Bubo®-M (Bubo-M)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of viral hepatitis B, diphtheria and tetanusVaccine for the prevention of viral hepatitis B, diphtheria and tetanus
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  • Bubo®-M
    suspension w / m 
    COMBIOTECH NPK, ZAO     Russia
    • Dosage form: & nbsp

    suspension for intramuscular injection

    Composition:

    The preparation contains in one inoculation dose (0.5 ml): 10 μg HBsAg, 5 flocculating units (Lf) of diphtheria and 5 antitoxin-binding units (EC) of tetanus toxoid, 0.45 mg of aluminum hydroxide (A13+). Preservative - merthiolate 25 mcg.

    Bubo®-M the vaccine is a combination of aluminum-sorbed hydroxide recombinant yeast surface antigen of hepatitis B virus (HBsAg) and purified from ballast proteins of diphtheria and tetanus toxoid.

    Description:

    Homogeneous suspension of white with a light yellow shade of color, separated when standing on a colorless transparent liquid and a loose white precipitate with a light yellow shade of color, easily broken when shaken, without visible foreign inclusions.

    Pharmacotherapeutic group:MIBP vaccine
    ATX: & nbsp

    J.07   Vaccines

    Pharmacodynamics:

    Immunobiological properties

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

    Indications:

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

    Bubo®-M 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.

    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 ARVI, acute intestinal diseases and other vaccinations are carried out immediately after the normalization of temperature.

    Patients with chronic diseases are vaccinated when they reach full or partialremission. 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, HIV infection, 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 FAP) on the day of vaccination is interviewing 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.

    Pregnancy and lactation:Pregnancy. 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:

    Bubo®-M 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 due to a decrease in the effectiveness of the hepatitis component and the possibility of enhancing local reactions.

    Primary vaccination children older than 6 years and adolescents who were not previously vaccinated against diphtheria, tetanus and hepatitis B are given three times according to the scheme: the first dose on the selected day, the second dose after 1 month, the third dose 6 months after 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. With an increase in the interval between the first and second vaccinations for 5 months. and a third vaccination is given no earlier than 1 month later. after the second. Subsequent revaccinations of ADS-M toxoid are carried out in accordance with the vaccination calendar.

    Revaccination of persons, previously vaccinated against diphtheria and tetanus, but not vaccinated against hepatitis B, is carried out once, followed by vaccination with hepatitis B vaccine with the missing vaccinations against hepatitis B at age dosage.

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

    For injection, only a disposable syringe is used.

    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.

    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.

    Interaction:

    Vaccinations Bubo®-M vaccine can be administered concomitantly with other vaccines of the vaccination schedule or after 1 month. After vaccinations against other infections. The Bubo®-M vaccine may be given with antiall Contraindications to the use of Bubo®-M vaccines are severe (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 vaccine B, as well as allergic reactions to yeast and other components of the vaccine.

    Form release / dosage:

    Suspension for intramuscular injection.

    Packaging:In ampoules of 0.5 ml (inoculation dose). For 10 ampoules in a contour acheive box in a pack of cardboard with instructions for use.
    Storage conditions:

    The preparation is stored and transported according to SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed. Keep out of the reach of children.

    Shelf life:

    Shelf life - 3 years. The drug with expired shelf life is not subject to application.

    Terms of leave from pharmacies:For hospitals
    Registration number:P N000048 / 01
    Date of registration:19.11.2007
    Expiration Date:Unlimited
    The owner of the registration certificate:COMBIOTECH NPK, ZAO COMBIOTECH NPK, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp11.03.2017
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