Кансидас®

General characteristics. Structure:

Active ingredient: 60,6 mg of a kaspofungin of acetate that corresponds to 54,6 mg of a kaspofungin (in the form of the anhydrous basis).

Excipients: sucrose, Mannitolum, acetic acid ice, sodium hydroxide - q.s. to pH 6.

* including surplus for providing the corresponding dosage of active agent (50 and 70 mg respectively).

Pharmacological properties:

Pharmacodynamics. Antifungal drug for system use. Represents the semi-synthetic lipopeptidny connection (эхинокандин) synthesized from Glarea lozoyensis fermentation product. Kaspofungin inhibits synthesis β-(1,3) - D-glucan - the most important component of a cell wall of many rifomitset and yeast.

In vitro каспофунгин is active concerning various pathogenic fungi of the sort Aspergillus (including Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger, Aspergillus nidulans, Aspergillus terreus and Aspergillus candidus) and Candida (including Candida albicans, Candida dubliniensis, Candida glabrata, Candida guilliermondii, Candida kefyr, Candida krusei, Candida lipolytica, Candida lusitaniae, Candida parapsilosis, Candida rugosa and Candida tropicalis).

In vivo is revealed activity of a kaspofungin at parenteral administration by an animal with the normal and reduced immunity infected with Aspergillus and Candida. Use of a kaspofungin in these cases promotes increase in life expectancy of the infected animals (Aspergillus and Candida) and an eradikation of a pathogenic fungi (Candida) in the struck bodies. Also каспофунгин it is active at the animals with an immunodeficiency infected with Candida glabrata, Candida krusei, Candida lusitaniae, Candida parapsilosis, Candida tropicalis at which the eradikation of a pathogenic fungi (Candida) in the struck bodies is reached. Kaspofungin shows high activity at prevention and treatment of pulmonary aspergillomycosis that is revealed at a research on models of lethal pulmonary infections in vivo.

Kaspofungin is active concerning strains of mushrooms of Candida, resistant to a flukonazol, Amphotericinum In or to a flutsitozin, having other mechanism of action.

At some patients in the course of treatment drug allocates kinds of mushrooms of Candida with reduced sensitivity to a kaspofungin. Definition of the minimum overwhelming concentration (MOC) for a kaspofungin is not carried out as correlation between MPK and clinical performance of drug is not observed. Medicinal drug resistance at patients with an invasive aspergillosis is not noted.

The standardized methods of definition of sensitivity to synthesis inhibitors β-(1,3) - D-glucan are not created, and results of studying of sensitivity of in vitro can not correlate with clinical data.

Pharmacokinetics. Distribution. After single in/in infusion during 1 h concentration of a kaspofungin in plasma decreases in a multiphase way. Right after infusion there comes the short α-phase which the β-phase with T1/2 from 9 to 11 h which is the main characteristic of a profile and has clear logarithmic and linear dependence between 6 and 48 h after infusion follows. For this period concentration of drug in plasma significantly decreases. Also there is an additional γ-phase with T1/2 from 40 to 50 h. The prevailing mechanism influencing plasma clearance is rather a distribution, than excretion or biotransformation. Kaspofungin intensively contacts proteins (about 97%) at the minimum penetration into erythrocytes. About 92% of a 3H-tag are found in fabrics in 36-48 h after introduction of a single dose of 70 mg marked 3H kaspofungin of acetate. During the first 30 h after introduction excretion and biotransformation of a kaspofungin are insignificant.

Metabolism. Kaspofungin is slowly metabolized by hydrolysis and N-acetylation and is exposed to spontaneous chemical destruction before peptide connection with an open ring. In later terms (in 5 and more days after introduction of a single dose marked 3H kaspofungin of acetate) in plasma low level (less than 7 »¼«½ý/mg a squirrel or 1.3% or less from the entered dose) covalent binding of a radioactive label is noted that can be caused by formation of two reactive intermediate products of chemical destruction of a kaspofungin. Additional metabolism includes hydrolysis to the making amino acids and their derivatives, including дигидроксигомотирозин and N-acetyl-digidroksigomotirozin. These two derivative tyrosines are found only in urine that indicates their bystry renal clearance.

Removal. About 75% of drug are removed from an organism (the pharmacokinetic research with is radioactive a marked kaspofungin): 41% - with urine and 34% - with a stake. Concentration in plasma of a tag and kaspofungin during the first 24-48 h after introduction of a dose do not differ then the level of drug decreases quicker, and decrease in its concentration lower than the level of quantitative definition is observed in 6-8 days after introduction of a dose, and a radioactive label – in 22.3 weeks. A small amount of a kaspofungin is allocated in not changed view with urine (about 1.4% of a dose). The renal clearance of initial drug low also makes about 0.15 ml/min.

Pharmacokinetics in special clinical cases. Concentration of a kaspofungin in plasma at healthy men and women in the 1st day after introduction of a single dose of 70 mg identical. After 13 daily introductions on 50 mg concentration of a kaspofungin in plasma at some women is about 20% higher, than at men.

The maintenance of a kaspofungin in plasma at healthy men and women of advanced age (65 years are also more senior), in comparison with healthy young men, is a little increased for 28% (AUC). Patients of advanced age have c invasive candidiasis or when performing empirical therapy the same moderate changes of concentration of drug in plasma, as well as in group of healthy elderly patients in relation to healthy patients of young age were observed. Correction of the mode of dosing for elderly (65 years are also more senior) patients is not required.

Concentration of a kaspofungin in plasma of patients with a slight liver failure (5-6 points on a scale of Chayld-Pyyu) after introduction of a single dose of 70 mg increases approximately by 55% (AUC), in comparison with healthy volunteers. Administration of drug to these patients within 14 days (70 mg in the 1st day with the subsequent daily introduction on 50 mg) is followed by moderate increase in its concentration in plasma and makes 19-25% (AUC) for the 7th and 14th day, in comparison with healthy volunteers.

5 long clinical trials with studying of the drug Kansidas® at patients up to 18 years, including drug pharmacokinetics researches are conducted (originally a research teenagers (12-17 years) and children (2-11 years), then - at children of younger age (3-23 months), and at newborns and children of the first three months have lives).

At the teenagers (12-17 years) receiving каспофунгин in a dose of 50 mg/sq.m (the maximum daily dose - 70 mg), concentration in a blood plasma (AUC0-24 of the h) in general corresponded to concentration at the adults accepting a kaspofungin in a dose of 50 mg/days. All teenagers received каспофунгин in a dose higher than 50 mg, and 6 of 8 patients received the maximum daily dose of 70 mg. Concentration of a kaspofungin in a blood plasma at these patients was lower in comparison with concentration at the adults receiving drug in a daily dose of 70 mg, that dose which was most often appointed to teenagers.

At children at the age of 2-11 years receiving каспофунгин in a dose of 50 mg/sq.m in days (the maximum daily dose of 70 mg), its concentration in a blood plasma (AUC0-24) was comparable with a similar indicator at adult patients to whom entered каспофунгин in a dose 50 mg/days. In the first day of use concentration of drug in a blood plasma (AUC0-24) was slightly higher at children in comparison with adults (for 37% at the compared doses of 50 mg/sq.m and 50 mg of 1 times/days). However, it is necessary to emphasize that concentration in a blood plasma (AUC0-24) at children in the first day nevertheless was lower, than at adults at prolonged treatment.

At children at the age of 3-23 months to which appointed каспофунгин in a daily dose 50 mg/sq.m (the maximum dose - 70 mg), concentration of a kaspofungin in a blood plasma at prolonged use was comparable to concentration at adults to whom the dose of drug of 50 mg/days was appointed. As well as at more senior children, at the children of this age group receiving каспофунгин in a dose of 50 mg/sq.m, concentration of drug in a blood plasma was higher in the first day of treatment in comparison with the adults receiving a standard dose of a kaspofungin of 50 mg. Pharmacokinetic parameters of a kaspofungin in a dose of 50 mg/sq.m at children of a younger age group (3-23 months) and more senior group (2-11 years) at the identical mode of dosing were comparable.

At newborns and children up to 3 months to which каспофунгин appointed 25 mg/sq.m in a dose peak concentration of a kaspofungin (S1ch) and its threshold concentration (S24ch) after repeated introductions corresponded to similar indicators at the adults receiving drug in a dose of 50 mg/days. In the first day peak concentration S1ch was comparable to adults, and threshold concentration S24ch was moderately increased at newborns and children of chest age in comparison with the corresponding indicators at adults. Definition of concentration of drug in a blood plasma (AUC0-24) was not carried out in this research because of difficulties of sampling. It is necessary to consider what studying of efficiency and safety during prospective adequate clinical trials of the drug Kansidas® at newborns and children up to 3 months was not carried out.

Indications to use:

— empirical therapy at patients with a febrile neutropenia at suspicion of a fungal infection;

— invasive candidiasis (including a kandidemiya) at patients with a neutropenia and without it;

— an invasive aspergillosis (at patients, refractory to other therapy or not transferring it);

— ezofagealny candidiasis;

— orofaringealny candidiasis.

Route of administration and doses:

The daily dose of Kansidas is entered in the way slow into infusions (≥1 h) by 1 times/days. At empirical therapy in the first day enter a single load dose of 70 mg, in the second and the next days of treatment the daily dose makes 50 mg/days. Duration of treatment depends on clinical and microbiological performance of drug. Empirical therapy has to be carried out to full permission of a neutropenia. At confirmation of a fungal infection patients have to receive drug not less than 14 days; therapy by Kansidas both the fungal infection, and a neutropenia should continue not less than 7 days after disappearance of clinical manifestations. The existing data on safety and Kansidas's portability allow to increase a daily dose to 70 mg if the daily dose of 50 mg is well transferred by the patient, but does not give the expected clinical effect.

At invasive candidiasis in the 1st day of therapy enter a single load dose of 70 mg, in the 2nd and the next days of treatment the daily dose makes 50 mg/days. Duration of treatment of invasive candidiasis is defined by clinical effect and microbiological efficiency. The general rule is continuation of antifungal therapy not less than 14 days after the last receiving a hemoculture. More prolonged treatment to permission of a neutropenia can be required by patients with a persistent neutropenia.

At an invasive aspergillosis in the 1st day the single load dose of 70 mg is entered, in the 2nd and the next days of treatment the daily dose makes 50 mg/days. Duration of treatment depends on weight of a basic disease, extent of recovery of the patient from immunosuppression, clinical and microbiological effect of the carried-out therapy.

The existing data on safety and Kansidas's portability allow to increase a daily dose to 70 mg if the daily dose of 50 mg is well transferred by the patient, but does not give the expected clinical effect.

At ezofagealny and oropharyngeal candidiasis the daily dose makes 50 mg/days in all days of treatment.

Dose adjustment is not required to patients of advanced age (65 years are also more senior).

Patients do not need correction of the mode of dosing at purpose of drug with depression of function of kidneys, and also at sexual and racial distinctions.

Dose adjustment is not required to patients with a slight liver failure (5-6 points on a scale of Chayld-Pyyu). At a moderate liver failure (from 7 to 9 points on a scale of Chayld-Pyyu) the supporting daily dose of Kansidas decreases to 35 mg/days, but at the corresponding indications the load dose of 70 mg in the first days of therapy remains. There is no clinical experience of use of drug for patients with a heavy liver failure (more than 9 points on a scale of Chayld-Pyyu).

The daily dose of the drug Kansidas® is entered to children (from 3 months to 17 years) way slow into infusions (≥ 1 h) 1 times/days.

The dose of drug is calculated taking into account the surface area of a body of the patient by a formula Mosteller.

For all indications in the first day the single load dose of 70 mg/sq.m (should not exceed an admissible dose of 70 mg), in the next days - 50 mg/sq.m a day is entered (should not exceed an admissible dose of 70 mg). Duration of therapy is defined individually and depends on the indication to appointment.

It is possible to increase a daily dose of the drug Kansidas® to 70 mg/sq.m if the daily dose of 50 mg/sq.m is well transferred by the patient, but does not give the expected clinical effect (should not exceed an admissible dose of 70 mg).

At co-administration of the drug Kansidas® with inductors of clearance of medicines (rifampicin, efavirenzy, not Virapinum, Phenytoinum, dexamethasone or carbamazepine) the possibility of increase in a daily dose of the drug Kansidas® to 70 mg/sq.m for the specified group of patients has to be considered (but without exceeding an admissible dose of 70 mg).

There is no clinical experience of use of drug for children with any degree of a liver failure.

Drug Kansidas® solution preparation for in/in infusions by the adult. It is impossible to use the solutions containing a dextrose (A - D - glucose) since in the infusion solutions containing a dextrose, Kansidas® is unstable.

Кансидас® does not mix up and it is not entered along with any other medicines as there are no data on its compatibility with other drugs for in/in introductions.

Examine ready infusion solution to be convinced of absence in it suspended particles or discoloration.

Stage 1. Preparation of primary solution in a bottle. Before cultivation the cold bottle with powder needs to be brought to room temperature and in the conditions of observance of an asepsis to add 10.5 ml of sterile water for injections (bacteriostatic water for injections, methylparaben, propylparaben or bacteriostatic water for injections with benzyl alcohol). Concentration of drug in primary solution will make 7 mg/ml (a bottle of 70 mg) or 5 mg/ml (a bottle of 50 mg).

White or almost white deposit will completely be dissolved. Carefully mix bottle contents before receiving transparent solution. Examine primary solution to be convinced of lack of the weighed deposit or discoloration. Primary solution prepared thus can be stored in a bottle to 24 h at a temperature below 25 °C.

Stage 2. Preparation of final infusion solution. Solution for infusions is prepared in the conditions of observance of an asepsis. As solvents use sterile normal saline solution for infusions or Ringer's solution with a lactate. For preparation of the final infusion solution intended for introduction to the patient with infusional solvent (sterile normal saline solution for infusions or Ringer's solution with a lactate) with a capacity of 250 ml add the corresponding amount of primary solution of Kansidas prepared at 1 stage to a plastic infusional bag or a bottle (as shown in table 1). If the daily dose of 50 mg or 35 mg is entered, it is possible to reduce infusion volume to 100 ml.

It is impossible to use the muddy or containing a deposit solution. Ready final infusion solution needs to be used during 24 h if it is stored at the room temperature (below 25 °C); during 48 h at storage in the refrigerator (2-8 °C).

Кансидас® enter in the way slow (≥1 h) into infusions.

Table 1. Preparation of final infusion solution of the drug Kansidas®.

* - 10.5 ml of solvent irrespective of its dose (50 mg or 70 mg) are always added to a bottle with Kansidas's powder.

** - in the absence of a bottle on 70 mg the dose can be prepared from 2 bottles on 50 mg.

Drug Kansidas® solution preparation for in/in infusions to children. Drug Kansidas® solution preparation process for in/in infusions to children is similar to preparation of solution for infusions by the adult. It includes the described higher than 2 stages — preparation of primary and final solution.

The main difference consists in definition of a dose of drug which is calculated by the formula given below and considers value of surface area of a body of the patient.

Determination of the body surface area (BSA) for calculation of a dose at children. Before preparation of infusion solution it is necessary to calculate the body surface area (BSA) of the child on the following formula (Mosteller's formula):

PPT (sq.m) = a square root from: Growth (cm) × Body weight (kg)/3600

Preparation of drug for introduction to children is aged more senior than 3 months (using a bottle of 70 mg). Define a load dose, necessary for this child, using PPT (calculated as it is described above) and the following equation:

PPT (sq.m) × 70 mg/sq.m = Load dose

The maximum load dose in the first day of treatment should not exceed 70 mg, irrespective of a calculated dose for this patient.

The choice of a bottle is defined by dose size in mg which is planned to be entered to this child. To provide dosing accuracy at children who need the dose which is not exceeding 50 mg it is recommended to use a bottle with the drug containing 50 mg of drug (concentration of a kaspofungin of 5.2 mg/ml). Bottles with the maintenance of a kaspofungin of 70 mg are recommended to be reserved for children who need the dose exceeding 50 mg.

Preparation of solution for infusions in 2 stages - see the section Drug Kansidas® Solution Preparation for in/in infusions by the adult. Take the drug volume equal to the calculated load dose from a bottle. In aseptic conditions transfer this volume (ml) of the recovered drug Kansidas to the capacity for in/in infusions containing 250 ml of 0.9%, 0.45% or 0.225% of solution of sodium of chloride for injections or Ringer's solution with a lactate for injections. If necessary the volume of final solution can be reduced so that final concentration of drug did not exceed 0.5 mg/ml.

Ready infusion solution should be used during 24 h at storage at a temperature not above 25 °C or during 48 h at storage in the refrigerator at 2-8 °C. If determined by the formula which is stated above the size of a load dose makes less than 50 mg, then it is possible to prepare infusion solution from a bottle of 50 mg (see below the section Drug Preparation for introduction to children 3 months are aged more senior (using a bottle of 50 mg). When using a bottle of 50 mg concentration of drug in primary solution will make 5.2 mg/ml.

Preparation of drug for introduction to children is aged more senior than 3 months (using a bottle of 50 mg). Define a daily maintenance dose, necessary for this child, using PPT (calculated as it is described above) and the following equation:

PPT (sq.m) x 50 mg/sq.m = Daily maintenance dose

The daily maintenance dose should not exceed 70 mg, irrespective of a calculated dose for this patient.

Preparation of solution for infusions in 2 stages - see the section Drug Kansidas® Solution Preparation for in/in infusions by the adult.

Take the drug volume equal to the calculated daily maintenance dose from a bottle. In aseptic conditions transfer this volume (ml) of the recovered drug Kansidas® to the capacity for in/in infusions containing 250 ml of 0.9%, 0.45% or 0.225% of solution of sodium of chloride for injections or Ringer's solution with a lactate for injections. If necessary the volume of final solution can be reduced so that final concentration of drug did not exceed 0.5 mg/ml.

Ready infusion solution should be used during 24 h at storage at a temperature not above 25 °C or during 48 h at storage in the refrigerator at 2-8 °C.

If the calculated daily maintenance dose more than 50 mg, then it is possible to use a bottle of 70 mg as it is described above, at the same time concentration of the recovered solution will make 7.2 mg/ml.

Features of use:

Use at pregnancy and feeding by a breast. There is no clinical experiment on use of drug at pregnancy and in the period of a lactation (breastfeeding). At animals каспофунгин gets through a placental barrier. Kaspofungin should not be appointed to women during pregnancy, except cases when purpose of drug is vital.

As there are no data on allocation of a kaspofungin with breast milk, in need of purpose of drug in the period of a lactation it is necessary to stop breastfeeding.

Use at abnormal liver functions. Dose adjustment is not required to patients with a slight liver failure (5-6 points on a scale of Chayld-Pyyu). At a moderate liver failure (from 7 to 9 points on a scale of Chayld-Pyyu) the supporting daily dose of Kansidas decreases to 35 mg/days, but at the corresponding indications the load dose of 70 mg in the first days of therapy remains. There is no clinical experience of use of drug for patients with a heavy liver failure (more than 9 points on a scale of Chayld-Pyyu).

Use at renal failures. Patients do not need correction of the mode of dosing at purpose of drug with depression of function of kidneys.

Use for children. Contraindication: children's age up to 3 months.

The daily dose of the drug Kansidas® is entered to children (from 3 months to 17 years) way slow into infusions (≥ 1 h) 1 times/days.

Use for elderly patients. Dose adjustment is not required to patients of advanced age (65 years are also more senior).

Special instructions. Use in pediatrics. Efficiency and safety of use of the drug Kansidas® for children from 3 months to 17 years is confirmed by enough these clinical trials on the basis of which drug is successfully used at this category of patients according to the same indications, as at adult patients.

Newborn children and children have no data on safety and efficiency of the drug Kansidas® 3 months are younger.

Side effects:

The revealed side reactions connected using drug usually had an easy current and seldom demanded drug withdrawal both from adults, and from children.

Widespread side effects: very often (≥ 1/10), it is frequent (≥ 1/100, but <1/10) and infrequently (≥ 1/1000, but <1/100).

At adults:

From an organism in general: often - fever, a headache, feeling of a fever.

From the alimentary system: often - nausea, diarrhea, vomiting, an abdominal pain, increase in blood serum of activity of ACT, ALT, ShchF, direct and general bilirubin.

From system of a hemopoiesis: often - anemia.

From cardiovascular system: often - tachycardia, phlebitis/thrombophlebitis, peripheral hypostases, venous post-infusional complications, inflows.

From a respiratory organs: often - an asthma.

From skin and a hypodermic fatty tissue: rash, an itch (including in a drug injection site), the increased perspiration.

From laboratory indicators: often - a hypoalbuminemia, a hypoproteinemia, a hypopotassemia, a hyponatremia, a hypomagnesiemia, a hypocalcemia, a leukopenia, a neutropenia, thrombocytopenia, an eosinophilia, decrease in hemoglobin and a hematocrit, increase in a partial tromboplastinovy and prothrombin time, a proteinuria, a leukocyturia, a microhematuria, increase in blood serum of concentration of creatinine; infrequently - a hypercalcemia.

There are separate messages on exceptional cases of dysfunction of a liver and allergic reactions - rash, a face edema, an itch, feeling of heat or a bronchospasm, and also an anaphylaxis. In the post-marketing period exceptional cases of dysfunction of a liver, and also peripheral hypostases and a hypercalcemia were revealed. Patients with an invasive aspergillosis have a fluid lungs, a respiratory distress syndrome at adults, infiltrates on the roentgenogram.

At children:

From an organism in general: very often - fever, it is frequent - a headache, feeling of a fever, gistaminoposredovanny reactions (i.e. allergic and anaphylactic reactions).

From cardiovascular system: often - tachycardia, decrease in the ABP, inflows, peripheral hypostases.

From the alimentary system: often - an abnormal liver function, increase in blood serum of activity of ACT, ALT.

From skin and a hypodermic fatty tissue: often - rash, an itch (including in a drug injection site).

From laboratory indicators: often - a hypopotassemia, a hypomagnesiemia, a hypercalcemia, an eosinophilia, increase in blood serum of concentration of glucose and phosphorus, decrease in concentration of phosphorus in blood serum.

Local reactions: often - pain in a catheter injection site, gistaminoposredovanny reactions in an injection site - a swelling.

Interaction with other medicines:

Kaspofungina acetate is not inhibitor of any enzyme of system of P450 (CYP) cytochrome, and also is not the inductor of the mediated CYP3A4 of metabolism of other drugs. Kaspofungin is not substrate for enzymes of a P-glycoprotein and represents weak substrate for P450 cytochrome enzymes.

Do not exert impact on Kansidas's pharmacokinetics итраконазол, Amphotericinum In, микофенолат, нелфинавир or такролимус.

In turn, Kansidas® does not influence pharmacokinetic indicators of an itrakonazol, Amphotericinum In, Rifampinum or active metabolites of a mikofenolat.

Кансидас® lowers an indicator of 12-hour concentration of a takrolimus in blood by 26%. At the patients receiving both drugs standard monitoring of concentration of a takrolimus in blood and, if necessary, correction of its mode of dosing is recommended.

At simultaneous use of Kansidas and cyclosporine perhaps tranzitorny (passing after cancellation of drugs) increase in activity of nuclear heating plant and ALT (no more than by 3 times, in comparison with the upper bound of norm), and also increase in AUC of a kaspofungin approximately by 35% without change of concentration of cyclosporine. At joint purpose of these drugs (lasting up to 290 days) the serious undesirable phenomena from a liver were not noted. Co-administration of Kansidas and cyclosporine can be considered reasonable when the potential advantage of such appointment exceeds possible risk.

Rifampinum can both accelerate, and to slow down distribution of a kaspofungin. At simultaneous joint appointment with Rifampinum within 14 days passing increase in concentration of a kaspofungin in plasma in the first day (increase in AUC approximately by 60%) was noted. At the same time such inhibiting effect was not observed when purpose of a kaspofungin happened against the background of the monotherapy which was carried out within 14 days Rifampinum, at the same time against the background of steady inductor effect of Rifampinum small decrease in AUC and concentration of a kaspofungin by the end of infusion, and threshold concentration - approximately for 30% was noted.

Simultaneous use with Kansidas of inductors of clearance of medicines (эфавиренз, not Virapinum, Phenytoinum, dexamethasone or carbamazepine) can lead to clinically significant decrease in concentration of a kaspofungin. The available data demonstrate that the decrease in concentration of a kaspofungin induced by these drugs happens rather due to elimination acceleration, than metabolism. Therefore at the combined use of Kansidas with efavirenzy, nelfinaviry, not Virapinum, Rifampinum, dexamethasone, Phenytoinum or carbamazepine it is necessary to consider the possibility of increase in a daily dose of Kansidas to 70 mg after use of a usual load dose of 70 mg.

Children have a combined use of dexamethasone and a kaspofungin can be followed by clinically significant decrease in threshold concentration of a kaspofungin.

Contraindications:

— children's age up to 3 months;

— hypersensitivity to drug components.

With care appoint drug at the combined use with cyclosporine, and also at patients with a moderate liver failure (from 7 to 9 points on a scale of Chayld-Pyyu).

Overdose:

There are no data on drug overdose. In clinical trials the highest of the tested doses - a single single dose of 210 mg (6 healthy volunteers) was well transferred.

Also good tolerance of drug at its introduction in a daily dose of 100 mg within 21 days (15 healthy volunteers) was shown.

At overdose of a kaspofungin dialysis is not carried out.

Storage conditions:

Drug should be stored in the place, unavailable to children, at a temperature from 2 °C to 8 °C. A period of validity - 2 years. Primary Kansidasa® solution prepared in a bottle can be stored at a temperature below 25 °C during 24 h before preparation of the infusion solution intended for introduction to the patient. The prepared final Kansidasa® infusion solution in a plastic infusional bag or a bottle for in/in infusions can be stored at a temperature below 25 °C during 24 h or in the refrigerator at a temperature from 2 °C to 8 °C during 48 h.

Issue conditions:

According to the recipe

Packaging:

Bottles of colourless glass with a capacity of 10 ml (1) - a pack cardboard.