Amphotericin B Liposome For Injection

Liposomal amphotericin B.

A yellow colored lyophilized mass.
Each vial contains amphotericin B liposome for injection 50 mg.
Excipients/Inactive Ingredients: Hydrogenated soy phosphatidylcholine, Cholesterol, Distearoylphosphatidylglycerol, Alpha tocopherol, Sucrose, Disodium succinate hexahydrate, Sodium hydroxide, Hydrochloric acid.

Pharmacotherapeutic group: Antimycotics for systemic use, antibiotics. ATC code: J02AA01.
Pharmacology: Pharmacodynamics: Mechanism of action and pharmacodynamics effects: Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced by Streptomyces nodosus.
Liposomes are closed, spherical vesicles formed from a variety of amphiphilic substances such as phospholipids. Phospholipids arrange themselves into membrane bilayers when exposed to aqueous solutions.
The lipophilic moiety of amphotericin allows the drug to be integrated into the lipid bilayer of the liposomes.
Amphotericin B is fungistatic or fungicidal depending on the concentration attained in body fluids and the susceptibility of the fungus. The drug is thought to act by binding to sterols in the fungal cell membrane, with a resulting change in membrane permeability, allowing leakage of a variety of small molecules. 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.
Microbiology: Amphotericin B, the antifungal component of Amphotericin B Liposome for Injection, shows a high order of in vitro activity against many species of fungi. Most strains of Histoplasma capsulatum, Coccidioides immitis, Candida spp., Blastomyces dermatitidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenkii, Mucor mucedo and Aspergillus fumigatus are inhibited by concentrations of amphotericin B ranging from 0.03 to 1.0 mcg/ml in vitro. Amphotericin B has minimal or no effect on bacteria and viruses.
Amphotericin B Liposome for Injection has been reported to be effective in animal models of visceral leishmaniasis (caused by Leishmania infantum and Leishmania donovani). In mice infected with Leishmania infantum and treated with Amphotericin B Liposome for Injection 3 mg/kg for 3-7 doses, all dosage regimens of Amphotericin B Liposome for Injection cured mice more promptly than sodium stibogluconate, and no toxicity was reported. In mice infected with Leishmania donovani, Amphotericin B Liposome for Injection was >5 times more effective and >25 times less toxic than amphotericin B.
Pediatric population: The pharmacodynamics profile of Amphotericin B Liposome for Injection in paediatric patients is consistent with that described in adult patients.
Pharmacokinetics: The pharmacokinetic profile of Amphotericin B Liposome for Injection, based upon total plasma concentrations of amphotericin B, was determined in cancer patients with febrile neutropenia and bone marrow transplant patients who received 1 hour infusions of 1.0 to 7.5 mg/kg/day Amphotericin B Liposome for Injection for 3 to 20 days. Amphotericin B Liposome for Injection has a significantly different pharmacokinetic profile from that reported in the literature for conventional presentations of amphotericin B, with higher amphotericin B plasma concentrations (C_max) and increased exposure (AUC_0-24) following administration of Amphotericin B Liposome for Injection than conventional amphotericin B.
After the first and last dose the pharmacokinetic parameters of Amphotericin B Liposome for Injection (mean ± standard deviation) ranged from: C_max: 7.3 μg/ml (±3.8) to 83.7 μg/ml (±43.0).
T_½: 6.3 hr (±2.0) to 10.7 hr (±6.4).
AUC_0-24: 27 μg·hr/ml (±14) to 555 μg.hr/ml (±311).
Clearance (Cl): 11 ml/hr/kg (±6) to 51 ml/hr/kg (±44).
Volume of distribution (Vss): 0.10 L/kg (±0.07) to 0.44 L/kg (±0.27).
Minimum and maximum pharmacokinetic values do not necessarily come from the lowest and highest doses, respectively. Following administration of Amphotericin B Liposome for Injection steady state was reached quickly (generally within 4 days of dosing).
Absorption: Amphotericin B Liposome for Injection pharmacokinetics following the first dose appear non-linear such that serum Amphotericin B Liposome for Injection concentrations are greater than proportional with increasing dose.
This non-proportional dose response is believed to be due to saturation of reticuloendothelial Amphotericin B Liposome for Injection clearance. There was no significant drug accumulation in the plasma following repeated administration of 1 to 7.5 mg/kg/day.
Distribution: Volume of distribution on day 1 and at steady state suggests that there is extensive tissue distribution of Amphotericin B Liposome for Injection.
Elimination: After repeated administration of Amphotericin B Liposome for Injection the terminal elimination half/life (t_½β) for Amphotericin B Liposome for Injection was approximately 7 hours.
The excretion of Amphotericin B Liposome for Injection has not been reported. The metabolic pathways of amphotericin B and Amphotericin B Liposome for Injection are not known.
Due to the size of the liposomes there is no glomerular filtration and renal elimination of Amphotericin B Liposome for Injection, thus avoiding interaction of amphotericin B with cells of the distal tubuli and reducing the potential for nephrotoxicity seen with conventional amphotericin B presentations.
Other special populations: Renal impairment: The effect of renal impairment on the pharmacokinetics of Amphotericin B Liposome for Injection has not been formally reported. Data suggest that no dose adjustment is required in patients undergoing haemodialysis or filtration procedures, however, Amphotericin B Liposome for Injection administration should be avoided during the procedure.
Toxicology: Preclinical safety data: In reported repeat dose toxicity studies in dogs (1 month), rabbits (1 month) and rats (3 months) at doses equal to or, in some species, less than the clinical therapeutic doses of 1 to 3 mg/kg/day, the target organs for Amphotericin B Liposome for Injection toxicity were the liver and kidneys, both known target organs for amphotericin B toxicity.
Amphotericin B Liposome for Injection was reported to be found to be non-mutagenic in bacterial and mammalian systems.
Carcinogenicity studies have not been reported with Amphotericin B Liposome for Injection.
No adverse effects on male or female reproductive function were reported in rats.

Amphotericin B Liposome for Injection is indicated in adults and children aged 1 month to 18 years old for the treatment of systemic mycotic infections due to organisms susceptible to this anti-infective, such as cryptococcosis, North American blastomycosis, disseminated candidiasis, coccidioidomycosis, aspergillosis, histoplasmosis, mucormycosis and in the treatment of some cases of American mucocutaneous leishmaniasis; for the treatment of fever of unknown origin (FUO) in neutropenic patients. In this context, FUO is defined as persisting fever, unresponsive to at least 96 hours of antibiotic treatment; it is highly indicative for a systemic fungal infection in this patient population. Before initiating Amphotericin B Liposome for Injection treatment, common viral, parasitic or mycobacterial infections should also be excluded as far as possible as causes for the observed FUO; as the primary therapy of visceral leishmaniasis in immunocompetent patients including both adults and children. In immunocompromised patients (e.g. HIV positive) Amphotericin B Liposome for Injection is also indicated as the primary therapy of visceral leishmaniasis.
This drug should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests.

Adult patients: Dosage of Amphotericin B Liposome for Injection must be adjusted to the specific requirements of each patient.
For treatment of systemic mycotic infections, therapy is usually instituted at a daily dose of 1.0 mg/kg of body weight, and increased stepwise to 3.0 mg/kg, as required. A cumulative dose of 1.0-3.0 g of Amphotericin B Liposome for Injection over 3-4 weeks has been typical.
Mucormycosis: Initiate treatment with 5 mg/kg administered daily. The duration of therapy should be determined on an individual basis. Courses of up to 56 days 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.
Doses greater than 5 mg/kg have been used in clinical trials and clinical practice. There are limited data on the safety and efficacy of Amphotericin B Liposome for Injection for the treatment of mucormycosis at these higher doses, therefore, a benefit-risk assessment should be made on an individual patient level to determine whether the potential benefits of treatment are considered to outweigh the known increased risk of toxicity at higher Amphotericin B Liposome for Injection doses.
For fever of unknown origin in neutropenic patients therapy should be initiated at 1.0 mg/kg/day; the dose may be raised to 3 mg/kg/day if indicated.
Visceral leishmaniasis: A dose of 1.0-1.5 mg/kg/day for 21 days or alternatively a dose of 3.0 mg/kg/day for 10 days can be used for treatment of visceral leishmaniasis. In immunocompromised patients (e.g. HIV positive), a dose of 1.0-1.5 mg/kg/day for 21 days may be used. Because of the risk of relapse, maintenance therapy or reinduction therapy may be necessary.
Paediatric population: Systemic fungal infections and fever of unknown origin have been successfully treated with Amphotericin B Liposome for Injection in paediatric patients, without reports of unusual adverse events. Amphotericin B Liposome for Injection has been reported in paediatric patients aged one month to 18 years old. Dosage should be calculated on the same per-kg body weight basis as for adults. The safety and efficacy of Amphotericin B Liposome for Injection has not been reported in infants under one month old.
Elderly population: No alteration in dose or frequency of dosing is required.
Renal impairment: Amphotericin B Liposome for Injection has been administered to patients with pre-existing renal impairment at doses of 1-5 mg/kg/day in reported clinical trials and no adjustment in dose or frequency of administration was required.
Hepatic impairment: No data are reported on which to make a dose recommendation for patients with hepatic impairment.
Method of administration: A test dose (1 mg) should be infused slowly for up to 10 minutes and the patient carefully observed for 30 minutes afterwards.
Amphotericin B Liposome for Injection should be administered by intravenous infusion over a 30-60 minute period. For doses greater than 5 mg/kg/day, intravenous infusion over a 2 hour period is recommended. The recommended concentration for intravenous infusion is 0.20 mg/ml to 2.00 mg/ml Amphotericin B Liposome for Injection.
For instructions on reconstitution and dilution of the product before administration, see Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product under Cautions for Usage.

Overdose and Treatment: The toxicity of Amphotericin B Liposome for Injection due to acute overdose has not been reported.
If overdose should occur, cease administration immediately. Carefully monitor clinical status including renal and hepatic function, serum electrolytes and haematological status. Haemodialysis or peritoneal dialysis does not appear to affect the elimination of Amphotericin B Liposome for Injection.
Special populations (including paediatric population): No additional information is available in special populations.

Hypersensitivity to the active substance or to any of the excipients unless, in the opinion of the physician, the condition requiring treatment is life-threatening and amenable only to Amphotericin B Liposome for Injection therapy.
Amphotericin B Liposome for Injection contains soya oil. If the patient is allergic to peanut or soya, do not use this medicinal product.

Anaphylaxis and anaphylactoid reactions: Anaphylaxis and anaphylactoid reactions have been reported in association with Amphotericin B Liposome for Injection. To detect idiosyncratic anaphylactic reactions and minimize the dose administered if a reaction occurs, a test dose should be administered initially. If a severe anaphylactic/anaphylactoid reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusion of Amphotericin B Liposome for Injection.
Infusion-related reactions: Other severe infusion-related reactions can occur during administration of amphotericin B-containing products, including Amphotericin B Liposome for Injection. Although infusion-related reactions are not usually serious, consideration of precautionary measures for the prevention or treatment of these reactions should be given to patients who receive Amphotericin B Liposome for Injection therapy. Slower infusion rates (over 2 hours) or routine doses of diphenhydramine, paracetamol, pethidine, and/or hydrocortisone have been reported as successful in their prevention or treatment.
Renal effects: Amphotericin B Liposome for Injection has been reported to be substantially less toxic than conventional amphotericin B; particularly with respect to nephrotoxicity, however, adverse reactions, including renal adverse reactions, may still occur.
In reported studies comparing Amphotericin B Liposome for Injection 3 mg/kg daily with higher doses (5, 6 or 10 mg/kg daily), it was found that the incidence rates of increased serum creatinine, hypokalaemia and hypomagnesaemia were notably higher in the high dose groups.
Regular laboratory evaluation of serum electrolytes, particularly potassium and magnesium, as well as renal, hepatic and haematopoietic function should be performed. This is particularly important in patients receiving concomitant nephrotoxic medications.
Due to the risk of hypokalaemia, appropriate potassium supplementation may be required during the course of Amphotericin B Liposome for Injection administration if clinically significant reduction in renal function or worsening of other parameters occurs, consideration should be given to dose reduction, treatment interruption or discontinuation.
Pulmonary effects: Acute pulmonary toxicity has been reported in patients given amphotericin B (as sodium deoxycholate complex) during or shortly after leukocyte transfusion. It is recommended that infusions are separated by as long a period as possible and pulmonary function should be monitored.
Diabetic patients: It should be noted that Amphotericin B Liposome for Injection contains approximately 900 mg of sucrose in each vial.
Renal dialysis patients: Reported data suggest that no dose adjustment is required in patients undergoing haemodialysis or filtration procedures, however, Amphotericin B Liposome for Injection administration should be avoided during the procedure.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially sodium-free.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been reported. Some of the reported undesirable effects of Amphotericin B Liposome for Injection presented (see Adverse Reactions) may impact the ability to drive and use machines.

Fertility: Teratogenicity studies in both rats and rabbits reported that Amphotericin B Liposome for Injection has no teratogenic potential in these species.
Pregnancy: The safety of Amphotericin B Liposome for Injection in pregnant women has not been reported. Amphotericin B Liposome for Injection should only be used during pregnancy if the possible benefits to be derived outweigh the potential risks to the mother and foetus. Systemic fungal infections have been successfully treated in pregnant women with conventional amphotericin B without obvious effect on the foetus, but the number of cases reported is insufficient to draw any conclusions on the safety of Amphotericin B Liposome for Injection in pregnancy.
Lactation: It is unknown whether Amphotericin B Liposome for Injection is excreted in human breast milk. A decision on whether to breastfeed while receiving Amphotericin B Liposome for Injection should take into account the potential risk to the child as well as the benefit of breastfeeding for the child and the benefit of Amphotericin B Liposome for Injection therapy for the mother.

Summary of adverse reactions: The following adverse reactions have been attributed to Amphotericin B Liposome for Injection, based on reported clinical trial data and post-marketing experience. The frequency is based on analysis from reported pooled clinical trials of 688 Amphotericin B Liposome for Injection treated patients: the frequency of adverse reactions identified from post-marketing experience is not known. Adverse reactions are listed as follows by body system organ class using MedDRA and are sorted by frequency.
Frequencies are defined as: Very common ≥10%, Common ≥1% and <10%, Uncommon ≥0.1% and <1%, Very rare <0.01%, Not known (cannot be estimated from the reported available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and Lymphatic System Disorders: Uncommon: thrombocytopenia.
Not known: anaemia.
Immune System Disorders: Uncommon: anaphylactoid reaction.
Not known: anaphylactic reactions, hypersensitivity.
Metabolism and Nutrition Disorders: Very common: hypokalaemia.
Common: hypomagnesaemia, hypocalcaemia, hyperglycaemia, hyponatraemia.
Nervous System Disorders: Common: headache.
Uncommon: convulsion.
Cardiac Disorders: Common: tachycardia.
Not known: cardiac arrest, arrhythmia.
Vascular Disorders: Common: vasodilatation, flushing, hypotension.
Respiratory, Thoracic and Mediastinal Disorders: Common: dyspnoea.
Uncommon: bronchospasm.
Gastrointestinal Disorders: Very common: nausea, vomiting.
Common: diarrhoea, abdominal pain.
Hepatobiliary Disorders: Common: abnormal liver function tests, hyperbilirubinaemia, alkaline phosphatase increased.
Skin and Subcutaneous Disorders: Common: rash.
Not known: angioneurotic oedema.
Musculoskeletal and Connective Tissue Disorders: Common: back pain.
Not known: rhabdomyolysis (associated with hypokalaemia), musculoskeletal pain (described as arthralgia or bone pain).
Renal and Urinary Disorders: Common: increased creatinine, blood urea increased.
Not known: renal failure, renal insufficiency.
General Disorders and Administration Site Conditions: Very common: rigors, pyrexia.
Common: chest pain.
Uncommon: phlebitis.
Description of selected adverse reactions: Infusion related reactions: Fever and chills/rigors are the most frequent infusion-related reactions expected to occur during Amphotericin B Liposome for Injection administration. Less frequent infusion-related reactions may consist of one or more of the following symptoms: chest tightness or pain, dyspnoea, bronchospasm, flushing, tachycardia, hypotension, and musculoskeletal pain (described as arthralgia, back pain, or bone pain). 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 addition, infusion-related reactions may also be prevented by the use of premedication. However, severe infusion-related reactions may necessitate the permanent discontinuation of Amphotericin B Liposome for Injection.
In reported two double-blind, comparative studies, Amphotericin B Liposome for Injection treated patients experienced a significantly lower incidence of infusion-related reactions, as compared to patients treated with conventional amphotericin B or amphotericin B lipid complex.
In reported pooled study data from randomized, controlled clinical trials comparing Amphotericin B Liposome for Injection with conventional amphotericin B therapy in greater than 1,000 patients, reported adverse reactions were considerably less severe and less frequent in Amphotericin B Liposome for Injection treated patients, as compared with conventional amphotericin B treated patients.
Renal effects: Nephrotoxicity occurs to some degree with conventional amphotericin B in most patients receiving the drug intravenously. In reported two, double-blind studies, the incidence of nephrotoxicity with Amphotericin B Liposome for Injection (as measured by serum creatinine increase greater than 2.0 times baseline measurement), is approximately half of that reported for conventional amphotericin B or amphotericin B lipid complex.
Interference with phosphorus chemistry assays: False elevations of serum phosphate may occur when samples from patients receiving Amphotericin B Liposome for Injection are reported to be analyzed using the PHOSm assay (e.g. used in Beckham Coulter analyzers including the Synchron LX20). This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples.

No specific interaction studies have been reported with Amphotericin B Liposome for Injection. However, the following drugs are known to interact with amphotericin B and may interact with Amphotericin B Liposome for Injection.
Nephrotoxic medications: Concurrent administration of Amphotericin B Liposome for Injection with other nephrotoxic agents, (for example ciclosporin, aminoglycosides and pentamidine) may enhance the potential for drug-induced renal toxicity in some patients. However, in patients receiving concomitant ciclosporin and/or aminoglycosides, Amphotericin B Liposome for Injection was associated with significantly less nephrotoxicity compared to amphotericin B.
Regular monitoring of renal function is recommended in patients receiving Amphotericin B Liposome for Injection with any nephrotoxic medications.
Corticosteroids, corticotropin (ACTH) and diuretics: Concurrent use of corticosteroids, ACTH and diuretics (loop and thiazide) may potentiate hypokalaemia.
Digitalis glycosides: Amphotericin B Liposome for Injection induced hypokalaemia and may potentiate digitalis toxicity.
Skeletal muscle relaxants: Amphotericin B Liposome for Injection induced hypokalaemia may enhance the curariform effect of skeletal muscle relaxants (e.g. tubocurarine).
Antifungals: Concurrent use with flucytosine may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion.
Antineoplastic agents: Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm and hypotension. Antineoplastic agents should be given concomitantly with caution.
Leukocyte transfusions: Acute pulmonary toxicity has been reported in patients given amphotericin B (as sodium deoxycholate complex) during or shortly after leukocyte transfusion. It is recommended these infusions are separated by as long a period as possible and pulmonary function should be monitored.

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in the following text.
Amphotericin B Liposome for Injection is incompatible with saline solutions and may not be mixed with other drugs or electrolytes.
Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product: Read this entire section carefully before beginning reconstitution.
Amphotericin B Liposome for Injection is NOT interchangeable with other amphotericin products.
Amphotericin B Liposome for Injection must be reconstituted using sterile water for injection (without a bacteriostatic agent) and diluted in Dextrose solution (5%) for infusion only.
The use of any solution other than those recommended, or the presence of a bacteriostatic agent (e.g. benzyl alcohol) in the solution, may cause precipitation of Amphotericin B Liposome for Injection.
Amphotericin B Liposome for Injection is NOT compatible with saline and must not be reconstituted or diluted with saline or administered through intravenous line that has previously been used for saline unless first flushed with dextrose solution (5%) for infusion. If this is not feasible, Amphotericin B Liposome for Injection should be administered through a separate line.
Do NOT mix Amphotericin B Liposome for Injection with other drugs or electrolytes.
Aseptic technique must be observed in all handling, since no preservative or bacteriostatic agent is present in Amphotericin B Liposome for Injection, or in the material specified for reconstitution and dilution.
Vials of Amphotericin B Liposome for Injection containing 50 mg of amphotericin are prepared as follows: 1. Add 12 ml of water for injection to each Amphotericin B Liposome for Injection vial, to yield a preparation containing 4 mg/ml amphotericin.
2. IMMEDIATELY after the addition of water, SHAKE THE VIALS VIGOROUSLY for 30 seconds to completely disperse the Amphotericin B Liposome for Injection. After reconstitution the concentrate is a translucent, yellow dispersion. Visually inspect the vial for particulate matter and continue shaking until complete dispersion is obtained. Do not use if there is evidence of precipitation of foreign matter.
3. Calculate the amount of reconstituted (4 mg/ml) Amphotericin B Liposome for Injection to be further diluted (see Table 1 as follows).
4. The infusion solution is obtained by dilution of the reconstituted Amphotericin B Liposome for Injection with between one (1) and nineteen (19) parts dextrose solution (5%) for infusion by volume, to give a final concentration in the recommended range of 2.00 mg/ml to 0.20 mg/ml amphotericin as Amphotericin B Liposome for Injection (see Table 1 as follows).
5. Withdraw the calculated volume of reconstituted Amphotericin B Liposome for Injection into a sterile syringe. Using the 5-micron filter provided, instill the Amphotericin B Liposome for Injection preparation into a sterile container with the correct amount of Dextrose solution (5%) for infusion.
An in-line membrane filter may be used for intravenous infusion of Amphotericin B Liposome for Injection. However, the mean pore diameter of the filter should not be less than 1.0 micron.
Preparation of Amphotericin B Liposome for Injection for infusion: An example is provided in the table as follows of the preparation of Amphotericin B Liposome for Injection dispersion for infusion at a dose of 3 mg/kg/day in dextrose 5% solution for infusion. Note that this table relates to doses of 3 mg/kg/day only, however other doses than this may be prescribed for a patient. If a dose other than 3 mg/kg/day has been prescribed for a patient, then the appropriate calculations must be undertaken and the table cannot be used. (See Table 1.)

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For single use only. Discard any unused contents.
Any unused product or waste material should be disposed of in accordance with local requirements.

Storage condition: Do not store above 25°C.
Shelf life: Unopened Product: 3 years.
Product once reconstituted with water for injections: Amphotericin B Liposome for Injection is a single dose unpreserved sterile lyophile. Therefore from a microbiological point of view, once reconstituted, the product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution and dilution has taken place under controlled and validated aseptic conditions.
Where reconstitution and dilution are conducted under controlled and validated aseptic conditions the following may be used in determining use periods.
Chemical and physical stability have been demonstrated for storage as follows: Glass vials: 24 hours at 25±2°C.
Glass vials: up to 7 days at 2-8°C.
Polypropylene syringes: Up to 7 days at 2-8°C.
Do not freeze.
Product once reconstituted with water for injections and further diluted in dextrose: Chemical and physical stability have been demonstrated at the following storage conditions using dextrose infusion as the dilution medium in PVC bag. (See Table 2.)

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Special precaution for storage: DO NOT STORE partially used vials for future patient use.

Antifungals

J02AA01 - amphotericin B ; Belongs to the class of antibiotics. Used in the systemic treatment of mycotic infections.

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