Combined hepatitis B vaccine and diphtheria-tetanus toxoid with a reduced antigen content (Combined hepatitis B vaccine and diphtheria-tetanus toxoid with a reduced antigen content)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsuspension for intramuscular injection
Composition:

The vaccine is a combination of aluminum adsorbed on the aluminum gel of the recombinant yeast surface antigen of the hepatitis B virus (HBsAg) and purified from ballast proteins of diphtheria and tetanus toxoid.

Composition of 1 dose (0.5 ml): 5 flocculating units (Lf) diphtheria toxoid, 5 units of tetanus toxoid binding (EC), 10 μg HBsAg, from 0.35 to 0.55 mg Aluminum hydroxide (A1), preservative - mertiolate - from 15 to 35 μg and not more than 50 μg of formaldehyde.

Description:

The preparation is a homogeneous suspension of a yellowish white color without foreign inclusions, separated when standing on a transparent supernatant and a loose sediment that completely breaks when shaken.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp
  • Combination of vaccines for the prevention of viral and bacterial infections
    • Indications:

    Prevention of hepatitis B, diphtheria and tetanus in persons aged 6 to 19 years.

    The vaccine is used:

    • in the course of vaccination in previously not vaccinated against diphtheria, tetanus and hepatitis B;

    • under the planned age revaccination against diphtheria and tetanus in previously vaccinated against hepatitis B.

    Contraindications:

    Contraindications to the use are strong and unusual response to previous administration of Td toxoid and / or hepatitis B vaccine: the temperature is above 40 ° C, edema, hyperemia than 8 cm in diameter at the injection site, and allergic reaction to baker's yeast and other components of the vaccine. Vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases.

    In forms of mild SARS, acute intestinal diseases and others. Grafting carried out after the disappearance of clinical symptoms.

    Patients with chronic diseases are vaccinated after achieving complete or partial remission.

    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 who performs vaccination on the day of vaccination.

    Pregnancy and lactation:

    It is not recommended to use this medication during pregnancy and during breastfeeding, as safety in the course of controlled clinical trials has not been studied.

    Dosing and Administration:

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

    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.

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

    Primary vaccination of children older than 6 years and adolescents not previously vaccinated against diphtheria, tetanus and hepatitis B is carried out three times according to the scheme: 1 dose on the selected day, 2 dose after 1-1.5 months, 3 dose after 6-7 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.Subsequent revaccinations against diphtheria and tetanus are carried out in accordance with the vaccination calendar.

    Revaccination of persons against diphtheria and tetanus, previously not vaccinated against hepatitis B, is carried out once, followed by the completion of the vaccination course with hepatitis B vaccine at the age-related 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.

    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 introduction of the drug is registered in the prescribed registration forms with the indication of the serial number, expiration date, manufacturer, date of introduction, the nature of the reaction to the administration of the drug.

    Precautions for use. 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 exacerbation, while stable manifestations of the disease (localized skin phenomena,latent bronchospasm, etc.) are not contraindications to vaccination, which can be performed against the background of appropriate therapy.

    Side effects:

    A part of the vaccinated in the first two days can develop short-term general (temperature increase, 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 people should be provided with medical supervision for 30 minutes.

    Vaccination sites should be provided with anti-shock therapy.

    Overdose:

    Cases of overdose are not established.

    Interaction:

    Vaccinations with the ADS-M-Hep B vaccine can be administered concomitantly with other vaccines of the national calendar of preventive vaccinations (with the exception of BCG vaccine) or 1 month after vaccination against other infections.

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

    Not installed.

    Form release / dosage:

    Suspension for intramuscular injection 0.5 ml / dose.

    Packaging:

    In ampoules of 0.5 ml (one inoculation dose). The package contains 10 ampoules with instructions for use.

    Storage conditions:

    Storage conditions. At a temperature of 2 to 8 ° C in accordance with SP 3.3.2.1248-03. Keep out of the reach of children. Freezing is not allowed.

    Conditions of transportation. At a temperature of 2 up to 8 ° С В accordance with SP 3.3.2.1248-03. Freezing is not allowed.

    Shelf life:

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

    Terms of leave from pharmacies:For hospitals
    Registration number:LP-000460
    Date of registration:01.03.2011 / 04.10.2013
    Expiration Date:01.03.2016
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp12.01.2017
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