Vaccine against pertussis, diphtheria, tetanus and hepatitis B adsorbed liquid (DTP-Hep B vaccine) (Vaccine against pertussis, diphtheria, tetanus and hepatitis B adsorbed liquid (DTP-Hep B vaccine))

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, whooping cough and tetanusVaccine for the prevention of viral hepatitis B, diphtheria, whooping cough and tetanus
Dosage form: & nbsp

suspension for intramuscular injection

Composition:

In 1 dose (0.5 ml) of the contentis:

Preservative preparation

Active substances:

Diphtheria toxin - 15 flocculating units (Lf);

Anatoxin tetanus - 5 units binding (EU);

Inactivated pertussis tankterii - 10 billion;

HBsAg - 5 mcg.

Auxiliary substances: Aluminum hydroxide (in terms of aluminum Al3+) - from 0.3 to 0.55 mg;

Formaldehyde - no more than 50 mcg; Preservative - thiomersal - from 35 to 50 mcg.

Preparation without preservative

Active substances:

Diphtheria toxin - 15 flocculating units (Lf);

Anatoxin tetanus - 5 units of binding (EU);

Inactivated pertussis bacteria - 10 billion;

HBsAg-5 mcg.

Auxiliary substances: Aluminum hydroxide (in terms of aluminum Al3+) - from 0.3 to 0.55 mg;

Formaldehyde - no more than 50 mcg.

Description:

Homogeneous suspension of yellowish-white color, separated by standing on a colorless transparent liquid and loose sediment of a yellowish white color, completely shattered by shaking.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp
  • Vaccine against diphtheria, hepatitis B, pertussis and tetanus
    • Pharmacodynamics:The vaccine is a mixture of formaldehyde-killed pertussis 1 phase and aluminum sorbed on aluminum gel of diphtheria and tetanus toxoid hydroxide and recombinant yeast surface antigen of hepatitis B virus (HBsAg).
    Indications:
    Prevention of pertussis, diphtheria, tetanus and hepatitis B in children. Maximum age of children for immunization with DTP-Hep B vaccine - before reaching the age of four (3 years 11 months 29 days).
    Contraindications:

    Children of the first year of life when using a vaccine containing a preservative.

    Progressive diseases of the nervous system, afefrilnye convulsions in the anamnesis,an allergic reaction to baker's yeast, as well as strong reactions (a rise in temperature in the first two days above 40 ° C, at the injection site - swelling and hyperemia over 8 cm in diameter) and post-vaccination complications for the administration of a previous dose of DTP-Hep B or DPT vaccine or hepatitis B vaccine.

    Children who have had acute illnesses are vaccinated not earlier than in four weeks after recovery, with mild forms of respiratory diseases (rhinitis, mild hyperemia of the throat, etc.), inoculation is allowed 2 weeks after recovery.

    Patients with chronic diseases are vaccinated no earlier than four weeks after reaching a stable remission.

    In order to identify contraindications, the doctor (paramedic at the FAP) on the day of vaccination is conducting a survey of parents and examining the child with mandatory thermometry. Children temporarily released from vaccination should be monitored and accounted for and promptly vaccinated.

    Pregnancy and lactation:

    Not applicable. The drug is used to vaccinate children.

    Dosing and Administration:

    Inoculations with the DTP-Hep B vaccine are carried out at the time when vaccinations against hepatitis B, pertussis, diphtheria and tetanus are carried out simultaneously.

    Children vaccinated with the hepatitis B monovalent during the first 24 hours of life and not at risk are immunized with DTP-Hep B vaccine at the age of 3 and 6 months. The second vaccination against whooping cough, diphtheria and tetanus is performed by a DTP vaccine in 4.5 months.

    Children not vaccinated with hepatitis B vaccine up to 3 months of age are immunized with DTP-Hep B vaccine three times according to the 3 months, 4.5 months, 6 months. Reduction of intervals is not allowed. If it is necessary to increase the intervals, the next vaccination should be carried out as soon as possible, determined by the state of children's health.

    In the presence of one or two DTP vaccine vaccinations in children not vaccinated with hepatitis B vaccine, up to 3 vaccines can be administered with DTP-Hep B vaccine. At the same time, up to 3 vaccines against hepatitis B are administered with a hepatitis B single vaccine with an interval of 1 and 6 months after the first administration. Revaccination against pertussis, diphtheria and tetanus is carried out by the DTP vaccine once at the age of 18 months (if the timing of vaccinations is violated - 12-13 months after the completed vaccination course), but not later than reaching the age of four.

    Note: if the child has not received a DTP vaccine after 4 years of age, then it is administered with a DSA toxoid for ages 4 years - 5 years 11 months 29 days or ADS-M-anatoxin for ages 6 and older.

    The DTP-Hep B vaccine is administered intramuscularly to the antero-thoracic region of the thigh in a dose of 0.5 ml. Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

    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 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. The preparation 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.

    The development of febrile seizures after the introduction of the vaccine is not a contraindication to its subsequent administration, in this case, with an increase in temperature should be prescribed in the age-related dosage paracetamol within 1-2 days.

    Stable manifestations of an allergic disease (localized skin manifestations, latent bronchospasm, etc.) are not contraindications to vaccination, which can be performed against the background of appropriate therapy.

    Side effects:

    At the part of vaccinated in the first two days can develop short-term general (fever, malaise) and local (soreness, congestion, swelling) reaction. In rare cases,
    complications: convulsions (usually associated with fever), episodes of piercing screaming, allergic reactions (Quincke's edema, urticaria, polymorphic rash).

    Given the possibility of developing allergic reactions of immediate type in especially sensitive children, it is necessary to provide medical supervision for those vaccinated within 30 minutes. Vaccination sites should be provided with anti-shock therapy.

    Note: when the child develops a strong general reaction (a rise in temperature in the first two days above 40 ° C, at the site of administration of the vaccine - edema and hyperemia over 8 cm in diameter) or post-vaccination complications, DTP vaccine - Hep B.If the child was vaccinated with DTP vaccine - Hep B twice, the vaccination against diphtheria and tetanus is considered complete, and vaccination against hepatitis B is completed with a monovalent one time one month after the second vaccination. If the child received one vaccination with the DTP vaccine - Hep B, the vaccination can be continued with the vaccine of combined hepatitis B and diphtheria-tetanus toxoid with a reduced content of antigens, which is administered only once before 3 months and then one month is administered hepatitis B monovalent.

    AT In both cases, the first revaccination is performed with ADS-M-anatoxin after 9-12 months after the last vaccination with the vaccine. DTP-Hep B or combination Hepatitis B vaccine and diphtheria-tetanus toxoid with reduced antigen content. If a strong reaction develops after the third vaccination with DTP-Hep B vaccine, the first revaccination is performed with ADS-M-anatoxin after 12-18 months.

    Subsequent revaccinations in the decremented ages of ADS-M-anatoxin.

    With an increase in temperature above 38.5 ° C, more than 1% grafted or the emergence of pronounced local reactions (swelling of soft tissue with a diameter of more than 5 cm, infiltration with a diameter of more than 2 cm) more than in 4% vaccinated, as well as the development of postvaccinal complications, vaccination with the drug of this series is discontinued.

    Overdose:

    Cases of overdose are not established.

    Interaction:

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

    Effect on the ability to drive transp. cf. and fur:Not applicable. The drug is used to vaccinate children.
    Form release / dosage:Suspension for intramuscular injection about 0.5 ml (one inoculation dose).
    Packaging:

    In ampoules of glass. 10 ampoules in a container (liner).

    1 container (liner) with instructions for use and ampoule scarifier (if necessary) in a pack of cardboard.

    Storage conditions:

    Conditions of transportation. When temperature from 2 to 8 ° C in accordance with SP 3.3.2.1248-03. Freezing is not allowed.

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

    Shelf life:18 months. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:For hospitals
    Registration number:LS-001032
    Date of registration:01.06.2011 / 29.09.2016
    Expiration Date:Unlimited
    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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