NeoCytotect solution for infusions of 100 U/ml 1 ml 10 pcs

NeoTsitotekt is a drug Ig, which is prepared from the plasma of donors with high antibody titer against the pathogen cytomegalovirus. The distribution of IgG subclasses corresponds to the distribution in the plasma of healthy donors.

pharmacokinetics

Bioavailability Ig against human CMV infection with / in the introduction of 100%. The distribution between plasma and extravascular fluid takes place quickly enough, and after 3-5 days equilibrium is reached between the intravascular and extravascular space. T _1/2 NeoTsitotekta an average of 24 days. IgG and its systems utilized by cells of the reticuloendothelial system.

Active substance:
Immunoglobulin cytomegalovirus

Manufacturer

Biotest AG, Germany

Composition

Colorless or light yellow, transparent slightly opalescent liquid.

Vials 10, 20 and 50 ml.

Indications

• prophylaxis of CMV infection in patients with suppressed immune system drugs, in particular after organ transplantation;
• the prevention of disease manifestations of CMV infection after;
• therapy of CMV infection in immunocompromised patients, such as premature babies, newborns, as well as in patients with a suppressed immune drugs or immunocompromised due to other causes (eg AIDS).

There are no age restrictions.

Contraindications

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

Side effects

Etc

Certain side effects may occur more often:

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

When administered drug NeoTsitotekt possible side effects such as fever, headache, fever, nausea, vomiting, decreased blood pressure, allergic reactions, arthralgia and slight pain in the lower back.

In rare cases, as a result of the introduction of Ig possible sharp drop in blood pressure and in rare cases – anaphylactic shock, even if the patient is under the previous administration were no manifestations of hypersensitivity.

With the introduction of normal human Ig observed cases signs of aseptic meningitis and in rare cases – hemolytic anemia, hemolysis, transient skin reactions (rash or redness), which are fully reversible after discontinuation of therapy.

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

We noted a few cases of thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis.

In the case of reactions indicative of intolerance to the preparation, it is necessary either to reduce the rate of introduction or suspend infusion until symptoms disappear. Selection of appropriate measures to prevent any side effects depends on the type and severity of side effects.

In case of a negative impact on renal function should weigh the decision to discontinue therapy Ig.

In the event of a shock, it is necessary to follow the current guidelines for the anti-shock therapy.

The frequency of side effects VOZobobschena gradation table: very often (≥1 / 10); commonly (≥1 / 100, but

How to accept, acceptance rate and dosage

Route of administration

Before the introduction of NeoTsitotekt need to visually check. The solution should be transparent or opalescent slug. Opaque or precipitate containing solution is prohibited to use.

Before the introduction of the drug is necessary to warm up to room temperature. NeoTsitotekt designed for intravenous infusion.

The initial infusion rate should be 0.08 ml / kg body weight / hour, over 10 min with good tolerability of the drug speed can be gradually increased to a maximum of 0.8 ml / kg body / weight h and retain it until the end of administration.

The preparation is not subject to a preliminary breeding.

NeoTsiotekt not be mixed with other drugs.

Open the vial should be used immediately. Because of the risk of bacterial contamination unused solution must be discarded.

In applying the drug NeoTsitotekt following recommended dosage:

Prevention of cytomegalovirus infection in immunosuppressed patients

The drug is administered in one dose of 1 ml per kg body weight. In CMV-seronegative patients for organ transplantation introduction should start on the day of transplantation, while bone marrow transplant – the day before transplantation. In CMV-seropositive patients prevention must begin 10 days before the transplant. The patient should receive not less than 6 unit 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 the disappearance of clinical symptoms.

Storage conditions

In the dark place at a temperature of 2-8 ° C (not frozen)

Active substance

Immunoglobulin cytomegalovirus

Interaction

Live attenuated virus vaccines: administering Ig may adversely affect at least 6 weeks to 3 months, to the action of live attenuated vaccines for viral diseases such as measles, rubella, mumps and varicella. Vaccination of these drugs should be carried out not earlier than after 3 months after administration NeoTsitotekta. In the case of vaccines against measles, this interval can be increased up to 1 year. In connection with patients receiving NeoTsitotekt and who need to be vaccinated against measles, should first be examined for the presence of specific antibodies against the measles.

Laboratory investigations: after the introduction of Ig may temporarily increase the titer of various passive administration of antibodies that can lead to false positive results for serological study.

Passively administered antibodies against erythrocyte antigens (e.g. A, B, D) may affect the individual serological parameters such as alloantibodies to erythrocytes (e.g. Coombs’ test), haptoglobin and reticulocyte count.

Special conditions

When applying medicaments from human blood or plasma due to transmission of infectious agents infection can not completely exclude the latter. This also applies to pathogens of hitherto unknown nature. To reduce the risk of transmission of pathogens, according to strict criteria for donor selection is carried out, tested and selected donor plasma and the plasma is controlled by the pool. The production process includes steps to remove and / or inactivate pathogens.

For manufacturing NeoTsitotekta used exclusively plasma from healthy donors, which were not detected antibodies to HIV type 1 and 2, hepatitis C virus and the surface antigen of hepatitis B virus and the activity of liver enzymes (transaminase) does not exceed the normal limit value. In addition to testing individual donor plasma exposed first control minipuly (PCR testing for HIV, hepatitis viruses A, B and C, parvovirus 19), and then the production of the plasma pool is processed at NeoTsitotekt (repeat testing for antibodies to HIV -1,2, hepatitis B and C, as well as viruses, hepatitis B and C) PCR for HIV. In manufacture the plasma pool is only for negative test results.

NeoTsitotekt produced by fractionation with ethanol in the cold. To inactivate and remove any viruses carry out processing -n three – butyl phosphate / Tween 80 and octanoic acid.

Precautions for the use of

Specific severe side effects of administration may depend on the speed. Since increasing with its associated tendency to increased side effects must be strictly observed rate of administration, the recommended under “Dosage and Administration”.

Certain side effects may occur more often:

• at high speed administering
• 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 another immunoglobulin preparation, or if treatment immunoglobulins performed for a long time.

True hypersensitivity reactions are extremely rare, in cases where the blood is absent immunoglobulin A (IgA) and antibody to form IgA.

In rare cases, after the administration of immunoglobulin possible decrease in blood pressure and in rare cases – anaphylactic shock, even if the patient is under the previous administration of the drug did not show excessive sensitivity.

In most cases, you can avoid possible complications if:

– it ensures that the patient has no allergic reaction is very slow intravenous immunoglobulin (0.08 ml / kg / min);

– closely watched during the entire administration of the drug for the patient and watch for signs of an adverse effect. Especially carefully it is necessary to observe throughout the infusion and for at least 1 hour after its completion, the patients never previously treated with human immunoglobulins, or receive other immunoglobulins or immunoglobulins that were introduced a long time ago.

All other patients should be monitored for at least 20 minutes after administration.

There are suspicions about the relationship between the administration of intravenous immunoglobulins and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis. It is believed that patients at risk, administration of high doses of immunoglobulin causes a relative increase in blood viscosity. Recommended with caution and administered immunoglobulins in the following patients: senile age, high blood pressure, diabetes, vascular disease or phenomena thrombosis history, hereditary or acquired trombofilnymi disorders patients, long time being in a stationary condition with severe hypovolemia and patients with chronic diseases in which the blood viscosity increases.

With the introduction of intravenous immunoglobulins described isolated cases of acute renal failure, which occurs in patients with additional risk factors: impaired renal function, diabetes, low blood volume, excess body weight, medication, providing nephrotoxicity, age over 65 years.

Most often impaired renal function and acute renal failure associated with the use of preparations containing sucrose as a stabilizer. Therefore, patients with any risk factor is recommended to use immunoglobulins that do not contain sucrose, for example, NeoTsitotekt. Patients who are at risk of acute renal failure or thromboembolism immunoglobulin drug should be administered with the lowest possible speed and in the lowest possible dose.

When treating NeoTsitotektom for all groups of patients should:

• a sufficient intake of fluids prior to the infusion of the drug;
• monitoring of urine output;
• check of the contents of serum creatinine;
• exclude concomitant use of diuretics.

Effects on ability to drive vehicles and management mechanisms

There are no indications that immunoglobulins can affect the ability to drive or maintain mechanisms.

When applying medicaments from human blood or plasma due to transmission of infectious agents infection can not completely exclude the latter. This also applies to pathogens of hitherto unknown nature. To reduce the risk of transmission of pathogens, according to strict criteria for donor selection is carried out, tested and selected donor plasma and the plasma is controlled by the pool. The production process includes steps to remove and / or inactivate pathogens.

For manufacturing NeoTsitotekta used exclusively plasma from healthy donors, which were not detected antibodies to HIV type 1 and 2, hepatitis C virus and the surface antigen of hepatitis B virus and the activity of liver enzymes (transaminase) does not exceed the normal limit value. In addition to testing individual donor plasma exposed first control minipuly (PCR testing for HIV, hepatitis viruses A, B and C, parvovirus 19), and then the production of the plasma pool is processed at NeoTsitotekt (repeat testing for antibodies to HIV -1,2, hepatitis B and C, as well as viruses, hepatitis B and C) PCR for HIV. In manufacture the plasma pool is only for negative test results.

NeoTsitotekt produced by fractionation with ethanol in the cold. To inactivate and remove any viruses carry out processing -n three – butyl phosphate / Tween 80 and octanoic acid.

Precautions for the use of

Specific severe side effects of administration may depend on the speed. Since increasing with its associated tendency to increased side effects must be strictly observed rate of administration, the recommended under “Dosage and Administration”.

Certain side effects may occur more often:

• at high speed administering
• 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 another immunoglobulin preparation, or if treatment immunoglobulins performed for a long time.

True hypersensitivity reactions are extremely rare, in cases where the blood is absent immunoglobulin A (IgA) and antibody to form IgA.

In rare cases, after the administration of immunoglobulin possible decrease in blood pressure and in rare cases – anaphylactic shock, even if the patient is under the previous administration of the drug did not show excessive sensitivity.

In most cases, you can avoid possible complications if:

– ensure that the patient has no allergic reaction is very slow intravenous immunoglobulin (0.08 ml / kg / min);

– closely watched during the entire administration of the drug for the patient and watch for signs of an adverse effect. Especially carefully it is necessary to observe throughout the infusion and for at least 1 hour after its completion, the patients never previously treated with human immunoglobulins, or receive other immunoglobulins or immunoglobulins that were introduced a long time ago.

All other patients should be monitored for at least 20 minutes after administration.

There are suspicions about the relationship between the administration of intravenous immunoglobulins and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis. It is believed that patients at risk, administration of high doses of immunoglobulin causes a relative increase in blood viscosity. Recommended with caution and administered immunoglobulins in the following patients: senile age, high blood pressure, diabetes, vascular disease or phenomena thrombosis history, hereditary or acquired trombofilnymi disorders patients, long time being in a stationary condition with severe hypovolemia and patients with chronic diseases in which the blood viscosity increases.

With the introduction of intravenous immunoglobulins described isolated cases of acute renal failure, which occurs in patients with additional risk factors: impaired renal function, diabetes, low blood volume, excess body weight, medication, providing nephrotoxicity, age over 65 years.

Most often impaired renal function and acute renal failure associated with the use of preparations containing sucrose as a stabilizer. Therefore, patients with any risk factor is recommended to use immunoglobulins that do not contain sucrose, for example, NeoTsitotekt. Patients who are at risk of acute renal failure or thromboembolism immunoglobulin drug should be administered with the lowest possible speed and in the lowest possible dose.

When treating NeoTsitotektom for all groups of patients should:

• a sufficient intake of fluids prior to the infusion of the drug;
• monitoring of urine output;
• check of the contents of serum creatinine;
• exclude concomitant use of diuretics.

Effects on ability to drive vehicles and management mechanisms

There are no indications that immunoglobulins can affect the ability to drive or maintain mechanisms.

Overdose

An overdose of the drug in patients belonging to a risk group, especially in older persons, as well as in patients with impaired renal function, may lead to increased blood viscosity.