*诺和灵R

出处:按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第343页(10409字)

【中文释文】:

(中性胰岛素)中性可溶性胰岛素注射液;生物合成人胰岛素

〔产品资料〕

诺和灵R是生物合成的中性可溶性胰岛素。它是通过基因重组技术,利用酵母生产的生物合成人胰岛素,与人体产生的胰岛素结构完全一致并具单组分纯度。

经皮下注射后,药物效用时间(大约数字):

起始时间:0.5h

最大时间:1~3h

持续时间:8h

〔适应证〕

糖尿病

〔剂量及用法〕

依照医师指示,选择适当的剂型、剂量及注射时间,注意遵守医师处方胰岛素的剂型及剂量。如既往使用混合或纯牛胰岛素而转用单组分人胰岛素,剂量可能需要调整,根据既往所用胰岛素之剂量、纯度、来源及剂型而定,血糖控制可能会有波动,按医师指示调整治疗。病人既往使用猪单组分或其他高纯度人或猪胰岛素者,除为控制血糖稳定作常规的调整外,不需更改剂量。除非另经医师指导,请不要任意改变剂型及剂量。诺和灵R应由皮下注射、肌肉注射或静脉注射。

〔胰岛素泵〕

由于会使某些泵导管产生沉淀,所以诺和灵R不推荐用于胰岛素泵。

〔注射程序〕

确定所用注射器的标量应与医嘱胰岛素制剂的用药量相符合。应用同类型和牌子的注射器,使用错误的注射器会导致剂量错误。除非医师另加指示,请如下进行:

1.胰岛素注射液可呈无色澄明的溶液(可溶性胰岛素)或浑浊的溶液(胰岛素混悬液)。

2.若只是使用一种类型胰岛素,用注射器抽取所需注射胰岛素等量的空气,并将空气注入该药瓶内。

将药瓶及注射器倒转,抽取正确剂量的胰岛素,然后将针头拔出,再将注射器内余有的气泡排出,并检查剂量是否正确。

3.若混合使用两种类型的胰岛素,使用混悬胰岛素之前应将瓶放置于双手掌心轻轻滚转,直至该胰岛素呈均匀混悬液。

用注射器抽取所需混悬型胰岛素等量的空气,并将该空气注入澄明胰岛素药瓶内,然后将针头拔出。

再用注射器抽取所需注射澄明胰岛素等量的空气,并将该空气注入澄明胰岛素药瓶内。然后将药瓶及注射器倒转,抽取正确剂量的澄明胰岛素,将注射器内余有的气泡排出,检查剂量是否正确。

再将针头插入混悬型胰岛素的药瓶内,抽取指定剂量的胰岛素,将余有的气泡排出,并检查剂量是否正确。

每次注射应依照如此顺序抽取胰岛素,并立即注射该混合物。

4.用手指捏起皮肤,在大约45°角度下,推入针头,在皮下注射胰岛素。将针头拔出,在注射点按压数秒钟,以防止胰岛素渗出。

5.在医师指导下,转换注射部位。

〔预防措施〕

1.低血糖反应 如果注射过多量胰岛素,未按时进食或运动过量,可能发生胰岛素反应(低血糖)。

低血糖中早期症状可以突然发生,包括出冷汗,心跳加速,神经过敏或震颤。应立即服用糖或含有糖分的食物,便能消除症状。病人应随身携带糖果等食物,以备不时之需。

曾有少部分病人报告使用人胰岛素时发生低血糖的早期症状比使用动物胰岛素时,较不明显。

最好使您的亲友知道您是糖尿病病人,并让他们知道如何帮助严重胰岛素反应的病人,如遇昏迷病人不该给予饮食(可能会发生窒息),应使病人头部侧卧,并即时就医,受过指导的亲友,可为病人注射高血糖素,以帮助病人立刻恢复知觉。恢复知觉后,应口服糖或葡萄糖。胰岛素使用过量时,除注射高血糖素外,医师可静脉注射葡萄糖。

如常有胰岛素反应,或导致昏迷,应向医师询问,因为可能需要更改注射胰岛素的剂量,若严重低血糖未能及时治疗,会引致暂时的或永久的脑部损伤,以致死亡。

2.糖尿病酮症酸中毒 糖尿病酮症酸中毒表示血糖过高,这是非常严重的情况。可能由于注射胰岛素量少于所需量而产生的,疾病、感染时对胰岛素需求量增加,饮食没有节制,注射少于医师处方的胰岛素剂量或没有注射胰岛素都会发生上述情况。尿液检查如含有大量的糖和酮体则显示酮症酸中毒。症状有口渴、尿量增多、食欲不振、疲倦、皮肤干燥、呼吸急促,大约在数小时到数天内,逐渐发生。应立即请示医师治疗。若此症状不予治疗,会引致糖尿病昏迷或死亡。

〔药物相互作用〕

部分药物经证实对胰岛素的需求量有影响,因此同一时间服用其它药物时,应请示医师。

〔贮存〕

胰岛素药瓶应盒装贮存于2~8℃的冰箱内(不要太接近冰格),避免暴露于严寒或阳光直射。使用中的药品可以在室温(最高25℃)保存6周。

小心存放,避免儿童触及。

〔注意〕

如果诺和灵R胰岛素液体不呈无色澄明溶液,请不要使用。每支胰岛素包装上注明有效日期,过期切勿使用。

〔保护盖〕

胰岛素药瓶带有颜色标志的保护性胶盖,从新的药瓶内抽取胰岛素,必须去掉保护盖。若新购买的药瓶,保护盖不密封,请将药瓶退回病房。

诺和灵R为丹麦诺和德公司的注册商标。

〔生产厂家〕

丹麦诺和德公司

【外文释文】:

(Neutral insnlin

Neutral insulin injection

Biosynthetic Human Insulin

Product information

Novolin R is a neutral solution of biosynthetic human insulin.

Biosynthetic human insulin is manufactured by recombinant DNA technology using yeast cells as the production organism,It is characterized by being identical to human insulin and of monocomponent purity.

Action profile after subcutaneous injection(approximate figures):onset 1/2 hour,maxi mum effect:between lst and 3rd hour,duration of action:8 hours.

Indication

Diabetes mellitus.

Dosage and administration

Follow the instructions from your doctor concerning type of insulin,dose and time of injection,Make sure that you have got the type and strength for insulin prescribed by your doctor.

When a switch is made from mixed species(porcine/bovine)or bovine insulin a dosage adjustment may be required dependent upon dosage,purity,species and formulation of the insulin(s)currently administered.

Variations in glycaemic control may occur and adjustments in therapy should be made under the guidance of your doctor.For patients currently controlled on porcine monocomponent or other highly purified human or porcine insulins,no dosage change is anticipated other than the routine adjustments made in order to maintain stable diabetic control.Do not change dosage or preparation except on your doctor's advice.

Novolin R is for subcutaneous,intramuscular or intravenous injection.

Insulin Pumps

Due to risk of precipitation in some pump catheters Novolin R is not recommended for use in insulin pumps.

Injection Procedure

Make sure that you are using a syringe which is marked corresponding to the strength of the insulin preparation prescribed by your doctor.

Always use the same type and brand of syringe.Failure to use the correct syringe can lead to dosage errors.Unless otherwise instructed by your doctor proceed as follows:

1.Insulin can either be clear(insulin solutions)or cloudy(insulin suspensions).

2.If you use only one insulin type:

Draw into the syringe a volume of air equal to the dose of insulin to be injected and introduce the air into the vial.

Turn the vial and svringe upside down and draw the correct insulin dose into the syringe.Then pull the needle out of the vial.Expel any air from the syringe and check that the dose is correct.

3.If you mix two insulin types:

Immediately before use,cloudy insulin should be rolled between your hands until the insulin is uniformly distributed throughout the liquid.

Draw into the syringe a volume of air equal to the dose to cloudy insulin,inject the air into the vial of cloudy insulin and take out the needle.

Draw into the syringe a volume of air equal to the dose of clear insulin.Inject the air into the vial of clear insulin,turn the vial and syringe upside down and withdraw the dose of clear insulin prescribed.Expel any air from the syringe and check that the dose is correct.Introduce the needle into the vial of cloudy insulin and withdraw the prescribed dose.Expel any air and check the dose.

Always draw up the insulin in the same order and inject the mixture immediately.

4.Pinch the skin between two fingers,push the needle into the fold at an angle of approx.45 degrees and inject the insulin under the skin(subcutaneously).

5.Remove the needle and press the injection spot gently for a few seconds to prevent any insulin seeping out.

6.Change the site of injection as advised by your doctor.

Precautions

An insulin reaction(hypoglycaemia)may occur if you take too much insulin miss meals or exercise more than usuaI.

The first symptoms of an insulin reaction can come on suddenly and may include a cold sweat,rapid heart beat,nervousness or shakiness.These symptoms may be abolished by immediately taking sugar or a sugar sweetened product.Therefore,always carry a few sugar lumps or sweets with you.

A few patients have reported that after being transferred to human insulin,the early warning symptoms for hypoglycaemia were less pronounced than they were with animalsource insulin.

Your relatives and close work-mates should know that you are a diabetic and how to help if you get a severe insulin reaction.They must be aware that an unconscious person should not be given anything to eat or drink(as choking is possible),but should be turned on his side and medical assistance sought immediately,Recovery from unconsciousness may be hastened by the injection of glucagon,which can be given by a relative of friend who has been instructed in its use.If glucagon is used,sugar or glucose should be given by mouth as soon as consciousness has been regained.In the event of an insulin overdose,in addition to glucagon,glucose may be given intravenously by your doctor.Consult your doctor if you have experienced repeated insulin reactions,or one leading to unconsciousness,since a change in insulin dosage may be necessary.If severe hypoglycaemia is not treated,it can cause temporary or permanent brain damage,and death.

Diabetic ketoacidosis means a condition in which the blood sugar is usually very high.This is a very serious condition,which may develop if you take less insulin than you need.This may be due to increased insulin demand during illness or infection,neglect of diet,omission of insulin doses or the injection of a smaller insulin dose than that prescribed by your doctor.A developing ketoacidosis will be revealed by urine tests which show large amounts of sugar and ketones.The symptoms of thirst,large urine volumes,loss of appetite,fatigue,dry skin and deep and rapid breathing come on gradually,usually over a period of some hours or days.If you recognize these symptoms,consult your doctor immediately.If such symptoms are not treated,they can cause diabetic coma and death.

Interactions

A number of drugs are known to influence insulin requirement.Therefore,if you are taking any other medication,please consult your doctor.

Storage

Insulin should be stored in its carton between 2-8℃,preferably in a refrigerator(not too near the freezing compartment).It must not be exposed to frost or sunlight.The vial in use may be kept at room temperature(max.25℃)for six weeks.

Keep out of reach of children.

Note

Insulin solutions should not be used if not water-clear and colourless.Never use insulin after the expiration date printed on the pack.

Snap-off Caps

The insulin vials is packed and shipped with a protective,colour coded,tamper-proof plastic cap.In order for you to withdraw insulin from a new vial,the cap must be removed.If the cap is not securely fastened to a newly purchased vial,return the vial to your pharmacy.

Novolin R is a trademark owned by Novo Nordisk Ais,Denmark.

Manufacturer

Novo Nordisk Ais,Denmark

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