Immunovinin - instructions for use, dose, side effects, contraindications

Immunovenin® is a purified fraction of immunoglobulins isolated by fractionation with ethyl alcohol at a temperature below 0 ° C from the blood plasma of healthy donors. For fractionation, a plasma mixture of at least 1000 donors is used. All plasma used in production is individually tested for the absence of a surface antigen of the hepatitis B virusHBsAg), antibodies to human immunodeficiency virus HIV-1 and HIV-2, antigen p24 of HIV-1, antibodies to hepatitis C virus, the absence of RNA of hepatitis C virus, antibodies to the causative agent of syphilis.

Immunovenin® contains a wide range of specific antibodies against infectious agents that are capable of opsonizing and neutralizing microbes and toxins.The introduction of the drug replenishes the level of antibodies in blood of the recipient. The drug also has nonspecific activity, manifested in increasing the resistance of the body. The introduction of the drug restores low levels of immunoglobulin G up to normal values.

Pharmacokinetics:

The entire administered dose of the drug comes directly into the bloodstream of the recipient immediately after administration. After approximately 6 days, an equilibrium of the distribution of the immunoglobulin between the intra- and extravascular bed is achieved.

Indications:

The drug is used without age restrictions:

- as part of complex therapy for the treatment of severe toxic forms of bacterial and viral infections;

- in the complex therapy of postoperative complications, accompanied by septicemia.

Substitution therapy:

- at primary (congenital agammaglobulinemia and hypogammaglobulinemia) immunodeficiency;

- with secondary immunodeficiency in patients with myeloma and chronic lymphatic leukemia with relapsing infections;

- with congenital HIV infection with recurrent infections in children.

Contraindications:

- PAn increased sensitivity to human immunoglobulin, especially in rare cases of a deficiency in the blood of an immunoglobulin class A (IgA) and the presence of antibodies against IgA;

- hypersensitivity to the components of the drug;

- presence in the anamnesis of allergic reactions to blood preparations.

In cases of severe sepsis, the only contraindication for administration is an anaphylactic shock to blood products in the anamnesis.

Carefully:

Persons suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions, the drug is administered against the background of antihistamines. It is recommended to continue their introduction within 3 days after the end of the course of treatment. During the acute allergic process, the drug is administered by the conclusion of an allergist according to vital indications.

Persons suffering from diseases in the genesis of which the immunopathological mechanisms (collagenosis, immune diseases of the blood, nephritis) are leading, the drug is appointed after consultation of the relevant specialist.

There are suspicions about the relationship between the administration of intravenous immunoglobulins and the phenomena of thromboembolism, such as myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis.

Use with caution in the following risk groups:

- in persons older than 65 years;

- with hypertension;

- with diabetes mellitus;

- with vascular disease or history of thrombosis in the anamnesis;

- with hereditary or acquired thrombophilic disorders;

- patients who were for a long time immobile;

- in patients with severe hypovolemia;

- in patients with chronic diseases, in which the viscosity of the blood is increased;

- in patients with impaired renal function;

- with a reduced volume of circulating blood;

- with excessive body weight;

- while taking medications that have a nephrotoxic effect.

Patients who have a risk of developing acute renal failure or thromboembolism should be given the drug at the lowest possible rate and at the lowest possible dose.

Pregnancy and lactation:

The safety of the use of this medication during pregnancy and lactation during controlled clinical trials has not been investigated.However, the long-term clinical experience of the use of immunoglobulins for intravenous administration in pregnancy shows that one should not expect any harmful effects in pregnancy, either in relation to the mother, or to the fetus or newborn.

Immunoglobulins are excreted with the mother's milk and can facilitate the transfer of protective antibodies from the mother to the newborn. The use during the period of breastfeeding is allowed on the recommendation of the attending physician.

Dosing and Administration:

The drug is administered intravenously, drip. Immunovinin® immediately before administration is dissolved in the supplied solvent-water for injections. After dissolution, the preparation is a colorless or slightly yellowish transparent liquid, slight opalescence is allowed.

For children a single dose of the drug is 0.15-0.2 g (3-4 ml) per kg of body weight, but not more than 1.25 g (25 ml). Imunovenin® is dissolved immediately in the supplied solvent and additionally diluted with 0.9% solution of sodium chloride at the rate of 1 part of the drug and 4 parts of the dilution solution. Diluted immunoglobulin is administered at a rate of 8-10 drops per minute (faster administrationcan cause the development of a collapoid reaction). Infusions are carried out daily for 3-5 days.

For adults a single dose of the drug is 1.25-2.5 g (25-50 ml). Dissolved Immunovenin® (without additional dilution) is administered at a rate of 30-40 drops per minute (faster administration may cause the development of a collapoid reaction). The course of treatment consists of 3-10 infusions, conducted in 24-72 hours (depending on the severity of the disease).

Substitution therapy for primary immunodeficiencies: single dose is 0.4-0.8 g (8-16 ml) per kg of body weight once. The administration is repeated every 2-4 weeks at a dose of 0.2-0.8 g (4-16 ml) per kg of body weight to maintain the IgG titer in the plasma at a level of 4-6 g / l. To determine the optimal dose and the interval between administrations, the level of IgG in the plasma should be monitored.

Substitution therapy for secondary immunodeficiency in patients with myeloma and chronic lymphocytic leukemia with recurrent infections; substitution therapy in children with congenital HIV infection with relapsing infections: the dose is 0.2-0.4 g (4-8 ml) per kg of body weight. The administration is repeated after 3-4 weeks to maintain the IgG titer in the plasma at a level of 4-6 g / l.To determine the optimal dose and the interval between administrations, the level of IgG in the plasma should be monitored.

Immunovenin® is used only in a hospital setting, while observing all asepsis rules. The preparation and solvent in bottles with broken integrity, marking, and also when the color of the preparation and the solvent, when the transparency of the solvent is changed, with expired shelf life, with improper storage is not suitable for use. Before administration, the vials are kept at a temperature of (20 ± 2) ° C for at least 2 hours. The preparation should be completely dissolved within 10 minutes in the volume of the applied solvent. Dissolved drug is not subject to storage.

Side effects:

The development of adverse reactions depends on the size of the dose and the rate of administration of the drug.

According to numerous studies of preparations of immunoglobulins for intravenous administration, the following side effects are possible:

- flu-like syndrome: chills, headache, hyperthermia;

- from the digestive system: nausea, vomiting;

- from the cardiovascular system: lowering blood pressure, rarely - collapse.

In isolated cases, it is possible to develop reversible aseptic meningitis, transient hemolytic anemia, hemolysis, acute renal failure and hypercreatinemia.

Since there is evidence that the administration of a high dose of immunoglobulin leads to a relative increase in blood viscosity, there is a relationship between intravenous immunoglobulin administration and thromboembolism, such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis, especially in at-risk groups.

Individuals with altered reactivity may develop allergic reactions of various types, and in extremely rare cases, anaphylactic shock, and therefore, those who receive the drug should be under medical supervision for an hour. In the room where the drug is administered, there should be antishock therapy.

Overdose:

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

Interaction:

The drug can be used in complex therapy of the disease in combination with other drugs. It is not allowed to mix the drug with other drugs, for the introduction should always use a separate system for infusion.

May reduce the effectiveness of active immunization: live vaccines (against measles, mumps, rubella, chicken pox) are administered no earlier than 3 months after the administration of immunoglobulin.

Special instructions:

During the administration of the drug, the patient's condition should be carefully monitored.

For all patients receiving immunoglobulin, it is necessary to conduct adequate hydration (intake of sufficient amount of fluid) before starting infusion, monitor diuresis, control the plasma creatinine concentration, exclude the use of loop diuretics.

The introduction of an immunoglobulin can lead to a transient increase in various passive transferred antibodies in the patient's blood and to false positive results of serological tests (for example, the Coombs test).

Due to the presence of glucose and maltose in the preparation, it is possible to increase the concentration of glucose in the blood of the patient, which affects the result of its determination.Elevated blood glucose values are determined at the time of drug administration and within 15 hours after drug administration. This fact should be taken into account when prescribing therapy for patients with diabetes mellitus.

The preparation should be registered in the prescribed registration forms with the name of the drug, serial number, date of issue, expiration date, manufacturer, date of administration and adverse reactions to the drug.

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

The drug does not affect the ability to drive vehicles, mechanisms, as well as activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Lyophilizate for the preparation of a solution for intravenous administration, 50 mg / ml (complete with a solvent).

Packaging:

The kit includes 1 bottle (bottle) with a drug lyophilized from a volume of 25 or 50 ml, and 1 bottle (bottle) with 25 or 50 ml of solvent (water for injection), respectively.

1 set with instructions for use in a pack of cardboard.

1 set with a system for blood transfusion and instructions for use in a pack of cardboard.

Storage conditions:

Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C out of the reach of children.

Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N000296 / 01

Date of registration:07.04.2009

The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Manufacturer: & nbsp

MICROGEN FGUP NGO Russia

Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Information update date: & nbsp14.10.2015

Illustrated instructions

Instructions

Immunovinin® (Immunovenin®)