País: Taiwan
Língua: chinês
Origem: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
Miglustat
嬌生股份有限公司 台北市中山區民生東路三段2號10樓及11樓 (30814854)
A16AX06
膠囊劑
Miglustat (9200080800) MG
鋁箔片盒裝
製 劑
須由醫師處方使用
ALMAC PHARMA SERVICES LIMITED SEAGOE INDUSTRIAL ESTATE, CRAIGAVON CO. ARMAGH, BT63 5UA, UNITED KINGDOM GB
miglustat
1、治療不適合接受酵素療法之輕度至中度第一型高雪氏症成人病人。2、適用於治療患有尼曼匹克症C型(Niemann-Pick type C disease)之成年病人與兒童病人的進行性神經表現。
有效日期: 2029/05/10; 英文品名: ZAVESCA hard capsule 100mg
2014-05-10
12.1 12.3 13 13.1 13.2 / 14 16 / 17 1 1.1 2 2.1 3 1 (100 mg)ZAVESCA ® ( ) 1 2 1(100 mg) 2.2 ( 50-70 mL/min/1.73 m 2 ) ZAVESCA ® 100 mg 2 ( 30-50 mL/min/1.73 m 2 )ZAVESCA ® 1 (100 mg)( < 30 mL/min/1.73 m 2 ) ZAVESCA ® ( []8.6 ) 3 ZAVESCA ® 100 mg miglustat OGT 918100 4 ZAVESCA ® 5 5.1 ZAVESCA ® 3% ZAVESCA ® 6 ZAVESCA ® / 5.2 (TREMOR) 30% 1 1 3 5.3 ZAVESCA ® 85%65%ZAVESCA ® ( - ) 12 ZAVESCA ® ( ) ZAVESCA ® / ( loperamide) ZAVESCA ® ZAVESCA ® ( ) ZAVESCA ® ( ) ZAVESCA ® 5.4 ZAVESCA ® 40% ZAVESCA ® ( 150 x 10 9 /L) (ERT) ZAVESCA ® 6 ● ( []5.1 ) ● ( []5.2 ) ● ( []5.3 ) ● ( []5.4 ) 6.1 2 1 80ZAVESCA ® 50 mg 200 mg18 69 ZAVESCA ® ( []5.1 ) 1 2ZAVESCA ® ZAVESCA ® (≥ 5%)( []5.2 5.3) ( []5.2 5.3) 228 ZAVESCA ® 100 mg3 ( 100 200 mg3 ) 12[ 1]1850 mg3 6 [ 2]1≥ 5% 1 ZAVESCA ® 2 ≥5% 1 (100 MG 3 ) 2 (50 MG3) (N) 28 18 - 89 89 29 44 18 50 14 22 4 11 0 6 7 0 7 0 0 6 39 67 21 22 11 11 0 11 4 11 7 0 0 6 0 17 0 11 7 6 0 6 3 6 ZAVESCA ® imiglucerase ZAVESCA ® imiglucerase( 3) 12 2≥ 5% 2≥ 5% ZAVESCA ® IMIGLUCERASE (N) 12 12 - 100 0 67 0 50 0 8 0 8 0 8 0 0 8 17 0 8 0 8 0 8 0 67 0 17 0 8 0 8 0 8 0 8 0 7 ZAVESCA ® imiglucerase70% imiglucerase ( []12.3 ) 8 8.1 C ZAVESCA ® ZAVESCA ® 2 miglustat miglustat ZAVESCA ® - 6 miglustat≥ 2 1420 60 180 mg/kg/day miglustat 17 () ( ≥ 2) 6 ( 20 ) 20 60 180 mg/kg/day miglustat (≥ 2) > 20 mg/kg/day ( ) 6 18 () 15 30 45 mg/kg/day miglustat15 mg/kg/day ( ) 180 mg/kg/day ( 65 mg/kg) 8.3 miglustat miglustat 8.4 ZAVESCA ® 45ZAVESCA ® 18 1 2 2.6 4 ZAVESCA ® 8.5 ZAVESCA ® 65 8.6 miglustat ( []12.3 ) ( 50 70 mL/min/1.73 m 2 )100 mg 2ZAVESCA ® ( 30 50 mL/min/1.73 m 2 )100 mg ZAVESCA ® ( < 30 mL/min/1.73 m 2 ) miglustat ZAVESCA ® 8.7 7miglustat 100 mg6 14 (mg/m 2 )miglustat 6 ( [(13.1] ) 11 ZAVESCA ® (miglustat100 mg) 酰 (glucosylceramide synthase)1 ZAVESCA ® N-(D-glucose) M i g l u s t a t 1 , 5 - ( b u t y l i m i n o ) - 1 , 5 - d i d e o x y - D - g l u c i t o l C 10 H 21 NO 4 219.28 Miglustat(off-white)( [free base]> 1000 mg/mL) ZAVESCA ® 100 Leia o documento completo