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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->化疗药物
处方药:处方药
包装规格: 250毫克/瓶
计价单位:
  点击放大  
生产厂家英文名:
Pharmacia & Upjohn Company
该药品相关信息网址1:
http://www.accessdata.fda.gov/scripts/cder/onctools/summary.cfm?ID=117
原产地英文商品名:
ZINECARD 250mg/Vial
原产地英文药品名:
DEXRAZOXANE
中文参考商品译名:
辛卡德-250毫克/瓶
中文参考化合物名称:
右雷佐生
原产地国家批准上市年份:
1995/05/26
英文适应病症1:
Prevention of cardio
英文适应病症2:
cardiomyopathy
临床试验期:
完成
中文适应病症参考翻译1:
预防心肌病
中文适应病症参考翻译2:
心肌病
药品信息:

---------------------------------------------------------------
详细处方信息以本药内容附件PDF文件(2020102823560623.pdf)的原文为准
---------------------------------------------------------------

【中文名】:右雷佐生

【英文名】:Dexrazoxane

【其它名称】

奥诺先、得拉唑沙、右丙亚胺、Cardioxane、Dextrazoxane、Eucardion、Zinecard

【分类】

肿瘤用药\抗肿瘤辅助药

【临床应用】

减轻或减少蒽环类抗生素(如多柔比星)化疗引起的心肌毒性(国外资料)

【用法用量】

国外参考信息 本药用量为多柔比星剂量的10倍。从开始给药计算,至少给予本药30min后使用多柔比星,应缓慢注射或较快的滴注。有亚硝基脲用药史者,本药最大耐受量为750mg/㎡;无亚硝基脲用药史者,本药最大耐受量为1250mg/㎡。


ZINECARD is a cytoprotective agent indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use ZINECARD with doxorubicin initiation.


INDICATIONS AND USAGE

ZINECARD is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy


DOSAGE FORMS AND STRENGTHS

ZINECARD (dexrazoxane for injection) is available in 250 mg or 500 mg single dose vials as sterile, pyrogen-free lyophilizates.


DESCRIPTION

ZINECARD (dexrazoxane for injection), a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration.

Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a whitish crystalline powder that melts at 191° to 197°C. It is sparingly soluble in water and 0.1 N HCl, slightly soluble in ethanol and methanol, and practically insoluble in nonpolar organic solvents. The pKa is 2.1. Dexrazoxane has an octanol/water partition coefficient of 0.025 and degrades rapidly above a pH of 7.0.

Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 25 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0.

Each 500 mg vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 50 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0.

The reconstituted ZINECARD solutions prepared from Sterile Water for Injection, USP, are intended for further dilution with Lactated Ringer's Injection, USP, for rapid intravenous drip infusion. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH

更新日期: 2021-02-05
附件:
20212422305414.PDF    



 
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