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

1 ml of the preparation contains:

active substance: immunoglobulin against tick-borne encephalitis virus (titer antibodies to tick-borne encephalitis virus at least 1:80 HAI);

adjuvant: Stabilizer - glycine (aminoacetic acid) - (22,5 ± 7,5) mg.

The preparation is a concentrated solution of purified immunoglobulin fraction isolated by fractionation with ethanol at a temperature below 0 ° C from the plasma of healthy donors containing antibodies to tick-borne encephalitis virus and checked individually from each donor in the absence of surface antigen of hepatitis B virus (HBsAg), antibodies to hepatitis C virus and human immunodeficiency virus (HIV-1 and HIV-2), as well as HIV-1 antigen p24. The concentration of protein in the preparation is from 10 to 16%. The drug does not contain preservatives and antibiotics.

Description:

Transparent or slightly opalescent liquid, colorless or slightly yellow in color. In the course of storage, a slight deposit may appear, disappearing with slight shaking.

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). The drug also increases the nonspecific resistance of the body.

Pharmacokinetics:

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

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

Severe allergic reactions to the introduction of human blood products in the anamnesis.

Carefully:

Persons suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or having a history of clinically expressed reactions to any allergens (food, medicinal, etc.), the drug is administered against the background of antihistamines. It is recommended to continue the use of antihistamines within 8 days after the last injection of immunoglobulin.

Persons suffering from systemic diseases, in the genesis of which are the leading immunopathological mechanisms (diseases of blood, connective tissue, nephritis, etc.), 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.

Dosing and Administration:

Immunoglobulin is injected intramuscularly into the upper outer quadrant of the buttockushcs or in the outer surface of the thigh. Before the injection, the ampoule with the drug is kept for 2 hours at a temperature of 18 to 22 ° 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 immunoglobulin and the frequency of its administration depend on the indications for use.

Prevention

FROM The purpose of prevention of the drug is administered once for 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 ml

20 kg

2 ml

30 kg

3 ml

40 kg

4 ml

50 kg

5 ml

60 kg

6 ml

70 kg

7 ml

80 kg

8 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 prevention, 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 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 vaccinated persons.

In the case of a new tick bite, after a month after the first injection, the drug is administered again in the same dose.

Introduction before the tick bite

The drug can be used before probable contact with tick-borne encephalitis virus - tick bite in the endemic area (pre-exposure prophylaxis). The protective effect manifests itself in 24-48 hours and lasts about 4 weeks. At the end of this period, in case of danger of infection, it is recommended to repeat the administration of immunoglobulin after 4 weeks.

Treatment

With a therapeutic purpose, the immunoglobulin is administered at the earliest possible time after the onset 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 of body weight, 3-5 days before the regression of common infectious symptoms (general improvement, 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 applied 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 overall 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 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 5-6 days before the temperature decreases and the neurological symptoms stabilize. The average course for an adult patient is an average of 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 patients with meningeal and focal forms of CE for any reasons in the fever stage of the disease did not undergo specific therapy, it is possible to administer the 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 via 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 that the temperature rises to 37.5 ° C during the first 24 hours after the administration of the drug.

Individual people with altered reactivity may develop allergic reactions of various types, and in extremely rare cases, anaphylactic shock.

Overdose:

Cases of overdose are not described.

Interaction:

The drug can be used in complex therapy 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:

Do not administer the drug intravenously.

To prevent the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen. Given the possible occurrence of anaphylactic reactions in particularly sensitive individuals, it is necessary to provide medical supervision of the patients after the administration of the drug for 30 minutes. Procedural rooms where immunoglobulin is administered should be provided with anti-shock therapy. When symptoms of an allergic reaction appear, appropriate therapy is immediately performed.

The introduction of immunoglobulin is recorded in the prescribed registration forms with the name of the drug, the number of the series, the expiration date, the manufacturer, the date of administration of the dose and the nature of the reaction to the administration.

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

The drug has no effect on the ability to drive vehicles, mechanisms, as well as activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:Solution for intramuscular injection.
Packaging:

For 1 or 3 ml in ampoules of glass.

A) For 10 ampoules with instructions for use, a vial ampoule or scarifier ampullum in a pack (box) of cardboard.

B) 5 ampoules in a cassette contour pack.

2 cassette contour packs with instructions for use in a pack of cardboard.

When packaging ampoules that have a break ring or an opening point, the ampoule knife or the ampoule scapegrator is not put in.

Storage conditions:

Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

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

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription
Registration number:LS-001279
Date of registration:01.08.2011 / 03.06.2013
Expiration Date:Unlimited
The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Manufacturer: & nbsp
Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Information update date: & nbsp07.11.2017
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