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  药店国别: 日本药房
产地国家: 日本
所属类别: 抗微生物药物->抗真菌药物
处方药:处方药
包装规格: 50毫克/瓶 10瓶
计价单位:
   
生产厂家中文参考译名:
安斯泰来
生产厂家英文名:
Astellas
该药品相关信息网址1:
http://www.thefreelibrary.com/Astellas+Pharma+Obtains+Approval+for+Funguard+and+Vesicare.-a0144774097
该药品相关信息网址2:
http://www.kegg.jp/medicus-bin/japic_med_product?id=00051442
原产地英文商品名:
Funguard 50mg 10vials
原产地英文药品名:
Micafungin
中文参考商品译名:
Funguard 50毫克/瓶 10瓶
中文参考药品译名:
米卡芬净注射剂
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Hematopoietic stem cell transplantation in patients with fungal infections
英文适应病症2:
Gastrointestinal candidiasis
临床试验期:
完成
中文适应病症参考翻译1:
造血干细胞移植患者的真菌感染
中文适应病症参考翻译2:
消化道念珠菌病
药品信息:
英文药名:Funguard(Micafungin Sodium for Infusion) 中文药名:米卡芬净注射剂 生产厂家:安斯泰来 药品介绍 米卡芬净(Micafungin)由日本藤泽公司开发,于2002年12月在日本上市,商品名为Fungusrd,2005年3月通过美国FDA认证,目前仅被批准用于治疗食道念珠菌感染、骨髓移植及ADS患者中性粒细胞减少症的预防治疗。 药品英文名 Micafungin 药品别名 Fungard、Mycamine、FK-463 药物剂型 注射剂:25mg 50mg 75mg 药理作用 本品为棘白菌素类广谱抗真菌药,对念珠菌属、曲菌属具有广泛抗真菌作用,对耐氟康唑与依曲康唑的念珠菌亦有作用。通过抑制真菌细胞壁的β-D-葡聚糖的合成发挥抗真菌作用。对临床分离的多种假丝酵母及曲霉有较强的杀灭作用,但对新型隐球菌无效。本品对念球菌属和曲霉菌属的抗菌谱较宽,各种真菌对本品的敏感性顺序为:白色假丝酵母>平滑假丝酵母>热带假丝酵母>葡萄牙假丝酵母>克鲁丝化假丝酵母>近平滑假丝酵母。本品与两性霉素B联合给药,可以显著增加药物对新型隐球酵母菌的抗菌活性,还可以使两性霉素B的抗菌谱增宽。 药动学 本品口服吸收差(约3%),仅能静脉给药。单剂量及多剂量连续8天给正常兔静注0.5mg/kg、1mg/kg、2mg/kg后的药动学结果表明,本品的体内过程符合线性动力学,在上述剂量下,其血药峰浓度超过体外最低抑菌浓度(MIC)和最低杀菌浓度(MBC)值。FK-463的体内半衰期(t1/2)为3h,上述三个剂量的药时曲线下面积(AIJC0~24h)分别为(5.66±0.42)μg·h/ml、(13.43±12.53)μg·h/ml、(22.94±2.28)μg·h/ml。 本品的组织分布有其特点:在血浆峰浓度(Cmax)为(10.29±2.20)μg/ml时,在肺中的分布最多;而当Cmax为(17.20±0.15)μg/ml和(19.67±2.74)μg/ml时,则分别在肝和脾、肾等器官中分布最多。 适应证 本品用于对其他抗真菌药不能耐受或已产生耐药菌的真菌感染患者,以及预防造血干细胞移植患者的真菌感染,治疗消化道念珠菌病。 禁忌证 对本品过敏者禁用。 注意事项 1.慎用:尚不知本品是否经乳汁分泌,哺乳期妇女慎用。本品生殖毒性分级为C。孕妇慎用。 2.儿童用药安全性尚未评价。 3.进行性肾功能异常患者在使用本品期间应监测肾功能。 4.本品可溶于5%葡萄糖注射液或生理盐水。 5.本品不能静注。6.15~30℃贮藏。 不良反应 本品耐受性良好,常见的不良反应是肝脏和肾功能改变。有报道在接受本品50~150mg/d治疗后,可能出现与组胺相关的不良反应症状:皮疹、瘙痒、面部肿胀、血管扩张和注射部位反应(包括静脉炎和血栓性静脉炎)。个别病例表现为过敏和超敏反应(包括休克)、严重溶血和溶血性贫血。 用法用量 静滴。治疗消化道念珠菌病:每日150mg,疗程10~30天。预防造血干细胞移植患者的真菌感染:每日50mg,平均疗程19天。 药物相应作用 本品可使西罗莫司的AUC增加21%,Cmax没有明显变化;可使硝苯地平的AUC、Cmax分别增加18%和42%。以上药物合用时应监测西罗莫司、硝苯地平的血药浓度,使用剂量应降低。 For the first time in Japan , micafungin sodium as an anti -fungal agents : additional dosage to children has been approved (trade name fan guard infusion ) . Opportunistic infections is likely to develop in patients being administered immunosuppressive drugs and cancer patients undergoing chemotherapy , deep-seated fungal infection by pathogenic fungi Candida , Aspergillus , Cryptococcus , and Mucor is greater the prognosis of these patients This is one of the determining factors . For the treatment of systemic fungal disease , antifungal agents and oral injection of (intravenous ) is used . Specifically , in addition to micafungin , amphotericin B ( trade name: Fungizone , etc.) , flucytosine (trade name: Ankochiru etc.) , fluconazole (brand name: Diflucan , etc.) , miconazole (trade name: Furorido etc.) , itraconazole (trade name : Itrizole etc.) , fosfluconazole ( trade name : Purojifu ) , voriconazole ( trade name : antifungals eight types of Vfend ) is used . Among them , from the viewpoint spectrum and antifungal activity , such as tissue penetration property , it 's been evaluated as drug safety and usefulness is superior to antifungals other , fluconazole , itraconazole , fosfluconazole , voriconazole it is an azole antifungal agents such as . Azole antifungal agents , acting bacteriostatic manner by specifically acting on the cytochrome P450 fungal inhibiting the biosynthesis of ergosterol , which is the main constituent of fungal cell membrane . However, in recent years , due to an increase in resistance to Candida and aspergillosis azole antifungal drugs not be fully effective , systemic fungal disease that struggling to treatment has increased . Has appeared in December 2002 as an effective drug to these fungi , it is of micafungin Candin antifungal drugs with a mechanism of action and new molecular structure . " Fungemia caused by Candida and Aspergillus , respiratory fungal diseases , gastrointestinal mycosis " in , adaptation , 1,3-β- glucan synthesis involved in the production of ( glucan polymer) major component of the cell wall of fungi by using specifically inhibiting the activity of the enzyme to exert antifungal activity . In addition to antifungal effect against resistant Candida and aspergillosis is high , fewer side effects for 1,3-β- glucan synthase is a point of action does not exist in the human host , micafungin is , evaluation of safety it is higher . However, until now , adaptation is limited to adults profound antifungals any agents with adaptive children were not present . It was status quo for this , in children area , pharmacokinetics also not been well understood , leave evidence of the efficacy and safety is also poor , it has been used in the groping an anti -fungal agent for adults . So micafungin is conducted clinical trials in pediatric ( infant - school children ) in the country , there is no difference between adults pharmacokinetics , since the efficacy and safety were also obtained results to be the same as adult , it is not was the addition of dosage and administration to the children of this time . To use in children and micafungin , the upper limit of the amount of daily doses 6mg / kg , and care should be taken not to exceed the daily dose 300mg as the upper limit of the adult patients of 50 kg or body weight. The fan guard , two formulation " infusion 50mg " and " infusion 75mg " is available from conventional , together that this time , adaptation to children has become added , nearly " infusion 25mg " formulation it is expected to be released .
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