NeoCytotect solution for infusion 100 U/ml 10ml vials, 1pc

Composition

Colorless or light yellow, transparent, slightly opalescent liquid.

Vials of 10,20 and 50 ml

Pharmacological action

Neocytectect is an Ig preparation that is made from the plasma of donors with a high titer of antibodies against the causative agent of cytomegaly. The distribution of IgG subclasses corresponds to the distribution in the plasma of healthy donors.

Pharmacokinetics

The bioavailability of human Ig against CMV infection with intravenous use is 100%. The distribution between plasma and extravascular fluid occurs fairly quickly, and after 3-5 days, the balance between intravascular and extravascular space is reached. T_1/2 NeoCytectomy takes an average of 24 days. IgG and its complexes are utilized by cells of the reticuloendothelial system.

Indications

• prophylaxis of CMV infection in patients with a suppressed immune system medicines, especially after organ transplantation;
• prevention of the onset of the disease after infection by CMV;
• therapy of CMV infection in patients with weakened immune systems, such as premature infants, newborns, and in patients with a depressed immune medicines or immunodeficiency due to other causes (e. g. AIDS).

There are no age restrictions.

Contraindications

Hypersensitivity to any component of the drug; hypersensitivity to human Ig, especially in rare cases of IgA deficiency in the blood and the presence of antibodies against IgA.

Side effects

Pr

Certain side effects may occur most frequently:

• at a high rate of use;
• in patients with complete or partial immunodeficiency, both in the presence and absence of IgA deficiency;
• in patients receiving human Ig for the first time or in rare cases when switching to another Ig drug, or if Ig treatment has been carried out for a very long time.

When Neocytectect is administered, side effects may include chills, headache, fever, nausea, vomiting, decreased blood pressure, allergic reactions, arthralgia, and mild lower back pain.

In rare cases, as a result of Ig use, a sharp decrease in blood pressure is possible and in isolated cases-anaphylactic shock, even if the patient did not show hypersensitivity at the previous use.

With the introduction of normal human Ig, there were cases of signs of aseptic meningitis and, in rare cases, hemolytic anemia, hemolysis, a transient skin reaction (rash or hyperemia), which completely disappeared after discontinuation of therapy.

In addition, there was an increase in serum creatinine and / or acute renal failure.

There have been isolated cases of thromboembolic reactions, such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis.

In case of reactions that indicate intolerance to the drug, it is necessary either to reduce the rate of use, or to suspend the infusion until the symptoms disappear. The choice of appropriate measures to prevent the occurrence of side effects depends on the type and severity of the side effect.

In case of adverse effects on renal function, the decision to discontinue Ig therapy should be considered.

In case of shock, it is necessary to follow the current recommendations for anti-shock therapy.

The frequency of side effects by gradation is summarized in the table: very common (≥1/10); common (≥1/100, but

Interaction

of Live attenuated viral vaccines:  use of Ig can negatively affect, at least from 6 weeks to 3 months, the effect of live attenuated vaccines against viral diseases such as measles, rubella, mumps and chickenpox. Vaccination with these drugs should be carried out no earlier than 3 months after the introduction of Neocytotect. In the case of measles vaccination, this interval can be extended to 1 year. Therefore, patients who have received Neocytectect and need to be vaccinated against measles should first be tested for the presence of specific antibodies against measles.

Laboratory tests:  after use of Ig, a temporary increase in the titer of various passively administered antibodies is possible, which can lead to false positive results in serological examination.

Passively administered antibodies against red blood cell antigens (e. g. A, B, D) can affect individual serological parameters, such as allo-antibodies to red blood cells (e. g. Coombs reaction), reticulocyte count, and haptoglobin.

How to take it, course of use and dosage

Method of use

Neocytectect should be visually checked before use. The solution should be clear or slightly opalescent. It is forbidden to use an opaque or sedimentary solution.

Before use, the drug should be heated to room temperature. Neocytectect is intended for intravenous infusion.

The initial infusion rate should be 0.08 ml / kg of body weight / h, after 10 minutes, if the drug is well tolerated, the rate can be gradually increased to a maximum of 0.8 ml / kg of body weight/ h and maintained until the end of use.

The drug is not subject to preliminary dilution.

NeoCyotect should not be mixed with other medicinal products.

An open bottle should be used immediately.Because of the risk of bacterial contamination, the unused solution should be discarded.

When using NeoCytotect, the following dosages are recommended::

Prevention of cytomegalovirus infection in immunocompromised patients

The drug is administered in a single dose of 1 ml per kg of body weight. In CMV-seronegative patients with organ transplantation, use should begin on the day of transplantation, and in bone marrow transplantation-on the day before transplantation. In CMV-seropositive patients, prevention should begin 10 days before transplantation. The patient should receive at least 6 single doses with an interval of 2-3 weeks.

Treatment of cytomegalovirus infection

A single dose of 1 ml per kg of body weight every 48 hours until clinical symptoms disappear.

Overdose

Overdose of the drug in patients at risk, especially in the elderly, as well as in patients with impaired renal function, can lead to increased blood viscosity.

Special instructions

for the use of medicinal products from human blood or plasma due to the transmission of pathogens of infectious diseases, infection with the latter cannot be completely excluded. This also applies to pathogens of a hitherto unknown nature. To reduce the risk of transmission of pathogens, donors are selected according to strict criteria, donor plasma is tested and selected, and the plasma pool is monitored. The production process includes steps for removing and/or inactivating pathogens.

For the production of NeoCytectect, only plasma from healthy donors is used, in which antibodies to HIV type 1 and 2, to the hepatitis C virus and the surface antigen of the hepatitis B virus were not detected, and the activity of liver enzymes (transaminases) does not exceed the normal limit value. In addition to testing the plasma of individual donors, minipuls are first monitored (PCR testing for HIV, hepatitis A, B and C viruses, parvovirus 19), and then a production pool of plasma processed for neocytect (repeated testing for antibodies to HIV -1.2, hepatitis B and C, as well as PCR for HIV, hepatitis B and C viruses). In production, a plasma pool is used only if the test results are negative.

Neocytectect is made by cold ethanol fractionation. Treatment with tri-n – butyl phosphate/tween 80 and octanoic acid is performed to inactivate and remove possible viruses.

Precautions for use

Certain severe side effects may depend on the rate of use. Since its increase is associated with a tendency to increase side effects, the rate of use recommended in the section “Dosage and use” should be strictly observed.

Certain side effects may occur most frequently :

• at a high rate of
• use in patients with complete or partial immunodeficiency, both in the presence and absence of IgA deficiency;
• in patients receiving human immunoglobulin for the first time or in rare cases when switching to another immunoglobulin preparation, or if treatment with immunoglobulins has been carried out for a very long time.

True hypersensitivity reactions are extremely rare, in cases where there is no immunoglobulin A (IgA) in the blood and antibodies to IgA are formed.

In rare cases, a decrease in blood pressure may occur after use of immunoglobulin, and in isolated cases – anaphylactic shock, even if the patient did not show excessive sensitivity during the previous use of the drug.

In most cases, possible complications can be avoided if::

— make sure that the patient has no allergic reactions to very slow use of immunoglobulin (0.08 ml / kg / min);

— carefully monitor the patient during the entire use of the drug and monitor for signs of undesirable effects. Patients who have never received human immunoglobulins before, or who have received other immunoglobulins, or who have been given immunoglobulins for a very long time, should be especially carefully monitored during the entire infusion and at least 1 hour after it ends.

All other patients should be monitored for at least 20 minutes after the end of use.

There is a suspected association between intravenous immunoglobulin use and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis. It is assumed that in patients at risk, the introduction of a high dose of immunoglobulin leads to a relative increase in blood viscosity. It is recommended to prescribe and administer immunoglobulins with caution to the following patients: senile age, with high blood pressure, diabetes mellitus, vascular diseases or a history of thrombosis, hereditary or acquired thrombophilic disorders, patients who have been stationary for a long time, with severe hypovolemia, as well as patients with chronic diseases in which blood viscosity increases.

With the introduction of intravenous immunoglobulins, isolated cases of acute renal failure have been described, which occurred in patients with additional risk factors: impaired renal function, diabetes mellitus, reduced circulating blood volume, overweight, taking medications that have a nephrotoxic effect, age over 65 years.

Most often, impaired renal function and acute renal failure are associated with the use of drugs containing sucrose as a stabilizer. Therefore, patients with any risk factor are recommended to use immunoglobulins that do not contain sucrose, for example, NeoCytotect. In patients at risk of developing acute renal failure or thromboembolism, the immunoglobulin preparation should be administered at the lowest possible rate and at the lowest possible dose.

When treating with Neocytotect for all groups of patients, it is necessary:

• sufficient fluid intake before the infusion of the drug;
• control of diuresis;
• control of serum creatinine;
• exclude simultaneous use of diuretics.

Influence on the ability to drive motor vehicles and manage mechanisms

There is no indication that immunoglobulins can affect the ability to drive a car or maintain machinery.

When using drugs from human blood or plasma due to the transmission of pathogens of infectious diseases, infection with the latter cannot be completely excluded. This also applies to pathogens of a hitherto unknown nature. To reduce the risk of transmission of pathogens, donors are selected according to strict criteria, donor plasma is tested and selected, and the plasma pool is monitored. The production process includes steps for removing and/or inactivating pathogens.

For the production of NeoCytectect, only plasma from healthy donors is used, in which antibodies to HIV type 1 and 2, to the hepatitis C virus and the surface antigen of the hepatitis B virus were not detected, and the activity of liver enzymes (transaminases) does not exceed the normal limit value. In addition to testing the plasma of individual donors, minipuls are first monitored (PCR testing for HIV, hepatitis A, B and C viruses, parvovirus 19), and then a production pool of plasma processed for neocytect (repeated testing for antibodies to HIV -1.2, hepatitis B and C, as well as PCR for HIV, hepatitis B and C viruses). In production, a plasma pool is used only if the test results are negative.

Neocytectect is made by cold ethanol fractionation. Treatment with tri-n – butyl phosphate/tween 80 and octanoic acid is performed to inactivate and remove possible viruses.

Precautions for use

Certain severe side effects may depend on the rate of use. Since its increase is associated with a tendency to increase side effects, the rate of use recommended in the section “Dosage and use” should be strictly observed.

Certain side effects may occur most frequently :

• at a high rate of
• use in patients with complete or partial immunodeficiency, both in the presence and absence of IgA deficiency;
• in patients receiving human immunoglobulin for the first time or in rare cases when switching to another immunoglobulin preparation, or if treatment with immunoglobulins has been carried out for a very long time.

True hypersensitivity reactions are extremely rare, in cases where there is no immunoglobulin A (IgA) in the blood and antibodies to IgA are formed.

In rare cases, a decrease in blood pressure may occur after use of immunoglobulin, and in isolated cases – anaphylactic shock, even if the patient did not show excessive sensitivity during the previous use of the drug.

In most cases, possible complications can be avoided if::

— make sure that the patient has no allergic reactions to very slow use of immunoglobulin (0.08 ml / kg / min);

— carefully monitor the patient during the entire use of the drug and monitor for signs of undesirable effects. Patients who have never received human immunoglobulins before, or who have received other immunoglobulins, or who have been given immunoglobulins for a very long time, should be especially carefully monitored during the entire infusion and at least 1 hour after it ends.

All other patients should be monitored for at least 20 minutes after the end of use.

There is a suspected association between intravenous immunoglobulin use and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis.It is assumed that in patients at risk, the introduction of a high dose of immunoglobulin leads to a relative increase in blood viscosity. It is recommended to prescribe and administer immunoglobulins with caution to the following patients: senile age, with high blood pressure, diabetes mellitus, vascular diseases or a history of thrombosis, hereditary or acquired thrombophilic disorders, patients who have been stationary for a long time, with severe hypovolemia, as well as patients with chronic diseases in which blood viscosity increases.

With the introduction of intravenous immunoglobulins, isolated cases of acute renal failure have been described, which occurred in patients with additional risk factors: impaired renal function, diabetes mellitus, reduced circulating blood volume, overweight, taking medications that have a nephrotoxic effect, age over 65 years.

Most often, impaired renal function and acute renal failure are associated with the use of drugs containing sucrose as a stabilizer. Therefore, patients with any risk factor are recommended to use immunoglobulins that do not contain sucrose, for example, NeoCytotect. In patients at risk of developing acute renal failure or thromboembolism, the immunoglobulin preparation should be administered at the lowest possible rate and at the lowest possible dose.

When treating with Neocytotect for all groups of patients, it is necessary:

• sufficient fluid intake before the infusion of the drug;
• control of diuresis;
• control of serum creatinine;
• exclude simultaneous use of diuretics.

Influence on the ability to drive motor vehicles and manage mechanisms

There is no indication that immunoglobulins can affect the ability to drive a car or maintain machinery.

Product form

solution for infusions

Storage conditions

Store in a dark place, at a temperature of 2-8 °C (do not freeze)

Shelf life

2 years

Active ingredient

Human anti-cytomegalovirus immunoglobulin

Conditions of release from pharmacies

By prescription

Dosage form

infusion solution