NeoCytotect - instructions for use, doses, side effects, contraindications

Active substanceImmunoglobulin human anti-cytomegalovirusImmunoglobulin human anti-cytomegalovirus

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Neocytotect

solution d / infusion

Biotest Pharma GmbH Germany

Cytotect

solution

Biotest Pharma GmbH Germany

Dosage form: & nbspsolution for infusions

Composition:

In 1 ml of solution contains:

Active substance:

Proteins of human plasma	50 mg
of which immunoglobulin G (IgG)	not less than 96%
immunoglobulin A (IgA)	not more than 2 mg
the content of antibodies against cytomegalovirus	not less than 100 Е *

* The units of the reference preparation of the Paul Ehrlich Institute, Germany

Excipients:

glycine	300 μmol
water for injections	up to 1 ml

Distribution of immunoglobulin subclasses G (IgG):

IgGl	about 65%
IgG2	about 30%
IgG3	about 3%
IgG4	about 2%

Description:

Colorless or light yellow, transparent slightly opalescent liquid

Pharmacotherapeutic group:MIBP - globulin

ATX: & nbsp

J.06.B.B.09 Immunoglobulin human anti-cytomegalovirus

Pharmacodynamics:

Neocytotect is a preparation of immunoglobulin, which is made from a plasma of donors with a high titer of antibodies against the causative agent of cytomegaly. Distribution of immunoglobulin subclasses G (IgG) corresponds to the distribution in the plasma of healthy donors.

Pharmacokinetics:

Bioavailability of human immunoglobulin against cytomegalovirus infection with intravenous administration is 100%.The distribution between plasma and extravascular fluid occurs rather quickly, and in 3-5 days an equilibrium is achieved between the intravascular and extravascular space. The half-life of NeoTzitotek is on average 24 days. Immunoglobulin G and complexes IgG are utilized by the cells of the reticuloendothelial system.

Indications:

Prevention of cytomegalovirus infection in patients with suppressed medications by the immune system, in particular after organ transplantation. Prevention of the manifestation of the disease after infection with cytomegalovirus (CMV).

Therapy of cytomegalovirus infection in immunocompromised patients, such as preterm infants, newborns, and patients with suppressed medications immunity or immunodeficiency caused by other causes (eg, AIDS).

There are no age restrictions.

Contraindications:

Hypersensitivity to any component of the drug.

Hypersensitivity to human immunoglobulin, especially in rare cases of a deficiency in the blood of immunoglobulin class A (IgA) and the presence of antibodies against IgA.

Carefully:It is recommended to carefully prescribe and administer immunoglobulins to the following patients: senile, high blood pressure, diabetes mellitus, vascular disease or history of thrombosis, hereditary or acquired thrombophilic disorders, long-term immobile patients with severe hypovolemia, and patients with chronic diseases, in which the viscosity of the blood increases.

Pregnancy and lactation:

The absence of risk of using this drug during pregnancy has not been studied in controlled clinical trials, therefore it should be used with caution in pregnancy and lactation, although the long experience of medical use of immunoglobulins does not allow expecting any harmful effect on the course of pregnancy, as well as on the fetus and the newborn. The introduced immunoglobulins are secreted from the mother's milk and can facilitate the transfer of protective antibodies to newborns.

Dosing and Administration:

When using the drug NeoCytotheca, the following doses are recommended:

- Prevention of cytomegalovirus infection in patients with suppressed immunity.

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

- Therapy of cytomegalovirus infection.

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

Method of administration

Prior to the introduction of NeoTzitotekt need to visually check. The solution should be clear or slightly opalescent. An opaque or precipitating solution should not be used.

Before the introduction of the drug should be brought to room temperature.

Neocytotect is intended for intravenous infusion.

The initial infusion rate should be 0.08 ml / kg body weight / hour, after 10 min with good drug tolerance, the rate can be gradually increased to a maximum of 0.8 ml / kg body weight / hour and stored until the end of the injection.

The preparation is not subject to preliminary dilution.

Neocystect can not be mixed with other drugs.

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

Side effects:

Certain side effects can occur more often:

- at a high rate of administration;

- in patients with complete or partial immunodeficiency both in the presence and in the absence IgA-deficiency;

- in patients receiving human immunoglobulin for the first time or in rare cases when switching to another preparation of immunoglobulin, or if treatment with immunoglobulins was carried out for a long time.

With the introduction of the drug NeoCitotect possible side effects such as chills, headache, fever, nausea, vomiting, lower blood pressure, allergic reactions, arthralgia and mild pain in the lower back.

In rare cases, as a result of the introduction of immunoglobulin, a sharp drop in blood pressure and, in isolated cases, anaphylactic shock, even if the patient had no hypersensitivity during the previous administration, is possible.

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

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

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

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

In the event of a negative impact on kidney function, a decision to discontinue immunoglobulin therapy should be weighed.

In the event of a shock, it is necessary to follow the current recommendations for antishock therapy.

The frequency of adverse events by WHO graduation is summarized in the table: very often (≥ 1/10); often (≥ 1/100,but <1/10); infrequently (≥ 1/1000, but <1/100); rarely (≥ 1/10000, but <1/1000); very rarely (<1/10000); unknown (impossibility of evaluation according to available data).

Classification of lesions of the body systems according to the medical dictionary of normative and legal activity MedDRA	Undesirable reactions	Frequency
Violations of the blood and lymphatic system	Reversible hemolytic anemia / hemolysis	unknown
Disturbances from the nervous system	Headache	infrequently
Disorders from the gastrointestinal tract	Nausea, vomiting	infrequently
Disorders of the kidneys and genitourinary tract	Increased level of serum creatinine and / or acute renal failure	unknown
Disturbances from the skin and subcutaneous tissues	Transient Skin Reactions	rarely
Disturbances from musculoskeletal and connective tissue	Arthralgia, mild pain in the lower back	infrequently
Infectious and parasitic diseases	Reversible aseptic meningitis	unknown
Vascular diseases	Low blood pressure, thromboembolic reactions, such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis	infrequently very rarely
General disorders and disorders at the site of administration	Chills, fever	infrequently
Immune system disorders	Allergic reactions	infrequently
Immune system disorders	Hypersensitivity reactions with sudden drop in blood pressure and, in some cases, anaphylactic shock, even if the patient had no hypersensitivity in the previous administration	rarely

Overdose:

Overdose of the drug in patients at risk, especially in elderly people, as well as in patients with impaired renal function, may lead to an increase in blood viscosity.

Interaction:

Live attenuated viral vaccines:

The introduction of immunoglobulins can adversely affect at least 6 weeks to 3 months on the effect of live attenuated vaccines against such viral diseases as measles, rubella, mumps and chicken pox. Vaccination with these drugs should be carried out no earlier than after 3 months after the introduction of NeoCytotec. In the case of measles vaccination, this interval can be increased to 1 year. In this connection, patients who received NeoCytotect and who need to be vaccinated against measles should first be examined for the presence of specific antibodies against measles.

Special instructions:

It is necessary to strictly follow the recommended rate in the section "Dosage regimen, mode of administration", since with its increase there is a tendency to an increase in side effects. Patients should be fully tested and carefully monitored for any symptoms during the entire infusion time.

In rare cases, after the introduction of immunoglobulin, it is possible to lower blood pressure and, in isolated cases, anaphylactic shock, even if the patient had no hypersensitivity during the previous administration.

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

In most cases, possible complications can be avoided if:

- make sure that the patient does not have allergic reactions to very slow administration of immunoglobulin (0.08 ml / kg / h);

- watch carefully during the entire injection of the drug for the patient and monitor the appearance of signs of undesirable effects.

Especially it is necessary to observe carefully during the entire infusion and, at least, within 1 hour after its end,for patients who have never before received human immunoglobulins, or who received other immunoglobulins, or who received immunoglobulins very long ago. All other patients should be monitored for at least 30 minutes. after the end of the introduction.

There is a possible relationship between the administration of intravenous immunoglobulins and the phenomena of thromboembolism, such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis. It is suggested that in patients at risk, the administration of a large dose of immunoglobulin results in a relative increase in blood viscosity.

When using immunoglobulins intended for intravenous administration, single cases of acute renal failure have been described that occurred in patients who have additional risk factors: renal dysfunction, diabetes mellitus, decreased circulating blood volume, overweight, taking drugs that have a nephrotoxic effect, age over 65 years of age.

When treating the drug Neocytotect for all groups of patients it is necessary:

- sufficient fluid intake before the infusion of the drug;

- control of diuresis;

- control serum creatinine;

- To exclude simultaneous reception of diuretics.

Most often, renal dysfunction and acute renal failure are associated with the use of drugs containing sucrose as a stabilizer. Therefore, patients with any of the above additional risk factors are encouraged to use immunoglobulins that do not contain sucrose, for example Neocytotect. Patients who are at risk for developing acute renal failure or thromboembolism should be given the immunoglobulin preparation at the lowest possible rate and at the lowest possible dose.

Laboratory research

After the introduction of immunoglobulin, a temporary increase in the titer of various passively introduced antibodies is possible, which can lead to false positive results in serological testing.

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.

Additional information

When using drugs from human blood or plasma, the risk of transmission of infectious agents can not be completely ruled out. This also applies to causative agents of a still unknown nature. To reduce the risk of transmission of pathogens, donor criteria are selected according to strict criteria, donor plasma is tested and selected and the pool of plasma is monitored.

The production process includes stages for the removal and / or inactivation of pathogens.

For the production of Neocytotec, only the plasma of healthy donors is used, in which no antibodies to HIV type 1 and 2 have been detected, the hepatitis C virus and the hepatitis B surface antigen, and the activity of liver enzymes (transaminase) do not exceed the normal limit value. In addition to testing the plasma of individual donors, miniipules are first tested (testing by PCR for HIV, hepatitis A, B and C viruses, paravovirus B19), and then the production pool of plasma processed for Neocytotect (re-testing for antibodies to HIV type 1 and 2, hepatitis B and C viruses, as well as the PCR method for HIV, hepatitis B and C viruses).In production, a pool of plasma is used only with negative test results.

Neocytotect is made by fractionating ethanol in the cold. For inactivation and removal of possible viruses, treatment with tri-n-butyl phosphate / tween 80, octanoic acid and filtration is carried out. Additionally, the nanofiltration procedure is carried out.

Effect on the ability to drive transp. cf. and fur:

There is no indication that immunoglobulins can affect the ability to drive vehicles or service mechanisms.

Form release / dosage:

Solution for infusion, 100 U / ml.

Packaging:

For 10 ml or 50 ml of the drug in bottles of colorless glass, sealed with a cork made of bromobutyl rubber with an aluminum cap, one bottle in a pack of cardboard with instructions for use.

Storage conditions:In the dark place at a temperature of 2 to +8 ° C, do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:On prescription

Registration number:LS-002341

Date of registration:15.02.2012

The owner of the registration certificate:Biotest Pharma GmbHBiotest Pharma GmbH Germany

Manufacturer: & nbsp

BIOTEST PHARMA, GmbH Germany

Representation: & nbspBIOTEST PHARMA GmbHBIOTEST PHARMA GmbHRussia

Information update date: & nbsp13.10.2015

Illustrated instructions

Instructions

Neocytotect (NeoCytotect)