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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In a double-blind study involving patients, the incidence of nephrotoxicity with AmBisome as measured by serum creatinine increase greater than 2. Hydrogenated soy phosphatidylcholine Cholesterol Distearoylphosphatidylglycerol Alpha tocopherol Sucrose Disodium succinate hexahydrate Sodium hydroxide for pH adjustment Hydrochloric acid for pH adjustment. Elderly patients No alteration in dose or frequency of dosing is required.
Am B isome is indicated for the following:. Vials of AmBisome containing 50 mg of amphotericin are prepared as follows: 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 ppackage adverse events.
An in-line membrane filter may be used for intravenous infusion of AmBisome. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Amphotericin B for Injection, USP | X-Gen Pharmaceuticals, Inc
The product should be administered under strict medical supervision. Qualitative and quantitative composition 3. 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.
Special populations including paediatric population: The insedt profile of AmBisome liposomal amphotericin B L-AmBbased upon total plasma concentrations of amphotericin Ambsome, was determined in cancer patients with febrile neutropenia and bone marrow transplant patients who received 1 hour infusions of 1. These resolve rapidly on stopping the infusion and may not occur with every subsequent dose or when slower infusion rates over 2 hours are used.
In another double-blind study involving patients, the incidence of nephrotoxicity with AmBisome as measured by serum creatinine increase greater than 2.
Amphotericin B for Injection, USP
Due to the size of the liposomes, there is no glomerular 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. Phospholipids arrange themselves into membrane bilayers when exposed to aqueous solutions. L-AmB was found to be non-mutagenic in bacterial and mammalian systems.
Method of administration AmBisome should be administered by intravenous infusion over a 30 – 60 minute period. Systemic fungal infections have been successfully treated in pregnant women with conventional amphotericin B without obvious effect on the fetus, but the number of cases reported is insufficient to draw any conclusions on the safety of AmBisome in pregnancy.
Invasive mucormycosis zygomycosis There are no large-scale randomised clinical trials in mucormycosis. Last updated on eMC: Minimum and maximum pharmacokinetic values do not necessarily relate to the lowest and highest doses, respectively. There was no significant drug accumulation in the plasma following repeated administration of 1 to 7. Infections successfully treated with AmBisome include: Patients were monitored for 12 weeks.
Breast-feeding It is unknown whether AmBisome is excreted in human breast milk. Serum Phosphate false elevation. Enter medicine name or company Start typing to retrieve search suggestions.
Marketing authorisation number s 9. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5. AmBisome is incompatible with saline solutions and may not be mixed with other medicinal products or electrolytes. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.
No studies on the effects on the ability to drive and use machines have been performed.
AmBisome-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants e. AmBisome contains approximately mg of sucrose in each vial. Haemodialysis or peritoneal dialysis does not appear to affect the elimination of AmBisome. As AmBisome does not contain any bacteriostatic agent, from a microbiological point of view, the reconstituted or diluted product should packzge used immediately.
The following adverse reactions have been attributed to AmBisome based on clinical trial data and post-marketing experience. 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. All are known targets for amphotericin B toxicity.