AMBISOME PACKAGE INSERT PDF
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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These symptoms do not occur with every dose and usually do not recur on subsequent administrations when the infusion rate is slowed.
In any event, treatment should be discontinued after a maximum of 42 days. 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. Breast-feeding It is unknown whether AmBisome is excreted in human breast milk. Diabetic patients AmBisome contains approximately mg of sucrose in each vial.
However, the following chemical and physical in-use stability data for AmBisome has been demonstrated: Patient management should include laboratory evaluation of renal, hepatic, and hematopoietic function, and serum electrolytes magnesium and potassium.
However, the following drugs are known to interact with amphotericin B and may interact with Am B isome: Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. The use of any solution other than those recommended, or the presence of a bacteriostatic agent e.
Concurrent use of corticosteroids, ACTH and diuretics loop and thiazide may potentiate hypokalemia. Serum Phosphate false unsert.
Amphotericin B for Injection, USP
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:. Do not use if there is any evidence of precipitation of foreign matter.
PVC or Polyolefin infusion unsert The product should be administered under strict medical supervision. Visually inspect the vial for particulate matter and continue shaking until complete dispersion is obtained. 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.
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After reconstitution the concentrate is a translucent, yellow dispersion. If clinically significant reduction in renal function or worsening of other parameters occurs, consideration should be given to dose reduction, insertt interruption or discontinuation.
Antimycotics for systemic use, antibiotics; ATC code: No data are available on which to make a dose recommendation for patients with hepatic impairment See section 4.
Sterile, powder for solution for infusion.
AmBisome® | AmBisome (amphotericin B) liposome for injection
AmBisome and Micafungin were administered for a median duration of 15 days. All are known targets for amphotericin B toxicity. Treatment of visceral leishmaniasis A total dose of No additional information is available in special populations.
Method of administration AmBisome should be administered by intravenous infusion over a 30 – 60 minute period. To bookmark a medicine you must sign up and log in. Marketing authorisation number s 9. 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.
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.
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.
However, severe infusion-related reactions may necessitate the permanent discontinuation of AmBisome see section 4.
Particulars as to the optimal dosage and the eventual development of resistance are as yet incomplete. 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. Leukocyte transfusions Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions.
Liposomes are closed, spherical vesicles formed from a variety of amphiphilic substances such as phospholipids. Dosage of amphotericin B as AmBisome must be adjusted to the specific requirements of each patient. 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.
This non-proportional dose response is believed to be due to saturation of reticuloendothelial L-AmB clearance. Where these symptoms were noted, reaction developed within a few minutes after the start of infusion and disappeared rapidly when the infusion was stopped. The frequency is based on analysis from pooled clinical trials of AmBisome treated patients; the frequency of adverse reactions identified from post-marketing experience is not known.
L-AmB has a significantly different pharmacokinetic profile from that reported in the literature for conventional presentations of amphotericin B, with higher amphotericin B plasma concentrations Cmax and increased exposure AUC compared to conventional amphotericin B.
In two double-blind, comparative studies, AmBisome treated patients experienced a significantly lower incidence of infusion-related reactions, as compared to patients treated with conventional amphotericin B or amphotericin B lipid complex. A total dose of Name of the medicinal product 2. This information is intended for use by health professionals. The lipophilic moiety of amphotericin ambsiome the molecule to be integrated into the lipid bilayer of the liposomes.
Continue typing to refine. Inser to the active substance or to any of the excipients listed in section 6. To email a medicine you must sign up and log in. See table below for recommendations. AmBisome contains approximately mg of sucrose in each vial.