Иммуновенин®

General characteristics. Structure:

Active ingredient: 1,25 g of immunoglobulin G.

Excipients: maltose monohydrate, dextrose monohydrate, glycine. Drug does not contain preservatives and antibiotics.

Immunovenin ® represents the cleared fraction of immunoglobulins allocated with a fractionation method alcohol at a temperature below 0 °C from a blood plasma of healthy donors. For fractionation plasma mix not less than from 1000 donors is used.

Pharmacological properties:

Active component of drug are the immunoglobulins having activity of antibodies of various specificity. Drug has also nonspecific activity which is shown in increase in resistance of an organism.

Indications to use:

Drug is used without age restrictions:

• as a part of complex therapy for treatment of severe toxic forms of bacterial and viral infections;
• as a part of complex therapy of the postoperative complications which are followed by a septicaemia.

Replacement therapy.

• at primary (an inborn agammaglobulinemia and a hypogammaglobulinemia) an immunodeficiency;
• at secondary immunodeficience at patients with a multiple myeloma and chronic lymphoid leukosis with recurrent infections;
• at inborn HIV infection with recurrent infections at children.

Route of administration and doses:

The drug is administered intravenously, kapelno. Immunovenin ® just before introduction dissolve in the enclosed solvent - water for injections. After dissolution drug represents colourless or slightly yellowish transparent liquid, weak opalescence is allowed.

For children the single dose of drug makes 0,15-0,2 g (3-4 ml) on body weight kg, but no more than 1,25 g (25 ml). Just before introduction of Immunovenin® dissolve in the enclosed solvent and in addition part 0,9% with chloride sodium solution at the rate of 1 part of drug and 4 parts of the parting solution.

Divorced immunoglobulin is entered with a speed of 8-10 thaws a minute (more bystry introduction can cause development of kollaptoidny reaction). Infusions carry out daily within 3-5 days.

For adults the single dose of drug makes 1,25 - 2,5 g (25 - 50 ml). Dissolved Immunovenin® (without additional cultivation) is entered with a speed of 30-40 thaws a minute (more bystry introduction can cause development of kollaptoidny reaction). The course of treatment consists of 3-10 infusions which are carried out in 24-72 hours (depending on disease severity).

Replacement therapy at primary immunodeficiences: the single dose makes 0,4-0,8 g (8-16 ml) on body weight kg once. Introduction is repeated by each 2 - 4 weeks in a dose of 0,2-0,8 g (4-16 ml) on body weight kg for maintenance of a caption of IgG in plasma at the level of 4 - 6 g/l.

For definition of an optimum dose and an interval between introductions it is necessary to control the IgG level in plasma.

Replacement therapy at secondary immunodeficiences at patients with a multiple myeloma and a chronic lymphoid leukosis with recurrent infections; replacement therapy at children with inborn HIV infection with recurrent infections: the dose makes 0,2 - 0,4 (4 - 8 ml) on body weight kg. Introduction is repeated in 3 - 4 weeks for maintenance of a caption of IgG in plasma at the level of 4 - 6 g/l. For definition of an optimum dose and an interval between introductions it is necessary to control the IgG level in plasma.

Immunovenin ® apply only in the conditions of a hospital at observance of all rules of an asepsis. Drug and solvent in bottles with the broken integrity, marking is not suitable for use, and also at discoloration of drug and solvent, at change of transparency of solvent, at the expired period of validity, at the wrong storage. Before introduction bottles maintain at a temperature (20±2) ºС not less than 2 hours. Drug has to be dissolved completely within 10 min. in volume of the enclosed   solvent.

The dissolved  drug       is not subject to storage.

Features of use:

To the persons having allergic diseases (bronchial asthma, atopic dermatitis, a recurrent small tortoiseshell) or inclined to allergic reactions administration of drug is carried out against the background of antihistamines. At the same time it is recommended to continue their introduction within 3 days after the termination of a course of treatment. In the period of an aggravation of allergic process administration of drug is carried out according to the conclusion of the allergist according to vital indications.

To the persons having diseases in which genesis leaders are immunopathological mechanisms (collagenoses, immune diseases of blood, nephrite) drug it is appointed after consultation of the corresponding specialist.

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

To apply with care in the following risk groups:

• at persons 65 years are more senior;
• at hypertensia;
• at a diabetes mellitus;
• at diseases of vessels or the phenomena of thromboses in the anamnesis;
• at the hereditary or acquired trombofilny disturbances;
• at the patients who were long in a motionless state;
• at patients with a heavy hypovolemia;
• at patients with chronic diseases at which viscosity of blood is increased;
• at patients with a renal failure;
• at the lowered volume of the circulating blood;
• at excess body weight;
• at a concomitant use of the drugs having nephrotoxic effect.

Patients who have a risk of development of an acute renal failure or thromboembolism the drug should administer with the lowest speed and the lowest dose.

Use at pregnancy and during breastfeeding. Safety of use of this medical supply at pregnancy and feeding by a breast in the course of controlled clinical tests was not investigated. However long-term clinical experience of use of immunoglobulins for intravenous administration at pregnancy shows that it is not necessary to expect any adverse effect at pregnancy neither concerning mother, nor concerning a fruit or the newborn.

Immunoglobulins are emitted with milk of mother and can promote transfer of protective antibodys from mother to the newborn. Use during breastfeeding is allowed according to the recommendation of the attending physician.

Side effects:

Development of collateral reaktsiyzavisit from the size of a dose and rate of administering of drug.

According to numerous researches of drugs of immunoglobulins for intravenous administration the following side effects are possible:
• grippopodobny syndrome: fever, headache, hyperthermia;
• from the alimentary system: nausea, vomiting;
• from cardiovascular system: the lowering of arterial pressure, is rare – a collapse.

In isolated cases development of reversible aseptic meningitis, passing hemolitic anemia, hemolysis, an acute renal failure and a hypercreatinemia is possible. As there are data that introduction of a high dose of immunoglobulin leads to relative increase in viscosity of blood, assume existence of interrelation between intravenous administration of immunoglobulins and the phenomena of a thromboembolism, such as myocardial infarction, stroke, embolism of lungs and deep vein thrombosis, especially in risk groups.

At individuals with the changed reactivity allergic reactions of various type, and in exclusively exceptional cases - an acute anaphylaxis in this connection, the persons who received drug have to be under medical observation within an hour can develop.

Indoors, where administer the drug, there have to be means of antishock therapy.

Interaction with other medicines:

Drug can be used in complex therapy of a disease in combination with other medicines. At the same time mixing of drug with other medicines is not allowed, for introduction it is always necessary to use separate system for infusion.

Can reduce efficiency of active immunization: live vaccines (against measles, epidemic parotitis, a rubella, chicken pox) enter not earlier than in 3 months after administration of immunoglobulin.

Contraindications:

• hypersensitivity to immunoglobulin of the person, especially in seldom found deficit cases in blood of immunoglobulin of a class A (IgA) and existence of antibodies against IgA;
• hypersensitivity to drug components;
• existence in the anamnesis of allergic reactions to blood preparations.

In cases of heavy sepsis the only contraindication for introduction is the acute anaphylaxis on blood preparations in the anamnesis.

Storage conditions:

In the dry, protected from light place, at a temperature of 2-10 °C. To store in the place, unavailable to children. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for preparation of solution for intravenous administration. Is issued complete with solvent. 1 bottle (bottle) with the drug lyophilized from volume 25 or 50 ml, and 1 bottle (bottle) from 25 or 50 ml of solvent (water for injections) respectively is included in the package. 1 set with the application instruction in a pack from a cardboard. 1 set with system for hemotransfusion and the application instruction in a pack from a cardboard