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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Each vial contains 50 mg of amphotericin 50, units encapsulated in liposomes. Infections successfully treated with AmBisome include: AmBisome should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests. Therapy is usually instituted at a daily dose of 1.

Data are presently insufficient to define total dosage requirements and duration of treatment necessary for resolution of mycoses. However, a cumulative dose of 1. Dosage of amphotericin B as AmBisome must be adjusted to the specific requirements of each patient.

Amphotericin B for Injection, USP

The duration of therapy should be determined on an individual basis. 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. A total dose of 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.

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. 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. AmBisome has been studied in paediatric patients aged one month to 18 years old.

AmBisome is not recommended for use in children below 1 month old due to lack of data on safety and efficacy. No data are available on which to make a dose recommendation for patients with hepatic impairment See section 4. AmBisome should be administered by intravenous infusion over a 30 – 60 minute period. The recommended concentration for intravenous infusion is 0. For instructions on reconstitution and dilution of the product before administration, see section 6.

Hypersensitivity to the active substance or to any of the excipients listed in section 6. Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion.

Allergic type reactions, including severe infusion-related reactions can occur during administration of amphotericin-containing products, including AmBisome see section 4. Therefore, administration of a test dose is still advisable before a new course of treatment. For this purpose a small amount of an AmBisome infusion e. Other severe infusion-related reactions can occur during administration of amphotericin B-containing products, including AmBisome see section 4.

Although infusion-related reactions are not usually serious, consideration of precautionary measures for the prevention or treatment of these reactions should be given to patients who receive AmBisome therapy. AmBisome has been shown to be substantially less toxic than conventional amphotericin B, particularly with respect to nephrotoxicity; however, renal adverse reactions may still occur. In particular, caution should be exercised when prolonged therapy is required. Regular laboratory evaluation of serum electrolytes, particularly potassium and magnesium as well as renal, hepatic and haematopoietic function should be performed, at least once weekly.

This is particularly important in patients receiving concomitant nephrotoxic medications see section 4. Renal function should be closely monitored in these patients. Due to the risk of hypokalaemia, appropriate potassium supplementation may be required during the course of AmBisome administration. If clinically significant reduction in renal function or worsening of other parameters occurs, consideration should be given to dose reduction, treatment interruption or discontinuation.

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Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions. It is recommended that these infusions are separated by as long a period as possible and pulmonary function should be monitored. AmBisome contains approximately mg of sucrose in each vial. This should be taken into account when treating diabetic patients.

No specific interaction studies have been performed with AmBisome. However, the following medicinal products are known to interact with amphotericin B and may interact with AmBisome:. Concurrent administration of AmBisome with other nephrotoxic agents for example ciclosporin, aminoglycosides, polymixins, tacrolimus and pentamidine may enhance the potential for drug-induced renal toxicity in some patients.

Regular monitoring of renal function is recommended in patients receiving AmBisome with any nephrotoxic medications. Concurrent use of corticosteroids, ACTH and diuretics loop and thiazide may potentiate hypokalemia. AmBisome-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants e.

No evidence of benefit from the use of flucytosine with AmBisome has been observed. Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm and hypotension. Antineoplastic agents should be given concomitantly with caution.

It is recommended these infusions are separated by as long a period as possible and pulmonary function should be monitored. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5.

Systemic fungal infections have been successfully treated in pregnant women with conventional amphotericin B without obvious effect on the fetus, but the number of cases reported is insufficient to draw any conclusions on the safety of AmBisome in pregnancy.

AmBisome should only be used during pregnancy if the possible benefits to be derived outweigh the potential risks to the mother and fetus. It is unknown whether AmBisome is excreted in human breast milk. A decision on whether to breastfeed while receiving AmBisome should take into account the potential risk to the child as well as the benefit of breast feeding for the child and the benefit of AmBisome therapy for the mother.

No studies on the effects on the ability to drive and use machines have been performed. Some of the undesirable effects of AmBisome presented below may packate the ability to drive and use machines. The following adverse reactions have been attributed to AmBisome based on clinical trial data and post-marketing experience.

The frequency is based on analysis from pooled aambisome trials of AmBisome treated patients; the frequency of adverse reactions identified from post-marketing experience is not known. Adverse reactions are listed below by body system organ class using MedDRA and are sorted by frequency.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

AmBisome® | AmBisome (amphotericin B) liposome for injection

Frequencies are defined as:. Less frequent infusion-related reactions may consist of one or more of the following symptoms: These resolve rapidly on stopping the infusion and may not occur with every subsequent dose or when slower infusion rates over 2 hours are used. In addition, infusion-related reactions may also be prevented by the use of premedication. However, severe infusion-related reactions may necessitate the permanent discontinuation of AmBisome see section 4. 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.

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. Nephrotoxicity occurs to some degree with conventional amphotericin B in most patients receiving the product intravenously.

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In a double-blind study involving patients, the incidence of nephrotoxicity with AmBisome as measured by serum creatinine increase greater than 2. In another double-blind study involving patients, the incidence of nephrotoxicity with AmBisome as measured by serum creatinine increase greater than 2.

False elevations of serum phosphate may occur when samples from patients receiving AmBisome are analyzed using the PHOSm assay e. This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples. Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:.

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The toxicity of AmBisome due to acute overdose has not been defined. If overdose should occur, cease administration immediately. Carefully monitor clinical status including renal and hepatic function, serum electrolytes and haematological status. Haemodialysis or peritoneal dialysis does not appear to affect the elimination of AmBisome. Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced by Streptomyces nodosus.

Amphotericin B is fungistatic or fungicidal depending on the concentration attained in body fluids and the susceptibility of the fungus.

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

The molecule is thought to act by binding to sterols in padkage fungal ineert membrane, with a resulting change in membrane permeability, allowing leakage of a variety of small molecules. Mammalian cell membranes also contain sterols, and it ambisone been suggested that the damage to human cells and fungal cells caused by amphotericin B may share common mechanisms.

The lipophilic moiety of amphotericin allows the molecule to be integrated into the lipid bilayer of the liposomes. Liposomes are closed, spherical vesicles formed from a variety of amphiphilic substances such as phospholipids.

Phospholipids arrange themselves into membrane bilayers when exposed to aqueous solutions. The efficacy of AmBisome has been established in a number of clinical oackage for the treatment of systemic mycotic infections, anbisome empirical therapy for fever of unknown origin in neutropenic wmbisome and for the treatment of visceral leishmaniasis.

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. The efficacy of AmBisome in the treatment of visceral leishmaniasis has been clearly demonstrated in a large population of immunocompetent and immunocompromised patients.

Patients were monitored for 12 weeks. Differences were not statistically significant. The median time to resolution of fever was similar in the standard-dose and loading-dose groups 6 and 5 days, respectively. AmBisome and Micafungin were administered for a median duration of 15 days.

The favourable overall response was The working group in zygomycosis of the European confederation of medical mycology ECMM prospectively collected cases of patients with inxert, patients received liposomal amphotericin B L-AMB as first-line therapy, either alone 68 or in combination.

The pharmacodynamic profile of AmBisome in paediatric patients is consistent with that described in adult patients. The pharmacokinetic profile of AmBisome liposomal amphotericin B L-AmBbased upon total plasma concentrations of amphotericin B, was determined in cancer patients with febrile neutropenia and bone marrow transplant patients who received 1 hour infusions of 1.

L-AmB has a significantly different pharmacokinetic profile ibsert 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.

Minimum and maximum pharmacokinetic values do not necessarily relate to the lowest and highest doses, respectively.

Following administration of liposomal amphotericin B L-AmB steady state was reached quickly generally within 4 days of dosing.