 6 REXULTI 3 3 6 1 / 2 / 4 / PJG/WR PJG/ and <500 mg/dL) 6% (15/253)* 10% (7/72)* 8% (19/232)* 10% (22/226)* / PJG/WR PJG/ 0% (0/303)* 0% (0/94)* 0% (0/283)* 0.4% (1/283)* * n/N N= n= 6% ( ) 2% ( ) REXULTI 17% ( ) REXULTI 13% 0.4% 0.6% ( REXULTI) 4 6 4 6 N=362 1 / N=120 2 / N=362 4 / N=362 ( ) +0.2 +1.0 +1.2 +1.2 ( ) (*N/N) 4% (15/362)* 10% (12/120) * 11% (38/362) * 10% (37/362) * * n/N N= n= 0.6% REXULTI 26 1.3 52 2 20% 10% 5.6 REXULTI : REXULTI ( ) (WBC) (Absolute neutrophil countANC) (WBC) (ANC) (CBC) (WBC) REXULTI <1000/mm 3 REXULTI (WBC) 5.8 REXULTI (2% vs. 2%) (0.4% vs. 0.2%) (0.1% vs. 0%) ( ) ( ) REXULTI 5.9 REXULTI 5.10 REXULTI 5.11 REXULTI 5.12 ( REXULTI) 5.13 REXULTI 6 ( ) REXULTI 5% 3% ( ) REXULTI 6 [ (5.1)] [ (5.2)] (NMS) [ (5.3)] [ (5.4)] [ (5.5)] [ (5.6)] [ (5.7)] [ (5.8)] [ (5.9)] [ (5.10)] [ (5.11)] [ (5.12)] [ (5.13)] 6.1 REXULTI 852 (18 65 ) 6 REXULTI 1 2 4 [ (14.1)] ( 6 ) REXULTI Citiți documentul complet