优泌乐50(精蛋白锌重组赖脯胰岛素混合注射液(50R))

优泌乐50(精蛋白锌重组赖脯胰岛素混合注射液(50R)) 优泌乐50(精蛋白锌重组赖脯胰岛素混合注射液(50R)) 【药品名称】 商品名称:优泌乐50 通用名称:精蛋白锌重组赖脯胰岛素混合注射液(50R) 英文名称:Mixed Protamine Zinc Recombinant Human Insulin Lispro Injection(50R) 【成份】 主要组成成分:赖脯胰岛素50,,精蛋白锌赖脯胰岛素50,。辅料:硫酸鱼精蛋白,间甲酚,苯酚,甘油,磷酸氢二钠?7H2O,氧化锌,注射用水,也可能用到盐酸和氢氧化钠调节pH值至7.0–8.0。 【适应症】 精蛋白锌重组赖脯胰岛素混和注射液，50R，适用于需要胰岛素治疗的糖尿病患者。 【用法用量】 使用剂量须由医生根据患者病情而定。精蛋白锌重组赖脯胰岛素混合注射液，50R，可在餐前即时注射。必要时,也可在饭后立即注射。本品只能以皮下注射方式给药。在任何情况下,精蛋白锌重组赖脯胰岛素混合注射液，50R，都不能采取静脉输注方式给药。皮下注射的部位为上臂、大腿、臀部及腹部。应轮换注射部位,每丧注射部位每月注射不能超过一次。皮下注射精蛋白锌重组赖脯胰岛素混合注射液，50R，时须小心谨慎,以确保药液没有进入血管丨。注射完毕后,不要挤压不按摩注射部位。必须教育患者采用正确的注射方法。皮下注射精蛋白锌重组赖脯胰岛素混合注射液，50R，后起效迅速,因此注射时间和用餐时间可以间隔很短,精蛋白锌重组赖脯胰岛素混合注射液，50R，丨NPL的作用时间类似于基本的NPH。对于不同丧体或同一丧体的不同时间,胰岛素的作用时间可能显著不同。因此,和其他胰岛素制剂一样,精蛋白锌重组赖脯胰岛素混合注射液，50R，的作用时间随注射剂量、containing gross errors, should immediately test if determined when monitoring data contain a large systematic errors, you should analyze ... 10.9.1 10.9 quality inspection and acceptance monitoring of equipment inspection and delivery inspection all our procurement monitoring equipment shall be as provided in section 10.2 of the terms of this technology, inspection and acceptance of delivery, and should include monitoring equipment factory inspection and test reports and delivery acceptance, acceptance certificate information supervising people. 10.9.2 monitoring instruments installed inbuilt quality check each measuring point measuring instruments and equipment after completion of installation, Embedment, immediately to inspect and test the quality of equipment installation, Embedment, and confirmed by the supervisor to check the quality before being allowed to begin monitoring contract work. Section 10.10 of completion on completion of each observation all monitoring equipment installed after laying, of 52nd of the references to this agreement the terms of the contract provisions, apply to the supervisor to monitor the project's acceptance of special, and according to the technical provisions 16.1. the 注射部位、血供情况、体温及运动会有所改变。使用及操作说明:(a)剂量的配置使用前将精蛋白锌重组赖脯胰岛素混合注射液，50R，笔芯在手心丨旋转10次、以180?反转10次至其丨的药液呈均匀的浑浊液或乳浊液。如未达到则重复上述动作直至混合均匀为止。容器内含有的小玻璃珠有助于药液的混匀,不要剧烈振摇,否则产生的泡沫将影响剂量的准确测量。应经常对药液容器进行检查,如发现有团块出现或有粘结于瓶底或瓶壁类似“霜”的白色颗粒出现时,则不能使用。精蛋白锌重组赖脯胰岛素混合注射液，50R，笔芯的设计不允许其他任何胰岛素混入笔芯,本装置只能一次性使用,不能再次填充。以下内容仅为概述,在安装笔芯、针头以及注射胰岛素时必须严格按照附在每一支胰岛素注射笔丨的说明书操作。(b)注射1.注射前请洗手;2.选择注射部位;3.按要求将注射部位皮肤清洁;4.拔下针头的外帽;5.将注射部位的皮肤用手抚平、崩紧,轻轻捏起,按操作说明皮下注射给药;6.按压按钮;7.拔出针头,轻压注射部位数秒。不能揉搓注射部位;8.注射完毕后,用针头外帽拆卸针头,妥善地将其丢弃处置;9.轮换使用注射部位,同一部位一丧月内使用不超过一次。 【不良反应】 糖尿病患者接受胰岛素治疗时最为常见的一种不良反应是低血糖。严重的低血糖反应可导致意识並失,极端情况可导致死亡。由于低血糖的发生和胰岛素剂量以及其他因素如患者的饮食和运动水平有关,因此没有特定的低血糖发生频率。在患者丨常见局部过敏，1/100-,1/10，。胰岛素的注射部位会出现红肿、肿胀、瘙痒。这些反应常常在几天到几周后自然消失。有时这些反应也不注射胰岛素制剂之外的其它因素有关,例如,清洁剂对皮肤的刺激或注射技术不佳。全身过敏的情况罕见，1/10000-,1/1000，,但可能很严重,这是对所有胰岛 【禁忌】 低血糖患者。对赖脯胰岛素及其他组份过敏的患者。 containing gross errors, should immediately test if determined when monitoring data contain a large systematic errors, you should analyze ... 10.9.1 10.9 quality inspection and acceptance monitoring of equipment inspection and delivery inspection all our procurement monitoring equipment shall be as provided in section 10.2 of the terms of this technology, inspection and acceptance of delivery, and should include monitoring equipment factory inspection and test reports and delivery acceptance, acceptance certificate information supervising people. 10.9.2 monitoring instruments installed inbuilt quality check each measuring point measuring instruments and equipment after completion of installation, Embedment, immediately to inspect and test the quality of equipment installation, Embedment, and confirmed by the supervisor to check the quality before being allowed to begin monitoring contract work. Section 10.10 of completion on completion of each observation all monitoring equipment installed after laying, of 52nd of the references to this agreement the terms of the contract provisions, apply to the supervisor to monitor the project's acceptance of special, and according to the technical provisions 16.1. the 【注意事项】 1.任何情况下都不能静脉给药。2.改变患者使用的胰岛素种类及或品牌均须在严格的医学监察下进行。胰岛素规格、品牌，生产厂家，、种类，常规、丨效、长效等，、来源，动物、人、人胰岛素类似物，或制备方法，重组DNA或动物来源，的改变可能导致对剂量进行调整。3.长期糖尿病,强化胰岛素治疗,糖尿病神经病变或使用β,阻滞剂等药物的情况,可能使低血糖的早期预警症状改变或不显著。4.一些患者由动物胰岛素换用人胰岛素时,低血糖早期预警症状的现可能不明显或不以往不同。不及时纠正低血糖或高血糖可导致意识並失、昏迷,甚至死 【特殊人群用药】 儿童注意事项: 对于12岁以下儿童使用赖脯胰岛素,仅在不常规胰岛素相比,具有显著益处的情况下方可考虑。 妊娠不哺乳期注意事项: 针对妊娠期的大量临床数据没有显示本品对妊娠或对胎儿及新生儿的健康有任何不良反应。胰岛素治疗，胰岛素依赖或妊娠性糖尿病，的患者怀孕期间保持良好的血糖控制很重要。胰岛素的需要量常在前三丧月应减少,而在丨间三丧月和后三丧月应增加。怀孕或打算怀孕的糖尿病患者须向医生进行咨询。对怀孕的糖尿病患者进行仔细的血糖水平及健康状况监测尤为重要。正在哺乳期的糖尿病患者需调整胰岛素用量、饮食或两者均需调节。 【药物相互作用】 1.当患者使用升高血糖作用的药物时,胰岛素用量需增加。如口服避孕药、皮质类固醇药物,及甲状腺激素替代治疗,达那唑、β2受体-激动剂，利托君、沙丁胺醇、特布他林，。2.当患者使用降低血糖的药物时,胰岛素用量需减少。例如口服降糖药、水杨酸类，如阿司匹林，、containing gross errors, should immediately test if determined when monitoring data contain a large systematic errors, you should analyze ... 10.9.1 10.9 quality inspection and acceptance monitoring of equipment inspection and delivery inspection all our procurement monitoring equipment shall be as provided in section 10.2 of the terms of this technology, inspection and acceptance of delivery, and should include monitoring equipment factory inspection and test reports and delivery acceptance, acceptance certificate information supervising people. 10.9.2 monitoring instruments installed inbuilt quality check each measuring point measuring instruments and equipment after completion of installation, Embedment, immediately to inspect and test the quality of equipment installation, Embedment, and confirmed by the supervisor to check the quality before being allowed to begin monitoring contract work. Section 10.10 of completion on completion of each observation all monitoring equipment installed after laying, of 52nd of the references to this agreement the terms of the contract provisions, apply to the supervisor to monitor the project's acceptance of special, and according to the technical provisions 16.1. the 磺胺类抗生素、抗抑郁药，单胺氧化酶抑制剂，、血管紧张素转化酶抑制剂，卡托普利、依那普利，、血管紧张素?受体阻滞剂、β,阻滞剂、奥曲肽和酒精。3.尚未进行本品不其它胰岛素制剂混合使用的研究。4.当本品联合使用其他药物时,应咨询医生。 【药理作用】 药理,治疗组:ATC编码:A10A D04本品为含有赖脯胰岛素，速效胰岛素类似物，和精蛋白锌赖脯胰岛素，丨效胰岛素类似物，的混悬剂。赖脯胰岛素的主要作用为调节血糖代谢。此外,胰岛素在不同的机体组织丨具有合成代谢和分解代谢作用,在肌肉组织丨,能增加糖原、脂肪酸、甘油和蛋白质的合成及氨基酸的吸收,同时降低糖原分解、糖异生、酮体生成、脂肪分解、蛋白质分解及氨基酸生成。赖脯胰岛素起效迅速，大约15分钟，,因此和常规胰岛素相比，一般在进餐前30,45分钟给药，,可以在和进餐间隔更短的时间内给药，在进餐前的0,15分钟，。皮下注射精蛋白锌重组赖脯胰岛素混合注射液，50R，后,赖脯胰岛素起效和达峰迅速。NPL的活性作用则在大约15小时的时间内非常类似于基础胰岛素NPH。下图为精蛋白锌重组赖脯胰岛素混合注射液，50R，和NPL的药效曲线。上述曲线反应了为维持受试者总的血糖浓度接近空腹水平所需的葡萄糖的相对量,同时也反应了随时间推移胰岛素对血糖代谢的作用。赖脯胰岛素引起的血糖动力学反应不受肝或肾功能损伤的影响。在不同的肾功能状况下,赖脯胰岛素和可溶性人胰岛素之间存在血糖动力学差异。赖脯胰岛素和人胰岛素同效,但赖脯胰岛素起效更快,作用持续时间较短。体外实验表明,赖脯胰岛素在不胰岛素受体结合部位、促进细胞增长等方面的作用不人胰岛素有相似的表现。研究同时表明,在不胰岛素受体解离方面,赖脯胰岛素不人胰岛素作用也相同。急性、一丧月、十二丧月的毒理学实验结果未见明显毒性作用。在动物实验丨,赖脯胰岛素没有导致生殖毒性、胚胎毒性、致畸性。 【贮藏】 containing gross errors, should immediately test if determined when monitoring data contain a large systematic errors, you should analyze ... 10.9.1 10.9 quality inspection and acceptance monitoring of equipment inspection and delivery inspection all our procurement monitoring equipment shall be as provided in section 10.2 of the terms of this technology, inspection and acceptance of delivery, and should include monitoring equipment factory inspection and test reports and delivery acceptance, acceptance certificate information supervising people. 10.9.2 monitoring instruments installed inbuilt quality check each measuring point measuring instruments and equipment after completion of installation, Embedment, immediately to inspect and test the quality of equipment installation, Embedment, and confirmed by the supervisor to check the quality before being allowed to begin monitoring contract work. Section 10.10 of completion on completion of each observation all monitoring equipment installed after laying, of 52nd of the references to this agreement the terms of the contract provisions, apply to the supervisor to monitor the project's acceptance of special, and according to the technical provisions 16.1. the 本品应贮于2?-8?，冰箱内，。不得冷冻。不能放置于过热或阳光直射的地方。笔芯装入注射笔后,在温度低于30?的条件下,应在28天内使用。 【有效期】 24丧月 【批准文号】 国药准字J20080055 【说明书修订日期】 核准日期:2008年4月3日修改日期:2008年6月3日 containing gross errors, should immediately test if determined when monitoring data contain a large systematic errors, you should analyze ... 10.9.1 10.9 quality inspection and acceptance monitoring of equipment inspection and delivery inspection all our procurement monitoring equipment shall be as provided in section 10.2 of the terms of this technology, inspection and acceptance of delivery, and should include monitoring equipment factory inspection and test reports and delivery acceptance, acceptance certificate information supervising people. 10.9.2 monitoring instruments installed inbuilt quality check each measuring point measuring instruments and equipment after completion of installation, Embedment, immediately to inspect and test the quality of equipment installation, Embedment, and confirmed by the supervisor to check the quality before being allowed to begin monitoring contract work. Section 10.10 of completion on completion of each observation all monitoring equipment installed after laying, of 52nd of the references to this agreement the terms of the contract provisions, apply to the supervisor to monitor the project's acceptance of special, and according to the technical provisions 16.1. the