Index of drugs

Revaccination (so-called booster) against diphtheria, tetanus, pertussis and pertussispoliopeople from the age of 4. The vaccine is not indicated for primary vaccination. The vaccine should be administered according to official recommendations.

1 dose (0.5 ml) contains not less than 2 IU diphtheria toxoid, not less than 20 IU tetanus toxoid, antigensBordetella pertussis (8 μg of pertussis toxoid, 8 μg of filamentous haemagglutinin, 2.5 μg of pertactin) and inactivated poliovirus (40 U of poliovirus type 1 - strain Mahoney propagated in Vero cell culture, 8 μg of Polio virus type 2 antigen - strain MEF-1 propagated in Vero cell culture, 32 j. Polio virus type 3 antigen - strain Saukett propagated in Vero cell culture).

Diphtheria vaccine, tetanus, pertussis (acellular, complex) andpolio (inactivated), adsorbed (on aluminum hydroxide, hydrated and aluminum phosphate), with a reduced content of antigens.

Hypersensitivity to the active substances or to any of the substances or to neomycin or polymyxin. Hypersensitivity after previous administration of diphtheria, tetanus, pertussis or polio vaccines. The vaccine is contraindicated in people with known encephalopathy of unknown aetiology, which occurred within 7 days after administration of a vaccine containing pertussis antigens. In these people, one should give up vaccinations against the phlegm and continue the vaccination course with diphtheria, tetanus and polio vaccines. The vaccine should not be used in people with known transient thrombocytopenia or neurological complications (information on seizures and hypotonic-hyporesponsive episodes) after previous vaccination against diphtheria and / or tetanus. Administration of the vaccine should be postponed to people who are in a period of acute and severe illness with fever. A mild infection is not a contraindication to the use of a vaccine.

Vaccination should be preceded by a thorough medical history (with particular reference to previous vaccinations and side effects that could have been caused by them). If any of the following symptoms appeared temporally with vaccination with the vaccine containing the pertussis component, the decision on the Next dose of the vaccine containing the pertussis component should be carefully considered: fever ≥40.0st.C within 48 h after the administration of the vaccine, not caused by any identifiable factor; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 h 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 children with a currently diagnosed or progressive severe neurological disorder. Patients should be given adequate immediate treatment if anaphylactic reactions occur after vaccination. The vaccine should be used with caution in patients with thrombocytopenia or bleeding disorders, because bleeding may occur after intramuscular administration. After administration of the vaccine, a firm pressure should be applied at the injection site (without plaque) for at least 2 minutes. The vaccine should in no case be administered intravascularly. Convulsions in a family history or interview and side effects after family history of family vaccinations are not a contraindication. HIV infection is not a contraindication. However, patients with immune disorders may not have a normal immune response.Loss of consciousness (syncope) may occur after administration or even before administration of the vaccine, particularly in adolescents, as a psychogenic reaction to a needle prick. This may be accompanied by neurological symptoms such as transient visual disturbances, paresthesia, and tonic-clonic limb movements when recovering consciousness. It is important to follow the appropriate procedures to avoid injuries during fainting. As with any vaccine, there may be no protective immune response in all vaccinated people. The safety and efficacy of the preparation in children under 4 years have not been established.

There are no data from prospective clinical trials on the use of the vaccine during pregnancy. Therefore, the vaccine can be used during pregnancy only when it is really needed and when the potential benefits outweigh the risks to the fetus. As with other inactivated vaccines, the vaccine is not expected to have an adverse effect on the fetus. After the use of diphtheria diphtheria or tetanus or inactivated polyovirus vaccines in pregnant women, no teratogenic effects have been observed. The effect of using the vaccine during breastfeeding was not assessed. However, due to the fact that the preparation contains toxoids and inactivated antigens, it should not be expected to pose a risk to the breast-fed child. If you are advised to give a vaccine to a woman who is breastfeeding, the doctor should consider whether the resulting benefits to the mother outweigh the possible risks to the child.

Clinical tests. Children aged 4-8. Very common: reactions at the injection site (such as redness and / or swelling), pain at the injection site, drowsiness. Common: loss of appetite, irritability, headache, fever (≥37,5 ° C, including> 39 ° C), extensive swelling of the limb to which the vaccine has been administered (sometimes involving an adjoining joint), reactions at the injection site (such as bleeding , pruritus, induration). Uncommon: generalized enlargement of the lymph nodes, sleep disturbances, apathy, dry throat, diarrhea, vomiting, abdominal pain, nausea, and tiredness.People aged 10-93. Very common: headache, reactions at the injection site (such as redness and / or swelling), fatigue, pain at the injection site. Common: loss of appetite, gastrointestinal disturbances (such as vomiting, abdominal pain, nausea), fever (≥37,5 ° C), reactions at the site of injection (such as hematoma, pruritus, induration, warming and numbness). Uncommon: cold sores, generalized enlargement of the lymph nodes, paresthesia, drowsiness, dizziness, asthma, pruritus, joint pain, muscle pain, extensive swelling of the limb, in which the vaccine was administered (sometimes including a neighboring joint), fever (> 39.0st .C), chills, pain.Additional adverse reactions reported during clinical trials of another vaccine against diphtheria, tetanus and pertussis (acellular) with reduced antigen content (Boostrix). Children aged 4-8. Common: stomach and intestinal disorders. Uncommon: inflammation of the upper respiratory tract, attention deficit, conjunctivitis, rash, pain.People aged 10-76. Very often: bad mood. Common: injection site reactions (such as infiltration at the injection site and sterile abscess at the injection site). Uncommon: upper respiratory tract inflammation, pharyngitis, fainting, cough, bigunka, increased sweating, rash, joint stiffness, musculoskeletal stiffness, flu-like illness.After placing the preparation on the market: allergic reactions (including anaphylactic and anaphylactoid), hypotensive-hyperactive episode, seizures (with or without fever), urticaria, angioneurotic edema, asthenia. The data indicate that in people who received childhood vaccination with DTP vaccine, the booster dose may increase the severity of local reactions. After administration of tetanus toxoid vaccines, side effects such as ascending or even respiratory paralysis (eg, Guillain-Barre syndrome) have been reported on very rare occasions.

Deep intramuscularly (preferably in the deltoid muscle).Adults and children from 4 years: 1 dose (0.5 ml) according to official recommendations and / or local practice for the use of vaccines containing low (for adults) dose of diphtheria, tetanus and pertussis antigens in combination with virus antigenspolio. In people over 40 years of age who have not been vaccinated with any vaccine containing diphtheria or tetanus in the last 20 years (including those who have never been vaccinated and those who are not known or vaccinated), 1 dose of vaccine induces an immune response against pertussis and in most cases protects against tetanus and diphtheria. Administration of 2 consecutive doses of the vaccine containing the diphtheria and tetanus components after 1 month and 6 months after the first dose will increase the immune response against diphtheria and tetanus. The vaccine may be administered as part of the management of wounds that present a risk of tetanus in people who have previously received a primary tetanus toxoid vaccination course and who have an indication for booster diphtheria, pertussis andpolio. Parallel anti-tetanus immunoglobulin should be administered in accordance with official recommendations. Repeated vaccination against diphtheria, tetanus, pertussis and pertussispolio perform at officially recommended intervals.