Država: Tajvan
Jezik: kineski
Izvor: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
Decitabine
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)
L01BC08
凍晶注射劑
Decitabine (1010001000) MG
玻璃小瓶裝;;盒裝
製 劑
限由醫師使用
BSP PHARMACEUTICALS S.p.A VIA APPIA KM 65,561, LATINA SCALO(LT), 04013, ITALY IT
decitabine
(1)適用於治療不適合進行標準誘導化學療法之新診斷出患有原發性或續發性急性骨髓性白血病成人病人(AML,依據世界衛生組織(WHO)分類)。須符合Poor-or intermediate-risk Cytogenetics,且不適合用於Acute Promyelocytic Leukemia (M3 Classification)。(2)適用於治療骨髓化生不良症候群(MDS)成人病人,包括先前曾接受治療及未曾接受治療、所有French-American-British亞型之原發性與續發性MDS (頑固性貧血、環形鐵粒幼細胞的頑固性貧血、頑固性貧血併有過量芽細胞、頑固性貧血併有過量芽細胞轉變型、以及慢性骨髓單核球性白血病)、以及國際預後評分系統分類為中度危險-1、中度危險-2與高危險的病人。
有效日期: 2024/09/30; 英文品名: Dacogen Powder for Concentrate for Solution for Infusion
2014-09-30
1 Dacogen ® Powder for Concentrate for Solution for Infusion. 2 50decitabine 105 decitabine 0.5(E340)0.29(E524) 6.1 3 () 4 4.1 (1) (AML (WHO) ) Poor-or intermediate-risk CytogeneticsAcute Promyelocytic Leukemia (M3 Classification) (2) (MDS) French-American-British MDS ( ) -1-2 4.2 (1) AML Dacogen ® 51 20/ 2 Dacogen ® ( 5 )20/ 2 100/ 2 4 4 4 4 ( ) ( ) Dacogen ® ( ) AML ● ( ≥38.5 ° C <1,000/ μ L) ● ( ) ● ( <25,000/ μ L) ( ) Dacogen ® Dacogen ® (2) MDS ● ● (CBC) A. 5 1 20/ 2 Dacogen ® ((B.)) (ANC1,000/µL50,000/ µL)4 4 4 B. Dacogen ® 6 Dacogen ® ● 68 – 2 ● 8 10 – 2 Dacogen ® Dacogen ® ● 2 mg/dL ● (Alanine transaminase (ALT)) 2(upper limit of normal (ULN)) ● Dacogen ® <18AML 4.85.15.2 MDS ( 4.4 5.2) ( 4.45.2) Dacogen ® 6.6 4.3 decitabine (6.1) (4.6) 4.4 AML MDS( ) Dacogen ® ( ) 3/4(baseline) 2 1 0Dacogen ® Dacogen ® /(4.24.8) decitabine( ) (4.8) Dacogen ® Dacogen ® ( 4.25.2) Dacogen ® ( [CrCl] <30/ )Dacogen ® ( 4.2) Dacogen ® decitabine( (retinoic acid)) ( 4.8 ) (corticosteroids) Dacogen ® 0.5 1 (39) 0.29(6.67) 13.8-138(0.6-6) WHO20.7-7% 4.5 decitabine ( ) / decitabine( )- decitabine decitabine (CYP) 450 decitabine Decitabine (<1%)decitabine decitabineP-gp P-gp(5.2) 4.6 / decitabine (5.3 ) Dacogen ® 6 Dacogen ® 3(5.3) decitabine Dacogen ® decitabine( 5.3 ) Dacogen ® Dacogen ® decitabine Dacogen ® (4.3) decitabine decitabine Dacogen ® Dacogen ® 4.7 Dacogen ® 4.8 (1) AML (≥35%) 3/4 (≥20%) 30%Dacogen ® 25% 30 Dacogen ® (43%32%) 293Dacogen ® AML 1 AML (≥1/10)(≥1/100 <1/10)(≥1/1,000 <1/100)(≥1/10,000 <1/1,000) (<1/10,000) ( ) 1DACOGEN ® ( ) A (%) 3-4 A (%) * 24 20 * 15 7 ( ) * b,c,d 63 39 * 6 4 * 9 8 3 1 ( ) * 34 32 * 32 30 e * 41 38 38 31 20 18 * <1 <1 f 1 <1 13 3 16 1 <1 <1 14 2 31 2 18 1 33 <1 7 1 * 11 3 g 5 <1 (Sweet ) <1 NA 48 9 a b c DACO-016 d e f g 11% 3-42% * NA= Dacogen ® decitabine ( ) (CNS)(2%) (GI)(2%) / ( G-CSF) decitabine 4.2 (infestations) decitabine () decitabine decitabine( ) decitabine( (retinoic acid)) ( 4.4) AML(1 14 ) (n=1 Pročitajte cijeli dokument