英文药名:Dacarbazine Injection(Dacarbazine)
中文药名:达卡巴嗪注射液
日文药名:ダカルバジン注用
生产厂家:协和发酵麒麟
ダカルバジン注用100
类别名称 抗肿瘤药 欧文商標名 Dacarbazine Injection 一般名 ダカルバジン Dacarbazine 化学名 5-(3, 3-Dimethyl-1-triazeno)imidazole-4-carboxamide 略名 DTIC又はDIC 分子式 C6H10N6O=182.18 化学構造式
性状 易溶于冰醋酸,在极微溶于水,而在乙醇或几乎不溶于乙醚。 熔点 约204℃(分解) 分配系数 logP'OCT=-0.20(测量方法:摇瓶法正辛醇/pH7.4缓冲溶液) 条件批准 儿科霍奇金在日本(霍奇金淋巴瘤)的疾病,以确认该药物的安全性进行了的情况下的目的上市后特别调查。 药效药理 1.抗肿瘤 在小鼠实验中,B16黑色素瘤的节目的存活益处,也表现出对移植人黑素瘤SK-MEL-26裸鼠,MELA3的肿瘤生长抑制效果。小鼠白血病L1210,P815,L5178,也显示出生存益处为L4946,在实体瘤中观察到的肉瘤,Adenocarcinoma755,淋巴肉瘤P1798肿瘤缩小的效果。 MTX,6-MP,6-TG抗性菌株的L1210,也针对P815的5-FU抗性菌株有效。 2. 作用机序 (1) 通过在体内代谢产生的重氮甲烷它被认为是表达由烷基化作用的抗肿瘤作用。 (2) 对细胞周期G1期的细胞在低浓度的情况下,在高浓度的情况下的效果,还起到在G2期的细胞。 适应证 用于黑色素瘤、何杰金氏病(何杰金氏淋巴瘤)、嗜铬细胞瘤 用法用量 *黑色素瘤 成人,五天静脉,此后约四周其余的日剂量为100〜200毫克每日给药。一个疗程重复给药。该剂量可以根据年龄和症状进行调整。 *何杰金氏病(何杰金氏淋巴瘤) 成人的孩子,在与其他抗肿瘤剂组合,每日一次375mg/平方米(体表面积)静脉内给予如达卡巴嗪,随后停药13天。重复此两次,一个疗程,重复给药。 些外;根据患者的年龄和症状使用。 *嗜铬细胞瘤 成人,在用环磷酰胺水合物和硫酸长春新碱组合,每日一次600mg的/平方米(体表面积)的每天给药两天静脉内如达卡巴嗪,随后停药至少19天。 这是一个过程,重复给药。些外,根据该状态的患者减肥。 包装规格 100毫克/瓶 5瓶/盒(棕色瓶)
制造厂商 协和发酵麒麟有限公司 完整处方资料附件:http://www.info.pmda.go.jp/go/pack/4219401D1031_1_07/ Dacarbazine Injection(Dacarbazine) Dacarbazine Injection 100(ダカルバジン注用100) Brand name : Dacarbazine Injection 100 Active ingredient: Dacarbazine Dosage form: injection Print on wrapping: Effects of this medicine This medicine shows antineoplastic activity by combining with DNA of cancer cells and inhibiting DNA replication. It is usually used to treat malignant melanoma, Hodgkin's disease (Hodgkin's lymphoma), and pheochromocytoma. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have hepatic or renal disorder, infection, varicella. •If you are pregnant, possibly pregnant, or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •For malignant melanoma:In general, for adults, this medicine is injected intravenously and then discontinue temporarily. This dosing schedule is repeated. •For Hodgkin's disease (Hodgkin's lymphoma): In general, for both of adults and children, this medicine is injected intravenously once a day and then discontinue temporarily. This dosing schedule is repeated. •For pheochromocytoma: In general, for adults, this medicine is injected intravenously once a day for 2 consecutive days and then discontinue temporarily. This dosing schedule is repeated. •In any case, duration of administration may vary by other concomitant drug and condition of the patient. Ask your doctor about your dosing schedule. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include nausea, vomiting, angialgia, hepatic dysfunction and loss of appetite. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •general malaise, lightheadedness, impaired consciousness [anaphylactic shock] •nasal bleeding, general malaise, fever [marrow depression such as pancytopenia, anemia, leukopenia and thrombocytopenia] •nausea, vomiting, intense abdominal pain [serious hepatic disorder with hepatic vein thrombosis or hepatic cell necrosis] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Kyowa Hakko Kirin Co.,LtdInjection Published: 7/2013 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
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