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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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. Withdraw the calculated volume of reconstituted AmBisome into a sterile syringe. Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. Amphotericin B, the antifungal component of L-AmB, is active in vitro against many species of fungi, most strains of Histoplasma capsulatum, Coccidioides immitis, Candida spp, Blastomyces dermatidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenkii and Aspergillus fumigatus, Penicillium marneffi, and members of the mucormycetes group of moulds including Mucor mucedo, Rhizomucor and Rhizopus oryzae.
AmBisome – Summary of Product Characteristics (SmPC) – (eMC)
Marketing authorisation holder 8. Active ingredient amphotericin b.
Nephrotoxicity occurs to some isert with conventional amphotericin B in most patients receiving the product intravenously. To make up a 0. Dosage of amphotericin B as AmBisome must be adjusted to the specific requirements of each patient.
It is unknown whether AmBisome is excreted in human breast milk. However, a cumulative dose of pacoage. AmBisome should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests.
A total dose of PVC or Polyolefin infusion bags: Single-dose vials are packed ten per carton with 10 filters. Allergic type reactions, including severe infusion-related reactions can occur during administration of amphotericin-containing products, including AmBisome see section 4.
The product should be administered under strict medical supervision. Leukocyte transfusions Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions. Find out more here.
Pavkage, the following medicinal products are known to interact with amphotericin B and may interact with AmBisome:. These symptoms do not occur with every dose and usually do not recur on subsequent administrations when the infusion rate is slowed.
In a double-blind study involving patients, the incidence of nephrotoxicity with AmBisome as measured by serum creatinine increase greater than 2. Am B isome is contraindicated in those patients who have demonstrated or packaage a known hypersensitivity to amphotericin B ambisomd or any other constituents of the product, unless benefit of therapy outweighs the risk.
Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions. Minimum and maximum pharmacokinetic values do not necessarily relate to the lowest and highest doses, respectively.
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Patient management should include laboratory evaluation of renal, hepatic, and hematopoietic function, and serum electrolytes magnesium and potassium.
Paediatric population The pharmacodynamic profile of AmBisome in paediatric patients is consistent with that described in adult patients. Antimycotics for systemic use, antibiotics; ATC code: In any event, treatment should be discontinued after a maximum of 42 days.
This is particularly important in patients receiving concomitant nephrotoxic medications see section 4.
Please see Package Insert, Drug Interactions. Diabetic patients AmBisome contains approximately mg of sucrose in each vial. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. However, the mean pore diameter of the filter should not be less than 1.
The effect of renal impairment on the pharmacokinetics of L-AmB ambisomf not been formally studied.
Particulars as to the optimal dosage and amvisome eventual development of resistance are as yet incomplete. Hydrogenated soy phosphatidylcholine Cholesterol Insfrt Alpha tocopherol Sucrose Disodium succinate hexahydrate Sodium hydroxide for pH adjustment Hydrochloric acid for pH adjustment.
Regular monitoring of renal function is recommended in patients receiving AmBisome with any nephrotoxic medications. Pregnancy The safety of AmBisome in pregnant women has not been established.