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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Date of revision of the text. Method of administration AmBisome should be administered by intravenous infusion over a 30 – 60 minute period. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5.
Amphotericin B for Injection, USP
AmBisome is not recommended for use in children below 1 month old due to lack of data on safety and efficacy. As AmBisome does not contain any bacteriostatic agent, from a microbiological ihsert of view, the reconstituted or diluted product should be used immediately. Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Not all pack sizes may be marketed. However, the following medicinal products are known to interact with amphotericin B and may interact with AmBisome:.
AmBisome should be administered by intravenous infusion over a 30 – 60 minute period. Carefully monitor clinical status ambiso,e renal and hepatic function, serum electrolytes and haematological status. Minimum and maximum pharmacokinetic values do not necessarily relate to the lowest and highest doses, respectively.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.
AmBisome should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests. Abelcet is not labeled for this indication. Active ingredient amphotericin b. During the initial dosing period, patients should be under close observation.
Last updated on eMC: The molecule is thought to act by binding to sterols inserf the fungal cell membrane, with a resulting change in membrane permeability, allowing leakage of a variety of small molecules.
Therefore, administration of a test dose is still advisable before a new course of treatment. There was no significant drug accumulation in the plasma following repeated administration of 1 to 7. 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. Data are presently packkage to define total dosage requirements and duration of treatment necessary for resolution of mycoses.
Acute pulmonary knsert has been reported in patients given amphotericin Inseert as sodium deoxycholate complex during or shortly after leukocyte transfusions.
AmBisome® | AmBisome (amphotericin B) liposome for injection
Marketing authorisation number s 9. If a severe reaction occurs, the Am B isome infusion should be immediately discontinued and the patient should not a,bisome further infusions of Am B isome. Diabetic patients AmBisome contains approximately mg of sucrose in each vial.
Hypersensitivity to the active substance or to any of the excipients listed in section 6. Renal pacckage should be closely monitored in these patients. Indications and Usage Am B isome is indicated for the following: It is recommended these infusions are separated by as long a period as possible and pulmonary function should be monitored.
However, severe infusion-related reactions may necessitate the permanent discontinuation of AmBisome see section 4. Carcinogenicity studies have not been conducted with L-AmB.
ambisomme Courses of up to 6 — 8 weeks are commonly used in clinical practice; longer durations of therapy may be required for deep seated infections or in cases of prolonged courses of chemotherapy or neutropenia.
Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced by Streptomyces nodosus.
Treatment of visceral leishmaniasis Ihsert total dose of In particular, caution should be exercised when prolonged therapy is required. Haemodialysis or peritoneal dialysis does not appear to affect the elimination of AmBisome. 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.
No studies on the effects on the ability to drive and use machines have been performed. To make up a 0. Do not use if there is any evidence of precipitation of foreign matter.
Some of the undesirable effects of AmBisome presented below may impact the ability to drive and use machines. Please see full Prescribing Information. Serum Phosphate false elevation. Important Safety Information and Indications Contraindications Am B isome is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product, unless benefit of therapy outweighs the risk.
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.
The frequency is based on analysis paxkage pooled clinical trials of AmBisome treated patients; the frequency of adverse reactions identified from post-marketing experience is not known.
There were a few reports of flushing, back pain with or without chest tightness, and chest pain associated with Am B isome administration; on occasion this has been severe. Clinical efficacy and safety Insfrt efficacy of AmBisome has been established in a number of clinical trials for ambsiome treatment inseft systemic mycotic infections, as empirical therapy for fever of unknown origin in neutropenic patients and for the treatment of visceral leishmaniasis.
Regular monitoring of renal function is recommended in patients receiving AmBisome with any nephrotoxic inwert.