氨柔比星 ,氨柔比星 CALSED Injection 50mg(Amrubicin Hydrochloride)

药店国别:

产地国家:日本

处方药:

所属类别: 50毫克/瓶

包装规格: 50毫克/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Dainippon Sumitomo Pharma

原产地英文商品名:Calsed injection(カルセド注射用)50mg/vial

原产地英文药品名:Amrubicin Hydrochloride

中文参考商品译名:凯德注射剂(カルセド注射用)50毫克/瓶

中文参考药品译名:氨柔比星

曾用名:

简介

部份中文凯德处方资料(仅供参考)

通用名:注射用盐酸氨柔比星

英文名:CALSED(Amrubicin Hydrochloride for Injection)

商品名:凯德(CALSED)注射剂

有效成分:Amrubicin Hydrochloride (盐酸氨柔比星)

批准上市时间:2002年

开发与上市厂商:日本住友制药公司(Sumitomo)研制,2002年12月6日在日本首次上市。

适应症

用于非小细胞肺癌及小细胞肺癌的治疗有效率完全缓解率9.1% ,奏效率75.8%。药理性本品为蒽环类药物,是一種嵌入型拓扑异构酶Ⅱ(Topo Ⅱ)抑制剂。本品与多柔比星的作用机制略有不同,主要是通过抑制Topo Ⅱ的活性,最终导致DNA的断裂而抑制肿瘤细增殖。

给药说明

治疗肺癌药物氨柔比星。氨柔比星(amrubicin,Calsed)由日本住友制药公司开发,于2002年4月被批准用于非小细胞肺癌及小细胞肺癌的治疗,2002年12月首次在日本上市。作为一种蒽环霉素类药物,氨柔比星是一种嵌入型拓扑异构酶Ⅱ(topoisomeraseⅡ,TopoⅡ)抑制剂。

它的作用机制和阿霉素略有不同,主要是通过抑制TopoⅡ的活性,最终导致DNA的断裂而抑制肿瘤细胞增殖。早在临床前的研究工作中,氨柔比星就表现了比传统蒽环霉素类药物有更佳的抗癌活性。

Ⅱ期临床试验数据表明,氨柔比星对非小细胞肺癌的有效率达到了27.9%(其中完全缓解率为1.6%),对小细胞肺癌的有效率则达到了75.8%(其中完全缓解率为9.1%)。

用法用量

以盐酸氨柔比星计,成人1次/d,每次45mg/m2,溶于20ml生理盐水或5%葡萄糖注射液中,连续3天静脉推注,然后停药3~4周,再进行下一疗程的治疗。カルセド注射用20mg/カルセド注射用50mg药效分类名抗恶性肿瘤性抗生物质。

包装:凯德注射剂カルセド注射用20mg:1凯德注射剂バイアルカルセド注射用50mg:1

英文版说明

Amrubicin Hydrochloride for Injection)Efficiency classification nameAntineoplastic antibioticSales name20 mg for carved injectionGeneral nameAmrubicin hydrochloride (amrubicin hydrochloride)Amrubicin HydrochlorideChemical name7 – [(2 – deoxy – β – D – erythro – pentopyranosyl) oxy] – 7,8,9,10 – tetrahydro – 6, 11 -dihydroxy-5, 12-naphthacenedione hydrochlorideMolecular formulaC25 H25 NO 9 HCl (519.93)PropertyIt is reddish-red powder or lump.It is slightly soluble in water, 0.05 mol / L phosphate buffer (pH 3.0) and 0.005 mol / L phosphate buffer (pH 2.5), slightly soluble in N, N-dimethylformamide and methanol, ethanol (95) and hardly soluble in acetonitrile.Additives (in 1 vial)Lactose hydrate 50 mgL-cysteine ​​hydrochloride monohydrate 3.2 mgPH regulator (hydrochloric acid, sodium hydroxide) qsContraindicationsPatients with severe bone marrow function suppression [May complicate severe infectious diseases etc, which may be fatal]Patients with severe infections [The infectious disease may exacerbate and become fatal]Patients with interstitial pneumonia or pulmonary fibrosis, which are clear in chest radiography and clinical symptoms [The symptoms may be exacerbated and fatal]Patients with cardiac dysfunction or a previous history [myocardial damage may occur]If the pretreatment with a cardiotoxic drug such as other anthracycline drugs is the limit amount (25 mg/kg total dose for daunorubicin hydrochloride for the body weight, the total dose for doxorubicin hydrochloride is 500 mg/m 2 for body surface area, epirubicin hydrochloride Patients who have reached a total dose of 900 mg/m 2 per body surface for salt, 9.5 mg/m 2 per body surface area for pirarubicin hydrochloride, total dose of pirarubicin hydrochloride etc.) [There is a danger of myocardial damage appeared]Patients with a history of severe hypersensitivity to the ingredients of this drugPregnant women or women who may be pregnant [see "Administration to pregnant women, maternity women, lactating women, etc."]Indication or effectNon small cell lung cancer, small cell lung cancerUsually, for adults, 45 mg (titer)/m2(body surface area) as amrubicin hydrochloride is dissolved in about 20 mL of Japanese Pharmaceutical Saline or 5% glucose injection solution and administered intravenously every day for 3 days once a day Then, take off for 3 to 4 weeks. Let this be one course and repeat dosing. Incidentally, weight reduction is made according to the condition of the patient.Severe bone marrow function suppression may occur by administration of this drug, so after administering, pay attention to fluctuations in the blood test value, and the dosage for the next course should be reduced as appropriate according to the condition of the patient ("clinical record" Section)Careful AdministrationPatients with bone marrow function suppression [there is a risk that bone marrow function suppression will be exacerbated]Patients with infectious diseases [There is a risk of infection exacerbation]Patients with interstitial pneumonia or pulmonary fibrosis [Interstitial pneumonia or pulmonary fibrosis may exacerbate]Other anthracycline drugs etc Patients who had previously been treated with drugs with cardiotoxicity [Myocardial disorder may occur]Patients with hepatic impairment [The blood concentration of this drug rises, side effects may appear strongly. ]Patients with renal impairment [Side effects may appear strongly]Elderly (see "Administration to the elderly" section)Chickenpox patients [Fatal systemic lesions may occur]Serious side effectsBone marrow function suppression(More than 90%), anemia (more than 80%), thrombocytopenia (more than 40%), pancreatic depression (frequency unknown), leucocytopenia (more than 90%), neutropenia (including febrile neutropenia) ), Etc. may occur, so observe peripheral blood thoroughly and if abnormality is observed, take appropriate measures such as weight loss and withdrawal. In addition, deaths due to the development of severe infections (septicemia, pneumonia, etc.) caused by advanced bone marrow function suppression have been reported, so pay attention to signs of infection during administration, and when abnormality is found Discontinue administration and take appropriate measures.Interstitial pneumonia (less than 0.1 to 5%)Interstitial pneumonia may develop, so observe thoroughly, if abnormalities are observed, discontinue administration and take appropriate measures such as administration of adrenocortical hormone drugs.Stomach · duodenal ulcer (frequency unknown)Gastric/duodenal ulcer accompanied by hematemesis (less than 0.1 to 5%), bleeding, perforation may occur, so observe the condition of the patient adequately. If abnormality is observed, appropriate measures such as discontinue administration should be taken.Medicinal pharmacologyAntitumor effectAmrubicin hydrochloride showed an antitumor effect on Ehrlich solid tumor, S-180 sarcoma, P-388, Lewis lung carcinoma and Colon 38 which are mouse experimental tumor lines (in vivo). 8) Lu-99, LC-6, and L-27, which are nude mouse-capable transplantable human tumor strains MX-1 (derived from breast cancer), LX-1 and Lu-24 (the two cell lines are derived from small cell lung cancer) (These three cell lines were derived from non-small cell lung cancer), showed antitumor effect against SC-6, SC-9, St-4 and 4-1ST (4 cell strains derived from stomach cancer) (in vivo) .Amrubicin hydrochloride and active metabolite amrubicinol showed cytostatic activity against human tumor cell lines Calu-1 and A 549 lung cancer strains and osteosarcoma strains such as MG-63 etc. (in vitro)Doxorubicin hydrochloride tolerance P388 cell line showed cross-resistance to amrubicin hydrochloride and active metabolite amrubicinol (in vitro)Mechanism of actionAmrubicin hydrochloride and active metabolite amrubicinol showed DNA intercalation activity, topoisomerase II inhibition action, DNA cleavage action through the stabilization of cleavable complex by topoisomerase II, and radical production action (in vitro)

 

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