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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 up to 1 ml.

Description:

Transparent or slightly opalescent liquid, colorless or slightly yellow in color. A slight precipitate may appear, disappearing when shaken at a temperature of (20 ± 2 ° C).

Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp
  • Human immunoglobulin against tick-borne encephalitis
  • 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.

    The drug is used only as prescribed by the doctor.

    Carefully:
    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.
    Individuals 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:

    The use of the drug during pregnancy and breastfeeding 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 INSERT.

    Before the injection, the ampoule with the drug is kept for 2 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 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 tick-borne encephalitis virus - a 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 tick-borne encephalitis or who received an incomplete vaccination course that noted the sucking of ticks 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.

    In the case of a new contact with mites, it is possible to reapply the drug 1 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 4th day after the tick bite.

    Prophylactic dosages of human immunoglobulin against tick-borne encephalitis

    Weight bodies

    5 kg

    10 kg

    20 kg

    30 kg

    40 kg

    50 kg

    60 kg

    70 kg

    80 kg

    Scope injections

    0.5ml

    1.0ml

    2.0ml

    3.0ml

    4,0ml

    5,0ml

    6,0ml

    7.0ml

    8.0ml

    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, 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 at least 21.0 ml of the drug;

    - with meningeal form of tick-borne encephalitis The drug is used 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 overall condition improves on 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 70.0 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 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 is 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 specific meningeal and focal forms of tick-borne encephalitis have not been carried out for any reason in the febrile stage of the disease, it is possible to administer the immunoglobulin at the acute stage of the apyrexia for a 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:

    Reactions to the introduction of immunoglobulin, as a rule, are absent. In rare cases, local reactions in the form of hyperemia, pain in the area of ​​injection and an increase in temperature to 37.5 ° C during the first 24 hours after injection can develop.

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

    Persons receiving the drug should be monitored for 30 minutes.

    Overdose:

    Symptoms of an overdose in the use of human immunoglobulin against tick-borne encephalitis have not been revealed.

    Interaction:

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

    Treatment with drugs immunoglobulin reduces the effectiveness of vaccination, so vaccinations are carried out not earlier than 2-3 months after the introduction of immunoglobulin.

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

    Special instructions:
    The introduction of immunoglobulin is recorded in the prescribed registration forms with the serial number, date of manufacture, expiration date, manufacturer, date of administration, dose, and the nature of the reaction to administer the drug.

    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, presence of non-breaking flakes), with improper storage.

    Do not freeze.

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

    There is no evidence of any effect of immunoglobulin on the ability to drive vehicles or other mechanisms.

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

    In ampoules of 3 ml.

    For 10 ampoules with instructions for use and a knife ampoule in a pack of cardboard box.

    Storage conditions:

    In a dry, dark place at a temperature of 2 to 8 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001640
    Date of registration:09.04.2012
    Date of cancellation:2017-04-09
    The owner of the registration certificate:Vologda Regional Blood Transfusion Station No.1 Vologda Regional Blood Transfusion Station No.1 Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.02.2016
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