AMBISOME PACKAGE INSERT PDF

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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Volume of distribution on day 1 and at steady state suggests that there is extensive tissue distribution of amphotericin B. Systemic fungal infections have been successfully treated in pregnant women with conventional amphotericin B without obvious effect on the fetus, but the ambisone of cases reported is insufficient to draw any conclusions on the safety of AmBisome in pregnancy. Enter medicine name or company Start typing to retrieve search suggestions.

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

AmBisome and Micafungin were administered for a median duration of 15 days. 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. Some of the undesirable effects of AmBisome presented below may impact the ability to drive ajbisome use machines. During the initial dosing period, patients should be under close observation.

L-AmB has a significantly different pharmacokinetic profile from that reported in the literature for conventional presentations of amphotericin B, with higher amphotericin B plasma concentrations Cmax and increased exposure AUC compared to conventional amphotericin B.

Carcinogenicity studies have not been conducted with L-AmB. Not known cannot be estimated from the available data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. See table below for recommendations.

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By continuing to browse the site you are agreeing to our policy on the use of cookies. No data are available on which to make a dose recommendation for patients with hepatic impairment See section 4.

This is particularly important in patients receiving concomitant nephrotoxic medications see section inaert. Leukocyte transfusions Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions. However, the following drugs are known to interact with amphotericin B and may interact with Am B isome: Antifungals No evidence of benefit from the use of flucytosine with AmBisome has been observed.

No studies on the effects on the ability to drive and use machines have been performed. Minimum and maximum pharmacokinetic values do not necessarily relate to the lowest and highest doses, respectively.

Antineoplastic agents should be given concomitantly with caution.

However, the following medicinal products are known to interact with amphotericin B and may interact with AmBisome: Clinical efficacy and safety The efficacy of AmBisome has been established in a number of clinical trials for the treatment of systemic mycotic infections, as empirical therapy for fever of unknown origin in neutropenic patients pafkage for the treatment of visceral leishmaniasis. Liposomes are closed, spherical vesicles formed from a variety of amphiphilic substances such as phospholipids.

The efficacy of AmBisome has been established in a number of clinical trials for the treatment of systemic mycotic infections, as empirical therapy for fever of unknown origin in neutropenic patients and for the treatment of visceral leishmaniasis.

Amphotericin B for Injection, USP

Qualitative and quantitative composition 3. Special populations including paediatric population: Regular monitoring of renal function is recommended in patients receiving AmBisome with any nephrotoxic medications.

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Haemodialysis or peritoneal dialysis does not appear to affect the elimination of AmBisome. Not all pack sizes may be marketed. Nephrotoxicity occurs to some degree with conventional amphotericin B in most patients receiving the product intravenously.

Sterile, powder for solution for infusion.

It is unknown whether AmBisome is excreted in human breast milk. Marketing authorisation holder 8. Courses of up to 6 — 8 weeks are commonly used in clinical practice; longer durations of therapy may be required for deep seated infections or in cases of prolonged courses of chemotherapy or neutropenia. Please see full Prescribing Information.

There was no significant drug accumulation packqge the plasma following repeated administration of 1 to 7. Do not use if there is any evidence of precipitation of foreign matter.

Particulars as to the optimal dosage and the eventual development of resistance are as yet incomplete. Active ingredient amphotericin b. Patient management should include laboratory evaluation of renal, hepatic, and hematopoietic function, and serum electrolytes magnesium and potassium. The primary endpoint was safety and the study was not designed to draw statistically meaningful conclusions related to efficacy.

The use of any solution other than those recommended, or the presence of a bacteriostatic agent e. This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples. This should be taken into account when treating diabetic patients.

No inaert information is available in special populations. Marketing authorisation number s 9. Treatment should be continued until the recorded temperature is normalised for 3 consecutive days. However, the mean pore diameter of the filter should not be less than 1.