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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In addition, infusion-related reactions may also be prevented by the use of premedication. The efficacy of AmBisome in the treatment of visceral leishmaniasis has been clearly demonstrated in a large population of immunocompetent and immunocompromised patients. To bookmark a medicine you must sign up and log in. Infusion-related reactions Other severe infusion-related reactions can occur during administration of amphotericin Ambisomd products, including AmBisome see section 4. In particular, caution should be exercised when prolonged therapy is required.
No specific interaction studies have been performed with AmBisome. This is particularly important in patients receiving concomitant nephrotoxic medications see section 4. A decision on whether to breastfeed while receiving AmBisome should take into account the potential risk to the child as well insrt the benefit of breast feeding for the child and inxert benefit of AmBisome therapy for the mother.
Digitalis glycosides AmBisome-induced hypokalemia may potentiate digitalis toxicity.
Amphotericin B for Injection, USP
Amphotericin B, the antifungal component of L-AmB, is active in vitro against many species of fungi, most strains of Histoplasma capsulatum, Coccidioides immitis, Candida spp, Blastomyces dermatidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenkii and Aspergillus fumigatus, Penicillium marneffi, and members of the mucormycetes group of moulds including Mucor mucedo, Rhizomucor and Rhizopus oryzae.
All are known targets for amphotericin B toxicity. Back to top Gilead Sciences Ltd contact details. Invasive mucormycosis zygomycosis There are packagr large-scale randomised clinical trials in mucormycosis. It is unknown whether AmBisome is excreted in human insret milk.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6. Patients were monitored for 12 weeks. The primary endpoint was safety and the study was not designed to draw statistically meaningful conclusions related to efficacy.
Concurrent use of corticosteroids, ACTH inset diuretics loop and thiazide may potentiate hypokalemia. Date of revision of the text. 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.
Differences were not statistically significant. AmBisome should only be used during pregnancy if the possible benefits to be derived outweigh the potential risks to the mother and fetus. Not all pack sizes may be marketed.
AmBisome – Patient Information Leaflet (PIL) – (eMC)
No evidence of benefit from the use of flucytosine with AmBisome has been observed. Paediatric population 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.
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. Elderly patients No alteration in dose or frequency of dosing is required.
No studies on the effects on the ability to drive and use machines have been performed. To make up a 0. Frequencies are defined as: To make up a 2.
Breast-feeding It is unknown whether AmBisome is excreted in human breast milk. During the initial dosing period, patients should be under close observation. See table below for recommendations. Due to the size of the liposomes, there is no glomerular filtration and renal elimination of L-AmB, thus avoiding interaction of amphotericin B with the cells of the distal tubuli and reducing the potential for nephrotoxicity seen with conventional amphotericin B presentations.
Am B isome is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product, unless benefit of therapy outweighs the risk.
Regular monitoring of renal function is recommended in patients receiving AmBisome with any nephrotoxic medications. Indications and Usage Am B isome is indicated for the following: Pregnancy The safety of AmBisome in pregnant women has not been established. Aseptic technique must be strictly observed in all handling, since no preservative or bacteriostatic agent is present in AmBisome, or in the materials specified for reconstitution and dilution. Nephrotoxicity occurs to some degree with conventional amphotericin B in most patients receiving the product intravenously.
Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced by Streptomyces nodosus. Carcinogenicity studies have not been conducted with L-AmB.
Please see full Prescribing Information.