放线菌素D注射剂Actinomycin(COSMEGEN IV Injection 0.5mg)

产地国家:日本

所属类别:0.5毫克/瓶 1瓶

包装规格:0.5毫克/瓶 1瓶

计价单位:瓶

生产厂家英文名:Nobel Pharma Corporation

原产地英文商品名:COSMEGEN IV Injection(コスメゲン静注用)0.5MG/vial

原产地英文药品名:Actinomycin D

中文参考商品译名:COSMEGEN(コスメゲン静注用)0.5毫克/瓶 1瓶

中文参考药品译名:放线菌素D

简介

部份中文更生霉素放线菌素处方资料(仅供参考)

英文名:Actinomycin D

商品名:COSMEGEN IV Injection 0.5mg

中文名:放线菌素D

生产商:Nobel Pharma Corporation

药物分类名称:抗肿瘤抗生素

批准日期:2013年1月

商品名:COSMEGEN IV Injection 0.5mg

一般名:アクチノマイシンD (Actinomycin D)

化学名:

Specific stereoisomer of N , N ‘-[(2-amino-4, 6-dimethyl-3-oxo-3H-phenoxazine-1, 9-diyl)-bis[carbonylimino(2-hydroxypropylidene)carbonyliminoisobutylidenecarbonyl-1, 2-pyrrolidinediyl carbonyl (methylimino)methylenecarbonyl]]-bis[N -methyl-L-valine]dilactone

分子式:C62H86N12O16

分子量:1255.42

融点:241.5~243℃ (分解)

性状:它是红色至红色结晶粉末。易溶于丙酮,微溶于乙腈或甲醇,溶于乙醇(99.5),不溶于水。

药用药理学

1.抗肿瘤作用在使用小鼠和大鼠等动物的实验中,放线菌素D对吉田肉瘤,艾氏腹水癌,Krebs2腹水癌,肉瘤180腹水癌,白血病1210,甲基胆蒽肉瘤,乳腺癌和可移植的肾母细胞瘤等具有抗性。已发现它具有肿瘤作用。

2.对HeLa细胞的作用在使用HeLa细胞的实验中,放线菌素D充当HeLa细胞的核毒物并且已经显示出表现出细胞病变效应。3.行动机制认为通过该药物与DNA的结合,抑制了RNA聚合酶对DNA的转录反应。

适应症

1.肾母细胞瘤,绒毛膜上皮瘤,破坏性肺泡痣2.与其他抗肿瘤药物联合治疗以下恶性肿瘤小儿恶性实体瘤(尤文肉瘤家族肿瘤,横纹肌肉瘤,肾母细胞瘤和其他肾原发性恶性肿瘤)

用法与用量

1.Wilms肿瘤,绒毛膜上皮瘤和破坏性肺泡痣的一般给药方式如下。

成人:通常每天静脉注射0.010毫克(10微克)/千克体重1天应为一个疗程。

儿科:通常每天静脉注射5天,每公斤体重1天为0.015毫克(15微克)。药物假期通常为2周,但如果前一次服用出现中毒症状,我们就会起飞,直到中毒症状消失。

2.与其他抗肿瘤药物联合治疗小儿恶性实体瘤(尤文肉瘤家族肿瘤,横纹肌肉瘤,肾母细胞瘤和其他肾脏原发性恶性肿瘤)

(1)用量和与一种施用其他抗肿瘤剂,一种1.25〜1.35毫克/米@2天组合施用(称重30千克或多个:每天最大剂量2.3毫克)或0.045毫克/千克(体重小于30kg)静脉注射或静脉注射。

(2)给药方案联合给予分割其它抗肿瘤剂,每日一次0.015毫克/千克(每日最大剂量0.5毫克)静脉注射或静脉滴注,连续给药五天到。药物假期通常为2周,但如果前一次服用出现中毒症状,我们就会起飞,直到中毒症状消失。应根据年龄,伴随药物,患者病情适当减轻体重。

<制备方法>每1瓶该药物加入1.1mL注射用水(不含防腐剂)并溶解。该溶液含有约0.5mg的放线菌素D,1mL。它不能完全溶解在1.1mL生理盐水溶液中并变得混浊,因此一定要溶解在注射用水中。·务必准备使用并丢弃未使用的化学品。临床结果在日本进行的一般临床试验中通过给予该药物的适应症指示判断效果的情况下的临床结果概要如下。

(1)肾母细胞瘤通过该药物治疗和肾肿瘤切除手术或肾肿瘤切除手术和放射治疗,获得了81.0%(17/21例)的有效率。

(2)绒毛膜癌单独使用破坏性肺泡寄生虫和绒毛膜上皮瘤治疗该药物后,治疗效果率为95.5%(21/22例患者),并且使用该药物与甲氨蝶呤联合治疗后,获得了72.1%的有效率(31/43例)。

包装:1小瓶0.5mg:1小瓶

英文版说明书

Cosmegen (Dactinomycin)COSMEGEN®MSDDactinomycinAntineoplasticAction AndClinical Pharmacology: Dactinomycin is an antibiotic obtained as the principalcomponent of the mixture of actinomycins produced by S. parvullus. Thisorganism, unlike other species, yields an essentially pure substance thatcontains only traces of similar compounds differing in the amino acid content of the peptide side chains. It is available for clinical use as a sterile, yellowl yophilized powder which, in aqueous solution, produces a clear gold color.Generally, the actinomycins exert an inhibitory effect on gram positive and gram negative bacteria and on some fungi. However, the toxic properties of the actinomycins (including dactinomycin) in relation to antibacterial activity are such as to preclude their use as antibiotics in the treatment of infectious diseases.Because the actinomycins are cytotoxic, they have an antineoplastic effect which has been demonstrated in experimental animals with various types of tumor implant. This cytotoxic action is the basis for their use in the palliative treatment of certain types of cancer.Pharmacokinetics: Results of a study in patients with malignant melanoma indicate that dactinomycin (actinomycin D) is minimally metabolized, is concentrated in nucleated cells, and does not penetrate the blood brain barrier. Approximately 30% of the dose was recovered in urine and feces in one week. The terminal plasma half-life for radioactivity was approximately 36 hours.Indications And Clinical Uses: Wilms ’Tumor: Theneoplasm responding most frequently to dactinomycin is Wilms’ tumor.With low doses of both dactinomycin and radiotherapy, temporary objective improvement may be as good as and may last longer than with higher doses of each given alone. In the National Wilms’ Tumor study, combination therapy with dactinomycin and vincristine together with surgery and radio therapy,  was shownto have significantly improved the prognosis of patients in groups II and III.Dactinomycin and vincristine were given for a total of seven cycles, so thatmaintenance therapy continued for appro ximately 15 months Postoperati veradiotherapy in group I patients and optimal combination chemotherapy for thosein group IV are unsettled issues. About 70% of lung metastases have disappeared with an appropriate combination of radiation, dactinomycin andvincristine.Rhabdomyosarcoma: Temporary regression of the tumor and beneficialsubjective results have occurred with dactinomycin in rhabdomyosarcoma which,like most soft tissue sarcomas, is comparatively radioresistant.Several groupshave reported successful use of cyclophosphamide, vincristine, dactinomycin anddoxorubicin hydrochloride in various combinations. Effective combinations haveincluded vincristine and dactinomycin; vincristine, dactinomycin andcyclopho sphamide (VAC therapy) and all 4 drugs in sequence. At present, the mosteffective treatment for children with inoperable or metastatic rhabdomyosarcomahas been VAC chemotherapy. Two-thirds of these children were doing well withoutevidence of disease at a median time of three years after diagnosis.Carcinoma ofTestis and Uterus: The sequential use of dactinomycin and methotrexate, alongwith meticulous monitoring of human chorionic gonadotropin levels until normal,has resulted in survival in the majority of women with metastaticchoriocarcinoma. Sequential therapy is used if there is: stability ingonadotropin titers following two successive courses of an agent; risinggonadotropin titers during treatment; severe toxicity preventing adequatetherapy.In patients with nonmetastatic choriocarcinoma, dactinomycin ormethotrexate or both have been used successfully, with or withoutsurgery.Dactinomycin has been beneficial as a single agent in the treatment ofmetastatic non-seminomatour testicular carcinoma when used in cycles of 500µg/day for 5 consecutive days, every 6 to 8 weeks for periods of four months orlonger.Other Neoplasms: Dactinomycin has been given i.v. or by regionalperfusion, either alone or with other antineoplastic compounds or x-ray therapy,in the palliative treatment of Ewing’s sarcoma and sarcoma botryoides. Fornon-metastatic Ewing’s sarcoma, promising results were obtained whendactinomycin (45 µg/m and cyclophosphamide (1 200 mg/m were given sequentiallyand withradiotherapy, over an 18 month period.

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