Active substanceHuman immunoglobulin against hepatitis BHuman immunoglobulin against hepatitis B
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    Biotest Pharma GmbH     Germany
  • Dosage form: & nbspRAsterol for intramuscular injection
    Composition:

    One dose (1 ampoule) contains:

    Active substance:

    Antibodies to HBsAg of hepatitis B virus - not less than 100 ME (International units).

    Excipients:

    Glycine (aminoacetic acid), stabilizer - (22.5 ± 7.5) mg / ml. The estimated content, in the finished product is not determined.

    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 after a slight shaking at a temperature (20 ± 2) ° C

    Pharmacotherapeutic group:MIBP - globulin
    ATX: & nbsp

    J.06.B.B.04   Human immunoglobulin against hepatitis B

    Pharmacodynamics:

    It is a concentrated solution of the immunologically active protein fraction of immunoglobulin isolated by fractionation with ethyl alcohol at a temperature below 0 ° C from the blood plasma of healthy donors and immunized with the hepatitis B vaccine authorized for use in practice health.

    Pharmacological properties

    The active principle of the drug is antibodies to the surface antigen of the hepatitis B virus (HBsAg), which block the receptors of the virus.

    Pharmacokinetics:The maximum concentration of antibodies in the blood is reached after 24 hours, the half-life period is 4-5 weeks.
    Indications:

    Emergency prophylaxis of hepatitis B in children and adults; treatment of mild to moderate severe forms of acute hepatitis B virus adults.

    Contraindications:

    Contraindicated the introduction of human immunoglobulin against hepatitis B to persons who had a history of severe allergic reactions to the administration of human blood products.

    In the presence of a history of clinically pronounced allergic reactions on the day of immunoglobulin and for the next 3 days, the appointment of antihistamines is recommended.

    Persons suffering from immunopathological systemic diseases (blood diseases, connective tissue, nephritis, etc.), the drug should Enter on a 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 administered intramuscularly.

    Prevention

    The dose of the drug and the frequency of its administration depend on the indications for use:

    - newborns from motherscarriers of HBsAg or patients with acute hepatitis B during the delivery period, 1 dose of the drug (100 IU) is administered in the first 12 hours after birth simultaneously with the hepatitis B vaccine, but in different parts of the body (hereinafter children are to be vaccinated with hepatitis B vaccine at the age of 1, 2 and 12 months);

    - persons not previously vaccinated against hepatitis B, or to persons who have not completed vaccination, or when the level of HBs-antibodies is below protective (<10 IU / L), after accidental infection as a result of exposure to infected material (when injected , dental manipulation, blood transfusion, splashing of infected material into the mouth or eyes, etc.), the drug is administered at a rate of 0.1 ml / kg of mass as soon as possible after contact (if possible within 24-48 hours).

    Simultaneously (on the same day), it is necessary to start (continue) vaccination against hepatitis B according to the scheme 0-1-2-12 months.

    - persons belonging to high-risk groups infected with hepatitis B virus (patients with chronic hemodialysis centers, patients suffering from various diseases,which according to vital indications receive frequent transfusions of blood and its contact preparations in hepatitis B foci, etc.), not vaccinated against hepatitis B, immunoglobulin is administered before the procedure - hemodialysis, blood transfusion and its preparations, etc .; children under 10 years old - 100 ME, children over 10 years and adults - at the rate of 0.1 ml / kg of weight.

    Simultaneously with the introduction of immunoglobulin, a course of vaccination against hepatitis B should be initiated according to the truncated scheme - 3 administration of the vaccine at intervals of 1 month. After 12 months after the start of immunization, 4 additional doses of the vaccine are administered. The first dose of the vaccine is administered simultaneously with the immunoglobulin, but in different parts of the body.

    If it is necessary to use large volumes (more than 5 ml) of the drug, it is recommended to inject into different parts of the gluteus muscle and the external surface of the thigh.

    The drug is used only as directed by a doctor (paramedic).

    The introduction of immunoglobulin is recorded in the prescribed registration forms, indicating the serial number, date of issue, expiry date, manufacturer, date of administration, dose, response to administration.

    Treatment

    With a therapeutic purpose, the drug is prescribed in the first five days from the onset of icteric viralhepatitis B.

    The drug is administered in a single dose of 0.1 ml / kg of body weight, daily for 3 days.

    Side effects:

    As a rule, reactions to administration are absent.

    In rare cases, local reactions in the form of hyperemia may develop, raising the temperature to 37.5 ° C during the first 24 hours after the administration.

    Individuals with altered reactivity may develop allergic reactions of various types, and in exceptionally rare cases, anaphylactic shock, and therefore persons who have received drug, should be under medical supervision within 30 minutes after the introduction of immunoglobulin. Vaccination sites should be provided with anti-shock therapy.

    Overdose: Cases of overdose are not established.
    Interaction:

    The introduction of immunoglobulins can adversely affect the efficacy of live attenuated vaccines. Immunization with live vaccines (against measles and other viral infections) is possible not earlier than 3 months after the administration of immunoglobulin for preventive or curative purposes.

    Special instructions:

    Before the injection, the ampoule with the drug is kept for 2 hours at room temperature.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 changing physical properties (discoloration, turbidity, presence of an undetectable precipitate), expired shelf life, if storage conditions are violated. To prevent the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen.

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

    The drug does not affect the management of vehicles, as well as activity requiring increased concentration attention and speed of psychomotor reactions.

    Form release / dosage:

    Solution for intramuscular injection.

    Packaging:

    1 dose (not less than 100 ME) in a volume of 2 ml in an ampoule.

    10 ampoules in a pack of cardboard with instructions for use and a scarifier ampoule.

    When packing ampoules that have a notch, ring or break point, the scarifier is not inserted.

    Storage conditions:

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

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

    Shelf life:2 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:Р N000073 / 01
    Date of registration:25.01.2012 / 16.04.2013
    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: & nbsp06.09.2017
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