Land: Taiwan
Sprog: kinesisk
Kilde: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
dinutuximab beta
吉帝藥品股份有限公司 台中市北屯區綏遠路二段216之5號6樓、216號地下一層 (16647167)
L01XC16
注射液劑
主成分 () ; dinutuximab beta (1013009300) MG/ML
玻璃瓶裝;;盒裝
菌 疫
限由醫師使用
PATHEON ITALIA S.P.A. 2 TRAV. SX VIA MOROLENSE, 5-03013 FERENTINO (FR), ITALY IT
dinutuximab beta
神經母細胞瘤:- 適用於治療有殘存或沒有殘存疾病的高危險性神經母細胞瘤,年齡12個月以上的病人,這些病人以前接受過誘導化學療法並至少達到了部分緩解,隨後進行了清髓治療和幹細胞移植 。- 適用於治療有殘存或沒有殘存疾病且具復發或難治性病史的神經母細胞瘤,年齡12個月以上的病人。
有效日期: 2026/09/15; 英文品名: Qarziba 4.5 mg/mL concentrate for solution for infusion
2021-09-15
Qarziba 4.5 mg/mL concentrate for solution for infusion 1. Qarziba 4.5 mg/mL concentrate for solution for infusion 4.5 / 2. 1 4.5 dinutuximab beta 20 dinutuximab beta 4.5 Dinutuximab beta DNA 6.1 3. 4. 4.1 - Qarziba12 Qarziba12 4.2 Qarziba Qarziba535100 / • 1-1010/240 • 1-520/8 IL-2QarzibaIL-2 6×106 IU /60×106 IU / 5 dinutuximab beta75dinutuximab betadinutuximab beta15 • > 94 • ≥500/ΜL≥20,000 /ΜL> 8.0 G / DL • ALT /AST<5ULN • GRF> 60// 1.73 dinutuximab beta dinutuximab beta50 3 / DINUTUXIMAB BETA dinutuximab beta • 34 • 2 • 3 • 3 • 4<120 mEq / L • 4 5.2 Qarziba12 Qarziba (Dinutuximab beta) 6.6 泵2/ 48/ 8 13mL / (pre-medication) 4.4 6.6 4.3 6.1 34GvHD 4.4 paracetamol ibuprofen Gabapentin dinutuximab beta310/ /Gabapentin2×10/ /dinutuximab beta 3×10/ / Gabapentin300 Gabapentindinutuximab beta dinutuximab beta • dinutuximab beta20.020.05/ / • dinutuximab beta0.03/ / • dinutuximab beta dinutuximab beta0.01/ /4 • 0.02/ / 0.01/ / 0.005/ /5 • 5dinutuximab beta20 460.20.4/ tramodol CRS CRS dinutuximab beta dinutuximab beta diphenhydraminedinutuximab beta20 dinutuximab46 adrenaline prednisolone prednisolone35 /adrenaline 2 CLS CLS CLS212 dinutuximab beta 3 Qarziba 4 dinutuximab beta 2 Qarziba 42 4.5 TNF-IL-6CYP 2dinutuximab beta1 dinutuximab betadinutuximab beta dinutuximab 4.6 Dinutuximab betaGD2 Qarziba Qarziba dinutuximab beta Qarziba6 dinutuximab beta Qarziba dinutuximab beta6 4.7 Dinutuximab beta dinutuximab beta 4.8 51498416 13-cis retinoic307IL-2 88 77 63 57 5140 39 MedDRA ≥1/10 ≥1/100<1/10≥1 / 1,000 <1/100 39 184 32 3.5 dinutuximab beta CLS CLS3-4 133 3 2 9 1-2 IL-2 QarzibaIL-292vs. 79 CLS50vs. 25 dinutuximab beta 75vs. 63 43vs. 2614vs.7 / 4.9 dinutuximab beta 5. 5.1 ATC L01XC Dinutuximab betaIgG12GD2 Dinutuximab betaGD2CDCADCC dinutuximab beta dinutuximab beta dinutuximab betadinutuximab betaGD2 1 5451010//dinutuximab betaIL-26×10 6 IU / /1-58-1213-cis-RA 160//142 984049 1265 6137 MYCNINSS 416MYCN14 14 ASCT 7226 1EFSOS 3 Dinutuximab beta20 //5813-cis-RAIL -2 370 Læs hele dokumentet