产地国家：美国 处方药：是 所属类别： 50毫克/瓶 包装规格： 50毫克/瓶 计价单位：瓶 生产厂家英文名：OTSUKA AMERICA PHARM 原产地英文商品名：DACOGEN injection 50mg/vial 原产地英文药品名：DECITABINE 中文参考商品译名：DACOGEN冻干粉注射剂 50毫克/瓶 中文参考药品译名：地西他滨

简介：

部份中文达珂处方资料(仅供参考) 商品名称：达珂 通用名称：注射用地西他滨 英文名称：Decitabine for Injection 汉语拼音：Zhusheyong Dixitabin 主要成份：地西他滨Decitabine 化学名称：4-氨基-1-(2-脱氧-β-D-赤式-呋喃核糖)-1，3，5-三嗪-2(1H)-酮。性　　状达珂外观为白色至类白色细微粉末。 适 应 症：适用于IPSS评分系统中中危-2和高危的初治、地西他滨说明书复治骨髓增生异常综合征(MDS)患者，包括原发性和继发性的MDS，按照FAB分型所有的亚型：难治性贫血，难治性贫血伴环形铁粒幼细胞增多，难治性贫血伴原始细胞过多，难治性贫血伴有原始细胞增多-转变型，慢性粒-单核细胞白血病。 用法用量：(首次给药周期)推荐剂量为15mg/m2，连续静脉输注3小时以上，每8小时1次，连续3天。患者可预先使用常规止吐药。每6周重复一个周期。推荐至少重复4个周期。进口地西他滨价格然而，获得完全缓解或部分缓解的患者可以治疗4个周期以上。如果患者能继续获益可以持续用药。依据血液学实验室检查值进行的剂量调整或延迟给药：如果经过前一个周期的治疗，血液学恢复(ANC≥1000/uL，血小板≥50000/uL)需要超过6周，地西他滨疗效 则下一周期的治疗应延迟，且剂量应按以下原则进行暂时性的调整：恢复时间超过6周，但少于8周-达珂给药应延迟2周，且重新开始治疗剂量减少到11mg/m2，每8小时1次，(33mg/m2/天，99mg/m2/周期);恢复时间超过8周，但少于10周-患者应进行疾病进展的评估(通过骨髓穿刺评估)，如未出现进展，达珂给药应延迟2周以上，重新开始时剂量减少到11mg/m2，每8小时1次(33mg/m2/天，99mg/m2/周期)，然后在接下来的周期中，根据临床情况维持或增加剂量。如果出现以下任一非血液学毒性，暂停达珂治疗直至毒性恢复：血清肌酐≥2mg/dL;SGPT、总胆红素≥2倍ULN;活动性或未控制的感染。 禁 忌：禁用于已知对地西他滨过敏的患者。 注意事项：在达珂治疗过程中，会发生中性粒细胞减少症和血小板减少症，须进行全血和血小板计数以监测反应和毒性，地西他滨多少钱 保证在每个给药周期前至少达到最低限。在第一个周期按推荐剂量给药后，随后的周期中给药剂量应按照"用法用量"中所述进行调整。医生应当考虑早期应用生长因子和/或抗微生物药，以防治感染。在用药的第一或第二个周期较常出现骨髓抑制和中性粒细胞减少，但并不一定意味着基础疾病MDS的病情进展。尚缺乏肝肾功能不全患者使用达珂的数据，因此这类人群应慎用。虽然代谢广泛，但细胞色素P450酶系统并不参与代谢。临床试验中，不用于血清肌酐>2.0mg/dL，转氨酶超过正常值2倍，或血清胆红素>1.5mg/dL的患者。实验室检查：应进行全血细胞和血小板计数以监测反应和毒性，保证在每个给药周期前至少达到最低限。在开始治疗前应检测肝脏生化和血清肌酐。 规格：50mg/瓶 贮藏：玻璃瓶贮藏在25°C(77°F);允许范围为15-30°C(59-86°F)。 有效期：36个月

英文版说明书：

Treatment with DACOGEN (decitabine)DACOGEN is a prescription medicine for patients with myelodysplastic syndrome (MDS), including previously treated and untreated MDS and de novo (cause unknown) and secondary (treatment-related) MDS of all French-American- British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups.This site will provide you with information about DACOGEN, how DACOGEN may affect MDS, and what you can expect from treatment with DACOGEN, along with helpful resources.INDICATION:DACOGEN is a prescription medicine indicated for treatment of patients with myelodysplastic syndromes (MDS), including:Previously treated and untreated MDSDe novo (cause unknown) and secondary (treatment-related) MDS:◦All French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia)◦Intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groupsIMPORTANT SAFETY INFORMATION:Treatment with DACOGEN is associated with serious, sometimes fatal, blood disorders including:◦fewer white blood cells (neutropenia and leukopenia), platelets (thrombocytopenia), and/or red blood cells (anemia)◦fever associated with low white blood cell counts (febrile neutropenia)◦bone marrow suppression◦infectionsYour doctor will test and monitor your blood cells before and during treatment with DACOGEN. Your doctor may prescribe medicine to help manage your blood cell counts and/or medicines to prevent or treat infections. Your doctor may need to delay your treatment and/or reduce your dose if you experience certain side effects. Patients should monitor and report any symptoms or fever to their doctor as soon as possibleHarm to a fetus when administered to a pregnant woman: Women of childbearing potential and men with female partners of childbearing potential should use effective contraception and avoid pregnancy while taking DACOGENOther common side effects including: ◦feeling tired (fatigue)◦fever (pyrexia)◦nausea◦cough◦reddish or purplish spots (petechiae)◦constipation◦diarrhea◦high blood sugar (hyperglycemia)DACOGEN should be used with caution if you have kidney or liver problemsYou are encouraged to report side effects of DACOGEN® (d