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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Treatment of visceral leishmaniasis A total dose of To make up a 0. PVC or Polyolefin infusion bags: The effect of renal impairment on the pharmacokinetics of L-AmB has not been formally studied. This information is intended for use by health professionals.
Minimum and maximum pharmacokinetic values do not necessarily relate to the lowest and highest doses, respectively. Frequencies are defined as: Pregnancy The safety of AmBisome in pregnant women has not been established.
Amphotericin B for Injection, USP
Where these symptoms were noted, reaction developed within a few minutes after the start of infusion and disappeared rapidly when the infusion was stopped.
To view the changes to a medicine you must sign up and log in. Intrinsic resistance, though rare, may be primarily due to decrease in ergosterol or a change in the target lipid, leading to reduced binding of amphotericin B to the cell membrane. Therefore, administration of a test dose is still advisable before a new course of treatment.
AmBisome – Patient Information Leaflet (PIL) – (eMC)
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. No additional information is available in special populations.
Pulmonary toxicity Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions. The working group in zygomycosis of the European confederation of medical mycology ECMM prospectively collected cases of patients with zygomycosis, patients received liposomal amphotericin B L-AMB as first-line therapy, either alone 68 or in combination.
Marketing authorisation number s 9. Breast-feeding It is unknown whether AmBisome is excreted in human breast milk.
Amphotericin B for Injection, USP | X-Gen Pharmaceuticals, Inc
ATC classification Pharmacotherapeutic group: Abelcet is not labeled for this indication. Skeletal muscle relaxants AmBisome-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants e. Some of the undesirable effects of AmBisome presented below may impact the ability to drive and use ambiskme.
If a severe reaction occurs, the Am B isome infusion should be immediately discontinued and the patient should not receive further infusions of Am B isome.
The toxicity of AmBisome due to acute overdose has not paackage defined. For a full list of excipients, see section 6. Leukocyte transfusions Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions.
Due to the size of the liposomes, there is no packaeg 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. As AmBisome does not contain any bacteriostatic agent, from a microbiological point of view, the reconstituted or diluted product should be used immediately.
Mechanism of action and pharmacodynamic effects Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced by Streptomyces nodosus. Sign Up Log In Cancel. Hydrogenated soy phosphatidylcholine Cholesterol Distearoylphosphatidylglycerol Alpha tocopherol Sucrose Disodium succinate hexahydrate Sodium hydroxide for pH adjustment Hydrochloric acid for pH adjustment.
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A total dose of Withdraw the calculated volume of reconstituted AmBisome into a sterile syringe. 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. Amphotericin B is fungistatic or fungicidal depending on the concentration attained in body fluids and the susceptibility of the fungus.
Regular monitoring of renal function is recommended in patients receiving AmBisome with any nephrotoxic medications. Visually inspect the vial for particulate matter and continue shaking until complete dispersion is obtained. For this purpose a small amount of an AmBisome infusion e. Amphotericin B pharmacokinetics following the first dose of L-AmB appear non-linear such that amphotericin B concentrations are greater than proportional with increasing dose. AmBisome should be administered by intravenous infusion over a 30 – 60 ambismoe period.
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. Infections successfully treated with AmBisome include: An in-line membrane filter may be used for intravenous infusion of AmBisome.
Patients were monitored for 12 weeks. The closure consists of a grey butyl rubber stopper and aluminium ring seal fitted with a removable plastic cap. Particulars as to the optimal dosage and the eventual development of resistance are as yet incomplete.