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

Active component: human immunoglobulin in a protein concentration of 100 to 160 mg / ml;

Excipients: aminoacetic acid (glycine) from 15 to 30 mg / ml, water for injection up to 1 ml.

Description:

Transparent or slightly opalescent liquid, colorless or slightly yellow in color. The appearance of a slight precipitate, which disappears when shaken, is allowed.

Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp

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

Pharmacodynamics:

Immunologically active agent obtained by fractionating human plasma containing antibodies to tick-borne encephalitis virus, tested individually from each donor for the absence of antibodies to HIV-1, HIV-2, to hepatitis C virus and hepatitis B surface antigen. The drug also increases nonspecific resistance organism.

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:

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

Contraindications:

Contraindications for the use of immunoglobulin are severe allergic reactions in the history of the administration of human blood products.

Persons with allergic diseases or having a history of clinically expressed reactions to any allergens (food, medicinal, etc.), on the day of immunoglobulin administration and for the next 8 days, the appointment of antihistamines is recommended.

If you have any of the listed diseases, always consult a doctor before using the drug.

Pregnancy and lactation:

Studies on the effect of immunoglobulin on reproductive function have not been conducted, experience in pregnant women is limited. Immunoglobulin should be used only with convincing indications. It should be used with caution during lactation (breastfeeding). Immunoglobulins pass into breast milk and can facilitate the transfer of protective antibodies to newborns.

Dosing and Administration:

Enter intramuscularly, in the upper outer quadrant of the gluteus muscle or in the external surface of the thigh. Do not administer the drug intravenously!

Before the 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. 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.

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

Prevention

Prophylaxis before tick bite

The drug can be used before probable contact with tick-borne encephalitis virus - tick bite in the endemic area (pre-exposureprevention). 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 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.

Table of prophylactic dosages of immunoglobulin against tick-borne encephalitis

Body weight, kg

5

10

20

30

40

50

60

70

80

Injection volume, ml

0,5

1,0

2,0

3,0

4,0

5,0

6,0

7,0

8,0

Prophylaxis after tick bite

For the purpose of emergency prophylaxis, the drug is administered primarily unvaccinated against tick-borne encephalitis or who received an incomplete vaccination course that noted tick sucking in endemic areas, as well as suspected laboratory infection with tick-borne encephalitis 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. Children under 12 years - 1 ml; 12-16 years old - 2 ml; from 16 years and older - 3 ml.

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 4 days after the tick bite.

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.

- Patients with erased and abortive forms of tick-borne encephalitis (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.

- When meningeal form of tick-borne encephalitis the drug is applied daily in a single dose of 0.1 ml / kg of body weight with an interval 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 a meningeal form of infection of at least 70.0 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 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 no specific therapy was performed in patients with meningeal and focal forms of tick-borne encephalitis for any reason, it is possible to administer immunoglobulin at the acute stage of the apyrexia of the acute disease for 5-6 days in a single dose of 0.1 ml / kg body weight after 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:

If, when using the drug, all recommendations for administration, dosage and precautions are met, reactions to immunoglobulin administration are generally not available.

In rare cases, there may be hyperemia at the injection site and an increase in temperature to 37 ° C during the first 24 hours after the administration.

Individuals with altered reactivity may develop allergic reactions of various types, in exceptional cases - anaphylactic shock, and therefore persons receiving the drug should be under medical supervision for 30 minutes. In the room where the drug is administered, there should be antishock therapy.

Overdose:

At present, no cases of drug overdose have been reported.

Interaction:

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

Special instructions:

Treatment with immunoglobulin drugs reduces the effectiveness of vaccination, so vaccinations are conducted no earlier than 2-3 months after the administration of immunoglobulin.

Persons who suffer from allergic diseases or are prone to allergic reactions on the day of immunoglobulin administration and for the next 8 days are recommended to prescribe antihistamines.In the period of aggravation of the allergic process, the drug is administered by the conclusion of an allergist.

With the development of anaphylactoid reactions, antihistamines, glucocorticosteroids and adrenomimetics are used.

Persons suffering from autoimmune diseases (blood diseases, connective tissue, nephritis and others) should be given the drug on the background of appropriate therapy.

Immunoglobulins for intramuscular injection are categorically forbidden to be administered intravenously.

The drug is not suitable for use in ampoules with broken integrity and marking, with a change in physical properties (turbidity, intense staining, the presence of flakes that do not break when shaken).

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

The effect of immunoglobulin on the ability to perform work requiring increased attention and speed of psychomotor reactions has not been revealed.

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

1 ml in an ampoule with a capacity of 2 ml of 10 pieces in a pack of cardboard.

Storage conditions:

In dry, dark place at a temperature of 2 to 10 ° C. Do not freeze.

Keep out of the reach of children.

Transport any kind of indoor transport at a temperature of 2 to 10 ° C.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription
Registration number:P N002722 / 01
Date of registration:14.08.2008 / 21.12.2012
Expiration Date:Unlimited
The owner of the registration certificate:SANGVIS SEC №2 СО СОЗ SANGVIS SEC №2 СО СОЗ Russia
Manufacturer: & nbsp
Information update date: & nbsp07.11.2017
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