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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗微生物药物->抗病毒药物
处方药:处方药
包装规格: 50毫克/12.5毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
安斯泰来
生产厂家英文名:
Astellas Pharma US, Inc.
该药品相关信息网址1:
http://www.ambisome.com/
该药品相关信息网址2:
http://www.drugs.com/ambisome.html
该药品相关信息网址3:
http://www.rxlist.com/ambisome-drug.htm
原产地英文商品名:
AMBISOME 50mg/12.5mL/vial
原产地英文药品名:
AMPHOTERICIN B
中文参考商品译名:
AMBISOME 50毫克/12.5毫升/瓶
中文参考药品译名:
脂质体两性霉素B
原产地国家批准上市年份:
1997/08/11
英文适应病症1:
Meningitis
英文适应病症2:
Cryptococcal meningitis
临床试验期:
完成
中文适应病症参考翻译1:
脑膜炎
中文适应病症参考翻译2:
隐球菌脑膜炎
药品信息:

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 详细处方信息以本药内容附件PDF文件(202122322315829.pdf)的“原文Priscribing Information”为准
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部分中文AmBisome处方资料(仅供参考)

中文名称: 两性霉素 B

中文同义词: 两性霉素 B;二性霉素B;两性霉素;两性霉素乙;两性霉素B;可溶性两性霉素 B;两性霉属B;庐山霉素

英文名称: Amphotericin B

英文同义词: ABELCET;AMBISOME;AMPHOTERCIN B;AMPHOTERICIN B;AMPHOTERICIN B SOLUBILIZED;AMPHOTERICIN B, SOLUBLE;AMPHOTERICIN B, STREPTOMYCES NODOSUS;AMPHOTERICIN B, STREPTOMYCES SPECIES

FDA批准Gilead生产的AmBisome用于治疗AIDS相关的隐球菌脑膜炎
    经美国食品与药物管理局(FDA)批准,Gilead的抗真菌药AmBisome可以用来治疗HIV感染者发生的隐球菌脑膜炎(cryptococcal meningitis)。
    Gilead 说,AmBisome,即注射用的脂质体形式的两性霉素B,是第一个用于这类隐球菌脑膜炎的脂类试剂。伊利诺斯州的一家日本公司Deerfield将在美国销售AmBisome。
    隐球菌脑膜炎是由新型隐球菌引发的脑部感染。这种病菌主要存在于灰尘和鸟粪中。通常情况下,免疫系统能够抑制和攻击新型隐球菌。然而,当HIV病毒削弱了免疫系统时,新型隐球菌就可以引起隐球菌脑膜炎或者引发脑膜和脊髓鞘膜肿胀。
    Gilead说,隐球菌脑膜炎是HIV感染者最常见的隐球菌感染,其感染率为5%-10%。
    其它使用AmBisome的指征包括:当癌症病人发生中性粒细胞减少和发热时,如果考虑有真菌感染,则可用AmBisome来治疗;曲霉菌属、念珠菌属和/或普通两性霉素B难以控制的隐球菌属感染;内脏利什曼病的治疗。
    另外,当病人由于肾功能障碍或不可接受的毒性而不适于使用普通两性霉素B时,可以使用AmBisome进行治疗。
    Gilead说,FDA在二月份曾批准了他们关于标签的一个补充说明。这个补充说明中称,在用于发热的中性粒细胞减少的癌症病人时,AmBisome的安全性优于Abelcet。Abelcet是由Liposome Company生产的两性霉素B与脂的复合物。
    Gilead补充说,虽然临床实验表明,与使用Abelcet相比,AmBisome的肾毒性显著降低,但是仍能观察到使用AmBisome所引起的剂量限制(dose-limiting)的肾毒性。

Introduction
AmBisome is an antifungal agent consisting of a liposomal preparation of amphotericin B that is administered by intravenous injection.

AmBisome is a true single bilayer liposomal drug delivery system, consisting of unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Details of the physical and chemical properties of AmBisome are presented in the Overview.

Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug抯 functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products.

AmBisome is indicated for (see Efficacy for complete details):
Empirical therapy for presumed fungal infection in febrile, neutropenic patients.
Treatment of cryptococcal meningitis in HIV-infected patients.
Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.
Treatment of visceral leishmaniasis.In immunocompromised patients with visceral leishmaniasis treated with AmBisome, relapse rates were high following initial clearance of parasites (see Pivotal Trials).

For clinically supported details regarding the safety profile of AmBisome, see the Safety and Tolerability section.

AmBisome should be administered by intravenous infusion using a controlled infusion device, over a period of approximately 120 Minutes. Specific administration instructions, as well as dosage details for each indication, are presented in the Dosage and Administration section.

No formal clinical studies of drug interactions have been conducted with AmBisome. However, a list of drugs that are known to interact with amphotericin B and may interact with AmBisome is shown in the Drug Interactions section.

Amphotericin B, the active ingredient of AmBisome, acts by binding to the sterol component of a cell membrane, leading to alterations in cell permeability and cell death.

Frequently asked questions about AmBisome and its use, as well as answers to these questions, can be found in the FAQs section.

Clinical study evidence supporting the efficacy and safety of AmBisome can be found in the Pivotal Trials section.

A guide to reimbursement for AmBisome can be found in the Reimbursement section.

A chronological bibliography containing clinical references to AmBisome, as well as a query tool for these references, can be found in the Bibliography section.

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 详细处方信息以本药内容附件PDF文件(202122322315829.pdf)的“原文Priscribing Information”为准
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更新日期: 2021-2-24
附件:
202122322315829.pdf    



 
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