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NAFAMOSTAT Injection 50mg(注射用甲磺酸萘莫司他)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 50毫克/瓶 10瓶/盒 
包装规格 50毫克/瓶 10瓶/盒 
计价单位: 盒 
生产厂家中文参考译名:
Meiji Seika Pharma Co., Ltd.
生产厂家英文名:
Meiji Seika Pharma Co., Ltd.
该药品相关信息网址1:
http://meds.qlifepro.com/detail/640453118/injectable-mesilate-10-meek-10-mg
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
NAFAMOSTAT for Injection(注射用ナファモスタット)50mg/vials 10vials/box
原产地英文药品名:
nafamostat mesilate
中文参考商品译名:
NAFAMOSTAT(注射用ナファモスタット)50毫克/瓶 10瓶/盒
中文参考药品译名:
甲磺酸萘莫司他
曾用名:
简介:

 

部分中文萘莫司他处方资料(仅供参考)
药品英文名
Nafamostat       
药品别名
甲磺酸萘莫司他、FUT、Futhan、Nafamostat Mesilate     
药物剂型
注射剂:10mg、100mg、50mg。
药理作用
本药为合成的丝氨酸蛋白水解酶抑制药,具有抗凝、抗纤维蛋白溶酶和抗血小板聚集的作用。
具体作用特点如下:
1.酶抑制作用:本药对胰蛋白酶、激肽释放酶(血管舒缓素)、血纤维蛋白溶酶、纤维蛋白酶以及补体系统经典途径的CL-r、CL-s等胰蛋白酶样丝氨酸蛋白酶有很强的选择性抑制作用;对磷脂酶A2也有抑制作用。体外对与α2-巨球蛋白结合的胰蛋白酶也有抑制作用。
2.对实验性急性胰腺炎的作用:大鼠和兔静脉滴注本药,对胰蛋白酶、肠激酶以及内毒素经胰管逆行注入而引起的各种实验性胰腺炎,可抑制由胰腺炎引起的胰酶活性上升以及进入血中的酶的活性,并降低死亡率。
3.对激肽释放酶-激肽系统的作用:对胰腺炎患者给予本药,可改善由激肽释放酶激活引起的激肽原总量的减少。
4.对血液凝固与纤维蛋白溶解系统的作用:本药通过抑制纤维蛋白酶和凝血因子Ⅻa和Ⅹa而产生抗凝作用。体外实验还发现,本药可抑制血小板聚集。动物实验中,本药静脉给药可使兔被激活的部分凝血活酶(凝血激酶)时间以及尿激酶激活的纤维蛋白块溶解时间延长。由于肝素有增加出血的危险性,故本药可作为肝素的替代物。
5.对补体系统的作用:对于静脉注射溶血素引起的全身性福斯曼嗜异性休克的豚鼠,口服及静脉注射本药均能延长其生命。
药动学
健康男子在90min内静脉滴注本药10mg、20mg和40mg,60~90min内血药浓度达峰值,分别为16.4ng/ml、61.5ng/ml和93.2ng/ml。在各组织中分布的药物浓度由高至低依次为肾、肝脏、肺及胰,均大于血药浓度。本药从血液中清除迅速,停药后1h血药浓度下降至5ng/ml以下,给药后4h仅从肝脏中可检出。药物主要在血和肝脏中代谢,由肾脏排泄。
适应证
1.用于急性胰腺炎、慢性胰腺炎急性恶化。
2.也用于血液透析、冠状动脉搭桥术、肝脏切除术时的抗凝,以及肾小球肾炎伴系统性红斑狼疮或混合型冷球蛋白血症(Cryoglobulimemia)。
禁忌证
对本药过敏者。
注意事项
1.本药粉针剂溶解后应立即使用。出现皮疹、红斑、瘙痒等过敏症状时,应停药。出现休克症状时应立即停药。
2.慎用:
(1)过敏体质者。
(2)有过敏史者。
(3)活动性出血(可因持续输注本药而增加出血的危险性)者。
(4)严重高血压(增加脑出血的危险性)患者(国外资料)。
(5)严重血小板减少症(增加出血的危险性)患者(国外资料)。
(6)高钾血症(使用本药可能加重高钾血症)患者(国外资料)。
(7)小儿。
3.药物对妊娠的影响:孕妇慎用本药。
4.药物对哺乳的影响:哺乳妇女慎用本药。
5.用药前后及用药时应当检查或监测:应定期监测:
(1)血常规、血小板计数及血清钾。
(2)激活的部分凝血活酶时间(APTT)、活化全血凝固时间(ACT)、凝血因子Ⅱ时间(PT)、凝血酶-抗凝血酶复合物(TAT)、α2纤溶酶抑制物-纤溶酶复合物(PIC)、凝血因子Ⅰ和纤维蛋白降解产物(FDP)。
不良反应
未见严重的不良反应。主要不良反应有:
1.过敏反应:皮疹、红斑、瘙痒等(1.7%)。
2.消化系统:恶心、腹泻(0.3%)等胃肠道反应,也可出现丙氨酸氨基转移酶、天门冬氨酸氨基转移酶升高(0.5%)。
3.血液:白细胞减少和血小板增加。
4.局部:注射部位红肿、疼痛较少见。
5其他:胸部不适、头痛等。国外不良反应参考:
1.血液:连续血液透析的患者使用本药抗凝时可引起出血(发生率为4%),但发生率明显低于使用肝素(67%)和低分子肝素者(29%)。也有引起嗜酸性粒细胞增多的报道,停药后即恢复正常。
2.中枢神经系统:罕见头痛和倦怠,但与本药的因果关系尚不明确。
3.代谢/内分泌系统:有引起高钾血症的报道。
4.胃肠道:畏食、恶心、呕吐罕见,与本药的因果关系尚不明确。
5.其他:有引起过敏反应的个案报道。
用法用量
1.成人常规剂量:静脉滴注:一次10mg,溶于5%葡萄糖注射液500ml中静脉滴注2h,一日1~2次。根据病情适当增减剂量。
2.儿童常规剂量:体外循环:接受体外膜式氧合(Extracorporeal membrane oxygenation)的新生儿,可用本药(加小剂量肝素)降低血液并发症。平均剂量为每小时0.48mg/kg(剂量范围为每小时0.29~1.1mg/kg)。
药物相应作用
尚不明确。
NAFAMOSTAT for Injection 50 "MEEK"(注射用ナファモスタット50「MEEK」)
Brand name : NAFAMOSTAT for Injection 50 "MEEK"
 Active ingredient: Nafamostat mesilate
 Dosage form: Injection
 Print on wrapping: 
Effects of this medicine
This medicine improves visceral disorders and bleeding tendency caused by blood clotting tendency in the vessels. It prevents coagulation in the blood circuit during hemodialysis.
It is usually used to prevent disseminated intravascular coagulation (DIC) and clotting of perfusing blood in extracorporeal blood circuit.
Before using this medicine, be sure to tell your doctor and pharmacist
If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you are pregnant or breastfeeding.
If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>
Disseminated intravascular coagulation (DIC): In general, this medicine is injected by continuous intravenous infusion over a period of 24 hours.
Prevention of perfusing blood coagulation in extracorporeal blood circuit: In general, the inside of blood circuit is rinsed and filled prior to the start of extracorporeal circulation and then this medicine is continuously injected through an anticoagulant injection line after start of extracorporeal circulation.
The treatment period with this medicine is determined based on your symptoms.
Precautions while taking this medicine
Since hyperpotassemia or hyponatremia may occur, your serum potassium and serum sodium values are periodically checked. Keep all appointments/laboratory test schedules.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash, erythema, itching and bleeding tendency. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
decreased blood pressure, conscious disorder, respiratory distress [shock, anaphylactoid symptoms]
weakness, numbness of limbs and lips, paralysis of limbs [hyperpotassemia]
nausea, convulsion, headache [hyponatremia]
nose/gum bleeding, subcutaneous bleeding of limbs, etc. [thrombocytopenia]
sore throat, fever, headache [leukopenia]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Meiji Seika Pharma Co., Ltd. Injection
Published: 2/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.  

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