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  药店国别: 美国药房
产地国家: 法国
所属类别: 激素内分泌药物->降糖药物
处方药:处方药
包装规格: 100U/毫升注射剂,5支笔/盒,3毫升/支
计价单位:
   
生产厂家中文参考译名:
礼来
生产厂家英文名:
Lilly France S.A.
该药品相关信息网址1:
http://app1.sfda.gov.cn/webportal/portal.po?UID=DWV1_WOUID_URL_11635827&&POpType=DBSearch&subSearch=dbDetail&dbDetail=7344&selDbName=PLDB_TBL_TABLE8&tblCol=OID&mainUid=dj
原产地英文商品名:
HUMALOG-100U/ml Pen,5Pens*3ml PER PEN/Box
原产地英文药品名:
INSULIN LISPRO
中文参考商品译名:
优泌乐-100U/毫升注射剂,5支笔/盒,3毫升/支
中文参考药品译名:
赖脯胰岛素
原产地国家批准上市年份:
2002/12/08
英文适应病症1:
Hyperglycaemia
临床试验期:
完成
中文适应病症参考翻译1:
高血糖症
药品信息:

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 详细处方信息以本药内容附件PDF文件(200931222152812.pdf)的“原文Priscribing Information”为准
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赖脯胰岛素

Insulin lispro

中文别名: 赖脯胰岛素、基因重组胰岛素、莱斯普鲁胰岛素

英文别名: Humalog

药品类别: 胰腺激素及其它影响血糖药

适 应 症
1.Insulin is a hormone naturally produced by your pancreas. Insulin enables your body to use the sugar in food as a source of energy. When the body does not produce enough insulin, or when the insulin produced by the body is not effective enough, the condition is called diabetes mellitus. This condition allows sugar levels in the blood to become very high. Diabetics must use man-made insulin or insulin that comes from pigs (which is very similar to human insulin) to lower these high blood sugar levels.
2.There are three types of insulin, which differ in how soon they begin to work and how long their effects last. Insulin lispro starts to work in 15 minutes and its effects last for 3 to 5 hours.
3.Insulin lispro may also be used for purposes other than those listed in this medication guide.
用法用量
1.Use insulin lispro exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse, or pharmacist to explain them to you.
2.Insulin lispro should be given within 15 minutes before or immediately after a meal because it begins to work very soon after injecting a dose and hypoglycemia (low blood sugar) may occur if eating is delayed.
3.If you have stored your insulin lispro in the refrigerator, warm it to room temperature before using it.
4.If you are mixing different types of insulins in the same syringe, follow your doctor's directions and always draw up the different insulins in the same order (usually the clear insulin first). This may prevent a dosage error.
5.Change your injection sites exactly as directed by your doctor. Usually, you should not inject within 1 inch of the same site within 1 month.
6.Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.
7.Do not change the insulin strength (e.g., U-100) or insulin type (e.g., lispro) unless your doctor approves a change for you.
8.Do not change the brand of insulin lispro or syringe that you are using without first talking to your doctor or pharmacist. Some brands of insulin lispro and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.
9.Follow any diet and exercise plan that you have developed with your doctor or nurse. Changes in what you eat or how much you exercise can change the amount of insulin that you need to control your blood sugar levels.
10.Ask your doctor or nurse what to do if you are sick with a cold, flu, or fever. These illnesses may change your insulin requirements.
11.Wear some type of medical identification bracelet, necklace, or other alert tag to inform others that you have diabetes and that you require insulin in the case of an emergency.
12.To adequately control diabetes, proper foot care, eye care, dental care, and overall proper health care are necessary. Visit your doctor, dentist, eye doctor, and other heath care practitioners as recommended by your doctor.
13. Do not use any insulin that is discolored, looks thick, has particles in it, or looks different from your previous bottles, cartridges, or pens of insulin lispro.
14.Keep the bottle, pen, or cartridge that you are using at room temperature in the original carton, if possible, protected from direct sunlight and extreme heat or cold.
15.The Humalog vials, cartridges, and pens can be kept unrefrigerated for 28 days, as long as they are kept as cool as possible (at temperatures not greater than 30 degrees Celsius or 86 degrees Fahrenheit). Unrefrigerated vials, cartridges, and pens must be used within this time period or discarded.
16.Store unused bottles, cartridges, and pens of insulin lispro in the refrigerator in the original carton. Most insulin lispro is good for up to 1 year if it is stored unopened in the refrigerator. Throw away any expired insulin lispro.


不良反应
1.Rarely, people have allergic reactions to insulin. Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
2.The side effects of insulin therapy result mostly from blood sugar levels that are either too high or too low. You should be familiar with the symptoms of both high and low blood sugar levels and know how to treat both conditions. Also, be sure your family and close friends know how to help you in an emergency.
3.Low blood sugar may occur when too much insulin is used; when meals are missed or delayed; if you exercise more than usual; during illness, especially with vomiting or diarrhea; if you take other medications; after drinking alcohol; and in other situations.
4.Hypoglycemia, or low blood sugar, has the following symptoms: shaking, headache, cold sweats, pale, cool skin, anxiety, and difficulty concentrating.
5.Keep hard, sugary candy; chocolate; fruit juice; or glucose tablets on hand to treat episodes of low blood sugar.
6.Increased blood sugar may occur if not enough insulin is used, if you eat significantly more food then usual, if you exercise less than usual, if you take other medications, if you have a fever or other illness, and in other situations.
7.Hyperglycemia, or high blood sugar, has the following symptoms: increased thirst, increased hunger, and increased urination.
8.Monitor your blood sugar levels and ask your doctor how to adjust your insulin doses if your blood sugar levels are too high.
9.Side effects may also occur at the site of injection. If the area becomes thickened, hard, or pitted, talk to your doctor before injecting at that site again.
10.Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


注意事项
1.Know the signs and symptoms of low blood sugar (hypoglycemia), which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.
2.Insulin lispro should be given within 15 minutes before or immediately after a meal because it begins to work very soon after injecting a dose and hypoglycemia (low blood sugar) may occur if eating is delayed.
3.Follow any diet and exercise plan that you have developed with your doctor or nurse. Changes in what you eat or how much you exercise can change the amount of insulin that you need to control your blood sugar levels.
4.Ask your doctor or nurse what to do if you are sick with a cold, flu, or fever. These illnesses may change your insulin requirements.
5.Do not change the brand of insulin lispro or syringe that you are using without first talking to your doctor or pharmacist. Some brands of insulin lispro and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.
If Miss a Dose: 1.Follow your doctor's directions if you miss a dose of insulin. To prevent missed doses, be sure to always have enough insulin on hand, especially if you are going on vacation. Contraindications: 1.Do not use insulin lispro if you are allergic to insulin or if you have an intolerance of a certain insulin lispro product.
2.Insulin lispro can be used during pregnancy and breast-feeding. Insulin lispro is not expected to harm a baby. In fact, it is very important to control blood sugar levels during pregnancy. Insulin is the best treatment option for pregnant or breast-feeding women.
Special Concerns: 1.Do not use alcohol without first talking to your doctor. It lowers blood sugar, and you may experience dangerously low blood sugar levels.
2.Follow any diet and exercise plan that you have developed with your doctor or nurse. Changes in what you eat or how much you exercise can change the amount of insulin you need to control your blood sugar levels.


药物相互作用
1.Many drugs can interact with insulin or affect your blood sugar levels. Do not take any other medicines, including prescription products or over-the-counter medicines or supplements without first talking to your doctor or pharmacist during treatment with insulin.


药品过量
1.Seek emergency medical attention. 2.Symptoms of an insulin overdose reflect very low blood sugar levels and include headache, irregular heartbeat, increased heart rate or pulse, sweating, tremor, nausea, increased hunger, and anxiety.

 

自1923年美国礼来公司制造出首支动物胰岛素(Iletin)以来,礼来公司已拥有80余年的胰岛素生产历史。对于糖尿病患者来说,最好的治疗方法就是使患者的血糖水平接近甚至恢复正常。1985年在JDFI摩纳哥会议上就胰岛素治疗得出这样的结论:“提高胰岛素或新型胰岛素的吸收能力是精确模拟生理性人胰岛素分泌的必须条件。单体胰岛素和胰岛素衍生物须经过测试。”新型胰岛素必须符合以下两方面:安全性,即不增加严重低血糖事件、不破坏低血糖预警症状、无新的不良生物活性以及不增加免疫原性;有效性,即更好地控制血糖、提高患者的依从性和使用方便。以下就速效胰岛素类似物赖脯胰岛素,及速效预混胰岛素类似物优泌乐25[25%赖脯胰岛素(Lispro)+75%鱼精蛋白锌赖脯胰岛素(NPL)]临床进展情况综述如下。
 针对餐后血糖升高的餐前制剂——优泌乐
目前,常规使用的人胰岛素存在起效缓慢(需餐前30~45分钟给药)、患者使用不便、效力过长(持续12小时)、可能引起迟发性餐后低血糖(需额外加餐)等问题。胰岛素类似物通过改变胰岛素结构,改变其药代动力学曲线,力图使其更加接近生理性胰岛素的分泌。优泌乐的结构和内源性人胰岛素的不同之处在于,B链末端28、29位上的两个氨基酸——脯氨酸和赖氨酸的位置发生了交换,减弱了胰岛素单体间的交联,从而使胰岛素起效更快(15分钟内),达峰更早(1小时)。
既往的研究表明,与餐前皮下注射常规人胰岛素相比,餐前注射优泌乐25可使患者血浆胰岛素更快达峰,同时可降低餐后血糖的升高,也能更快恢复血糖至基线的水平。Lalli等的研究结果显示,餐前使用优泌乐12月可降低患者HbA1c水平(P<0.05),并且可显著降低轻度低血糖的发生率。Brunelle等进行的荟萃分析表明,与常规人胰岛素相比,餐前注射优泌乐可降低严重低血糖发生危险(P=0.024)。

   【药理作用】研究发现赖脯胰岛素与等摩尔胰岛素具有同等的药效胰岛素的主要作用包括赖脯胰岛素在内是调节葡萄糖的代谢此外在人体的许多组织中所有胰岛素都有几种合成代谢的抑制分解的作用在肌肉组织和其它组织中(除脑组织外)胰岛素可以使细胞内的葡萄糖和氨基酸快速转运促进合成代谢会抑制蛋白质的分解在肝脏胰岛素可促进以肝糖原形式存在的葡萄糖的摄取和储存抑制糖异生促进过多的葡萄糖转变成脂肪与普通胰岛素相比赖脯胰岛素的快速起效较短的作用时间的特点在患有肝功能和肾功能损害的患者中仍然存在大剂量皮下注射赖脯胰岛素进行慢性毒性研究经一年的动物试验结果表明:和人胰岛素一样未发现器官和组织增生及肿瘤产生试验没有发现动物生殖能力损伤
【药物相互作用】胰岛素剂量在使用某些有升血糖作用的药物时需要增加如口服避孕药肾上腺皮质激素或甲状腺激素替代治疗
胰岛素剂量在使用某些有降血糖作用的药物时需要减少如口服降糖药水杨酸类(如阿斯匹林),磺胺类抗生素或一些抗抑郁药(单胺氧化酶抑制剂)
 研究显示在那些已使用最大剂量磺脲类口服降糖药物的2型糖尿病病人中加用赖脯胰岛素可明显降低其HbA1c的水平
与赖脯胰岛素同时服用任何药物均应请示医生
赖脯胰岛素和其它动物源性胰岛素混合后效果尚未确定
【不良反应】常与胰岛素有关的不良反应有:
全身反应- 过敏反应
皮肤和皮肤附件- 注射部位局部反应脂肪萎缩瘙痒皮疹
其它- 低血糖
低血糖是胰岛素治疗最常见的不良反应每个糖尿病人都可能发生过严重低血糖可导致意识丧失甚至死亡(见[注意事项]下预防措施)
局部的过敏反应可出现注射部位红肿痒这些轻微反应可于数日或数周内消失这些反应在某些病例中并非由胰岛素所致而是由于其它因素如皮肤消毒剂的刺激作用或注射技术欠佳等造成胰岛素全身过敏反应少见但较严重全身过敏反应可引起全身皮疹气短喘息血压下降脉快或大汗严重的全身过敏反应可威胁病人生命
【禁忌症】赖脯胰岛素在低血糖发作时严禁使用病人对赖脯胰岛素或其赋形剂过敏者严禁使用
【用法用量】 赖脯胰岛素剂量由医生根据病人的需要情况来决定 赖脯胰岛素是快速起效产品给药时间更接近用餐时间(用餐前15分钟之内)而常规胰岛素需在餐前较长时间给药(用餐前30分钟到45分钟)赖脯胰岛素可根据医生建议与长效胰岛素或口服磺酰脲类联合应用赖脯胰岛素皮下注射部位可选择上臂大腿臀部或腹部应轮换注射部位同一注射部位每月注射不能超过一次注射时应小心不要损伤血管应教育病人掌握正确的注射技术 12岁以下儿童的安全性和有效性尚未建立在肝肾功能不全的情况下胰岛素的需要量可能会减小
【注意事项】 赖脯胰岛素与其它胰岛素不同,由于其独特的结构导致起效快和持续时间短,病人从以前的胰岛素转换为赖脯胰岛素时可能需要调整剂量。
低血糖:低血糖是胰岛素最常见的副作用,包括赖脯胰岛素。某些情况下低血糖的早期警告性症状可能不一样,或不明显,如在长期的糖尿病或强化血糖控制时。
胰岛素转换:任何胰岛素转换必需小心且在监护下进行。任何转换包括胰岛素浓度剂型(例如,常规,中效)、种类(牛、猪、牛-猪、人胰岛素、人胰岛素类似物)或生产方法(基因重组技术、动物源性胰岛素)都可能导致剂量的改变。

  

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 详细处方信息以本药内容附件PDF文件(200931222152812.pdf)的“原文Priscribing Information”为准
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2009-3-13更新

更新日期: 2009-3-13
附件:
200931222152812.pdf    

 
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