Vaccine for the prevention of viral hepatitis B, diphtheria and tetanus (Vaccinum ad prophylaxim hepatitis epidemicae B, diphtheriae et tetani)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Vaccines, serums, phages and toxoids

Included in the formulation
  • Bubo®-M
    suspension w / m 
    COMBIOTECH NPK, ZAO     Russia
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    J.07   Vaccines

    Pharmacodynamics:

    The introduction of the drug in accordance with the approved vaccination scheme causes the formation of specific immunity against hepatitis B, diphtheria and tetanus.

    Pharmacokinetics:

    No data.

    Indications:

    Prevention of hepatitis B, diphtheria and tetanus in children older than 6 years, adolescents and adults.

    The vaccine is used:

    when the course of vaccination is administered to children over 6 years old, not previously vaccinated against diphtheria, tetanus and hepatitis B;

    for planned age-related revaccinations (according to the scheme of ADS-M use) of children over 6 years of age, adolescents and adults not previously vaccinated against hepatitis B;

    with the coincidence of the timing of revaccination of children and adolescents against diphtheria and tetanus with one of the vaccines vaccination course with hepatitis B vaccine.

    ICD-10

    XXI.Z20-Z29.Z24.6   The need for immunization against viral hepatitis

    XXI.Z20-Z29.Z27.8   The need for immunization against other combinations of infectious diseases

    Contraindications:

    Contraindications to the use of Bubo-M vaccine are strong (temperature above 40 ° C, edema, hyperemia more than 8 cm in diameter at the site of administration) and unusual reactions to previous administration of diphtheria-tetanus toxoid or hepatitis B vaccine, as well as allergic reactions to yeast and other components of the vaccine.

    Scheduled vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases.

    With mild acute respiratory viral infections, acute intestinal diseases and other vaccinations are carried out immediately after the temperature is normalized.

    Patients with chronic diseases are vaccinated after achieving complete or partial remission. Persons with neurological changes are vaccinated after excluding the progression of the process. Patients with allergic diseases are vaccinated 2-4 weeks after the end of the exacerbation, while stable manifestations of the disease (localized skin conditions, hidden bronchospasm, etc.) are not contraindications to vaccination, which can be performed against the background of appropriate therapy.

    Pregnancy. The effect of the vaccine on the fetus has not been studied.The possibility of vaccinating a pregnant woman can be considered individually.

    Immunodeficiencies, infections of the human immunodeficiency virus, as well as supporting course therapy, including steroid hormones and psychopharmaceuticals, are not contraindications to vaccination.

    In order to identify contraindications, the doctor (paramedic at the feldsher-midwife point) on the day of vaccination is conducting a survey of parents and examining the vaccinated with mandatory thermometry. When vaccinating adults, preliminary selection of persons to be vaccinated is possible with their subsequent interviewing by a medical worker conducting vaccination with thermometry on the day of vaccination. Persons temporarily released from vaccination should be monitored and accounted for and promptly vaccinated.

    Carefully:

    Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules. The drug in the opened ampoule is not subject to storage. The preparation of the drug is registered in the established registration forms with the serial number, control number, expiration date, manufacturer, date of introduction.

    Pregnancy and lactation:

    The effect of the vaccine on the fetus has not been studied.The possibility of vaccinating a pregnant woman can be considered individually.

    Dosing and Administration:

    The vaccine is injected intramuscularly into the deltoid muscle in a single dose of 0.5 ml.

    Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

    Subcutaneous administration of the drug and the introduction of the gluteus muscle is not recommended because of a decrease in the effectiveness of the hepatitis component and the possibility of enhancing local reactions.

    Primary vaccination of children older than 6 years and adolescents not previously vaccinated against diphtheria, tetanus and hepatitis B is performed three times according to the scheme: the first dose on the selected day, the second dose after 1 month, the third dose after 6 months after the first dose.

    If it is necessary to increase the intervals, the vaccination should be carried out as soon as possible, determined by the state of health of the vaccinated person. If the interval between the first and second vaccinations is increased by 5 months or more, the third vaccination is carried out no earlier than 1 month after the second. Subsequent revaccinations of ADS-M toxoid are carried out in accordance with the vaccination calendar.

    Revaccination of persons who received earlier vaccinations against diphtheria and tetanus, but not vaccinated against hepatitis B,is carried out once with the subsequent vaccination with hepatitis B vaccine with the missing vaccinations against hepatitis B at the age-related dosage.

    The preparation is not suitable for use in ampoules with broken integrity, lack of marking, changing physical properties (discoloration, presence of non-developing flakes), expired shelf life, improper storage.

    For injection, only a disposable syringe is used.

    Side effects:

    Adverse events with the introduction of the vaccine are rare. 3-5% of those vaccinated in the first two days of the day can develop short-term general (fever, malaise, joint and muscle pain, dizziness) and local (soreness, hyperemia, swelling) reactions.

    In extremely rare cases, allergic reactions (Quincke's edema, hives, polymorphic rash), slight exacerbation of allergic diseases can develop. Given the possibility of developing allergic reactions of immediate type in particularly sensitive individuals, vaccinated patients should be provided with medical supervision for 30 minutes.

    Vaccination sites should be provided with anti-shock therapy.

    Overdose:

    No data.

    Interaction:

    Vaccination with the vaccine can be carried out simultaneously with other vaccines of the vaccination calendar or 1 month after vaccinations against other infections. The vaccine can be administered with antiallergic drugs. Interaction with other drugs has not been established.

    Special instructions:

    Scheduled vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases. Patients with chronic diseases are vaccinated after achieving complete or partial remission.

    Scheduled vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases. Patients with chronic diseases are vaccinated after achieving complete or partial remission.

    It is used in children older than 6 years and teenagers.

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