Index of drugs

Active immunization against diphtheria, tetanus and pertussis from 2 months old (primary vaccination). The vaccine is also indicated as a booster dose in children aged 6 who have previously received 3 or 4 doses of diphtheria, tetanus and acellular pertussis (DTPa) or diphtheria vaccine, tetanus and pertussis containing whole pertussis cells (DTPw).

1 dose (0.5 ml) contains not less than 30 IU a diphtheria toxoid adsorbed on aluminum hydroxide, not less than 40 IU. tetanus toxoid adsorbed to aluminum hydroxide and antigensBordetella pertussis (25 μg pertussis toxoid, 25 μg filamentous hemagglutinin, 8 μg pertactin) adsorbed to aluminum hydroxide.

Combination tetanus-pertussis-pertussis (acellular) vaccine. The diphtheria and tetanus toxoids are derived from culturesCorynebacterium diphtheriae andClostridium tetani, have been inactivated and purified. The acellular pertussis ingredient has been prepared from culturesBordetella pertussis. One month after the end of the primary vaccination course during the first 6 months of life, approximately 99% of the vaccinated infants had an antibody titres of more than 0.1 IU / ml for both diphtheria and tetanus. In clinical trials, the response to pertussis antigens was over 95%. After the use of booster vaccination in the 2nd year of all children, the antibody titres were over 0.1 IU / ml in the case of diphtheria and tetanus, in this case the response to pertussis antigens was over 96%. The protective efficacy of a pertussis vaccine is, on exposure conditions, an average of 88.7%.

Hypersensitivity to any of the components of the preparation or the occurrence of symptoms of hypersensitivity after previous administration of diphtheria, tetanus, acellular pertussis (DTPa), diphtheria and tetanus vaccine (DT) or diphtheria, tetanus and whole cell pertussis (DTPw) vaccines. Established encephalopathy of unknown aetiology that occurred within 7 days after administration of a vaccine containing pertussis antigens (these children should stop pertussis vaccination and continue vaccination with diphtheria and tetanus vaccines). acute infections or other diseases with fever. A mild infection is not a contraindication to the use of a vaccine. The vaccine should not be used in children over 7 years of age because the lower dose of diphtheria is recommended at this age.

The vaccine should in no case be administered intravenously. If any of the following symptoms appear temporally with vaccination containing the pertussis component, the decision on the Next dose of the vaccine containing the pertussis component should be carefully considered: fever ≥40st.C (measured in the rectum) within 48 h after the administration of the vaccine, by any identifiable factor; collapse or shock-like state (hypotensive-hyporesponsive episode) within 48 hours after vaccination; chronic, persistent crying lasting ≥3 h, occurring within 48 h after vaccination; convulsions with or without fever, occurring within 3 days after vaccination. In some circumstances, such as high exposure to pertussis, the potential benefits may outweigh the risks. The potential risk and benefit of administering the vaccine or postponing this vaccination should be carefully considered in infants and children with a currently diagnosed or progressive severe neurological disorder. Caution should be used in people with thrombocytopenia or bleeding disorders, because bleeding may occur after intramuscular administration. History of fever convulsions and convulsions reported in a family history are not contraindications. HIV infection is not a contraindication, but patients with immune disorders may not have a normal immune response.The risk of apnea and the need to monitor respiratory function for 48-72 h should be considered when administering primary immunization doses to very premature premature babies (born ≤28 weeks of gestation), especially for children with symptoms of immaturity of the respiratory system. Due to the significant benefits of vaccinating this group of infants, vaccination should not be withheld or deferred.

Not applicable - the vaccine is not intended for use in adults.

Very common: irritability, drowsiness, redness, swelling at the injection site ≤50 mm, fever ≥38st.C. Common: loss of appetite, anxiety, unusual crying, diarrhea, vomiting, pruritus, pain, swelling at the injection site ≤50 mm, fever ≥38st.C. Uncommon: headache, cough, bronchitis, rash, injection site reactions (including sclerosis), fatigue, fever ≥39.1st.C, diffuse swelling of the limb, in which the vaccine was given (sometimes with a neighboring joint, swelling after a booster dose is more likely in children who received acellular pertussis vaccine as primary vaccination compared to children vaccinated with whole cell pertussis vaccine, in the case of a booster dose administered between 4 and 6 anemia swelling at the injection site (> 50 mm) and diffuse swelling of the limb may be more common, these reactions disappear on average after 4 days). In addition, thrombocytopenia, hypersensitivity reactions (including anaphylactic and anaphylactoid reactions), collapse or shock-like state (hypotensive-hyporesponsive episode), seizures (with or without fever) within 2-3 days after vaccination, apnea, angioedema have been observed. -neural, swelling of the entire limb to which the vaccine was given.

Deep intramuscularly (it is recommended that each subsequent dose be administered in a different place). The vaccination schedule should be consistent with the Protective Vaccine Program. The primary vaccination schedule consists of 3 doses of 0.5 ml (primary vaccination) and a booster dose (0.5 ml) administered in 2 years. The booster dose should be given in 6 years.