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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Therefore, administration of a test dose is still advisable before a new course of treatment.
This non-proportional dose response is believed to be due to saturation of reticuloendothelial L-AmB clearance.
Due to the risk of hypokalaemia, appropriate potassium supplementation may be required during the course of AmBisome administration. Not known cannot be estimated from the available data. A decision on whether to breastfeed while receiving AmBisome should take into account the potential pacmage to the child as well as the benefit of breast feeding for the child and the benefit of AmBisome therapy for the mother.
For a full list of excipients, jnsert section 6. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:.
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Single-dose vials are packed ten per carton with 10 filters. AmBisome and Micafungin insett administered for a median duration of 15 days.
Liposomes are closed, spherical vesicles formed from a variety of amphiphilic substances such as phospholipids. The primary endpoint was safety and the study was not designed to draw statistically meaningful conclusions related to efficacy. However, the following medicinal products ambixome known to interact with amphotericin B and may interact with AmBisome: No evidence of benefit from the use of flucytosine with AmBisome has been observed.
Show table of contents Hide table of contents 1. Special populations including paediatric population: AmBisome should only be used during pregnancy if the possible benefits to be derived outweigh the potential risks to the mother and fetus.
AmBisome® | AmBisome (amphotericin B) liposome for injection
Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm and hypotension. Am B isome has been shown to be significantly less toxic than amphotericin B deoxycholate; however, adverse events may still occur.
Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. Volume of distribution on day 1 and at steady state suggests that there is extensive tissue distribution of inseert B. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5. The lipophilic moiety of amphotericin allows the molecule to be integrated into the lipid bilayer of the liposomes.
This should be taken into account when treating diabetic patients. No data are available on which to make a dose recommendation for patients with hepatic impairment See section 4.
The effect of renal impairment on the pharmacokinetics of L-AmB has not been formally studied. False elevations of serum phosphate may occur when samples ambiwome patients receiving AmBisome are analyzed using the PHOSm assay e. 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.
It is recommended inserh infusions are separated by as long a period as possible and pulmonary function should be monitored. Concurrent use of corticosteroids, ACTH and diuretics loop and thiazide may potentiate hypokalemia.
No adverse effects on male or female reproductive function were noted in rats. Anaphylaxis has been reported with amphotericin B—containing drugs, including Am B isome. The toxicity of AmBisome due to acute overdose has not been defined.
AmBisome – Summary of Product Characteristics (SmPC) – (eMC)
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.
Adverse reactions are listed below by body system organ class using MedDRA and are sorted by frequency. Courses of up to 6 — 8 weeks are commonly used in clinical practice; longer durations of therapy inwert be required for deep seated infections or in cases of prolonged courses of chemotherapy or neutropenia. 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.
Amphotericin B for Injection, USP
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.