Vaccine for the prevention of diphtheria and tetanus, adsorbed, pertussis acellular, poliomyelitis inactivated (Vaccine for the prevention of diphtheria and tetanus, adsorbed, pertussis acellular, poliomyelitis inactivated)

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
  • Tetraxim
    suspension w / m 
    Sanofi Pasteur S.A.     France
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    J.07.C.A.02   Vaccine against diphtheria-pertussis-tetanus

    J.07.C.A   Combination of vaccines for the prevention of viral and bacterial infections

    Pharmacodynamics:

    The introduction of the drug in accordance with the approved scheme forms a specific immunity against pertussis, diphtheria, tetanus and poliomyelitis.

    The immune response after the initial course of vaccination:

    Researches of immunogenicity carried out in children of the first year of life who received a triple immunization with the vaccine, starting from the 2nd month of life, demonstrated that all vaccinated (100%) developed protective antibody titer (> 0.01 IU / ml) to diphtheria and tetanus antigens.

    For pertussis antigens, approximately a 90% increase in antibody titres to pertussis and filamentous hemagglutinin occurred in about 1 to 2 months after the completion of the primary vaccination course.In connection with the lack of an empirically established serological test for protection, a fourfold increase in antibody titers is considered a criterion for seroconversion.

    At least 99.5% of children after immunization had antibody titers for type 1, 2 and 3 polioviruses that exceeded level 5 (the inverse of serum neutralization dilution), considered to be protective against poliomyelitis.

    Immune response after revaccination:

    Immunogenicity studies conducted in children of the 2nd year of age who received a primary vaccination course in the form of 3 doses of the vaccine showed a high level of immune response to all components after the administration of the 4th dose (revaccination).

    Studies conducted in children aged 12-24 months who received a primary immunization course with three doses of vaccines with a whole-cell pertussis component demonstrated that subsequent vaccine revaccination is safe and immunogenic for all components of the vaccine.

    Pharmacokinetics:

    No data.

    Indications:

    Prevention of diphtheria, tetanus, pertussis, poliomyelitis in children, starting at 3 months of age.

    ICD-10

    XXI.Z20-Z29.Z27.3   The need for immunization against diphtheria-tetanus-pertussis and poliomyelitis

    Contraindications:

    - progressive encephalopathy, accompanied by cramps or without such;

    - encephalopathy, developed within 7 days after the previous administration of any vaccine containing antigens Bordetella pertussis;

    - a strong reaction that developed within 48 hours after a previous vaccination with a vaccine containing a pertussis component: an increase in body temperature to 40 ° C or higher, a syndrome of prolonged unusual crying for 3 or more hours, febrile or afefril convulsions, hypotonic hyporeactive syndrome ;

    - an allergic reaction that developed after the previous administration of any vaccine to prevent diphtheria, tetanus, pertussis, poliomyelitis;

    - a confirmed allergic reaction to any ingredient in the vaccine, as well as glutaraldehyde, neomycin, streptomycin and polymyxin AT;

    - diseases accompanied by an increase in body temperature, acute manifestations of an infectious disease or exacerbation of a chronic disease. In these cases, vaccination should be postponed until recovery.

    Carefully:

    PIf a child has a history of febrile convulsions other than previous vaccination,it is necessary to monitor the temperature of the body grafted within 48 hours after inoculation and, when it is increased, apply antipyretic (antipyretic) drugs during this period.

    Pregnancy and lactation:

    Does not apply to adults.

    Dosing and Administration:

    Immediately before administration, shake to form a homogeneous whitish turbid suspension. The vaccine is administered intramuscularly at a dose of 0.5 ml, the recommended place of administration is the middle third of the anterolateral femoral surface for children up to 24 months old and the deltoid shoulder muscle for older children.

    Do not administer intradermally or intravenously. Before administration, it must be ensured that the needle does not penetrate into the blood vessel.

    In accordance with the National Calendar of Prophylactic Vaccinations, the vaccination course for the prevention of diphtheria, tetanus, pertussis and poliomyelitis consists of 3 injections of the drug at intervals of 1.5 months, at the age of 3; 4,5 and 6 months respectively.

    Revaccination is carried out after 12 months (at the age of 18 months) by administering a single dose of the vaccine.

    If the schedule of vaccination is not met, subsequent intervals between the administration of the next dose of the vaccine do not change, including the interval before the 4th (revaccinating) dose - 12 months.Further revaccination against poliomyelitis is carried out within the time frames stipulated by the National Calendar of preventive vaccinations. In all cases of violation of the vaccination schedule, the doctor should be guided by the National Calendar of preventive vaccinations.

    Side effects:

    Local reactions: soreness at the injection site; redness and compaction at the injection site more than 2 cm in diameter. These reactions can develop within 48 hours after vaccination and last for 48-72 hours, pass independently without any treatment. Very rarely there were cases of severe reactions (more than 5 cm in diameter) at the site of administration of the vaccine, including swelling that spreads through one or both joints. These reactions appeared 24-72 hours after the administration of the vaccine and disappeared independently for 3-5 days without any additional treatment. It is believed that the likelihood of developing such reactions increases depending on the number of injections of the acellular pertussis component, this probability is greater after the 4th and 5th dose of such a vaccine.

    Common reactions: increase in body temperature:> 38 ° C - with a frequency of 1-10%; > 39 ° С - with a frequency of 0,1-1%; rarely (0,01-0,1%) - more than 40 ° С.(The rectal temperature was evaluated, which, as a rule, is higher than axillary (axillary) by 0.6-1.1 ° C).

    Other: irritability, drowsiness, sleep disturbances, decreased appetite, diarrhea, vomiting, less often - atypical or prolonged crying. In very rare cases (<0.01%), rash, hives, febrile and afebrile convulsions, hypotension and hypotonic-hyporeactive syndrome, anaphylactic reactions (facial edema, Quincke's edema, shock) were noted.

    It is estimated that after administration of other vaccines containing tetanus toxoid, Guillain-Barre syndrome and neural brachial neuritis were observed in a number of cases.

    In deeply premature infants (born at 28 weeks or earlier) within 2-3 days after vaccination, there may be cases of lengthening the time intervals between respiratory movements.

    Overdose:

    No data.

    Interaction:

    With the exception of immunosuppressive therapy, there is no reliable data on the possible mutual effects when used with other drugs.

    The vaccine can be administered in a single syringe with a conjugate vaccine against the infection caused by Haemophilus influenzae type b (Act-HIB), or simultaneously with this vaccine (in different parts of the body).

    Rarely, with concomitant administration with vaccines containing the HIB component, edema of one or both lower limbs has been reported (in the case where two vaccines are administered by a single syringe, with the predominant edema of the limb into which the vaccine was administered). Most edema was observed within the first few hours after the primary vaccination. These reactions were sometimes accompanied by an increase in body temperature, pain, prolonged crying, cyanosis or skin discoloration, less redness, petechiae or transitory purpura, fever, rash. These reactions passed independently for 24 hours without any residual phenomena, they were not associated with any adverse events on the part of the heart and respiratory system.

    Can be administered concurrently with vaccines against measles-mumps, rubella, chicken pox, hepatitis B in different parts of the body.

    The doctor should be informed of the recent or concurrent vaccination with the introduction of any other medication (including over-the-counter medication) to the child.

    Special instructions:

    The physician should be informed of all cases of adverse reactions, including those not listed in this manual.Before each vaccination, to prevent possible allergic and other reactions, the doctor should clarify the state of health, the history of immunization, the patient's history (in particular - allergic), the incidence of side effects on previous vaccine administrations. The physician should have the medicines and tools necessary for medical interventions in the development of the hypersensitivity reaction.

    Immunosuppressive therapy or the state of immunodeficiency can cause a weak immune response to the administration of the vaccine. In these cases it is recommended to postpone the vaccination before the end of such therapy or remission of the disease. However, for people with chronic immunodeficiency (eg, HIV infection), vaccination is recommended even if the immune response can be weakened.

    With thrombocytopenia and other bleeding disorders, the administration of the vaccine should be carried out with caution because of the risk of developing bleeding with intramuscular injection.

    When developing a history of Guillain-Barre syndrome or neuritis of the brachial nerve in response to any vaccine containing tetanus toxoid, the decision to vaccinate should be carefully justified.As a rule, in such cases, it is justified to complete primary immunization (if less than three doses are administered). The potential risk of developing apnea and the need to monitor breathing for 48-72 hours should be considered when conducting a primary course of immunization in deeply premature babies born at 28 weeks or earlier, especially those with a history of immaturity of the respiratory system. Since the immunization benefits of this group of children are high, vaccination should not be postponed or considered contraindicated.

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