药品名称:
商品名称:可利新
通用名称:注射用特利加压素
英文名称:Glypressin (Terlipressin for Injection)
成份:
特利加压素
适应症:
治疗食管静脉曲张出血。
规格:
冻干粉针剂:每小瓶1mg,附稀释剂5ml。
用法用量:
本品推荐开始剂量为2 mg,缓慢进行静脉注射(超过1分钟),同时监测血压及心率。维持剂量每4-6小时静脉给药1-2mg,直至出血得到控制,治疗时间为24-48小时。
建议每日最大剂量120-150 ug/Kg。如出血还未得到控制,应考虑采用其它治疗方法。
不良反应:
临床试验中最常见的不良反应(发生率1-10%)为皮肤苍白、血压升高、腹痛、恶心、腹泻和头痛。
本品不良反应发生率见下表 :
常见 (≥1%且<10%)
神经系统异常 :头痛 ;
心血管系统异常 :血压升高(高血压患者较为明显),血管收缩作用,如苍白、发绀和外周缺血 ;
胃肠道系统异常 :腹痛、恶心、腹泻。
偶见 (≥0.1%且<1%)
心血管系统异常 :心动过缓。
十分罕见 (<0.01%)
心血管系统异常 :心肌缺血和心梗、左心室衰竭、心律失常 ;
呼吸系统、胸廓和纵隔异常 :呼吸困难 ;一般症状和给药部位异常 :给药部分坏死。
本品的抗利尿作用可以引起低钠血症和低钙血症,除非液体平衡得到控制。
使用本品可能会出现子宫肌肉痉挛,子宫肌肉和子宫内膜的血液循环障碍。
禁忌:
本品禁用于 :对本品特利加压素及其组分过敏者 ;败血症性休克患者 ;妊娠妇女和儿童。
注意事项:
有下述合并症的患者应该在监测下慎用本品:支气管哮喘、高血压、心血管疾病(严重动脉硬化、冠状动脉供血不足、心律失常)、肾功能不全。
孕妇及哺乳期妇女用药:
本品禁用于孕妇。由于特利加压素对平滑肌的作用,在妊娠首3个月使用可能引起自发性流产。另外,在孕兔中进行的研究显示,药物可以导致器官畸形,因此在人体中也不能排除此作用。
本品对哺乳期妇女影响的资料不足。
儿童用药:
尚无儿童使用本品的临床经验。因此本品不适用于儿童。
老年用药:
老年患者应用本品的临床经验有限,目前尚无该人群推荐剂量的相关数据。因此使用本品时应特别慎重。
药物相互作用:
本品同时应用降低心率的药物如丙泊酚、舒芬太尼时可导致严重心动过缓。
药物过量:
高血压患者应用本药使血压增高时,可静脉注射可乐定150mg。
毒理研究:
Ames实验:5000 ug/皿的浓度无致突变活性。
仓鼠肺细胞的致突变性:特利加压素的超纯水溶液只有在毒性浓度才显示出微弱致突变性。
生殖毒性:大鼠每日皮下注射特利加压素10和/或50 .
药理作用:
特利加压素,化学名三甘氨酰赖氨酸加压素,是一种新型的人工合成的长效血管加压素制剂,它是一种前体药物,本身无活性,在体内经氨基肽酶作用,脱去其N末端的3个甘氨酰残基后,缓慢“释放”出有活性的赖氨酸加压素.
药代动力学:
特利加压素在体内经氨基肽酶作用,脱去其N末端的3个甘氨酰残基后,缓慢降解为有活性的赖氨酸加压素。特利加压素静脉途径给药的药代动力学模型为二室模型,清除半衰期约40分钟,代谢清除率约为9ml/kg/mi.
化学成份:
化学名称为:三甘氨酰基-赖氨酸-加压素
分子量:1227.4
性状:
白色冻干疏松块状物或粉末
贮藏:
室温保存。
有效期:
36个月,溶液配好后应马上使用。
生产企业:
辉凌制药有限公司
Glypressin
Main use:Bleeding from the oesophagus
Active ingredient:Terlipressin
Manufacturer:Ferring
How does it work?
Terlipressin is a medicine similar to a naturally occurring hormone present in the body, known as antidiuretic hormone (ADH) or vasopressin. ADH has two main effects in the body.
Firstly, it causes narrowing of blood vessels(vasoconstriction), thereby limiting blood flow to a particular area of the body. It also acts on receptors in the kidney to retain water in the body, which helps to prevent excessive loss of water in the urine.
Terlipressin is commonly used to stop bleeding of varices in the food pipe (oesophagus). Varices are fragile distended veins that can occur in various parts of the body such as the oesophagus.
This is caused by an increase in blood pressure in certain diseases such as severe liver disease.
These fragile varices can rupture and lead to life threatening bleeding.
Terlipressin is therefore given to narrow blood vessels, and so restricting blood flow to the varices and stopping the bleeding.
What is it used for?
Bleeding from dilated veins in the oesophagus (oesophageal varices)
Warning!
Individuals taking this medicine should be monitored for changes in blood pressure.
It is recommended that individuals taking this medicine have their fluid and salt (electrolyte) balance monitored regularly.
Use with caution in
Advanced disease of the arteries in which fat sticks to the inner wall leading to obstruction (atherosclerosis) Condition where the heart is unable to carry out its normal
function (cardiac insufficiency)
High blood pressure (hypertension)
Irregular heart beats (arrhythmias)
Not to be used in
Pregnancy
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and Breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the
mother outweigh the risks to the unborn baby.
Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
This medicine should not be used in pregnancy. Seek medical advice from your doctor.
There is no information available regarding the safety of this medicine during breastfeeding. Seek medical advice from your doctor.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this
medicine.
Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Headache
Abdominal cramps
High blood pressure (hypertension)
Temporary reduction in blood flow to the skin causing it to become pale (transient blanching)The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
There are no significant interactions known.
Other medicines containing the same active ingredientsTerlipressin
附件:
201112417342523.PDF
201112417342037.PDF
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产地国家: 英国
原产地英文商品名:
GLYPRESSIN INJ 0.12mg/ml 8.5ml/vial 5vials/box
原产地英文药品名:
TERLIPRESSIN
中文参考商品译名:
GLYPRESSIN注射剂 0.12毫克/毫升 8.5毫升/瓶 5瓶/盒
中文参考药品译名:
特利加压素
中文参考化合物名称:
三甘氨酰基-赖氨酸-加压素
生产厂家中文参考译名:
辉凌制药
生产厂家英文名:
Ferring