Index of drugs

Active immunization against invasive disease and acute otitis media caused byStreptococcus pneumoniae in infants and children from the age of 6 weeks to 2 years. The schedule of vaccine use should be established in accordance with local recommendations, including the impact of invasive infection on different age groups, as well as epidemiological data on serotype variability in different geographical areas.

1 dose (0.5 ml) contains a mixture of pneumococcal polysaccharides of serotypes: 1 - 1 μg, 4 - 3 μg, 5 - 1 μg, 6B - 1 μg, 7F - 1 μg, 9V - 1 μg, 14 - 1 μg, 18C - 3 μg, 19F - 3 μg, 23F - 1 μg adsorbed on aluminum phosphate (0.5 mg). Polysaccharides, serotypes 1, 4, 5, 6B, 7F, 9V, 14 and 23F, are conjugated to carrier protein D originating from non-enveloped strainsHaemophilus influenzae (9-16 μg). The polysaccharide serotype 18C is conjugated to tetanus toxoid as a protein carrier (5-10 μg). Polysaccharide 19F serotype is conjugated with diphtheria toxoid as a protein carrier (3-6 μg).

Pneumococcal vaccine, polysaccharide, conjugated, adsorbed. The vaccine contains 10 pneumococcal serotypes, which are among the most common in Europe. They cause about 56-90% of cases of invasive pneumococcal disease (IChP) in children aged <5 years. In a direct comparative study with a 7-valent vaccine (Prevenar) at least the equivalence of the immune response was demonstrated after 10-valent vaccine (Synflorix) for all serotypes except for serotypes 6B and 23F. In the case of serotypes 6B and 23F threshold antibody concentration (ie 0.20 μg / ml), one month after the third dose of Synflorix (in the 2, 3 and 4 cereal regimens), 65.9% and 81 were obtained, respectively 4% vaccinated compared to 79.0% and 94.1% after vaccination with three doses of 7-valent vaccine. The percentage of vaccinates who achieved the threshold antibody concentration with respect to the three additional serotypes included in the Synflorix vaccine (1, 5 and 7F) was 97.3%, 99.0% and 99.5%, respectively. Based on the similarity of the immune response in terms of the ability of antibodies to opsonize after administration of Synflorix and the 11-valent vaccine (containing 10 serotypes also contained in Synflorix) used in the clinical trial, Synflorix is ​​considered to provide similar protective efficacy against acute otitis media (AOM) ) caused by pneumococcus. The effectiveness of the 11-valent vaccine in preventing the first episode of AOMAS caused by the serotypes contained in the vaccine was 52.6%; serotype-specific vaccine efficacy has been demonstrated for serotypes 6B, 14, 19F and 23F. The effectiveness of the vaccine in preventing any episode of AOMA caused by any pneumococcal serotype was 51.5%.

Hypersensitivity to the components of the preparation or any carrier protein. Acute febrile illness (administration of the vaccine should be postponed); a mild infection, such as a cold, is not a contraindication to the use of the vaccine. Do not administer intravascularly or intradermally.

Particular care should be taken in very premature infants (born ≤ 28 weeks of pregnancy), especially those who had signs 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. Caution should be used in patients with thrombocytopenia or other coagulation disorders, as these patients may experience bleeding after intramuscular administration. There is not enough evidence that the vaccine provides protection against other pneumococcal serotypes than those contained in the vaccine or against non-enveloped strainsHaemophilus influenzae. It can be expected that the protection against otitis media caused by pneumococcal serotypes contained in the vaccine will be significantly lower than against invasive pneumococcal disease.In clinical trials, the vaccine induced an immune response to all serotypes contained in the vaccine, but the level of these responses differed depending on the serotype - the functional immune response against serotypes 1 and 5 was weaker than against all other vaccine serotypes. The immune response after 2 doses of vaccine in children aged 12-23 months is comparable to the response obtained after 3 doses in infants. The immune response to a booster dose after 2 primary doses was not assessed in children aged 12-23 months, but a supplementary dose may be needed to achieve optimal individual protection. In children with impaired immunity (caused by immunosuppressive therapy, genetic disorder, HIV infection or other cause), the response to vaccination may be reduced. There are no data on the safety and immunogenicity of the vaccine in children at high risk of pneumococcal disease (eg with sickle cell disease, congenital or acquired splenic dysfunction, HIV infection, cancer, nephrotic syndrome) - vaccination should be decided on an individual basis. A 2-dose schedule may not be sufficient to provide optimal protection for children aged 12-23 months belonging to the above-mentioned high-risk groups of pneumococcal disease - children from these risk groups should receive a 23-valent pneumococcal polysaccharide vaccine of ≥ 2 years of age when recommended. The interval between administration of Synflorix and the administration of 23-valent pneumococcal polysaccharide vaccine should not be shorter than 8 weeks. No data available to determine whether the use of polysaccharide pneumococcal vaccine in children previously vaccinated with Synflorix may result in a reduced immune response to subsequent doses of the polysaccharide vaccine pneumococcal or conjugated pneumococcal vaccine. Prophylactic administration of antipyretic drugs before or immediately after vaccination may reduce the incidence and severity of post-vaccine febrile reactions; available data suggest that prophylactic use of Paracetamol may weaken the immune response to the vaccine - the clinical significance of this observation is unknown, as well as the effect of antipyretic drugs other than paracetamol on the immune response after the vaccine administration. Prophylactic use of antipyretic drugs is recommended: in all children receiving the vaccine at the same time as vaccines containing whole cell pertussis; in children with impaired seizures or with febrile convulsions. There is no data on subcutaneous administration of the vaccine.

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

Very common: drowsiness, loss of appetite, reactions at the injection site (pain, erythema, edema), fever (≥38st.C measured in the rectum), irritability. Common: induration at the injection site, fever (> 39 ° C measured in the rectum). Uncommon: apnea in very premature premature babies (born ≤ 28 weeks of gestation), diarrhea, vomiting, injection site reactions (hematoma, bleeding and nodule), fever (> 40 ° C measured in the rectum), atypical crying. Rarely: febrile convulsions and fits unrelated to fever, rash, urticaria, allergic reactions (such as allergic dermatitis, atopic dermatitis, eczema).

Intramuscularly (infants - anterolateral lateral surface of the thigh, small children - deltoid muscle).Infants from 6 weeks of age to 6 months: 3 doses of primary vaccination (each 0.5 ml) - first dose usually in 2 months (can be given after the end of the sixth week of life), the Next with a gap of at least one month between doses; the fourth complementary dose is recommended to be administered at least 6 months after the last primary immunization dose, preferably between 12 and 15 months old. child. Alternatively, if the vaccine is administered as part of an existing vaccination program, a 2-dose primary vaccination schedule may be considered - the first dose can be given from 2 months of age, the second dose is 2 months later; the third supplementary dose is recommended to be administered at least 6 months after the last primary immunization dose.Premature babies (born after 27-36 weeks of pregnancy): 3 doses of primary vaccination (each of 0.5 ml) - the first dose usually in 2 months, followed by a gap of at least 1 month between doses; the fourth supplementary dose is recommended to be administered at least 6 months after the last primary immunization dose.Older babies and children who have not been vaccinated before: babies 7-11 months - 2 doses (0.5 ml each), with a gap of at least one month between doses; the third dose is recommended in 2 years, with a gap of at least 2 months between doses; children aged 12-23 months - 2 doses (0.5 ml each), with a gap of at least 2 months between doses; It has not been established whether a supplementary dose is required after the vaccination schedule above. The safety and efficacy of the vaccine in children> 24 months has not been established. It is recommended that patients who receive the first dose of Synflorix receive the full course of vaccination with the same vaccine.