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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For this purpose a small amount of an AmBisome infusion e. Back to top Gilead Sciences Ltd contact details. Am B isome is indicated for the following:. Important Safety Information and Indications Contraindications 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.
Antineoplastic agents Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm and hypotension. Not all pack sizes may be marketed. The working group in zygomycosis of the European confederation of medical mycology ECMM prospectively akbisome cases of patients with zygomycosis, patients received liposomal amphotericin B L-AMB as first-line therapy, either alone 68 or in combination.
AmBisome – Summary of Product Characteristics (SmPC) – (eMC)
Hydrogenated soy phosphatidylcholine Cholesterol Distearoylphosphatidylglycerol Alpha tocopherol Sucrose Disodium succinate hexahydrate Sodium hydroxide for pH adjustment Hydrochloric acid for pH adjustment. There were a few reports of flushing, back pain with or without chest tightness, and chest pain associated with Am B isome administration; on occasion this has been severe. Summary of adverse reactions The following adverse reactions have been attributed to AmBisome based on clinical trial data and post-marketing experience.
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.
Invasive mucormycosis zygomycosis There are no large-scale randomised clinical trials in mucormycosis. Intrinsic resistance, though rare, may be smbisome due to decrease in ergosterol or a change in smbisome target lipid, leading to reduced binding of amphotericin B to the cell membrane.
False elevations of serum phosphate may occur when samples from patients receiving AmBisome are analyzed using the PHOSm assay e. The duration of therapy should be determined on an individual basis.
In addition, infusion-related reactions may also be prevented by the use of premedication. Clinical efficacy and safety The inaert 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.
The median time to resolution of fever was similar in the standard-dose and loading-dose groups 6 and 5 days, respectively.
Amphotericin B for Injection, USP
Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. Shelf-life after dilution with Dextrose: If overdose should occur, cease administration immediately.
Find out more here. Volume of distribution on day 1 and at steady state suggests that there is extensive tissue distribution of amphotericin B. The toxicity of AmBisome due to acute overdose has not been defined. AmBisome is incompatible with saline solutions and may not be mixed with other medicinal products or electrolytes.
AmBisome has been studied in paediatric patients aged one month to 18 years old. For instructions on reconstitution and dilution of the product before administration, see section 6. 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.
In any event, treatment should be discontinued after a maximum of 42 days. Frequencies are defined as:. This should be taken into account when treating diabetic patients.
Diabetic patients AmBisome contains approximately mg of sucrose in each vial. No formal drug-interaction studies have been conducted with Am Packags isome. However, a cumulative dose of 1.
AmBisome should only be used during pregnancy if the possible benefits to be derived outweigh the potential risks to the mother and fetus. Please see full Prescribing Information. However, the following medicinal products are known to interact with amphotericin B and may interact with AmBisome: AmBisome should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests. Infections successfully treated with AmBisome include: The excretion of L-AmB has pwckage been studied.
No studies on the effects on the ability to drive and use machines have been performed. Amphotericin B pharmacokinetics following the first dose of L-AmB appear non-linear such that amphotericin B concentrations are greater than proportional with increasing dose. The metabolic pathways of pqckage B and L-AmB are not known. Anaphylaxis and anaphylactoid reactions Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion.
Amount AmBisome mg to be withdrawn for further dilution. 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.