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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The majority of clinically important fungal species seem to be susceptible to amphotericin B, although intrinsic resistance has rarely been reported, for example, for some strains of S.
L-AmB has been shown to be effective in animal models of visceral leishmaniasis caused by Leishmania infantum and Leishmania donovani. In a double-blind study involving packagd, the incidence of nephrotoxicity with AmBisome as measured by serum creatinine increase greater than 2. 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.
Allergic type reactions, including severe infusion-related reactions can occur during administration of amphotericin-containing products, including AmBisome see section 4.
All are known targets for amphotericin B toxicity. Back to top Gilead Sciences Ltd contact details.
Where these symptoms were noted, reaction developed within a few minutes after the start of infusion and disappeared rapidly when the infusion was stopped. 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.
L-AmB was found to be non-mutagenic in bacterial and mammalian systems.
Marketing authorisation holder 8. 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.
ambisoem No studies on the effects on the ability to drive and use machines have been performed. Please see full Prescribing Information. Antifungals No evidence of benefit from the use of flucytosine with AmBisome has been observed. 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.
Renal function should be closely monitored in these patients. Hepatic impairment Packsge data are available on which to make a dose recommendation for patients with hepatic impairment See section 4. Am B pacakge is indicated for the following:. Summary of adverse reactions The following adverse reactions have been attributed to AmBisome based on clinical trial data and post-marketing experience. Within each frequency grouping, undesirable effects are presented in order inset decreasing seriousness.
AmBisome and Micafungin were administered for a median duration of 15 days. Regular monitoring of renal function is recommended in patients receiving AmBisome with any nephrotoxic medications.
Any unused product or waste material should be disposed of in accordance with local requirements. Concurrent use of corticosteroids, ACTH and diuretics loop and thiazide may potentiate hypokalemia. Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm and hypotension.
In addition, infusion-related reactions may also be prevented by the use of premedication. The molecule is thought to pxckage by binding to sterols in the fungal cell membrane, with a resulting change in membrane permeability, allowing leakage of a variety of small molecules.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
AmBisome – Summary of Product Characteristics (SmPC) – (eMC)
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5. It is unknown whether AmBisome is excreted in human breast milk.
AmBisome must be reconstituted by suitably trained staff. Renal toxicity 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. AmBisome-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants e.
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. Warnings and Precautions Anaphylaxis has been reported with amphotericin B—containing drugs, including Am B isome. 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.
However, the following medicinal products are known to interact with amphotericin B and may interact with AmBisome: Treatment should be continued until the recorded temperature is normalised for 3 consecutive days. The effect of renal impairment on the pharmacokinetics of L-AmB has not been formally studied.
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 and for the treatment of visceral leishmaniasis. The use of any solution other than those recommended, or the presence of a bacteriostatic agent e.
Amphotericin B for Injection, USP
Very common Common Uncommon Very rare. Active ingredient amphotericin b. Pregnancy The ambisomd of AmBisome in pregnant women has not been established. For a full list of excipients, see section 6. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5.
Some of the undesirable effects of AmBisome presented below may impact the ability to drive and use machines.