两性霉素B脂质体AmBisome
AmBisome，注射用两性霉素B（AmB）脂质体冻干粉，原研单位：NexStar Pharmaceuticals，于1990年首先在欧洲上市，是世界上第一个药物脂质体制剂。现为Gilead Sciences 所属，在全球二十几个国家和地区使用，用于念珠菌、曲霉菌、隐球菌等造成的深部真菌感染以及内脏利什曼病。与AmB脱氧胆酸盐制剂相比，总有效率相当，不良反应发生率下降。
AmBisome由Gilead、Astellas、Danippon Sumitomo在全球不同地区销售，2009

1. NAME OF THE MEDICINAL PRODUCT
 AmBisome 50 mg Powder for solution for infusion

Go to top of the page2. QUALITATIVE AND QUANTITATIVE COMPOSITION
 Each vial contains 50 mg of amphotericin (50,000 units) encapsulated in liposomes. After reconstitution, the concentrate contains 4 mg/mL amphotericin B.

For a full list of excipients, see section 6.1.

Go to top of the page3. PHARMACEUTICAL FORM
 AmBisome is a sterile, Powder for solution for infusion. AmBisome is a yellow lyophilised cake or powder. After reconstitution, the product is an injectable intended to be administered by intravenous infusion.

Go to top of the page4. CLINICAL PARTICULARS
 
Go to top of the page4.1 Therapeutic indications
 AmBisome is indicated in:

• the treatment of severe systemic and/or deep mycoses

• the treatment of visceral leishmaniasis in immunocompetent patients including both adults and children.

• the empirical treatment of presumed fungal infections in febrile neutropenic patients, where the fever has failed to respond to broad spectrum antibiotics and appropriate investigations have failed to define a bacterial or viral cause.

Infections successfully treated with AmBisome include: disseminated candidiasis, aspergillosis, mucormycosis, chronic mycetoma, cryptococcal meningitis and visceral leishmaniasis.

This drug should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests.

Go to top of the page4.2 Posology and method of administration
 AmBisome should be administered by intravenous infusion over a 30 - 60 minute period. For doses greater than 5mg/kg/day, intravenous infusion over a 2 hour period is recommended (see section 4.4). The recommended concentration for intravenous infusion is 0.20 mg/ml to 2.00 mg/ml amphotericin B as AmBisome.

Adult Patients

Treatment of mycoses:

Therapy is usually instituted at a daily dose of 1.0 mg/kg of body weight, and increased stepwise to 3.0 mg/kg, as required. Data are presently insufficient to define total dosage requirements and duration of treatment necessary for resolution of mycoses. However, a cumulative dose of 1.0 - 3.0 g of amphotericin B as AmBisome over 3 - 4 weeks has been typical. Dosage of amphotericin B as AmBisome must be adjusted to the specific requirements of each patient.

Treatment of visceral leishmaniasis:

A total dose of 21.0 - 30.0 mg/kg of body weight given over 10-21 days may be used in the treatment of visceral leishmaniasis. Particulars as to the optimal dosage and the eventual development of resistance are as yet incomplete. The product should be administered under strict medical supervision.

Empirical treatment of febrile neutropenia:

The recommended daily dose is 3 mg/kg body weight per day. Treatment should be continued until the recorded temperature is normalised for 3 consecutive days. In any event, treatment should be discontinued after a maximum of 42 days.

Paediatric Patients: Both systemic fungal infections in children and presumed fungal infectio