Šalis: Taivanas
kalba: kinų
Šaltinis: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
ENTECAVIR
台灣必治妥施貴寶股份有限公司 台北市松山區健康路156號5樓 (11922609)
J05AF10
內服液劑
ENTECAVIR (0818003100) MG
塑膠瓶裝
製 劑
須由醫師處方使用
AstraZeneca Pharmaceuticals LP 4601 HIGHWAY 62 EAST, MOUNT VERNON, INDIANA 47620 USA US
entecavir
治療有B 型肝炎病毒複製跡象之成人及2 歲以上兒童之慢性B 型肝炎患者。
註銷日期: 2022/07/12; 註銷理由: 未展延而逾期者; 有效日期: 2021/06/22; 英文品名: Baraclude Oral Solution 0.05 mg/mL
已註銷
2006-06-22
0.5 024469 1 024468 0.05 / 024467 0.05 / BARACLUDE 10 0.5 20mL 1 entecavir 4 5 5.1 B B ( entecavir ) B [ (6.1) ] B B 5.2 B BARACLUDE HIV/HBV HIV HIV ( ) BARACLUDE B HIV [ (12.4) ] BARACLUDE /B HARRT BARACLUDE HIV BARACLUDE HIV 5.3 ( BARACLUDE) BARACLUDE ( ) BARACLUDE 6 [ , (5.1) ] [ (5.3) ] 6.1 (AI463014 AI463022 AI463026 AI463027) 1720 BARACLUDE 0.5 mg/ (n = 679) BARACLUDE 1 mg/ (n = 183) lamivudine (n = 858) 2 B AI463022 AI463027 BARACLUDE 69 lamivudine 63 AI463026 AI463014 BARACLUDE 73 lamivudine 51 BARACLUD E lamivudine BARACLUDE (≥3%) lamivudine 1% BARACLUDE 4% lamivudine 3 BARACLUDE lamivudine - 3 2 ENTECAVIR - ( 2 4) A B LAMIVUDINE C / BARACLUDE 0.5 mg n=679 Lamivudine 100 mg n=668 BARACLUDE 1 mg n=183 Lamivudine 100 mg n=190 15% 18% 22% 23% 2 4 a <1% 0 1% 0 <1% <1% 1% 0 <1% <1% <1% 2% <1% <1% <1% 0 1% 1% 3% 3% 2% 2% 4% 1% <1% <1% 0 1% <1% <1% 0 0 <1% <1% 0 <1% a b AI463022 AI463027 c AI463026 AI463014 BARACLUDE 1 mg lamivudine A1463014 lamivudine BARACLUDE (0.1 0.5 1 mg) lamivudine 100 mg 52 4 BARACLUDE lamivudine 4 2 ENTECAVIR A B LAMIVUDINE C BARACLUDE 0.5 MG N=679 LAMIVUDINE 100 MG N=668 BARACLUDE 1 MG N=183 LAMIVUDINE 100 MG N=190 35% 36% 37% 45% 2% 4% 2% 11% 11% 16% 12% 24% <1% <1% 0 2% 2% 2% 3% 2% 7% 6% 7% 7% 0 0 0 0 1% 1% 2% 1% 2% 1% 3% 1% 4% 3% 4% 6% 9% 10% 9% 6% 3 4 d ALT > 10 x ULN > 2 x ALT > 5.0 x ULN < 2.5 g/dL >2.5 x ULN ≥ 2.1 x ULN > 3.0 x ULN ≥ 0.5 mg/dL > 250 mg/dL e f < 50,000/mm3 <1% <1% <1% <1% a ( <2.5 g/dL) ≥ 0.5 mg/dL ALT >10 x ULN >2 x b AI463022 AI463027 HBV 0.015 mg/kg ( 0.5 ) 0.03 mg/kg ( 1 ) BARACLUDE AI463189 ( ) [ (1) (2.3) (6.2) (12.3) (14.2) ] lamivudine BARACLUDE B BARACLUDE [ (12.4) ] 2 BARACLUDE BARACLUDE HBV 8.5 BARACLUDE 65 Entecavir [ (2.4) ] 8.6 / Entecavir 8.7 <50 mL/min CAPD BARACLUDE [ (2.4) (12.3) ] 8.8 65 B (HBV) BARACLUDE HBV (DNA) 172 IU/mL ( 1000 copies/mL) BARACLUDE 1 mg ( B ) 82% 39% 37% 49 89% HBeAg 65 4 BARACLUDE 4 (2 1 1 ) BARACLUDE 4 61 60 B 53 ( 65 82%) 72 HBV DNA 53 HBV DNA <50 IU/ ( 300 copies/ ) 8 72 HBV DNA 3 BARACLUDE ( B ) HBV DNA ≥50 I Perskaitykite visą dokumentą