Name of the medicinal product. AmBisome 50 mg Powder for solution for infusion . 2. Qualitative and quantitative composition. Each vial contains 50 mg of. The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a. AmBisome is given as an infusion into a vein (a drip) by a doctor or nurse. . Package leaflet: information for the user. AmBisome®. Liposomal.

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Visually inspect the vial for particulate matter and continue shaking until complete dispersion is obtained.

These studies include comparative randomized studies of AmBisome versus conventional amphotericin B in confirmed Aspergillus and Candida infections where the efficacy of both medicinal products was equivalent. To make up a 0. Marketing authorisation number s 9. Mechanism of action and pharmacodynamic effects Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced by Streptomyces nodosus. The primary endpoint was safety and the study was not designed to draw statistically meaningful conclusions related to efficacy.

False elevations of serum phosphate may occur when samples from patients receiving Am B isome are analyzed using the PHOSm assay. Differences were not statistically significant. Each vial contains 50 mg of amphotericin 50, units encapsulated in liposomes. The favourable overall response was No additional information is available in special populations.

The majority of clinically important fungal species seem to be susceptible to amphotericin B, although intrinsic resistance has rarely been reported, for example, for some strains of S.

AmBisome – Patient Information Leaflet (PIL) – (eMC)

However, the mean pore diameter of the filter should not be less than 1. In two double-blind, comparative studies, AmBisome treated patients experienced a significantly lower incidence of infusion-related reactions, as compared to patients treated with conventional amphotericin B or amphotericin B lipid complex. False elevations of serum phosphate may occur amblsome samples from patients receiving AmBisome are analyzed using the PHOSm assay e.


Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. Treatment should be continued until the recorded temperature is normalised for jnsert consecutive days. To email a medicine you must sign up and log in. Posology Treatment of mycoses Therapy is usually instituted at a daily dose of 1. Some of the undesirable effects of AmBisome presented below may impact the ability to drive and use machines.

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In pooled study data from randomised, controlled clinical trials comparing AmBisome with conventional amphotericin B therapy in greater than 1, patients, reported adverse reactions were considerably less severe and less frequent in AmBisome treated patients as compared with conventional amphotericin B treated patients. Do not use if there is any evidence of precipitation of foreign matter. In another double-blind study involving patients, the incidence of nephrotoxicity with AmBisome as measured by serum creatinine increase greater than 2.

Am B isome is indicated for the following:.

L-AmB was found to be non-mutagenic in bacterial and mammalian systems. No data are available on which to make a dose recommendation for patients with hepatic impairment See section 4.

Amphotericin B for Injection, USP | X-Gen Pharmaceuticals, Inc

Vials of AmBisome containing 50 mg of amphotericin are prepared as follows: Mammalian cell membranes also contain sterols, and it has been suggested that the damage to human cells and fungal cells caused by amphotericin B may share common mechanisms. Patient management should include laboratory evaluation of renal, hepatic, and hematopoietic function, and serum electrolytes apckage and potassium.


Leukocyte transfusions Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions. Hydrogenated soy phosphatidylcholine Cholesterol Distearoylphosphatidylglycerol Alpha tocopherol Sucrose Disodium succinate hexahydrate Sodium hydroxide for pH adjustment Hydrochloric acid for pH adjustment.

AmBisome has been studied in paediatric patients aged one month to 18 years old. Therefore, administration of a test dose is still advisable before a new course of treatment. This site uses cookies.

AmBisome should only be used during pregnancy if oackage possible benefits to be derived outweigh the potential risks to the mother and fetus. An in-line membrane filter may be used for intravenous infusion of AmBisome. Dosage of amphotericin B as AmBisome must be adjusted to the specific requirements of each patient. Data suggest that ambiome dose adjustment is required in patients undergoing haemodialysis or filtration procedures, however, L-AmB administration should be avoided during the procedure.

Amphotericin B for Injection, USP

Invasive mucormycosis zygomycosis There are no large-scale randomised clinical trials in mucormycosis. Following administration of liposomal amphotericin B L-AmB steady state was reached quickly generally within 4 days of dosing.

Both systemic fungal infections in children and presumed fungal infections in children with febrile neutropenia have been successfully treated with AmBisome, without reports of unusual adverse events. Withdraw the calculated volume of reconstituted AmBisome into a sterile syringe.

Last modified: December 28, 2019