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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Patient management should include laboratory evaluation of renal, hepatic, and hematopoietic function, and serum electrolytes magnesium and potassium.

Amphotericin B for Injection, USP

Leukocyte transfusions Acute pulmonary toxicity has been reported in patients given amphotericin B as sodium deoxycholate complex during or shortly after leukocyte transfusions.

L-AmB has been shown to be effective in animal models of visceral leishmaniasis caused by Leishmania infantum and Leishmania donovani. ATC classification Pharmacotherapeutic group: However, the following medicinal products are known to pacage with amphotericin B and may interact with AmBisome: Name of the medicinal product 2.

AmBisome contains approximately mg of sucrose in each vial. Concurrent use of corticosteroids, ACTH and diuretics loop and thiazide may potentiate hypokalemia.

Treatment should be continued until the recorded temperature is normalised for 3 consecutive days. The toxicity of AmBisome due to acute overdose has not been defined. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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It is recommended these infusions are separated by as oackage a period as possible and pulmonary function should be monitored. AmBisome is not recommended for use in children below 1 month old due to lack of data on safety and efficacy.

Amphotericin B for Injection, USP | X-Gen Pharmaceuticals, Inc

Please see Package Insert, Drug Interactions. Antimycotics for systemic use, antibiotics; ATC code: Abelcet is not labeled for this indication. The closure consists of a grey butyl rubber stopper and aluminium ring seal fitted with a removable plastic cap.

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.

Vials of AmBisome containing 50 mg of amphotericin are prepared as follows: The majority of clinically important fungal species seem to be susceptible to amphotericin B, although intrinsic resistance has rarely inert reported, for example, for some strains of S.

Marketing authorisation number s 9.

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Infections successfully treated with AmBisome include: AmBisome and Micafungin were administered for a median duration of 15 days. Method of administration AmBisome should be administered by intravenous infusion over a 30 – 60 minute period.

Hepatic impairment No data are available on which to make oackage dose recommendation for patients with hepatic impairment See section 4. The efficacy of AmBisome has been established in a number of clinical trials for the treatment of systemic mycotic infections, as empirical therapy for fever of unknown origin in neutropenic patients and for the treatment of visceral leishmaniasis.

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The frequency is based on analysis from pooled clinical trials of AmBisome treated patients; the frequency of isert reactions identified from post-marketing experience is not known. L-AmB was found to be non-mutagenic in bacterial and mammalian systems.

AmBisome® | AmBisome (amphotericin B) liposome for injection

In another double-blind study involving patients, the incidence of nephrotoxicity with AmBisome as measured by serum creatinine increase greater than 2. Visually inspect the vial for particulate matter and continue shaking until complete dispersion is obtained.

Patients were monitored for 12 weeks. Other severe infusion-related reactions can occur during administration of amphotericin B-containing products, including AmBisome see section 4.

The favourable overall response was This medicinal product must not be mixed with other medicinal products except insery mentioned in section 6.

Not known cannot be estimated from the available data. Skeletal muscle relaxants AmBisome-induced hypokalemia may packagee the curariform effect of skeletal muscle relaxants e. Ambiso,e, the mean pore diameter of the filter should not be less than 1. To make up a 2. Am B isome has been shown to be significantly less toxic than amphotericin B deoxycholate; however, adverse events may still occur.

It is recommended that these infusions are separated by as long a period as possible and pulmonary function should be monitored.