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.
|Published (Last):||18 May 2011|
|PDF File Size:||7.46 Mb|
|ePub File Size:||12.73 Mb|
|Price:||Free* [*Free Regsitration Required]|
Some of the undesirable effects of AmBisome presented below may impact the ability to drive and use machines. Allergic type reactions, including severe infusion-related reactions can occur during administration of amphotericin-containing products, including AmBisome see section 4. 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.
No additional information is available in special populations. Mammalian cell membranes also contain sterols, and it has been suggested that the damage to human cells and fungal cells caused by amphotericin B may share common mechanisms.
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.
Serum Phosphate false elevation. No specific interaction studies have been performed with AmBisome.
Amphotericin B for Injection, USP
Find out more here. This non-proportional dose response is believed to be due to saturation of reticuloendothelial L-AmB clearance. Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions.
Marketing authorisation holder 8. 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. Aseptic technique must be strictly observed in all handling, since no preservative or bacteriostatic agent is present in AmBisome, or in the materials specified for reconstitution and dilution.
Hydrogenated soy phosphatidylcholine Cholesterol Distearoylphosphatidylglycerol Alpha tocopherol Sucrose Disodium succinate hexahydrate Sodium hydroxide for pH adjustment Hydrochloric acid for pH adjustment. No formal drug-interaction studies have been conducted with Am B isome. 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.
The product should be administered under strict medical supervision. If clinically significant reduction in renal function or worsening of other parameters occurs, consideration should be given to dose reduction, treatment interruption or discontinuation.
If this is not feasible, AmBisome should be administered through a separate line. The pharmacodynamic profile of AmBisome in paediatric patients is consistent with that described in adult patients. No adverse effects on male or female reproductive function were noted in rats. Antifungals No evidence of benefit from the use of flucytosine with AmBisome has been observed.
PVC or Polyolefin infusion bags: However, severe infusion-related reactions may necessitate the permanent discontinuation of AmBisome see section 4. Paediatric population Insery 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.
False elevations of serum phosphate may occur when samples from patients receiving AmBisome are analyzed using the PHOSm assay e.
AmBisome is indicated in adults and children aged 1 month to 18 years old for: Company contact details Gilead Sciences Ltd.
AmBisome – Summary of Product Characteristics (SmPC) – (eMC)
Sign Up Log In Cancel. Pulmonary toxicity Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions. Summary of adverse reactions The following adverse reactions have been attributed to AmBisome based on clinical trial data and post-marketing experience.
To make up a 2.
Volume of distribution on day 1 and at steady state suggests that there is extensive tissue distribution of amphotericin B. The primary endpoint was safety and the study was not designed to draw statistically meaningful conclusions related to efficacy.
In any paclage, treatment should be discontinued after a maximum of packgae days. Regular monitoring of renal function is recommended in patients receiving AmBisome with any nephrotoxic medications.
Withdraw the calculated volume of reconstituted AmBisome into a sterile syringe.
Amphotericin B for Injection, USP | X-Gen Pharmaceuticals, Inc
It is recommended that these infusions are separated by as ammbisome a period as possible and pulmonary function should be monitored. Back to top Gilead Sciences Ltd contact details.
However, the following medicinal products are known to interact with amphotericin B and may interact with AmBisome: The recommended concentration for intravenous infusion is 0. This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples.
Where these symptoms were noted, reaction developed within a few minutes after the start of infusion and disappeared rapidly when the infusion was stopped. Therapy is usually instituted at insfrt daily dose of 1. 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.