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APIDRA®（艾倍得） 是一种新型、速效胰岛素类似物，用于1型和2型糖尿病成人患者，控制高血糖。APIDRA® （艾倍得）给患者带来灵活的餐时剂量胰岛素—可以在餐前或餐后15分钟给药。APIDRA® 还可以为各种体型的患者带来方便，不论是胖还是瘦均适用。
艾倍得 预充注射液
[Apidra]
(谷赖胰岛素)
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预充注射液 : 300 iu x 3 mL/支
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注射用胰岛素及其类似物-速效 |
胰岛素制剂 [Insulin Preparations] (11a) |
注册证号 国药准字J20100127
原注册证号 S20100027
产品名称（中文） 谷赖胰岛素注射液
产品名称（英文） Insulin Glulisine Injection
商品名（中文） 艾倍得
商品名（英文） Apidra
剂型（中文） 注射液
规格（中文） 3ml:300U/预填充笔SoloStar
注册证号备注
包装规格（中文） 1支/盒（预填充笔）
生产厂商（中文）
生产厂商（英文） Sanofi-Aventis Deutschland GmbH
厂商地址（中文）
厂商地址（英文） Industriepark Hoechst,Brueningstrasse 50,D-65926 Frankfurt am Main,Germany
厂商国家（中文） 德国
厂商国家（英文） Germany
分包装批准文号 国药准字J20100127
发证日期 2010-09-09
有效期截止日
分包装企业名称 赛诺菲安万特（北京）制药有限公司
分包装企业地址 北京市北京经济技术开发区兴盛街7号
分包装文号批准日期 2010-09-09
分包装文号有效期截止日 2015-02-25
产品类别 生物制品
名称（中文）
名称（英文） Sanofi-Aventis Deutschland GmbH
地址（中文）
地址（英文） Industriepark Hoechst,Brueningstrasse 50,D-65926 Frankfurt am Main,Germany
国家（中文） 德国
国家（英文） Germany
Drug Forms:
- Insulin Glulisine Solution for injection (below)
- Insulin Glulisine injection
- Insulin Glulisine Solution for injection
Español:
- Insulina Glulisina, Solución para inyección
- Inyección de Insulina Glulisina
Insulin Glulisine Solution for injection
What is this medicine?
INSULIN GLULISINE (IN su lin; GLOO lis een) is a human-made form of insulin. This medicine lowers the amount of sugar in your blood. It is a fast acting insulin that starts working faster than regular insulin. It will not effect your blood sugar as long as regular insulin.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
•episodes of hypoglycemia
•kidney disease
•liver disease
•an unusual or allergic reaction to insulin, metacresol, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I use this medicine?
This medicine is for injection under the skin. Use exactly as directed. Your health care professional or doctor will tell you how long to wait after you inject your dose before eating a meal. Most of the time, you should wait about 5 to 10 minutes or less. You will be taught how to use this medicine and how to adjust doses for activities and illness. Do not use more insulin than prescribed. Do not use more or less often than prescribed.
Always check the appearance of your insulin before using it. This medicine should be clear and colorless like water. Do not use it if it is cloudy, thickened, colored, or has solid particles in it.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.
What may interact with this medicine?
•other medicines for diabetes
Many medications may cause an increase or decrease in blood sugar, these include:
•alcohol containing beverages
•aspirin and aspirin-like drugs
•chloramphenicol
•chromium
•diuretics
•female hormones, like estrogens or progestins and birth control pills
•heart medicines
•isoniazid
•MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
•male hormones or anabolic steroids
•medicines for weight loss
•medicines for allergies, asthma, cold, or cough
•medicines for mental problems
•niacin
•NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
•pentamidine
•phenytoin
•probenecid
•quinolone antibiotics like ciprofloxacin, levofloxacin, ofloxacin
•some herbal dietary supplements
•steroid medicines like prednisone or cortisone
•thyroid medicine
Some medications can hide the warning symptoms of low blood sugar. You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:
•beta-blockers such as atenolol, metoprolol, propranolol
•clonidine
•guanethidine
•reserpine
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your health care professional or doctor for regular checks on your progress. To control your diabetes you must use this medicine regularly and follow a diet and exercise schedule. Checking and recording your blood sugar and urine ketone levels regularly is important. Use a blood sugar measuring device before you treat high or low blood sugar.
Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure family members know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.
Make sure that you have the right kind of syringe for the type of insulin you use. Try not to change the brand and type of insulin or syringe unless your health care professional or doctor tells you to. Switching insulin brand or type can cause dangerously high or low blood sugar. Always keep an extra supply of insulin, syringes, and needles on hand. Use a syringe one time only. Throw away syringe and needle in a closed container to prevent accidental needle sticks.
Insulin pens and cartridges should never be shared. Sharing may result in passing of viruses like hepatitis or HIV.
Wear a medical identification bracelet or chain to say you have diabetes, and carry a card that lists all your medications.
Many nonprescription cough and cold products contain sugar or alcohol. These can affect diabetes control or can alter the results of tests used to monitor blood sugar. Avoid alcohol. Avoid products that contain alcohol or sugar.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your health care professional or doctor as soon as possible:
Symptoms of low blood sugar:
•You may feel nervous, confused, dizzy, hungry, weak, sweaty, shaky, cold, and irritable. You may also experience headache, blurred vision, rapid heartbeat and loss of consciousness.
Symptoms of high blood sugar:
•You may experience dizziness, dry mouth, dry skin, fruity breath, loss of appetite, nausea, stomach ache, unusual thirst, frequent urination
Insulin also can cause rare but serious allergic reactions in some patients, including:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•breathing problems
Side effects that usually do not require medical attention (report to your health care professional or doctor if they continue or are bothersome):
•increase or decrease in fatty tissue under the skin, through overuse of a particular injection
•itching, burning, swelling, or rash at the injection site
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store unopened insulin vials in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or use if the insulin has been frozen. Opened vials (vials currently in use) may be stored in the refrigerator or at room temperature, below 25 degrees C (77 degrees F). Keeping your insulin at room temperature decreases the amount of pain during injection. Once opened, your insulin can be used for 28 days. After 28 days, the vial of insulin should be thrown away.
Protect from light and excessive heat. Throw away any unused medicine after the expiration date or after the specified time for room temperature storage has passed.
アピドラ注ソロスター
治疗类名
超快速起效的胰岛素类似物制剂
认证
品牌名称
注SoloSTAR Apidora
编号产品名称
2492418G1027
审批和许可证号
批准文号
22100AMX00658
品牌名称
APIDRA
储存到期日期等
法藏
避免冷冻，避光储存至2℃8
到期日
显示纸箱
*分类监管
危险药物
处方药
注意 - 使用由医生处方
组成
活性成分：Gururijin胰岛素（重组）
工具包1（3毫升）的数额：300台
添加剂：间甲酚
工具包1（3毫升）的数量：9.45mg
添加剂：氨丁三醇
工具包1（3毫升）的数量：18mg
添加剂：氯化钠
工具包1（3毫升）的数量：15毫克
添加剂：吐温20
工具包1（3毫升）的数量：0.03mg
添加剂：pH值调节剂
工具包1（3毫升）的用量：qs的
行为
配方性能
晃曹秀无色液体（注射）
pH值
7.0至7.8
渗透压力比
0.9至1.1（生理盐水比）
通用名称
Gururijin胰岛素（重组）注射液
禁忌
（以下患者不宜给出）
1。患者有低血糖的症状
2。患者有过敏史的任何这种药物成分
功效或效力
功效或效力/用法和用量
糖尿病，胰岛素治疗，可以表明
注意事项有关的功效或效力
应仅用于确诊糖尿病的患者。
糖尿病的尿糖出现类似的正面除了糖耐量和糖尿病（血糖的中老年人，甲状腺功能减退，肾功能异常等代谢糖尿病）发病记住有。
用法和用量
通常情况下，两个大人 - 每餐前一个，但20单位皮下注射，结合胰岛素可以溶解或中间型的影响。该剂量的增加或减少对患者的症状和结果而定，包括胰岛素的剂量维持剂量或熔化中间类型的影响通常是从4至每天100单位。
注意事项相关的剂量和用法
1。降糖药物作用的这相当于速效胰岛素，起效更快的行动是快速起效的胰岛素制剂。这只是饭前药物（15分钟）[[和]药组]管理[3临床术语。引用。
2如果使用口服降糖药，这药如果你从改变使用口服降糖药。：
（1）以低剂量和药物作用[和] [部分药代动力学[2]临床术语。参照政府当局考虑剂量的特点出发。
（2）口服降糖药联合可能需要调整剂量和剂量的口服降糖药的时间表。
注意事项
仔细管理
（以下的患者，应谨慎对待）
1。患者严重的胰岛素需求变化
（1）手术，外伤，感染和病人
（2）孕妇[“6。怀孕妇女，孕妇，哺乳母亲和给予摘要”]
2。降血糖，病人或易下列条件
（1），严重肝或肾功能不全
（2）肾上腺功能不全或垂体功能不全
（3），腹泻，呕吐等胃肠道疾病
（4）饥饿，不规则的食物摄入量
（5），严重的肌肉锻炼
（6）过量饮酒
（7）老年人[“5。当局老人摘要”]
（8）“3。”互动（1），（3）所示的组合药物
3。患者有可能导致事故，造成低血糖（高空作业平台，如谁在驾驶从事的工作和病人）
4。与自主神经病变患者[未必清楚低血糖的症状]
重要注意事项
1。对胰岛素使用的最重要的是适应决定和患者教育。如果你每天使用胰岛素治疗糖尿病，教自己没有足够的处理，注射方法和低血糖的患者。从皮肤吸收，起效时间，注射部位，血流量，体温体重与锻炼，充足的耐心教育不同可以做适当注射技术有关。
2。2型糖尿病，除非紧急，糖尿病饮食是申请前的基础应该是足够的运动后进行审议。
3。因为它可能引起低血糖，要小心。特别是，食物摄入量或不这样做，如果你让一个意外剧烈运动，容易造成低血糖。继续造成低血糖和低血糖昏迷是未经处理的，（不可逆的中枢神经系统疾病，如死亡）严重后果，可能需要。低血糖的票据可足以保证病人及其家属。
4。如果有足够的胰岛素剂量，它可能会导致高血糖，要小心。继续在未经处理的高血糖，恶心，呕吐，嗜睡，潮红，在呼吸，酮症酸中毒口干，尿频，脱水，食欲不振，丙酮的气味，造成其他昏迷，但它采取的严重后果因为，应采取适当的措施。
5。由于血糖控制迅速出现或恶化糖尿病视网膜病变，眼屈光不正，治疗后（主要是疼痛）神经损伤注意，有可能会发生。
6由于这个从其他胰岛素药物的变化。，可能需要改变胰岛素的剂量。剂量的调整可能需要几周或几个月，从最初的治疗。
7。由于这种药物是一种无色透明液体，能够提供足够的指导，与病人和类型的影响胰岛素类似物已解散混淆。
一般名称
インスリン グルリジン（遺伝子組換え）注射液
Insulin Glulisine（Genetical Recombination）
分子式
C258H384N64O78S6
分子量
5822.58
性 状
白色の粉末である。
希酸あるいは希アルカリによく溶ける。水、エタノール及びメタノールにはほとんど溶けない。
吸湿性である。
等電点
pH5.12
包装
300単位／３mL×２本
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