Index of drugs

Active immunization of people from 2 months and older against invasive meningococcal disease caused byNeisseria meningitidisgroup B. Vaccination should consider the influence of invasive diseases in different age groups and differentiated epidemiology of the antigen for B group strains in different geographical areas. The vaccine should be used in accordance with official recommendations.

1 dose (0.5 ml) contains: 50 μg recombinant NHBA fusion protein from the strainsNeisseria meningitidis group B, 50 μg of NadA recombinant protein from strainsNeisseria meningitidis group B, 50 μg of recombinant fHbp fusion protein from the strainsNeisseria meningitidis B groups (produced in cellsE. coli using recombinant DNA technology, adsorbed on aluminum hydroxide), 25 μg intimal follicles (OMV) from strain NZ98 / 254Neisseria meningitidis group B - measured as the total amount of protein containing PorA P1.4 antibody (adsorbed on aluminum hydroxide).

B-group meningococcal (rDNA) vaccine, complex, adsorbed. Vaccination with the vaccine is intended to stimulate the production of bactericidal antibodies recognizing the vaccine antigens NHBA, NadA, fHbp and PorA P1.4 (immunodominant antigen of the OMV component) and having the expected protection against invasive meningococcal disease (IMD).

Hypersensitivity to the active substances or to any of the excipients.

Do not administer intravenously, subcutaneously or intradermally. Administration of the vaccine should be postponed in patients with severe febrile illness; The occurrence of a lighter infection, e.g. a cold, should not be a reason to postpone vaccination. Appropriate supervision and treatment should be possible in the event of anaphylactic reactions following administration of the vaccine. Vaccines should not be given to patients with thrombocytopenia or other blood clotting disorders that may constitute contraindications for intramuscular injection unless the potential benefit clearly outweighs the risks associated with the administration of the vaccine. The vaccine can not be expected to provide protection against all existing group B meningococcal strains. Prophylactic administration of antipyretics in infants and children <2 years of age (as per local guidelines) should be considered. There are no data on the use of the vaccine in immunocompromised patients; in such patients, the appropriate immune response may not occur. There are no data on the use of the vaccine in patients> 50 years old or in patients with chronic diseases. Special care should be taken in premature infants (≤ 28 weeks of pregnancy), especially those who had signs of immaturity of the respiratory system (risk of apnea should be considered and respiratory monitoring should be monitored for 48-72 h); Due to the significant benefits of vaccinating this group of infants, vaccination should not be abandoned or postponed. The syringe cap may contain natural rubber (latex); the benefit-risk ratio should be considered before giving the vaccine to patients with a history of hypersensitivity to latex. In the early stages of the vaccine production process, kanamycin is used, which is removed in subsequent stages of production; in the case of the presence of kanamycin in the final product, its concentration is <0.01 μg per dose of vaccine.

There are no adequate clinical data on the use of the vaccine in pregnant women (no maternal or fetotoxic effects on animals or effects on pregnancy or postnatal development have been observed in animals). Vaccination should not be withheld if there is a clear risk of exposure to meningococcal infection. There are no data on the safety of the vaccine during breastfeeding (no adverse reactions were seen in animals).The benefit-risk ratio should be evaluated before making a decision about vaccinations during breast-feeding.

There was no increase in the frequency or severity of adverse reactions after subsequent doses in the course of the vaccination course.Infants and children (up to 10 years old). Very common: appetite disorders, drowsiness, atypical crying, diarrhea, vomiting (uncommon after a booster dose), rash (children 12-23 months, uncommon after a booster dose), fever (≥38st.C), tenderness in at the injection site (including severe tenderness at the injection site defined as crying when moving the limb, which was injected), erythema at the injection site, swelling at the injection site, induration at the injection site, irritability. Common: rash (infants and children aged 2-10). Uncommon: convulsions (including febrile convulsions), pallor (rarely after the booster dose), eczema, fever (≥40st.C). Rarely: Kawasaki syndrome, urticaria.Youth (from the age of 11) and adults. Very common: headache, nausea, pain at the injection site (including severe pain at the injection site defined as inability to perform daily activities), injection site swelling, induration at the injection site, erythema at the injection site, malaise, muscle pain, arthralgia.

Intramuscularly (into the anterolateral thigh in infants or in the deltoid muscle of older patients).Infants 2-5 months. Primary vaccination: three doses of 0.5 ml at intervals of at least one month (the first dose in the 2nd cereal); then 1 supplementary dose between 12 and 15 hours (in case of delay, the supplementary dose should not be given later than 24 months). The safety and efficacy of the vaccine in infants <8 weeks of age has not yet been established.Unvaccinated infants aged 6-11 months. Primary vaccination: 2 doses of 0.5 ml at intervals of at least 2 months; then one supplementary dose in the second year, with a gap of at least 2 months between the series of primary vaccination and the supplementary dose.Unvaccinated children aged 12-23 months. Primary vaccination: 2 doses of 0.5 ml at intervals of at least 2 months; followed by one supplementary dose with an interval of 12-23 months between the series of primary vaccination and the booster dose.Children aged 2-10. Primary vaccination: 2 doses of 0.5 ml at intervals of at least 2 months; the need for a booster dose was not determined.Youth (from 11 years) and adults. Primary vaccination: 2 doses of 0.5 ml at intervals of at least 1 month; the need for a booster dose was not determined.