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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: 500毫克/瓶 1瓶
计价单位:
   
生产厂家英文名:
Pfizer
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 SDV Injection 500mg/Vial 1 Vial
原产地英文药品名:
DEXRAZOXANE
中文参考商品译名:
辛卡德 SDV注射剂-500毫克/瓶 1瓶
中文参考药品译名:
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:
【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® (dexrazoxane for injection) Pharmacia and Upjohn Company DESCRIPTION ZINECARD® (dexrazoxane for injection) is a sterile, pyrogen-free lyophilizate intended for intravenous administration. It is a cardioprotective agent for use in conjunction with doxorubicin. Chemically, dexrazoxane is (S)-4,4'-(1-methyl-1,2-ethanediyl)bis-2,6piperazinedione.The structural formula is as follows: Dexrazoxane, a potent intracellular chelating agent is a derivative of EDTA. Dexrazoxane is a whitish crystalline powder which 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. ZINECARD is available in 250 mg and 500 mg single use only vials. 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 the 25 mL vial of 0.167 Molar (M/6) Sodium Lactate Injection, USP diluent provided, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 3.5 to 5.5. 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 the 50 mL vial of 0.167 Molar (M/6) Sodium Lactate Injection, USP diluent provided, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 3.5 to 5.5. CLINICAL PHARMACOLOGY Mechanism of Action The mechanism by which ZINECARD exerts its cardioprotective activity is not fully understood. Dexrazoxane is a cyclic derivative of EDTA that readily penetrates cell membranes. Results of laboratory studies suggest that dexrazoxane is converted intracellularly to a ring-opened chelating agent that interferes with iron-mediated free radical generation thought to be responsible, in part, for anthracycline induced cardiomyopathy. 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. It is not recommended for use with the initiation of doxorubicin therapy (see WARNINGS). CONTRAINDICATIONS ZINECARD should not be used with chemotherapy regimens that do not contain an anthracycline. WARNINGS ZINECARD may add to the myelosuppression caused by chemotherapeutic agents. There is some evidence that the use of dexrazoxane concurrently with the initiation of fluorouracil, doxorubicin and cyclophosphamide (FAC) therapy interferes with the antitumor efficacy of the regimen, and this use is not recommended. In the largest of three breast cancer trials, patients who received dexrazoxane starting with their first cycle of FAC therapy had a lower response rate (48% vs 63%; p=0.007) and shorter time to progression than patients who did not receive dexrazoxane (see Clinical Studies section of CLINICAL PHARMACOLOGY). Therefore, ZINECARD should only be used in those patients who have received a cumulative doxorubicin dose of 300 mg/m2 and are continuing with doxorubicin therapy. Although clinical studies have shown that patients receiving FAC with ZINECARD may receive a higher cumulative dose of doxorubicin before experiencing cardiac toxicity than patients receiving FAC without ZINECARD, the use of ZINECARD in patients who have already received a cumulative dose of doxorubicin of 300 mg/m2 without ZINECARD, does not eliminate the potential for anthracycline induced cardiac toxicity. Therefore, cardiac function should be carefully monitored. Secondary malignancies (primarily acute myeloid leukemia) have been reported in patients treated chronically with oral razoxane. Razoxane is the racemic mixture, of which dexrazoxane is the S(+)-enantiomer. In these patients, the total cumulative dose of razoxane ranged from 26 to 480 grams and the duration of treatment was from 42 to 319 weeks. One case of T-cell lymphoma, a case of B-cell lymphoma and six to eight cases of cutaneous basal cell or squamous cell carcinoma have also been reported in patients treated with razoxane. PRECAUTIONS General Doxorubicin should not be given prior to the intravenous injection of ZINECARD. ZINECARD should be given by slow I.V. push or rapid drip intravenous infusion from a bag. Doxorubicin should be given within 30 minutes after beginning the infusion with ZINECARD. (See DOSAGE AND ADMINISTRATION). As ZINECARD will always be used with cytotoxic drugs, patients should be monitored closely. While the myelosuppressive effects of ZINECARD at the recommended dose are mild, additive effects upon the myelosuppressive activity of chemotherapeutic agents may occur. Patients with Moderate or Severe Renal Insufficiency Greater exposure to dexrazoxane may occur in patients with compromised renal function. The ZINECARD dose should be reduced by 50% in patients with creatinine clearance values <40 mL/min (see DOSAGE AND ADMINISTRATION).
更新日期:  2014-06-05
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