Index of drugs

Active immunization against diseases caused by bacterial serotypes 4, 6B, 9V, 14, 18C, 19F and 23FStreptococcus pneumoniae (including sepsis, meningitis, pneumonia, bacteremia and acute otitis media) in infants and children from 2 months to 5 years of age. The schedule of vaccine use should be established in accordance with the protective vaccination program, taking into account the presence of invasive disease in different age groups as well as epidemiological data on serotype variability in different geographical areas.

1 dose (0.5 ml) contains a mixture of highly purified polysaccharidesStreptococcus pneumoniae serotypes: 4 (2 μg), 6B (4 μg), 9V (2 μg), 14 (2 μg), 18C (2 μg), 19F (2 μg) and 23F (2 μg) conjugated to the CRM carrier protein₁₉₇ and adsorbed on aluminum phosphate (0.5 mg).

7-valent pneumococcal saccharide vaccine, conjugated, adsorbed. It contains the polysaccharides of the most widespread and invasive serotypesStreptococcus pneumoniae. It induces the formation of specific antibodies against all serotypes contained in the vaccine. It provides protection against disease caused by 54-84% of strains isolated during invasive pneumococcal disease (IChP) in European children up to 2 years old and 62-83% of strains in children aged 2-5 years. The serotypes contained in the vaccine protect against infections caused by over 80% of antibiotic resistant strains. Due to the fact that pathogens other than pneumococcal serotypes in the vaccine may cause pneumonia in children, protection against all clinically manifest pneumonia is expected to be lower than against invasive pneumococcal disease. The vaccine is effective in the prevention of otitis media caused by the serotypes corresponding to that contained in the vaccine. Because otitis media is caused by numerous microorganisms, including those other than the pneumococcal serotypes found in the vaccine, it should be taken into account that protection against otitis media may be less than protection against invasive disease. It is estimated that the vaccine can prevent 6-13% of all clinical episodes of acute otitis media.

Hypersensitivity to the active substances, to any of the excipients or to the diphtheria toxoid. Acute illness with fever (vaccination should be postponed); a small infection (eg a cold), but it should not be a reason to postpone vaccination.

Do not administer intravenously. Do not give to children with thrombocytopenia or other coagulation disorders that may be a contraindication for intramuscular injection, unless the potential benefits of vaccination far outweigh the risks of administration. At the time of vaccination, appropriate medicines and medical supervision should be provided in case of an anaphylactic reaction. Despite the possibility of a humoral response to diphtheria toxoid, administration of the vaccine is not a substitute for routine diphtheria vaccination. The vaccine does not prevent diseases caused by other serotypesStreptococcus pneumoniaethan those contained in the vaccine, it does not protect against other microorganisms that cause invasive or otitis media. As with other vaccines, it may not provide all vaccinated individuals with protection against pneumococcal disease. Because otitis media is caused by numerous microorganisms, including those other than the pneumococcal serotypes found in the vaccine, it should be taken into account that protection against otitis media may be less than protection against invasive disease. In children with impaired immunity (caused by immunosuppressive therapy, genetic disorder, HIV infection or other cause), the response to vaccination may be reduced. Based on limited data, the vaccine has been shown to produce an adequate immune response in infants with sickle cell disease with a safety profile similar to that seen in the low-risk group.There are no data on the safety and immunogenicity of the vaccine in children from other special high risk groups of invasive pneumococcal disease (eg children with congenital or acquired spleen dysfunction, HIV infection, cancer, nephrotic syndrome) - vaccination should be individual . The use of a 7-valent pneumococcal conjugate vaccine is not a substitute for the administration of 23-valent pneumococcal vaccines to children ≥ 24 months. from high-risk groups of invasive pneumococcal disease. If recommended, these children previously vaccinated with Prevenar should receive a 23-valent pneumococcal vaccine. The interval between administration of Prevenar and 23-valent should not be shorter than 8 weeks. There are no data available on whether the use of the 23-valent pneumococcal polysaccharide vaccine in children previously not vaccinated or vaccinated with Prevenar may cause a reduced immune response to subsequent doses of Prevenar. In children with seizure disorders or with febrile seizures and in all children receiving Prevenar simultaneously with vaccines containing whole cell pertussis component, prophylactic treatment with antipyretics is recommended. Particular care should be taken in very premature premature babies (born ≤ 28 weeks of gestation), especially those with symptoms of immaturity of the respiratory system (the risk of apnea should be considered and the need to monitor respiratory function for 48-72 h); Due to the significant benefits of vaccinating this group of infants, vaccination should not be abandoned or postponed.

Not applicable - preparation for children.

Very common: reactions at the injection site (eg erythema, induration or swelling, pain or tenderness), fever ≥38st.C, irritability, crying, drowsiness, restless sleep, vomiting, diarrhea, decreased appetite. Common: swelling or induration at the site of application and erythema with a diameter> 2.4 cm, tenderness impaired limb movement, fever> 39st.C. Uncommon: rash or urticaria. Rare: hypersensitivity reactions such as anaphylactic or anaphylactoid reactions (including anaphylactic shock, angioneurotic edema, bronchospasm, shortness of breath, swelling of the face), seizures (including febrile seizures), hypotonic-hyporesponsive episodes, hypersensitivity reactions at the injection site (dermatitis, pruritus, urticaria), redness. Very rare: enlarged lymph nodes around the injection site, erythema multiforme. In premature infants (≤ 28 weeks of pregnancy), apnea may occur after the administration of the vaccine. In children treated with vaccines containing a full-cell pertussis component or a 6-valent vaccine (DTaP / Hib (PRP-T / IPV / HepB), a higher incidence of febrile reactions was observed. In children> 24 months, receiving a single dose of vaccine, frequency of local reactions than in infants.

Intramuscularly (infants - anterolateral thigh area, children - deltoid muscle).Infants 2-6 months: 3 doses of 0.5 ml - the first dose usually in 2 months, followed by a gap of at least 1 month between doses (the fourth dose is recommended in 2 years). Alternatively, if the vaccine is administered as part of the current vaccination program, the following vaccination schedule may be considered - the first dose can be given from 2 months, the second dose at least 2 months later, the third (supplementary) dose at 11-15 months.Older babies and children who have not been vaccinated before: babies 7-11 months - 2 doses of 0.5 ml with a gap of at least 1 month between doses (the third dose is recommended in 2 years); children 12-23 months - 2 doses of 0.5 ml with a gap of at least 2 months between doses; children from 24 months to 5 years: single dose. It has not been found to date whether there is a need for a booster dose after the above treatment regimens.