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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No studies on the effects on the ability to drive and use machines have been performed. 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. Ambisomme hypokalemia may enhance the curariform effect of skeletal muscle relaxants e.
AmBisome – Patient Information Leaflet (PIL) – (eMC)
Sterile, powder for solution for infusion. AmBisome has been studied in paediatric patients aged one month to 18 years old. Please see full Prescribing Information. These symptoms do not occur with every dose and usually do not recur on subsequent administrations when the infusion rate is slowed.
Infections successfully treated with AmBisome include: Anaphylaxis has been reported with amphotericin B—containing drugs, including Am B isome. Invasive mucormycosis zygomycosis There are ambixome large-scale randomised clinical trials in mucormycosis. Shelf-life after dilution with Dextrose: The duration of ambisoome should be determined on an individual basis.
Amphotericin B for Injection, USP
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. Marketing authorisation number s 9.
Pregnancy The safety of AmBisome in pregnant women has not been established. Visually inspect the vial for particulate matter and continue shaking until complete dispersion is obtained.
Date of revision of the text. The product should be administered under strict medical supervision.
However, the following pafkage and physical in-use stability data for AmBisome has been demonstrated: Allergic type reactions, including severe infusion-related reactions can occur during administration of amphotericin-containing products, including AmBisome see section 4. 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 insrrt origin in neutropenic patients and for the treatment of visceral leishmaniasis.
For instructions on reconstitution and dilution of the product before administration, see section 6.
AmBisome – Summary of Product Characteristics (SmPC) – (eMC)
Anaphylaxis and anaphylactoid reactions Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. Single-dose vials are packed ten per carton with 10 filters. It is recommended that these ambiskme are separated by as long a period as possible and pulmonary function should be monitored.
This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples. AmBisome must be reconstituted by ambksome trained staff.
False elevations of serum phosphate may occur when samples from patients receiving AmBisome are analyzed using the PHOSm assay e. In addition, infusion-related reactions may also be prevented by the use of premedication. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Keep the container in the outer carton. The primary endpoint was safety and the study was not designed to draw statistically meaningful conclusions related to efficacy.
ATC classification Pharmacotherapeutic group: 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.
Yellow lyophilised cake or powder. However, the following drugs are known to interact with amphotericin B and may interact with Am B isome: False elevations of serum phosphate may occur when samples from patients receiving Am B isome are analyzed using the PHOSm assay.