Changchun Xinyang Trading Co., Ltd.

[Drug name] Ambisin, Amftek
[Common name] Amphotericin liposome for injection
[English name]
[Function and indications] Safety Bisu (liposomal amphotericin for injection) is indicated for patients with deep fungal infections who are unable to use effective doses of amphotericin due to kidney damage or drug toxicity, or who have received amphotericin. It can be used in patients who have failed to respond to mycomycin treatment.
[Usage and Dosage] For adults and children, the daily dose can be used as required. If there is no improvement or the fungal infection worsens, the dose may be increased to daily.
Dilute the dissolved product with % glucose injection and inject intravenously at a rate of 1 hour. Before the first dose of each course of treatment, it is recommended to make a test injection, injecting a small amount of medicine (the diluent contains...) for several minutes. Watch carefully for another minute.
If the patient can tolerate it and has no infusion-related reactions, the infusion time can be shortened to no less than an hour. If the patient has an acute reaction or cannot tolerate the infusion volume, the infusion time should be extended.
Instructions for dissolving the drug and preparing the infusion solution
This product must be dissolved in sterile water for injection. Use a sterile syringe and a needle to quickly add the following volume into the bottle so that each solution contains amphotericum. of solids, shaking and turning gently by hand to dissolve all solids. Note that the liquid may be milky or clear. /Bottle with Sterile Water for Injection/Bottle with Sterile Water for Injection
If used for infusion, further dilute the above dissolved liquid to a final concentration of approximately ./(./). The following table is a recommendation for dilution (only % glucose injection can be used for dilution)
Dilution method Recommended dose of Avotex Avotex reconstitution volume % glucose infusion bag volume for injection



Do not use physiological saline or glucose solution to dissolve the lyophilized powder, and do not mix the dissolved solution with physiological saline or electrolytes. When solutions other than those recommended above are used or in the presence of biocides (i.e. benzyl alcohol), the presence of this product in the solution may cause precipitation. When using this product, do not filter or use an infusion set with a built-in filter.
Do not mix infusion solutions with other medications. If an infusion line is being used, flush the line with % glucose before administration, or use a separate infusion line.
Injectable drugs should be inspected with the naked eye for foreign matter or discoloration before use. Do not use medicines that have sediment or foreign matter, or have problems with the seal of the original bottle. Since the lyophilized powder and the solutions used for dissolution and dilution do not contain preservatives, strict aseptic procedures must always be followed when preparing pharmaceutical solutions.
After further dilution with % glucose injection, the solution must be stored at ℃ and used within hours. Freezing is prohibited and unused solution must be discarded.
[Clinical Study] Aspergillus Infection This data is taken from an uncontrolled open study, one of which included emergency patients. Among patients with confirmed or suspected Aspergillus infection, the reason why the patient received this product was for There is no reaction to ordinary amphotericin, nephrotoxicity occurs when receiving ordinary amphotericin, there is existing kidney damage, or other reasons.
The average age of the patients (male and female) was years (months to years). Among patients whose median had low levels of neutrophils, median (%) neutrophils[/[][/]. The distribution of total patients is bone marrow transplantation (%), hematological tumors (%), solid organ transplantation (%), solid tumors (%), and other diseases (%, including surgical cases, infection cases, autoimmune cases leading to immune Inhibition cases, diabetes cases and unknown disease cases). The lungs were the main site of infection, with 99 cases (%), followed by sinus site cases (%), central nervous system cases (%), skin/wound cases (%), and other cases (%), including skeletal cases, liver disease cases, infectious cases, and one case each of endocarditis, ophthalmitis, otitis, and hard palate disease). Patients were treated for unresponsiveness to common amphotericin, of whom 3 had received common amphotericin within days, between days, and days before receiving treatment with this product.
These patients were determined to be ineffective by doctors based on comprehensive clinical indicators after having been treated with ordinary amphotericin for at least days or with a total dose of at least //. Nephrotoxicity means that the patient's serum creatinine is more than twice the basic level, that is, increases to ./ or to greater than ./. Preexisting renal impairment was defined when serum creatinine increased to or greater than ./ due to causes other than ordinary amphotericin.
The classification of diagnosis and effectiveness adopts the criteria proposed by the research group []. In this retrospective analysis, complete response refers to the disappearance of all relevant symptoms, features, cardiac abnormalities, etc. at the time of admission. Partial response is defined as a significant improvement in the above symptoms. The total number of responses is the sum of the above-mentioned complete response and partial response numbers.
In this patient population, 100 patients could be used for efficacy assessment, while others were excluded due to imprecise diagnosis, confusing condition, or use of doses less than or equal to 100%. Among the patients available for efficacy evaluation, the mean daily dose was days (.), the mean cumulative dose was (.), and the mean treatment time was days (days).
The response rate of evaluable patients
[]Total effective number, completely effective + partially effective, is determined based on comprehensive clinical indicators after receiving at least days or total dose/of amphotericin treatment. [] is defined as a twofold increase in serum creatinine from the basic level, that is, an increase in ./ or an increase to ./. [] is defined as an increase in serum creatinine due to reasons other than amphotericin./
Since there is no control group that can be directly compared with the above-mentioned patients, it cannot be confirmed that patients who are ineffective to amphotericin will continue to receive amphotericin. Will mycin treatment be effective? Randomized comparative studies of the use of this product and amphotericin in the treatment of aspergillosis are ongoing.
Renal function serum creatinine./ Some patients who started treatment with this product experienced a decrease in serum creatinine during treatment. Part of the reason may be that patients drop out of treatment during treatment. A medical history control group was selected by reviewing medical records from year to year at each medical center (Cancer Center, Cancer Research Center, University Cancer Center, Memorial Cancer Center, and University Bone Marrow Transplant Research Center). Determine the mean serum creatinine on the day a patient's serum creatinine reaches ./. As shown in the figure, serum creatinine was lower in patients treated with amphotericin than in medical controls who received regular amphotericin. Due to the lack of a control group for direct comparison, it cannot be determined whether this reduction is significantly better than that of patients who continued to receive amphotericin. Patients taking amphotericin deoxycholic acid. The above data were taken from two independent experiments, and no statistical tests were performed to determine the differences between them.
Serum creatinine./ Among patients with Aspergillus infection, the curve of the average serum creatinine level over time does not represent the clinical manifestations of a single patient, but is only the unblinded result of a group of patients.
[Precautions] This product should be administered intravenously. Acute reactions associated with infusion include fever, chills, hypotension, nausea, or tachycardia. These reactions usually appear hours after starting the infusion. These reactions are more severe and frequent during the first few doses and will gradually disappear later. Acute infusion-related reactions can be prevented by prior use of antihistamines and corticosteroids and/or managed by reducing the infusion rate and prompt administration of antihistamines and corticosteroids (see Adverse Reactions section). Rapid infusion should be avoided.
Based on the patient's response, the patient should be monitored, especially liver function, renal function, serum electrolytes, complete blood count and prothrombin reaction time.
[Contraindications] This product is contraindicated for patients who are allergic to any of its ingredients. Patients with a history of allergies should only use this product unless their doctor believes that the benefits of using this product outweigh the risks of allergy.
[Drug use in pregnant women] There are no reports of teratogenicity (pregnancy-like) in pregnant women using this product. In experiments on the reproductive system, rats were given 3 times the recommended human dose, and rabbits were given 3 times the recommended human dose. No evidence of harm to the fetus was found. Because animal reproduction experiments cannot completely predict human reactions, and strict testing on pregnant women has not been conducted, this product can only be used during pregnancy when the foreseeable benefits outweigh the potential risks to the fetus.
Lactating mothers do not know whether this product will be secreted into breast milk. Because of the potential for serious adverse effects of amphotericin in the infant and the importance of the drug to the mother, the nursing mother should make a choice between discontinuing breastfeeding or discontinuing the drug.
[Pediatric Use] A pediatric patient with a deep fungal infection used this product at a dose similar to the daily dose for adults, and no unexpected adverse reactions were reported.
[Specifications] Injections packed in bottles
[Packaging] Vials per box
[Price description] Yuan/box Yuan/box
[Storage] Stored away from light below degrees Celsius< br/> [Manufacturer] American Gidley and Mylan Corporation
[Supply Line]
[Customer Service]
[Contact Person] Liu Yanlan
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