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

In 1 ml contains:

Active substance:

Proteins of human plasma

of them:

100-160 mg

Immunoglobulin G

not less than 97%

Titer of antibodies to tick-borne encephalitis virus in RTGA

not less than 1:80

Excipients:

Glycine

22.5 mg

Sodium chloride

8.5 mg

Water for injections

up to 1 ml

Description:

Transparent or slightly opalescent liquid, colorless or slightly yellow in color. During storage, a slight white precipitate may appear, completely disappearing when the preparation is shaken.

Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp

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

Pharmacodynamics:

The effective beginning of the drug are immunoglobulins of class G, possessing the activity of antibodies, neutralizing the tick-borne encephalitis virus (TBE).

Immunoglobulin against tick-borne encephalitis is a concentrated solution of the purified immunoglobulin fraction G, isolated by fractionation with ethanol at a temperature below 0 ° C from the blood plasma of healthy donors containing antibodies to the tick-borne encephalitis virus and tested individually from each donor for the absence of the surface antigen of the hepatitis B virusHBsAg), antibodies to the hepatitis C virus and human immunodeficiency virus (HIV-1 and HIV-2).

Neutralizes the effect of tick-borne encephalitis virus; forms an immunity on average for one month. The drug also has nonspecific activity, increasing the resistance of the body.

The titre of hemagglutinating antibodies to tick-borne encephalitis virus in immunoglobulin is not less than 1:80.

The concentration of protein in the preparation is from 10 to 16%.

Pharmacokinetics:

The maximum concentration of antibodies in the blood is reached 24-48 hours after administration; the half-life of antibodies from the body is 4-5 weeks.

Indications:Emergency prophylaxis and treatment of tick-borne encephalitis in adults and children.
Contraindications:

Severe allergic reactions in history to the administration of human blood products.

Carefully:

- Patients suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or who had a history of symptomatic response to any allergen (food, drugs, etc.), drug administration is carried out against the background of antihistamines. It is recommended to continue their use within 8 days after the last administration of the immunoglobulin;

- patients suffering from systemic diseases in the genesis of which are the leading immunopathological mechanisms (diseases of blood, connective tissue, nephritis and others), immunoglobulin should be administered against the background of appropriate therapy.

Pregnancy and lactation:

There are no data on the safety of use during pregnancy and during breastfeeding.The use of the drug is possible only for life indications.

Dosing and Administration:

Do not administer the drug intravenously!

Immunoglobulin is injected intramuscularly into the upper outer quadrant of the gluteus muscle or to the external surface of the thigh.

Before injection, the ampoule with the drug is kept for 2 hours at room temperature (20 ± 2 ° C). Opening of ampoules and the procedure of administration are carried out with strict adherence to aseptic and antiseptic rules. The drug in the opened ampoule is not subject to storage. The preparation is not suitable for use in ampoules with broken integrity or marking, with a change in physical properties (color change, cloudiness of solution, the presence of unbreakable flakes), in the event of a violation of the temperature storage regime.

The dose of the drug for prevention or treatment is calculated by volume, depending on the patient's body weight.

Prevention

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

Table of prophylactic dosages of immunoglobulin against CE

Body mass

Injection volume

5 kg

0.5 ml

10 kg

1.0 ml

20 kg

2.0 ml

30 kg

3.0 ml

40 kg

4.0 ml

50 kg

5.0 ml

60 kg

6.0 ml

70 kg

7.0 ml

80 kg

8.0 ml

Introduction after a tick bite

The drug should be administered at the earliest possible time from the date of the alleged infection, no later than the 4th day after the tick bite.

For the purpose of emergency prophylaxis, the drug is administered in a single dose not vaccinated against tick-borne encephalitis or receiving an incomplete vaccination course that noted the sucking of ticks in endemic areas, as well as suspected of laboratory infection with the 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 in a single dose and inoculated patients.

Children under 12 years - 1 ml; 12-16 years old - 2 ml; over 16 years old - 3 ml.

In the case of a new tick bite, it is possible to repeat the use of the drug at the same dose one month after the first administration.

Introduction before the tick bite

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

Treatment

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

Patients with erased and abortive forms of CE (febrile forms of infection), immunoglobulin is administered daily in a single dose of 0.1 ml / kg body weight for 3-5 days before the regression of common infection symptoms (improvement in general condition, disappearance of fever). The average course dose for an adult is at least 21 ml of the drug.

With meningeal form of CE The drug is used daily in a single dose of 0.1 ml / kg of body weight twice a day 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 or reduction of meningeal symptoms). The average course of an immunoglobulin for an adult is at least 70 ml.

Patients with focal forms of tick-borne encephalitis depending on the severity of the disease, the drug is administered daily in a single dose of 0.1 ml / kg of body weight 2-3 times a day at intervals 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 is on average 80 to 130 ml of immunoglobulin.

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

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

In the case of a two-wave flow of tick-borne encephalitis, the drug is used repeatedly according to the scheme of treatment of meningeal or focal forms depending on the nature of the clinical manifestations.

Side effects:

Reactions to the introduction of immunoglobulin, as a rule, are absent.

In rare cases, local reactions in the form of hyperemia and pain in the area of ​​injection can develop. To prevent this, it is recommended to distribute a large dose of the drug to several parts of the body.

It is possible to raise the body temperature to 37.5 ° C during the first 24 hours after the administration of the drug.

Individual patients with altered reactivity may develop allergic reactions of various types, and in exceptional cases, anaphylactic shock.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

Cases of overdose are not described.

Interaction:

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

Active immunization with live viral vaccines (against measles, mumps, rubella) should be delayed for up to 3 months after the last administration of immunoglobulin, since it can reduce the effectiveness of the live vaccine.

The interval between the introduction of immunoglobulin and the subsequent administration of tick-borne encephalitis vaccine should be at least 4 weeks.

Special instructions:

To prevent the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen.

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

After the administration of the drug, patients should be under medical supervision for 30 minutes. The treatment rooms where the drug is administered should be equipped with anti-shock therapy. Patients with autoimmune diseases (including blood diseases, connective tissue, nephritis) should be given the drug on the background of appropriate therapy.

The drug is used only as prescribed by the doctor.

The introduction of immunoglobulin is registered in the prescribed registration forms with the serial number, control number, expiration date, manufacturer, date of administration, dose and nature of the reaction to the administration.

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 requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for intramuscular injection.

Packaging:

1 ml or 2 ml in ampoules with a break ring of glass HC with a capacity of 2 ml or 3 ml, respectively.

For 10 ampoules are placed in a tray of corrugated cardboard and together with instructions for use in a pack of cardboard box.

Storage conditions:

Store at a temperature of 2 to 8 ° C. Freezing is not allowed.

Keep out of the reach of children.

Transportation conditions

Transport 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:LP-003446
Date of registration:04.02.2016
Expiration Date:04.02.2021
The owner of the registration certificate:Chelyabinsk Regional Blood Transfusion StationChelyabinsk Regional Blood Transfusion Station Russia
Manufacturer: & nbsp
Information update date: & nbsp07.11.2017
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