Index of drugs

Active immunization against invasive disease, pneumonia and acute otitis media caused by bacteriaStreptococcus pneumoniae in infants from 6th week of life, children and adolescents up to 17 years of age. Active immunization against invasive disease and pneumonia caused by bacteriaStreptococcus pneumoniae in adults ≥ 18 years and older people. The use of the vaccine should be established in accordance with official recommendations, taking into account the risk of invasive disease and pneumonia in different age groups, comorbidities 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: 1 (2.2 μg), 3 (2.2 μg), 4 (2.2 μg), 5 (2.2 μg), 6A (2.2 μg), 6B (4.4 μg), 7F (2.2 μg), 9V (2.2 μg), 14 (2.2 μg), 18C (2.2 μg), 19A (2.2 μg), 19F (2.2 μg), 23F ( 2.2 μg) conjugated to the CRM carrier protein₁₉₇ and adsorbed on aluminum phosphate (0.125 mg).

13-valent pneumococcal saccharide vaccine, conjugated, adsorbed. It contains capsular polysaccharides contained in the 7-valent vaccine - Prevenar (4, 6B, 9V, 14, 18C, 19F, 23F) and 6 additional polysaccharides (1, 3, 5, 6A, 7F, 19A). The vaccine covers about 73-100% (depending on the country) of serotypesStreptococcus pneumoniae responsible for invasive pneumococcal disease (IChP) in children under the age of 5 years. Acute otitis media (AOM) is a common childhood disease of various aetiologies;S. pneumoniae is the most common cause of all AOM bacterial cases around the world. It is estimated that the vaccine covers over 90% of antibiotic-resistant serotypes responsible for IChP. In children and adolescents from 6 to 17 years of age, the incidence of pneumococcal disease is low, while there is an increased risk of morbidity and mortality in patients with concomitant diseases. For adults aged ≥50 years, pneumococcal serotypes present in the vaccine may account for at least 50-76% (depending on the country) of IChP in adults.

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.

The vaccine must not be administered intravascularly. Do not give intramuscularly to patients with thrombocytopenia or other coagulation disorders - can be given subcutaneously, if the potential benefits of vaccination far outweigh the risk of administration. At the time of vaccination, appropriate medicines and medical supervision should be provided in case of an anaphylactic reaction. 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 disease, pneumonia 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 clinical trials, the vaccine induced an immune response against all 13 serotypes, however, the immune response to serotype 3 after booster doses did not rise above the level observed after the infant immunization cycle. The percentage of children who achieved induction of biologically active antibodies (OPA titre ≥1: 8) against serotypes 1, 3 and 5 was high, however the geometric mean titres in the OPA test were lower than those against the other additional serotypes present in the vaccine.In patients with impaired immunity (caused by immunosuppressive therapy, genetic disorder, HIV infection or other cause), the response to vaccination may be reduced. Safety and immunogenicity data are available for a limited number of people with sickle cell disease, HIV-infected or after bone marrow hematopoietic transplantation. There are no data on the safety and immunogenicity of the vaccine in individuals in other specific immunocompromised groups (eg patients with cancer or nephrotic syndrome) - the decision to vaccinate should be made on an individual basis. Based on limited data, the 7-valent pneumococcal (Prevenar) 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. Children aged <2 years should receive the appropriate for the age of the number of doses of 13-valent pneumococcal conjugate vaccine. The use of this vaccine is not a substitute for the administration of 23-valent pneumococcal vaccines to children ≥ 2 years of high risk of invasive pneumococcal disease (sickle cell disease, lack of spleen, HIV infection, chronic disease or immunodeficiency). If recommended, these children previously vaccinated with Prevenar 13 should receive a 23-valent pneumococcal vaccine. The interval between administration of Prevenar 13 and 23-valent should not be shorter than 8 weeks. There are no data available to indicate whether the use of 23-valent pneumococcal polysaccharide vaccine in children previously not vaccinated or vaccinated with Prevenar 13 may cause a reduced immune response to subsequent doses of Prevenar 13. Particular care should be taken in very premature infants (≤ 28 weeks gestation), especially who had symptoms of respiratory immaturity (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. In children with seizure disorders or with febrile convulsions and in all children receiving Prevenar 13 simultaneously with vaccines containing whole cell pertussis, prophylactic treatment with antipyretics is recommended.

Due to lack of data, avoid use during pregnancy. It is not known whether the vaccine is excreted in human milk.

Infants and children up to 5 years old. Very common: reactions at the injection site (eg erythema, induration or swelling, pain or tenderness, erythema, induration or swelling at the injection site with a diameter of 2.5 cm-7 cm - after a booster dose and in older children - age 2 - 5 years), fever, irritability, drowsiness, restless sleep, decreased appetite. Common: fever> 39st.C, tenderness at the injection site that impairs the movement of the limb (due to pain), erythema, induration or swelling at the injection site with a diameter of 2.5 cm-7 cm - after the vaccination course in infants; vomiting, diarrhea, rash. Uncommon: erythema, induration or swelling at the injection site with a diameter of> 7 cm, crying, convulsions (including febrile seizures), urticaria or urticaria rash. Rare: hypersensitivity reactions (swelling of the face, shortness of breath, bronchospasm), hypotonic-hyporeactive episodes. After marketing, the vaccine was observed (frequency unknown): enlarged lymph nodes (near the site of vaccination), anaphylactic or anaphylactoid reactions (including anaphylactic shock, angioneurotic edema), erythema multiforme, reactions at the vaccination site (urticaria, dermatitis, pruritus), redness, apnea in premature infants (≤ 28 weeks of pregnancy). In children receiving the vaccine at the same time as 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 after the primary vaccination course.Children and teenagers 6-17 years old. Very common: irritability, reactions at the injection site (e.g.erythema, induration or swelling, pain or tenderness; including tenderness that impairs movement), drowsiness, restless sleep, decreased appetite. Common: headache, vomiting, diarrhea, rash, urticaria or urticaria rash, fever. Also, other side effects previously seen in infants and children from 6 weeks to 5 years of age may affect this age group. In children and adolescents with sickle cell disease, HIV infected or after hematopoietic bone marrow hematopoietic transplantation, the incidence of adverse reactions is similar, except for headache, vomiting, diarrhea and fever, fatigue and pain in joints and muscles that have occurred very frequently.Adults. Very common: decreased appetite, headache, diarrhea, vomiting (in adults aged 18-49), chills, tiredness, reactions at the site of vaccination (erythema, induration or swelling, pain or tenderness - severe pain or tenderness at the vaccination site occurred very often in adults between the ages of 18 and 39), impaired hand movement (significant handicap disability was very common in people aged 18 to 39), joint pain, muscle pain. Common: vomiting (in adults ≥ 50 years old), fever (very common in adults between 18 and 29 years of age). Uncommon: nausea, hypersensitivity reactions (including face edema, dyspnea, bronchospasm), enlargement of the lymph nodes around the site of vaccination. Rare: rash. In adults infected with HIV, the incidence of adverse reactions is similar, with the exception of fever and vomiting that occurred very often, and nausea, which occurred frequently. In adults following transplantation of bone marrow hematopoietic cells, the incidence of adverse reactions is similar, except for fever and vomiting, which were very common. A higher incidence of some expected systemic reactions was observed when co-administered with a 13-valent pneumococcal vaccine with a triple Inactivated Influenza Vaccine (TIV) compared to a TIV administered alone (headache, chills, rash, decreased appetite, joint pain and muscle pain) or for pneumococcal vaccine administered alone (headache, fatigue, chills, decreased appetite and joint pain).

Intramuscularly (infants - anterolateral thigh area, children and adults - deltoid muscle). It is recommended that children who receive the first dose of the 13-valent vaccine complete the vaccination course with Prevenar 13.Infants from 6 weeks to 6 months: 3 doses of 0.5 ml - the first dose usually in 2 months (it can be given at the age of 6 weeks), followed by a gap of at least one month between doses; the fourth dose (supplementary), it is recommended in 11-15 months. Alternatively, if the vaccine is administered as part of an existing vaccination program, the following vaccination schedule may be considered - the first dose from 2 months of age, the second dose at least 2 months later; the third dose (reminder) is recommended in 11-15 months.Premature babies (<37 weeks pregnant): 3 doses of 0.5 ml - the first dose in 2 bees (it can be given at the age of 6 weeks), followed by a gap of at least one month between doses; the fourth dose (supplementary), it is recommended in 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 2-17 years: single dose.Vaccination schedule in infants and children previously vaccinated with 7-valent vaccine (Prevenar). In infants and children who have started a 7-valent vaccination course, the 13-valent vaccine can be changed at any stage of the vaccination schedule. Children 12-59 months old, who are considered to be completely immunized with 7-valent vaccine (Prevenar), should receive one dose of 0.5 ml of Prevenar 13 vaccine to induce an immune response to 6 additional serotypes; this dose should be administered at least 8 weeks after the last dose of 7-valent vaccine. Children aged 5 to 17 years of age may receive one dose of 13-valent vaccine if they were previously vaccinated with one dose or several doses of 7-valent vaccine; this dose should be administered at least 8 weeksafter the last dose of 7-valent vaccine.Adults (including the elderly): single dose. If the use of a 23-valent polysaccharide vaccine appears to be justified, regardless of the previous pneumococcal vaccination status, Prevenar 13 should be given first.Special groups of patients. Individuals with comorbidities predisposing to invasive pneumococcal disease (eg patients with sickle cell disease or HIV), including those previously vaccinated with one or more doses of a 23-valent polysaccharide pneumococcal vaccine, may receive at least one dose of 13-valent vaccine. In the case of people with hematopoetic marrow hematopoietic transplantation, the recommended course of vaccination includes 4 doses of 13-valent vaccine: the basic cycle - 3 doses of 0.5 ml, the first dose is given 3-6 months after hematopoietic bone marrow hematopoietic transplantation. interval of at least one month between doses; the fourth dose (supplementary) is recommended 6 months after the third dose.