Human immunoglobulin normal, ampoules,1.5ml/dose 1.5ml,10pcs

Composition

Active ingredient:

• immunoglobulin G – 1.25 g.

Auxiliary substances:

• maltose monohydrate – 0.35 g;
• dextrose monohydrate-0.35 g;
• glycine-0.20 g.

The product does not contain preservatives or antibiotics.

Pharmacological action

Immunovenin ® is a purified fraction of immunoglobulins isolated by ethyl alcohol fractionation at temperatures below 0 < sup>o< / sup>C from the blood plasma of healthy donors.

A mixture of plasma from at least 1000 donors is used for fractionation.

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;
• as part of complex therapy for postoperative complications accompanied by septicemia;

Substitution therapy.

• with primary (congenital agammaglobulinemia and hypogammaglobulinemia) immunodeficiency;
• with secondary immunodeficiency in patients with myeloma and chronic lymphocytic leukemia with recurrent infections;
• with congenital HIV infection with recurrent infections in children.

Contraindications

• hypersensitivity to human immunoglobulin, especially in rare cases of deficiency in the blood of class A immunoglobulin (IgA) and the presence of antibodies against IgA;
• hypersensitivity to the components of the drug;
• a history of allergic reactions to blood products.

In cases of severe sepsis, the only contraindication for use is anaphylactic shock on a history of blood products.

Side effects

The development of adverse reactions depends on the dose and the rate of use of the drug. According to numerous studies of immunoglobulin preparations for intravenous use, the following side effects are possible: :

• flu-like syndrome: chills, headache, hyperthermia;
• from the digestive system: nausea, vomiting;
• from the cardiovascular system: reduced blood pressure, rarely-collapse.

In isolated cases, reversible aseptic meningitis, transient hemolytic anemia, hemolysis, acute renal failure, and hypercreatinemia may develop. Since there is evidence that high-dose immunoglobulin use leads to a relative increase in blood viscosity, it is suggested that there is a relationship between intravenous use of immunoglobulins and thromboembolic events, such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis, especially in at-risk groups. Individuals with altered reactivity may develop various types of allergic reactions, and in extremely rare cases-anaphylactic shock, and therefore, people who received the drug should be under medical supervision for an hour. In the room where the drug is administered, anti-shock therapy should be available.

Interaction

The drug can be used in complex therapy of the disease in combination with other medications. At the same time, it is not allowed to mix the drug with other drugs, and a separate infusion system should always be used for use. It may reduce the effectiveness of active immunization: live vaccines (against measles, mumps, rubella, chickenpox) are administered no earlier than 3 months after the introduction of immunoglobulin.

How to take, course of use and dosage

Diluted immunoglobulin is administered at a rate of 8-10 drops per minute (faster use may cause the development of a collaptoid reaction). Infusions are performed 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 use may cause the development of a collaptoid reaction). The course of treatment consists of 3-10 infusions, carried out in 24-72 hours (depending on the severity of the disease). Substitution therapy for primary immunodeficiency: a single dose is 0.4-0.8 g (8-16 ml) per kg of body weight once. use is repeated every 2 to 4 weeks at a dose of 0.2-0.8 g (4 to 16 ml) per kg of body weight to maintain the plasma IgG titer at the level of 4 to 6 g/l. Plasma IgG levels should be monitored to determine the optimal dose and interval between injections. Replacement therapy for secondary immunodeficiency in patients with myeloma and chronic lymphocytic leukemia with recurrent infections; replacement therapy in children with congenital HIV infection with recurrent infections: the dose is 0.2-0.4 g (4-8 ml) per kg of body weight. use is repeated after 3 to 4 weeks to maintain the IgG titer in plasma at the level of 4 to 6 g/l. Plasma IgG levels should be monitored to determine the optimal dose and interval between injections. Immunovenin ® is used only in a hospital setting in compliance with all the rules of asepsis. The preparation and solvent are not suitable for use in bottles with broken integrity, labeling, as well as when the color of the preparation and solvent changes, when the transparency of the solvent changes, when the expiration date has expired, and when stored improperly. Before use, 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 supplied solvent

Special instructions

Immunoglobulin is used only as prescribed by a doctor. The introduction of immunoglobulin is recorded in the established accounting forms with the indication of the batch number, release date, expiration date, manufacturer, date of use, dose, and the nature of the reaction to the drug use.

After the introduction of immunoglobulin, vaccinations against measles and mumps are carried out no earlier than 3 months later. After vaccination against these infections, immunoglobulin should be administered no earlier than 2 weeks; if necessary, the use of immunoglobulin earlier than this period, vaccination against measles or mumps should be repeated. Vaccinations against other infections can be carried out at any time before or after the introduction of immunoglobulin.

Product form

solution for injection

Storage conditions

Store in a dry place, protected from light, at a temperature of 2-8 °C. Freezing is not allowed.

Shelf life

1 year

Active ingredient

Human immunoglobulin is normal

Conditions of release from pharmacies

By prescription

Dosage form

infusion solution