重组罗米司亭_Romiplate_重组罗米司亭冻干粉注射剂中英对照说明书

  [caption id="attachment_42745" align="alignleft" width="300"] Romiplate for s.c.injection 250mcg(重组罗米司亭冻干粉注射剂)[/caption] 药店国别： 产地国家：日本 处 方 药：是 所属类别：250微克/瓶 包装规格：250微克/瓶 计价单位：瓶 生产厂家中文参考译名:协和发酵麒麟 生产厂家英文名:Kyowa Hakko Kirin Co.,Ltd 原产地英文商品名:Romiplate for s.c. injection 250μg/vial 原产地英文药品名:Romiplostim(Genetical Recombination) 中文参考商品译名:Romiplate 250微克/瓶 中文参考药品译名:罗米司亭 简介： 部份中文重组罗米司亭处方资料(仅供参考) 商品名：Romiplate 英文名：Romiplostim 中文名：重组罗米司亭冻干粉注射剂 生产商：协和发酵麒麟制药 药效分类名称：造血刺激因子制剂/血栓素受体激动剂 批准日期：2011年 4月 欧文商標名：Romiplate for s.c. injection 一般的名称：Romiplostim(Genetical Recombination)) 分子量：59,085 本質：Romiprotinm(基因重组)是一种重组Fc-肽融合蛋白，2至228th是人IgG1的Fc区域，229至269由含有人类血栓素受体结合序列的肽组成。 洛米普罗西姆是由269个氨基酸残基组成的亚单位2分子组成的蛋白质。 处理注意事项： 打开盒子后，请保存遮光。 批准条件 功效常见： 制定药品风险管理计划，并妥善实施。 慢性特发性血小板减少性紫杉醇 由于国内试验病例非常有限，在制造和销售后，直到收集了与一定数量的病例相关的数据，通过对所有病例进行使用结果调查，了解使用药物患者的背景信息， 尽早收集有关该制剂安全性和有效性的数据，并采取必要措施正确使用该剂。 再生障碍性贫血在现有治疗中效果不佳 由于国内试验病例非常有限，在制造和销售后，直到收集了与一定数量的病例相关的数据，通过对所有病例进行使用结果调查，了解使用药物患者的背景信息， 尽早收集有关该制剂安全性和有效性的数据，并采取必要措施正确使用该剂。 药效与药理 作用机制： 该剂直接作用于巨核细胞祖细胞，表现出血小板造血作用。 此外，该剂与血栓素受体结合，通过激活，促进巨核细胞祖细胞的生长和分化。 此外，作用于骨髓造血干细胞和造血祖细胞，促进这些细胞的生长和分化。 造血效果： 该剂，正常小鼠，大鼠，当静脉注射或皮下施用到恒河猴和卡尼库扎尔，显示血小板造血作用(血小板计数增加)，在皮下给药对脾切除小鼠也表现出相同的作用。 此外，通过产生血小板的自身抗体，通过皮下给药到W/BF1小鼠，血小板破坏发生血小板减少，对血小板计数减少有改善作用。 此外，通过皮下给药到骨髓抑制小鼠，通过化疗剂/辐射引起多系统骨髓衰竭，对血小板数量和红细胞计数的减少表现出改善作用。 适应症： 慢性特发性血小板减少性紫杉醇 现有治疗效果不佳的再生障碍性贫血 用法与用量： 慢性特发性血小板减少性紫杉醇 通常，成人皮下施用初始剂量1μg/kg作为Romiplostim(基因重组)。给药开始后，血小板计数，根据症状适当增加或减少剂量，每周皮下施用一次。此外，最大剂量为10μg/kg，每周一次。 再生障碍性贫血在现有治疗中效果不佳 通常，成人皮下施用初始剂量10μg/kg作为Romiplostim(基因重组)。给药开始后，根据患者的状态适当增加或减少剂量，每周皮下施用一次。此外，最大剂量为20μg/kg，每周一次。 包装规格：250μg/0.72ml  1小瓶 存储方法：储存在2至8°C 有效期：36 月 制造供应商：协和发酵麒麟   Romiplate for s.c. injection Brand name :Romiplate for s.c. injection 250 mcg Active ingredient: Romiplostim(Genetical Recombination) Dosage form: Injection Print on wrapping: Effects of this medicine This medicine acts on cells that produce platelets and increases or maintains the number of platelets. It is usually used to treat chronic idiopathic thrombocytopenic purpura, aplastic anemia which conventional treatments showed insufficient results. 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 a history of brain infarction, myocardial infarction and lung infarction. If you have renal or hepatic disease. If you are 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)) In general, inject this medicine subcutaneously, once a week. This medicine may be used for a long period of time depending on your response to treatment. Before and during use of this medicine, blood tests will be performed regularly to investigate the number and shape of various types of blood cells. Precautions while taking this medicine Possible adverse reactions to this medicine The most commonly reported adverse reactions include headache, fatigue, pain of the limbs, joint pain, muscle pain, nausea, injection site reaction, dizziness. 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. breathing difficulty/chest pain, edema/pain of lower limbs, feeling of suddenly compressed chest[thrombosis/thromboembolism] bone marrow fibrosis, hematopoietic disorder when bone marrow fibrosis becomes severe(general malaise caused by anemia, bleeding tendency)/splenomegaly(fullness, left upper quadrant pain) [increase in bone marrow reticulin] bleeding after withdrawal of this medicine[bleeding] 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. Storage conditions and other information Stopping the use of this medicine may result in higher risks of worsening of thrombocytopenia or bleeding compared to those before the use of this medicine. The patient's status will be carefully observed, and attention will be paid to platelet count for at least 4 weeks after discontinuation. Blood tests will thus be performed frequently. Injection Revised: 2/2020 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.