产地国家：日本 处 方 药：是 所属类别：100UI/3ml 2筆裝(冷藏) 包装规格：100UI/3ml 2筆裝(冷藏) 计价单位：盒 生产厂家中文参考译名: 诺和诺德 生产厂家英文名: NOVO Nodisk 原产地英文商品名: Tresiba Penfil 100UI/3ml 2pens (cold-storage) 原产地英文药品名: Insulin degludec 中文参考商品译名: Tresiba Penfil 100UI/3ml 2筆裝(冷藏) 中文参考药品译名: 胰岛素

简介

英文药名：TRESIBA Penfill(Insulin degludec(Genetical Recombination)) 中文药名：胰岛素预填充注射笔 生产厂家：诺和诺德 批准日期：2013年3月 商標名 TRESIBA Penfill 一般名 インスリン デグルデク(遺伝子組換え)[命名法：JAN] Insulin Degludec (Genetical Recombination)[命名法：JAN] 分子式 C274H411N65O81S6 分子量 6,103.97 性状 它是一种白色粉末。 审批条件 对医药风险管理计划的发展，要正确用药。 药效药理 作用机序 胰岛素Degurudeku呈现为六聚体可溶死在制剂中，在给药后，在皮下组织相关联，可溶形式的稳定的多六聚体保持暂时注入单元皮下组织。胰岛素单体逐渐从六多是缓慢而持续地吸收血液从给药部位，导致行动的持续时间较长解离。此外，通过脂肪酸侧链与皮下注射部位和血液白蛋白结合，有助于可持续作用。 本发明药物的主要药理学作用，含有该药物的胰岛素制剂是葡萄糖代谢的调节，结合到胰岛素受体，表达特定操作。 结合到胰岛素受体促进胰岛素在骨骼肌和脂肪细胞摄取糖和降低通过抑制葡萄糖产生肝脏中的血糖水平。另外，为了抑制在脂肪细胞中脂解作用和蛋白水解，它促进蛋白质的合成。 适应病症 糖尿病，胰岛素治疗 用法与用量 成人，最初皮下注射专用于一个4〜20个单位的胰岛素笔式注射器1天。所述剂量适当地增加或根据患者的条件降低。有时与其它胰岛素制剂，维持剂量，包括剂量的其他胰岛素制剂的组合使用，通常1天4-80单位。但是，它可以过量必要的剂量来使用。注射时间假设每一天作为一般规则是恒定的，但如果需要，可以改变注入时间。 儿童，与单个专用胰岛素笔式注射器1天皮下注射。注射时间假设每天恒定。所述剂量适当地增加或根据患者的条件降低。有时与其它胰岛素制剂，维持剂量，包括剂量的其他胰岛素制剂的组合使用，通常1天0.5-1.5单位/ kg。但是，它可以过量必要的剂量来使用。 包装规格 1カートリッジ3mL(100単位/mL) トレシーバ注 ペンフィル：2本 制造厂商 诺和诺德制药有限公司

英文版说明书

New sustained-release dissolved insulin analog preparation TRACYBA (R) Improved glycemic control without increasing risk of developing hypoglycemia at night by once a day administration Novo Nordisk Pharma Co., Ltd., a leading company in diabetes care, announced that on March , the sustained-release insulin analogue injectable solution Treaty (R) Note Flex Touch (R) and Traceyva® Note Penfill ( R) (hereinafter referred to as Traceyba (R), generic name: insulin degludek) will be released. Traceyba (R) achieves good glycemic control without increasing nighttime hypoglycemic frequency. Novo Nordisk Pharma Co., Ltd. (President: Klaus Eyelsin, headquarters: Chiyoda-ku, Tokyo), a leading company in diabetes care, announced that on March 7, a sustained-release insulin analogue injectable solution for treatment of diabetes insulin analog We will release Flex Touch (R) and Traceyver (R) Note Penfill (R) (hereinafter referred to as Traceyba (R), generic name: insulin degludek). Main characteristics of Traceyver (R) · It shows a more flat and stable hypoglycemic effect once a day, its effect lasts longer than 24 hours · In phase 3 Treat to Target * test, it showed a good hypoglycemic effect, and compared with the control drugs, nocturnal hypoglycemia Frequency of expression decreased · Once a day, it is possible to administer it at any given timing every day · The new prefilled pen injector Flextouch (R) is adopted as the injection button does not stretch and the injection button is light and easy to push. Flex touch (R) was developed reflecting the patient's voice. At the same time, Penfill (R) formulation to be used by setting it in a dedicated insulin pen type injector will also be released Traceyba (R) is a sustained-release insulin analog with a significantly lower frequency of nocturnal hypoglycemia compared with insulin glargine, while at the same level achieving improvement in glycemic control as insulin glargine 3, 4. Hypoglycemia is one of the symptoms patients feel uneasy. Especially when hypoglycemia occurs during sleeping, it may be unable to cope with hypoglycemia without being noticed, so it is a big concern for the patient. For patients experiencing hypoglycemia, treatment compliance decreases such as decreasing the number of administrations and dosages of insulin, leading to an increase in the risk of complications over the long term. Klaus Iracen, president of Novo Nordisk Pharma Co., Ltd. "We are very pleased to be able to deliver products developed for better insulin treatment to patients in Japan." Traceyver (R) is flat and stable from which it duration is longer, and is a formulation suitable for replenishment of insulin of basal secretion. from the properties of the formulation, to reduce low blood sugar, especially of nocturnal hypoglycemia anxiety, to enable a more aggressive blood sugar control it is expected. This until the patient basal insulin formulation was administered twice a day-san, will be avoid in the administration of once a day by Toreshiba (R). in addition injector, accuracy high has adopted a more easy-to-use flex touch (R). Novo Nordisk Pharma, through the promotion of the offer and the proper use of better products in the future, the treatment of patients We would like to contribute to the improvement of results and quality of life "and says. Treat to Target test is a trial comparing hypoglycemia frequency and severity etc with treatment aiming at similar blood glucose control including the control drug group. A state in which blood glucose levels drop abnormally is called "low blood sugar". Hypoglycemia may be caused by drinking drugs (oral hypoglycemic drugs) that lower blood glucose levels or by insulin therapy. If proper response is delayed, sufficient attention is required because consciousness loss and coma (konnichi) are caused and life is sometimes exposed to danger. Timing of administration such as "before bedtime", "before dinner", "before breakfast", etc. are determined for existing sustained release insulin preparations (insulin glargine, insulin detemir)