英文药名: Insulin humalog mix 75/25

中文药名: 胰岛素注射剂

生产厂家: Eli Lilly

药品简介

产品名称: 赖脯胰岛素注射液
英文名称: Recombinant Human Insulin Lispro Injection
商品名: 优泌乐
英文商品名: Humalog
产品分类: 代谢及内分泌系统用药\抗糖尿病药\胰岛素\短效胰岛素
生产企业 Eli Lilly Nederland B.V.
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通用名: 赖脯胰岛素
英文通用名: Insulin Lispro
其他名称: 赖脯胰岛素注射液, 优泌乐, 重组赖脯胰岛素, 重组赖脯胰岛素注射液
英文其他名称: Humalog, Recombinant Human Insulin Lispro Injection, Recombinant Lispro Insulin, Recombinant Lispro Insulin Injection
组成成份: 本品主要成分为赖脯胰岛素，是由基因重组技术生产的人胰岛素类似物，它是将胰岛素B链上第28位和第29位氨基酸互换而产生的。

适应症
用于需控制高血糖的糖尿病，尤其适用于生活不规律、外出活动较多的用胰岛素治疗的糖尿病以及常发生低血糖的1型糖尿病。

注意事项
1.禁忌症
(1)对本药过敏者。
(2)患者低血糖发作时。
2.慎用: 尚不明确。
3.药物对儿童的影响: 12岁以下儿童用药安全性和有效性尚未确定。
4.药物对妊娠的影响: 妊娠期使用本药的临床实验尚未进行，孕妇不推荐使用。但已知胰岛素需要量在妊娠早期减少，妊娠中，晚期增加，而产妇对胰岛素的需要量减少，因此在整个妊娠过程中应维持良好的血糖控制。妊娠糖尿病患者分娩后，其体内葡萄糖稳定性也发生变化(某些个体血糖可恢复正常)，因此应于分娩后6周以上复查，按标准重新分类。
5.药物对哺乳的影响
尚不明确本药是否泌入乳汁(但已知人胰岛素可泌入乳汁)。哺乳妇女应调整剂量、饮食或两者同时调整。
6.用药前后及用药时应当检查或监测
(1)各时点检测血糖(如各餐前、餐后及睡前)并定期测血糖化血红蛋白(以帮助制订降糖药的治疗方案)。
(2)每次随访应包括体重、体重指数、血压、尼龙丝试验、足背动脉搏动等。
(3)部分病情须定期检测视力、眼底、血脂谱、肝肾功能、尿常规、尿白蛋白排泄率、心电图、神经传导速率等，以发现微血管、大血管病变或神经病变等。

不良反应
1.代谢/内分泌系统
最常见低血糖(多见于1型糖尿病患者，尤其接受强化胰岛素治疗者，但使用本药时低血糖的发生率低于人正规胰岛素)，临床表现可因血糖下降的速度和程度而不同。若血糖下降快，可出现以交感神经兴奋为主的症状(如乏力、饥饿感、冷汗、皮肤苍白、心悸、兴奋、颤抖、神经质、头痛等)；若血糖下降缓慢或在上述基础上进一步下降且降低程度较重，则出现以神经低糖症为主的症状(如注意力不集中、反应迟钝、意识模糊、瞌睡，严重者出现偏瘫、惊厥、昏迷、病理反射等)。部分患者，尤其已有糖尿病神经病变的老年人，可无自主神经变化症状而直接出现中枢神经损害，甚至直接出现昏迷。频繁发生(或严重的)低血糖症可引起中枢神经系统不可逆损害，导致致死或致残。此外，部分患者在治疗初期可因钠潴留作用而发生轻度水肿，但可自行缓解而无需停药。
2.眼
部分患者注射胰岛素后出现视力模糊(为晶体屈光改变引起)，但常于数周内自然恢复。
3.过敏反应
胰岛素过敏反应可表现为局部性或全身性，前者远多于后者，多因使用不纯制剂引起。局部性过敏时在注射部位出现红斑、丘疹、硬结、肿胀、瘙痒，通常在注射后几小时或数日发生，在数日或数周后可消失。全身性过敏反应在注射后立即发生，表现为全身性荨麻疹、皮疹、伴或不伴有血管神经性水肿、哮喘、呼吸困难、脉搏加快或大汗，严重者血压降低、休克甚至死亡。
4.其它
各种胰岛素制剂均有一定的抗原性(与其种属有关，牛胰岛素的抗原性最强，其次为猪胰岛素，人胰岛素最弱)。临床上只有极少数患者发生胰岛素抗药性，此现象可于数月至1年内自行消失。如原来用动物胰岛素引起胰岛素抗药性，可改用人胰岛素制剂。此外，少见脂肪营养不良(在注射部位表现为皮下脂肪萎缩或增生，停止在该部位注射后可缓慢自然恢复，为防止其发生，应经常更换注射部位，还可使用高纯度或人胰岛素制剂)。

给药说明
1.本药可与长效胰岛素合用。
2.不同年龄阶段对胰岛素敏感性不一致，青春期前的儿童对胰岛素敏感性高，易发生低血糖，宜适当减少剂量；进入青春期则需稍增剂量，在青春期后又降低。老年人也易发生低血糖，且频繁、严重低血糖易造成不可逆脑损害，应特别注意饮食、体力活动与胰岛素用量的配合。
3.下列情况胰岛素需要量可能会增加：
(1)高热及上呼吸道炎症。
(2)甲状腺功能亢进。
(3)肢端肥大症。
(4)库欣综合征。
(5)糖尿病酮症酸中毒。
(6)严重感染、外伤、大手术。
(7)急性心肌梗死、脑卒中等应激情况。
(8)合用拮抗胰岛素的药物。
4.下列情况其胰岛素需要量可能会减少：
(1)严重肝功能损伤。
(2)肾功能损伤(但在尿毒症时，由于出现胰岛素抵抗，其需要量也随之变化，应监测血糖调整用量)。
(3)腺垂体功能减退症、肾上腺皮质功能减退症、甲状腺功能减退症。
(4)腹泻、胃瘫、肠梗阻，呕吐及其它引起食物吸收延迟的因素等。
5.低血糖发生主要因为相对于食物摄入量和(或)能量消耗兼有本药剂量过大所致。轻度低血糖一般口服葡萄糖可缓解，需调整胰岛素剂量、饮食和运动量。严重低血糖以及伴有昏迷、抽搐或神经系统损害时需肌内注射(或皮下注射)胰高血糖素或静脉滴注高浓度的葡萄糖，且须保持碳水化合物摄入并严密观察(因低血糖常在缓解后再度发生)。
6.使用正确剂量时未发现对驾驶和机器操作能力有不良影响。
7.药物过量的表现：低血糖伴有倦怠、意识模糊、心悸、大汗、呕吐、头痛。

用法用量：
成人
·常规剂量
·皮下注射
三餐前15分钟内各1次，剂量依据病情而定，并按血糖变化调整。如在治疗过程中改用本药，其剂量可能需要调整。有时为控制夜间高血糖，可于早晨加注1次中效胰岛素(但不能与中效胰岛素混合)；为控制次晨的高血糖，可于睡前加注1次中效胰岛素。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1次。
·肝功能不全时剂量
所需剂量可能需要减小。
·肾功能不全时剂量
所需剂量可能需要减小。
·其它疾病时剂量
疾病或精神紧张时，剂量可能需要增加。

禁忌：
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。

*药品简介只供参考。

Humalog mix 75/25
Generic Ingredients
Insulin Lispro/Insulin Lispro Protamine

75 U/ML-25 U/ML

Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin lispro is a fast-acting form of insulin. Insulin lispro protamine is an intermediate-acting form of insulin.
Humalog Mix 75-25 is used to treat type 1 (insulin-dependent) diabetes in adults. It is usually given together with another long-acting insulin.
Humalog Mix 75-25 may also be used for other purposes not listed in this medication guide.
Most important: Use this medication within 15 minutes before eating a meal.
Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.
Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.
Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.
Insulin lispro and insulin lispro protamine is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
Pharmacological action Humalog Mix 75/25
DNA-recombinant human insulin analogue. It is a mixture of insulin lispro (25%) – high-speed preparation of insulin and insulin lispro protaminovoy suspension (NPL) (75%) – a drug intermediate-acting insulin.
The main effect of the drug is regulation of glucose metabolism. In addition, it has an anabolic effect. In muscle and other tissues (except brain) insulin accelerates the intracellular transport of glucose and amino acids accelerates anabolism of proteins. Promotes conversion of glucose into glycogen in the liver, inhibits gluconeogenesis and stimulates the conversion of excess glucose into fat.
Insulin lispro insulin ekvimolyaren man. It is characterized by a more rapid onset of action, the earlier the onset of peak action and a shorter period of hypoglycemic activity compared with normal human insulin.
Results of studies in healthy volunteers with the fixation of glucose showed that the absorption profile of the NPL and is similar to that of the suspension isophane human insulin (NPH).
Pharmacokinetics Humalog Mix 75/25
Earlier onset of drug action, about 15 minutes after injection, associated with a higher rate of its absorption. This allows you to enter the drug immediately before a meal (15 min) in contrast to conventional human insulin, which is injected 30 minutes before eating. At the rate of absorption of insulin lispro and, consequently, the beginning of his actions may affect the choice of injections.
Statement Humalog Mix 75/25
- Treatment of diabetes in the presence of indications for insulin therapy.
Dosage and administration Humalog Mix 75/25
The dose is determined individually depending on the level of glycemia. Rapid onset of action of insulin lispro allows you to enter it for 15 minutes before a meal.
Humalog Mix 75/25 is introduced only n / k. The drug should not be given / in.
N / a is introduced into the shoulders, hips, buttocks or abdomen. Injection sites should be rotated so that the introduction in the same place made no more than about 1 times / month. When s / c infusion Humalog Mix 75/25 should be careful to avoid getting the drug into a blood vessel. Patients should be taught the proper use of insulin injection devices.
When using the bottle before applying to be a few times or turn the bottle until perekatat mixing insulin. After mixing, the insulin should look uniformly cloudy or like milk. Otherwise, repeat the above manipulation, while the contents are not mixed. For insulin use insulin syringe with markings indicating that it is designed for use with insulin concentration of 100 IU / ml.
If you use cartridges, which should be 10 times perekatat cartridge between your palms. Then, holding the cartridge in the cork should slowly turn it over 10 times at 180 °, so that the glass ball with each rollover moved the entire length of the cartridge. After mixing, the insulin should look uniformly cloudy or like milk. Otherwise, repeat the above manipulation, while the contents are not mixed. Recommendations for installing the cartridge into the device for insulin delivery and adherence to it before the introduction of insulin needles should be read in the instructions to the device manufacturer for insulin.
You can not use insulin if a white precipitate remains on the bottom of the vial after mixing, if it has, after mixing flakes, if the bottom or the walls of the bottle stuck solid white particles, creating the effect of frost.
In patients with renal and / or liver failure circulating levels of insulin increased, therefore, insulin requirements may be reduced. This requires careful control of glycemia and correction doses. More rapid onset and shorter duration of action of insulin lispro compared with regular human insulin in patients with renal and hepatic failure persists.
Side effect Humalog Mix 75/25
Adverse effects associated with the main action of the drug: hypoglycemia.
Allergic reactions: local allergic reaction – redness, swelling or itching at the injection site (usually disappear over a period of several days to several weeks in some cases, these reactions can be caused by factors not related to insulin, such as irritation of the skin cleaning agent or improper injection) systemic allergic reactions (occur rarely, but are more serious) – generalized itching, difficulty breathing, shortness of breath, decreased blood pressure, increased heart rate, increased sweating. Severe cases of systemic allergic reactions may be life-threatening.
On the part of the vision: transient disturbances of refraction (usually in patients who have not received insulin).
Other: lipodystrophy.
Contraindications Humalog Mix 75/25
- Hypoglycemia;
- Hypersensitivity to insulin lispro or to any of the ingredients of the drug.
Pregnancy and breast feeding Humalog Mix 75/25
Clinical trials on the drug Humalog Mix 75/25, with pregnancy have been conducted. In the case of planned pregnancy or the ensuing diabetic patients is recommended to inform your doctor.
It is unknown whether insulin lispro is allocated or insulin lispro protaminovaya suspension in significant amounts in breast milk. Patients with diabetes during lactation may require adjustment of insulin dose and diet.
Application of human liver Humalog Mix 75/25
In patients with hepatic impairment increased level of circulating insulin, so insulin requirements may be reduced. This requires careful control of glycemia and correction doses. More rapid onset and shorter duration of action of insulin lispro compared with regular human insulin in patients with liver failure remains.

Use in renal impairment Humalog Mix 75/25
In patients with renal insufficiency increased the level of circulating insulin, so insulin requirements may be reduced. This requires careful control of glycemia and correction doses. More rapid onset and shorter duration of action of insulin lispro compared with regular human insulin in patients with renal insufficiency persists.
Cautions
When assigning patients with diabetes mellitus Humalog Mix 75/25 may need to change the dose, which was used in the previous scheme insulin. Any change of insulin should be done cautiously and only under medical supervision. Changes in the activity of insulin, but its type (eg regular, NPH), a specific accessory (porcine, human insulin analogue insulin human) or method of manufacture (recombinant DNA insulin or insulin of animal origin) may lead to the correct dose.
Hypoglycemia is the most common side effects that occur with the introduction of insulin, including Humalog Mix 75/25 . Severe hypoglycemia can lead to unconsciousness and, in extreme cases, death. Under certain conditions, such as long duration or with intensive control of diabetes, early signs of hypoglycemia may differ or be less pronounced.
During various diseases or emotionally straining insulin requirements may increase.
In the presence of renal or hepatic impairment, insulin requirements may be reduced.
Correction doses of insulin may also require an increase in physical activity or when the usual diet.
If necessary, take other drugs along with drug Humalog Mix 75/25 the patient should consult a physician.
Use in Pediatrics
Safety and efficacy of Humalog Mix 75/25 in children and adolescents under the age of 18 years has not been established.
Effects on ability to drive and control mechanisms
Proper administration of adequate doses of insulin has no effect on ability to drive and control mechanisms.
The ability of the patient to the concentration and quick reactions may be reduced as a result of hypoglycemia. This may create a risk in situations where this ability is particularly important (for example, when performing work that requires concentration and quickness of psychomotor reactions).
Overdose Humalog Mix 75/25
Symptoms: hypoglycemia, accompanied by the following symptoms: fatigue, increased sweating, tachycardia, pale skin, headache, tremors, vomiting, confusion.
Treatment: mild state of hypoglycemia usually cropped ingestion of glucose (dextrose). May require adjustment of insulin dose, diet or physical activity. Severe hypoglycemia condition, accompanied by coma, convulsions or neurological disorders, cropped / m or s / c infusion of glucagon or / in the introduction of a concentrated solution of glucose (dextrose). After regaining consciousness the patient must give food rich in carbohydrates, in order to avoid a recurrence of hypoglycemia.
Drug Interactions Humalog Mix 75/25
Hypoglycemic effect of reducing Humalog Mix 75/25 oral contraceptives, corticosteroids, thyroid hormone drugs, thiazide diuretics, diazoxide, tricyclic antidepressants.
Hypoglycemic effect Humalog Mix 75/25 reinforce oral hypoglycemic agents, salicylates (eg aspirin), sulfonamides, MAO inhibitors, beta-blockers, ethanol and etanolsoderzhaschie drugs.
Beta-blockers, clonidine, reserpine, may mask the symptoms of hypoglycemia.