Active substanceImmunoglobulin against tick-borne encephalitisImmunoglobulin against tick-borne encephalitis
Dosage form: & nbspsolution for intramuscular injection
Composition:

1 ml of the preparation contains:

as an active substance: human immunoglobulin against tick-borne encephalitis 100-160 mg;

Excipients: glycine 20 mg, sodium chloride 9 mg, water for injection.

Description:

Transparent or slightly opalescent liquid, colorless or slightly yellow in color, without foreign inclusions.

Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp

J.06.B.B.12   Human immunoglobulin against tick-borne encephalitis

Pharmacodynamics:

The drug is a concentrated solution of the purified immunoglobulin fraction extracted from the donor plasma containing an antibody to tick-borne encephalitis (TBE) virus. The effective beginning of the drug are immunoglobulins of class G, possessing the activity of antibodies, neutralizing the CE virus.

To produce the drug, plasma is obtained from healthy donors tested for the absence of antibodies to human immunodeficiency virus (HIV) types 1 and 2, against hepatitis C virus, and also for the surface antigen of the hepatitis B virus. The protein concentration in the immunoglobulin is 10-16%. The titre of hemagglutinating antibodies to the CE virus is not less than 1:80.

The drug also increases the nonspecific resistance of the body.

Pharmacokinetics:

The maximum concentration of antibodies in the blood is reached after 24 hours; the half-life of antibodies from the body is 4-5 weeks.

Indications:

The drug is intended for emergency prevention and treatment of tick-borne encephalitis in adults and children.

Contraindications:

Contraindicated in the introduction of immunoglobulin to people who have a history of allergic reactions or severe systemic reactions to human blood products.

Pregnancy and lactation:

The use of the drug during pregnancy and lactation is possible only for life indications.

Dosing and Administration:

Immunoglobulin is injected intramuscularly into the upper outer quadrant of the gluteus muscle or to the external surface of the thigh. Do not administer the drug intravenously.

The dose of immunoglobulin and the frequency of its administration depend on the indications for use.

Prevention

Introduction before the tick bite

The drug can be used before a probable contact with the virus CE - tick bite in an endemic area (pre-exposure prevention). The protective effect manifests itself in 24-48 hours and lasts about 4 weeks. To maintain immune protection, in case of danger of infection, it is recommended to repeat the administration of immunoglobulin after 4 weeks.

For the purpose of prevention, the drug is administered intramuscularly once at a rate of 0.1 ml per 1 kg of body weight.

Introduction after a tick bite

For the purpose of emergency prophylaxis, the drug is administered primarily unvaccinated against CE or who received an incomplete vaccination course that noted tick sucking in endemic areas, as well as suspected laboratory infection with CE virus.

In cases of increased risk of infection (infection of sucking tick, multiple bites or simultaneous suction of several mites), the drug is administered to vaccinated individuals.

In the case of a new contact with ticks, it is possible to reapply the drug one month after the first administration.

In all cases, the drug should be administered at the earliest possible time from the date of the alleged infection, no later than the fourth day after the tick bite.

Prophylactic dosages of immunoglobulin against TB

Body mass

5 kg

10 kg

20 kg

30 kg

40 kg

50 kg

60 kg

70 kg

80 kg

Scope

injections

0.5 ml

1.0 ml

2.0 ml

3.0 ml

4.0 ml

5.0 ml

6.0 ml

7.0 ml

8.0 ml

Treatment

With therapeutic purpose, immunoglobulin is administered at the earliest possible time after the onset of the disease in various dosages, depending on the body weight, the clinical form of the infection, the severity of the course and the period of the disease.

- B(with febrile forms of infection), immunoglobulin is administered daily in a single dose of 0.1 ml / kg of body weight, for 3-5 days before the regression of common infectious symptoms (general improvement, disappearance of fever).The average course dose for an adult is at these forms not less than 21.0 ml of the drug.

- PIn the meningeal form of CE, the drug is applied daily in a single dose of 0.1 ml / kg of body weight at intervals of 10-12 hours for at least 5 days until the patient's general condition improves according to objective indicators (disappearance of fever, regression of common infectious symptoms, stabilization and reduction of meningeal symptoms). The average course of an immunoglobulin for an adult is at a meningeal form of infection of at least 70.0 ml.

- Bwith focal forms of tick-borne encephalitis, depending on the The severity of the disease is given daily in a single dose of 0.1 ml / kg of body weight with an interval of 8-12 hours for at least 5-6 days before the temperature decreases and the neurological symptoms stabilize. The average course dose for an adult patient is on the average not less than 80.0-130.0 ml of immunoglobulin.

In extremely severe disease, a single dose of the drug can be increased to 0.15 ml / kg body weight.

If patients with meningeal and focal forms of CE for any reason in the febrile stage of the disease, specific therapy was not performed,it is possible to administer the immunoglobulin and at the apyrexia stage of the acute period of the disease with a therapeutic purpose for 5-6 days in a single dose of 0.1 ml / kg of body weight in 10-12 hours.

In the case of a two-wave CE course, the drug is used repeatedly according to the treatment regimen for meningeal or focal forms, depending on the nature of the clinical manifestations.

Side effects:

In rare cases, local reactions may occur in the form of hyperemia and rise in temperature to 37.5 ° C during the first 24 hours after the administration, as well as dyspepsia.

Individual people with altered reactivity may develop allergic reactions of various types, and in exceptional cases, anaphylactic shock. Therefore, the person who received the drug should be monitored for 30 minutes.

Interaction:

The drug can be used in combination with other drugs, provided it is administered as a separate injection, without mixing with other drugs.

Special instructions:

The preparation should be visually transparent, should not contain a suspension and a sediment. It is considered suitable for use under the condition of the preservation of tightness and sealing, the absence of cracks in the ampoules, the safety of the label.The results of visual inspection and data labels (the name of the drug, the manufacturer, batch number) are recorded in the history of the disease.

Before the injection, the ampoule with the drug is kept for two hours at room temperature (20 ± 2) ° C. To prevent the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen.

The drug in the opened ampoule is not subject to storage.

Treatment with immunoglobulin drugs reduces the effectiveness of vaccination, so vaccinations are carried out no earlier than 2-3 months after the introduction of immunoglobulin against CE.

Persons with allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria), or prone to allergic reactions, on the day of immunoglobulin administration and for the next 8 days, the appointment of antihistamines is recommended. In the period of aggravation of the allergic process, the drug is administered by the conclusion of an allergist.

Persons suffering from immunopathological systemic diseases (blood diseases, connective tissue, nephritis and others) should be given the drug on the background of appropriate therapy. In the room where the drug is administered, there should be antishock therapy. With the development of anaphylactic reactions, antihistamines, glucocorticosteroids and adrenomimetics are used.

Form release / dosage:Solution for intramuscular injection, 100-160 mg / ml.
Packaging:

1 ml per ampoule with a capacity of 2 ml.

10 ampoules are packed in a pack of cardboard box. In the pack, put the instructions for use and the ampoule knife.

Storage conditions:

In dry, protected from light and out of reach of children at a temperature of 2 to 8 ° C.

Freezing is not allowed.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription
Registration number:P N001818 / 01
Date of registration:09.04.2009 / 11.09.2012
Expiration Date:Unlimited
The owner of the registration certificate:SVERDLOVSK REGIONAL STATION OF BLOOD TRANSFUSION OF GBUZ SOSVERDLOVSK REGIONAL STATION OF BLOOD TRANSFUSION OF GBUZ SO Russia
Manufacturer: & nbsp
Information update date: & nbsp24.10.2017
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