盐酸头孢唑兰_FIRSTCIN_盐酸头孢唑兰注射剂Cefmenoxime说明书
[caption id="attachment_34419" align="alignleft" width="300"] FIRSTCIN INTRAVENOUS 1Gm(盐酸头孢唑兰注射剂)[/caption]
药店国别:
产地国家:日本
处 方 药:是
所属类别:1克/瓶 10瓶/盒
包装规格:1克/瓶 10瓶/盒
计价单位:盒
生产厂家中文参考译名:武田薬品
生产厂家英文名:Takeda
原产地英文商品名:Firstcin1g/vial 10vials/box
原产地英文药品名:Cefmenoxime Hydrochloride
中文参考商品译名:FIRSTCIN1克/瓶 10瓶/盒
中文参考药品译名:盐酸头孢唑兰
简介:
部份中文盐酸盐头孢唑兰处方资料(仅供参考)
英文名:Cefozopran Hydrochloride
商标名:FIRSTCIN
中文名:盐酸盐头孢唑兰
生产商:武田
药效分类:抗生素制剂
批准日期:2000年11月
商标名:
FIRSTCIN INTRAVENOUS 0.5Gm.
FIRSTCIN INTRAVENOUS 1Gm.
FIRSTCIN INTRAVENOUS 1Gm.BAG S
FIRSTCIN INTRAVENOUS 1Gm.BAG G
一般名:Cefozopran Hydrochloride[JAN]
略号:CZOP
化学名:(6R,7R)-7-[(Z)-2-(5-Amino-1,2,4-thiadiazol-3-yl)-2-(methoxyimino)acetylamino]-3-(1H-imidazo[1,2-b]pyridazin-4-ium-1-ylmethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monohydrochloride
分子式:C19H17N9O5S2・HCl
分子量:551.99
融点(分解):带温度上升来褐变,在180海里附近发泡,在200片附近碳化,因此没有标明明确的融点和分解点。
性状:辅酶盐酸盐是白色到微黄色的结晶或结晶性的粉末。它容易溶于甲基苯甲氧或者甲酰胺,也不易溶于水、甲醇或乙醇(95),几乎不溶于乙酰苯或二甲酯。
力量价:以质量值表示作为测序计划(c19h17n9o5s2)的质量。测试后的盐酸盐标准品的1mg对应于0.934mg(权力值)。
处理上的注意:
【注意】对于包s和包g的情况
(1)为了保持产品的质量,不要将装本产品的外袋在使用前打开。
(2)下面的情况下不要使用。
1)外袋破损或溶解液漏出的时候。
2)在隔壁开通之前,抗生素已熔化的时候。
3)抗生素变色或溶解液显色的时候。
(3)容器的液刻度约作为标准使用。
药效药理:
1.抗菌作用
(1)革兰氏阳性菌和克阴性菌具有广泛的抗菌作用,特别是对葡萄球菌属、链球菌属、肠内细菌的各种细菌、流行性感冒菌有很强的抗菌作用。另外,对大多数抗生素显示出抗药性的肠球菌和绿脓菌也具有相对较强的抗菌能力。
(2)抗菌作用是杀菌的,以最小发育阻止浓度示出杀菌作用。
2.作用机制
阻碍细菌细胞壁的合成。本剂对革兰氏阳性菌及阴性菌表现出强烈的抗菌力,是β-ラクタマーゼ稳定,金黄色葡萄球菌对青霉素结合蛋白1及2、大肠杆菌及绿脓杆菌对青霉素结合蛋白3细胞亲和性高壁peptidoglycan据架桥形成阻碍作用强烈。
适应症:
为败血症、外伤创口感染、以及由G+、G-和绿脓杆菌等引起的各种感染。
用法与用量:
在使用本剂的时候,要确定是否需要连续服用,以使配药开始后的三天为周期,并检查是否要中断服用或切换成更合适的其他药物。另外,原则上本药剂的服用期间为14天以内。
成人:
通常成年人每日用1~2g(力价)的盐酸盐进行2次静脉内注射或点滴静脉内注射。根据年龄和症状适当增减,但是对于难治性或重病感染症,到1日4g(力价)为止增量,分2 ~ 4次服用。
小儿:
通常,小儿将一天40~80毫克(力价)/公斤分为3~4次进行静脉内注射或点滴静脉内注射。另外,对于疑难杂症或重症感染症,一天增加到160mg(权力价格)/kg,分3~4次服用。在化脓性脑膜炎中,每天可以增重200毫克(力价)/公斤。但是,容量不是成人每天最大4克(力量值)。
新生儿(包括低出生体重儿):
一般情况下,新生儿(包括低出生体重儿)每次20毫克(力气)/公斤为0天(出生后24小时以内),每天1 ~ 2次(出生后24小时以后),7天为1天2 ~ 3次,8天以后一天3 ~ 4次为静脉内注射或点滴静脉内注射。另外,1次可将重症或疑难杂症增加到40毫克(衰减量)/kg。
静脉注射的情况:
溶于日局“注射用水”、日局“生理食盐液”或日局“葡萄糖注射液”,缓缓地往静脉内注射。
点滴静脉注射的情况:
除糖液、电解质液或氨基酸制剂等容积液外,30分钟至2小时内在静脉内打点滴。
包的情况:
包s用手压生理食盐液一侧,包g用5%葡萄糖注射液一侧,开通隔壁,溶解芝麻盐盐酸盐后,用30分钟~ 2小时在静脉内打点滴。
临床成绩:
1.成人感染症
针对在制造和销售后的用途成绩调查4317例的成绩概要如表1所示。
2.儿童·新生儿感染症
在制造和销售后的782个使用成绩调查中的成绩概要如表2所示。
包装:
注射剂:
0.5克:10瓶/盒
1克:10瓶/盒
输注液:
1克包 S(添付:生理食盐液) 10包/盒
1克包 G (添付:5%葡萄糖注射液):10包
FIRSTCIN(Cefozopran Hydrochloride)
Summary
1. Development and marketing of the drug at home and abroad
This product is the fourth generation cephalosporin developed by Takeda Company of Japan. Firstcin was first marketed in Japan in 1995. The dosage form is injection powder with specifications of 0.5g and 1G. China has not yet imported this product, nor has it been reported by domestic manufacturers. According to the Regulations on the Administration of Drug Registration, this product should be a chemical.
2. The drug has been approved abroad and its application in clinical research
The clinical indications approved by the Pharmaceutical Inspection Bureau of the Ministry of Health and Welfare in Japan are sepsis, wound infection, and various infections caused by G+, G-and Pseudomonas aeruginosa.
3. Listed formulations and dosage
Powder needle for injection is 0.5g and 1G. It can be diluted to 100ml:1g with normal saline or 5% glucose injection.
Adult dosage: generally 1-2 g intravenous injection or intravenous drip per day; severe patients up to 4 g per day, 2-4 times per day.
Children (including infants) medication: usually 20-80 mg/kg per day, 3-4 times per day; severe patients up to 160 mg/kg per day, 3-4 times per day.
Pharmacological and Toxicological Effects and Clinical eva luation
Cefazolin is characterized by:
It has a high affinity for penicillin binding protein (PBPs).
(2) It can diffuse rapidly to the periplasm of bacteria through the outer membrane pore of G-bacteria and maintain high concentration.
(3) It has low affinity and inducibility to beta-lactamase and is stable to chromosome-mediated and plasmid-mediated beta-lactamases. Therefore, this product shows broad-spectrum antimicrobial activity against G + bacteria, G - bacteria and anaerobic bacteria. Compared with the third generation cephalosporins, it enhances the antimicrobial activity against G + bacteria, especially Streptococcus and pneumococcus. Cefazolin also has strong effects on common cephalosporins-insensitive Streptococcus faecalis, Citrobacter freudicus, Enterobacter cloacae and Pseudomonas aeruginosa.
The toxicity of this product is very low. LD50: intravenous injection > 5000mg/kg in mice. LD50: intravenous injection of about 5000mg/kg. There was no abnormality in reproductive test.
Clinical eva luation: In 1604 cases of various infections treated with this product, the total effective rate was 85.4% (1364/1604), of which the clearance rate of G + infectious bacteria was 88.8%, G - bacteria was 89.4%, and complex infectious bacteria was 79.0%. It shows that this product has good clinical application value.
用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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