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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Amphotericin B for Injection, USP
AmBisome is indicated in adults and children aged 1 month to 18 years old for: AmBisome contains approximately mg of sucrose in each vial. The lipophilic moiety of amphotericin allows the molecule to be integrated into the lipid bilayer of the liposomes. Please see full Prescribing Information.
Leukocyte transfusions Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions. AmBisome is not recommended for use in children below 1 month old due to lack of data on safety and efficacy.
Renal function should be closely monitored in these patients. The median time to resolution of fever was similar in the standard-dose and loading-dose groups 6 and 5 days, respectively. 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.
The effect of renal impairment on the pharmacokinetics of L-AmB has not been formally studied. The duration of therapy should be determined on an individual basis.
No evidence of benefit from the use of flucytosine with AmBisome has been observed. Data suggest that no dose adjustment is required in patients undergoing haemodialysis or filtration procedures, however, L-AmB administration should be avoided during the procedure. 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.
Nephrotoxic medications 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. Serum Phosphate false elevation. Data are presently insufficient to define total dosage requirements and duration of treatment necessary for resolution of mycoses.
If this is not feasible, AmBisome should be administered through a separate line. Carefully monitor clinical status including renal and hepatic function, serum electrolytes and haematological status. Any unused product or waste material should be disposed of in accordance with local requirements.
Patient management should include laboratory evaluation of renal, hepatic, and hematopoietic function, and serum electrolytes magnesium and potassium.
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.
AmBisome – Patient Information Leaflet (PIL) – (eMC)
Excipient with known effect: 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.
Each vial contains 50 mg of amphotericin 50, units encapsulated in liposomes. 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. Skeletal muscle relaxants AmBisome-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants e. Nephrotoxicity occurs to some degree with conventional amphotericin B in most patients receiving the product intravenously.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:. Special populations including paediatric population: AmBisome should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests.
In particular, qmbisome should be exercised when prolonged therapy is required. This is particularly important in patients receiving concomitant nephrotoxic medications see section 4.
Dosage of amphotericin B as AmBisome must be adjusted to the specific requirements of each patient. Concurrent administration of AmBisome with other nephrotoxic agents for example akbisome, aminoglycosides, polymixins, tacrolimus and pentamidine may enhance the potential for drug-induced renal toxicity in some patients.
Hypersensitivity to the active substance or to any of the excipients listed in section 6. It is unknown whether AmBisome is excreted in human breast milk. Less frequent infusion-related reactions may consist of one or more of the following symptoms: This information is intended for use by health professionals. Paediatric population The pharmacodynamic profile of AmBisome in paediatric patients is consistent with that described in adult patients.
In another double-blind study involving patients, the incidence of nephrotoxicity with AmBisome as measured by serum creatinine increase greater than 2. Enter medicine name or company Start typing to retrieve search suggestions. AmBisome has been studied in paediatric patients aged one month to 18 years old. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.
Differences were not statistically significant. Elderly patients No alteration in dose or frequency of dosing is required. No additional information is available in special populations. Keep the container in the outer carton. The favourable overall response was The following adverse reactions have been attributed to AmBisome based on clinical trial data and post-marketing experience.
Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions. AmBisome must be reconstituted by suitably trained staff.