PREVENAR

® 13

(vaccine pneumococcal polysaccharide conjugated adsorbed, thirteen-valent)

INTERNATIONAL NON-PROPRIETARY OR GROUPED NAME:

vaccine for prevention of pneumococcal infections

PHARMACEUTICAL FORM: suspension for intramuscular injection

Price: 3900 r.

Prevenar ® 13 vaccine is a capsular polysaccharide of 13 pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, individually conjugated to the diphtheria protein CRM 197 and adsorbed on aluminum phosphate .

COMPOUND

Composition per dose (0.5 ml):

Active substances :

Pneumococcal conjugates (polysaccharide — CRM 197):

Excipients : aluminum phosphate - 0.5 mg (in terms of aluminum 0.125 mg), sodium chloride - 4.25 mg, succinic acid - 0.295 mg, polysorbate 80 - 0.1 mg, water for injection - up to 0.5 ml.

DESCRIPTION

Homogeneous suspension of white color.

PHARMACOTHERAPEUTIC GROUP: MIBP vaccine.

ATX code: J07AL02

IMMUNOLOGICAL PROPERTIES

The introduction of the vaccine Prevenar ® 13 causes the production of antibodies to capsular polysaccharides Streptococcus pneumoniae, thereby providing specific protection against infections caused by pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F included in the vaccine.

According to the WHO recommendations for new pneumococcal conjugate vaccines, the equivalence of the immune response of Prevenar ® 13 was determined according to three criteria: the percentage of patients who reached the concentration of specific IgG antibodies ³ 0.35 µg/ml; geometric mean concentrations (SGK) of immunoglobulins and opsonophagocytic activity (OFA) of bactericidal antibodies (OFA titer ³ 1:8 and geometric mean titers (SGT)). For adults, a protective level of anti-pneumococcal antibodies has not been determined and serotype-specific OFA (SGT) is used.

The vaccine Prevenar ® 13 includes up to 90% of serotypes that cause invasive pneumococcal infections (IPI), including those resistant to antibiotic treatment.

Immune response when using three or two doses in a series of primary vaccinations

After the introduction three doses Prevenar ® 13 during the primary vaccination of children under the age of 6 months, a significant increase in the level of antibodies to all vaccine serotypes was noted.

After the introduction two doses during the primary vaccination with Prevenar ® 13 as part of the mass immunization of children of the same age group, there is also a significant increase in antibody titers to all components of the vaccine; for serotypes 6B and 23F, the level of IgG ³ 0.35 μg / ml was determined in a smaller percentage of children. At the same time, a pronounced booster response to revaccination was noted for all serotypes. The formation of immune memory is shown for both of the above vaccination schemes. Secondary immune response to a booster dose in children of the second year of life when using three or two doses in the primary vaccination series are comparable for all 13 serotypes.

When vaccinating premature babies (born at gestational age<37 недель), включая глубоко-недоношенных детей (родившихся при сроке гестации <28 недель), начиная с возраста двух месяцев, отмечено, что уровень защитных специфических противопневмококковых антител и их ОФА после законченного курса вакцинации достигали значений выше защитных у 87-100% привитых ко всем тринадцати включенным в вакцину серотипам.

Immunogenicity in children and adolescents aged 5 to 17 years

Children aged 5 to<10 лет, которые до этого получили как минимум одну дозу пневмококковой 7-валентной конъюгированной вакцины, а также ранее не вакцинированные дети и подростки в возрасте от 10 до 17 лет, получив по одной дозе вакцины Превенар ® 13, продемонстрировали иммунный ответ на все 13 серотипов, эквивалентный таковому у детей 12-15 месяцев, вакцинированных четырьмя дозами препарата Превенар ® 13.

A single administration of Prevenar ® 13 to children aged 5-17 years can provide the necessary immune response to all serotypes of the pathogen that are part of the vaccine.

Efficacy of Prevenar ® 13

Invasive pneumococcal infection (IPI)

After the introduction of Prevenar ® in the 2 + 1 regimen (two doses in the first year of life and a single revaccination in the second year of life), four years later, with 94% vaccination coverage, there was a 98% (95% CI: 95; 99) reduction in the incidence of IPD caused by vaccines -specific serotypes. After switching to Prevenar ® 13, there was a further decrease in the incidence of IPD caused by vaccine-specific additional serotypes, from 76% in children under the age of 2 years to 91% in children aged 5-14 years.

Serotype-specific efficacy against IPI for additional Prevenar® 13 serotypes in children aged ≤ 5 years ranged from 68% to 100% (serotype 3 and 6A, respectively) and was 91% for serotypes 1, 7F and 19A), with no cases of IPD caused by serotype 5 were observed. After the inclusion of Prevenar ® 13 in national immunization programs, the incidence of IPD caused by serotype 3 decreased by 68% (95% CI 6-89%) in children under 5 years of age. A case-control study performed in this age group showed a reduction in the incidence of IPD caused by serotype 3 by 79.5% (95% CI 30.3-94.8). Otitis media (SO)

After the introduction of Prevenar ® vaccination followed by the transition to Prevenar ® 13 according to the 2 + 1 scheme, a 95% decrease in the incidence of OS caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and serotype 6A, as well as by 89% reduction in the frequency of CO caused by serotypes 1, 3, 5, 7F and 19A.

Pneumonia

When switching from Prevenar ® to Prevenar ® 13, a 16% reduction in the incidence of all cases of community-acquired pneumonia (CAP) in children aged 1 month to 15 years was noted. PFS cases with pleural effusion decreased by 53% (p< 0,001), пневмококковые ВБП снизились на 63 % (р < 0,001). Во второй год после внедрения Превенар ® 13 отмечено 74 % снижение частоты ВБП, вызванных 6 дополнительными серотипами Превенар ® 13. У детей в возрасте младше 5 лет после внедрения вакцинации Превенар ® 13 по схеме 2+1 отмечено 68 % (95 % ДИ: 73; 61) снижение числа амбулаторных визитов и 32 % (95 % ДИ: 39; 22) уменьшение числа госпитализаций по поводу альвеолярной ВБП любой этиологии.

Carriage and population effect

The effectiveness of Prevenar ® 13 in reducing carriage in the nasopharynx of vaccine-specific serotypes, both common with Prevenar ® (4, 6B, 9V, 14, 18C, 19F, 23F), and 6 additional (1, 3, 5, 6A , 7A, 19A) and related serotype 6C.

A population effect (serotype-specific reduction in the incidence of unvaccinated persons) has been noted in countries where Prevenar ® 13 has been used as part of mass immunization for more than 3 years with high vaccination coverage and adherence to the immunization schedule. Unvaccinated Prevenar 13 individuals 65 years of age and older showed a 25% reduction in IDI, while IDI caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F decreased by 89% and IDI caused by 6 additional serotypes (1, 3, 5, 6A, 7A, 19A). The frequency of infections caused by serotype 3 decreased by 44%, by serotype 6A by 95%, by serotype 19A by 65%.

Immunogenicity of Prevenar ® 13 vaccine in adults

Clinical studies of Prevenar 13 provide data on immunogenicity in adults aged 18 years and older, including those aged 65 years and older and those previously vaccinated with one or more doses of pneumococcal polysaccharide 23-valent vaccine (PPV23) 5 years prior to inclusion into research. Each study included healthy adults and immunocompetent patients with chronic diseases in the stage of compensation, including comorbidities that form an increased susceptibility to pneumococcal infection (chronic cardiovascular disease, chronic lung disease, including asthma; kidney disease and diabetes mellitus, chronic liver disease, including alcohol injury), and adults with social risk factors such as smoking and alcohol abuse. The immunogenicity and safety of Prevenar 13 has been demonstrated in adults 18 years of age and older, including patients previously vaccinated with PPV23. Immunological equivalence was established for 12 serotypes common with PPV23. In addition, for 8 serotypes common with PPV23 and for serotype 6A, unique to Prevenar ® 13, a statistically significantly higher immune response to Prevenar ® 13 was demonstrated. 13 serotypes of Prevenar ® 13 were not lower than those in adults aged 60-64 years. Moreover, individuals aged 50-59 years had a statistically higher immune response to 9 of 13 serotypes compared to those aged 60-64 years.

Clinical efficacy of Prevenar® 13 was demonstrated in the randomized, double-blind, placebo-controlled CAPITA study (more than 84,000 patients) against community-acquired pneumococcal pneumonia (CAP) in adults aged 65 years and older: 45% against the first episode of CAP caused by serotypes overlapping Prevenar ® 13 (invasive and non-invasive); 75% for invasive infections caused by serotypes covered by Prevenar 13.

Immune response in adults previously vaccinated with PPV23

In adults aged 70 years and over who were vaccinated once with PPV23 ≥ 5 years ago, administration of Prevenar ® 13 demonstrated immunological equivalence for 12 common serotypes compared to the response to PPV23, with 10 common serotypes and serotype 6A immune response to Prevenar 13 was statistically significantly higher compared to the response to PPV23. Prevenar ® 13 gives a more pronounced immune response compared to revaccination with PPV23.

Immune response in special groups of patients

Patients with the conditions described below are at increased risk of pneumococcal infection.

sickle cell anemia

In an open, non-comparative study of 158 children and adolescents aged ≥ 6 and< 18 лет с серповидно-клеточной анемией, ранее вакцинированных одной или более дозами ППВ23 как минимум за 6 месяцев до включения в исследование показало, что введение первой дозы Превенар ® 13 при двукратной иммунизации с интервалом 6 месяцев приводило к статистически значимо высокому иммунному ответу (СГК IgG к каждому серотипу, определяемые методом иммуноферментного анализа (ИФА ), и ОФА СГТ к каждому серотипу). После ведения второй дозы иммунный ответ был сопоставим с таковыми после первой дозы препарата.

HIV infection

HIV-infected children and adults with a CD4 count ≥ 200 cells/μL (mean 717.0 cells/μL), viral load< 50 000 копий/мл (в среднем 2090,0 копий/мл), с отсутствием активных СПИД-ассоциированных заболеваний и ранее не получавшие вакцинации пневмококковой вакциной, получали 3 дозы Превенар ® 13. Показатели IgG СГК и ОФА были достоверно выше после первой вакцинации Превенар ® 13 по сравнению с довакцинальным уровнем. На вторую и третью дозы (через 6 и 12 месяцев) развивался более высокий иммунный ответ, чем после однократной вакцинации Превенар ® 13.

Hematopoietic stem cell transplantation

Children and adults who underwent allogeneic hematopoietic stem cell transplantation (HSCT), aged ≥ 2 years with complete hematological remission of the underlying disease or with satisfactory partial remission in the case of lymphoma and myeloma, received three doses of Prevenar ® 13 at least 1 month apart between doses. The first dose of the drug was administered 3-6 months after HSCT. The fourth (booster) dose of Prevenar ® 13 was administered 6 months after the third dose. In accordance with the general recommendations, a single dose of PPV23 was administered 1 month after the fourth dose of Prevenar ® 13. Titers of functionally active antibodies (OPA GT) were not determined in this study. The introduction of Prevenar ® 13 caused an increase in SGC serotype-specific antibodies after each dose. The immune response to the booster dose of Prevenar ® 13 was significantly higher for all serotypes compared to the response to the primary immunization series.

INDICATIONS FOR USE

- prevention of pneumococcal infections, including invasive (including meningitis, bacteremia, sepsis, severe pneumonia) and non-invasive (community-acquired pneumonia and otitis media) forms of diseases caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F from 2 months of age onwards without age limit:

- within the framework of the national calendar of preventive vaccinations;

- in individuals at increased risk of developing pneumococcal infection.

Vaccination is carried out within the framework of the national calendar of preventive vaccinations according to the approved deadlines, as well as for persons at risk for the development of pneumococcal infection: with immunodeficiency states, incl. HIV infection, oncological diseases receiving immunosuppressive therapy; with anatomical/functional asplenia; with a cochlear implant or planned for this operation; patients with leakage of cerebrospinal fluid; with chronic diseases of the lungs, cardiovascular system, liver, kidneys and diabetes mellitus; patients with bronchial asthma; premature babies; persons who are in organized groups (orphanages, boarding schools, army groups); convalescents of acute otitis media, meningitis, pneumonia; long-term and frequently ill children; patients infected with Mycobacterium tuberculosis; all persons over 50 years of age; tobacco smokers.

CONTRAINDICATIONS

• Hypersensitivity to previous administration of Prevenar ® 13 or Prevenar ® (including anaphylactic shock, severe generalized allergic reactions);
• hypersensitivity to diphtheria toxoid and / or excipients;
• acute infectious or non-infectious diseases, exacerbations of chronic diseases. Vaccination is carried out after recovery or during remission.

USE IN PREGNANCY AND DURING BREASTFEEDING

The safety of the vaccine during pregnancy and breastfeeding has not been established. There are no data on the use of Prevenar ® 13 during pregnancy. There are no data on the isolation of vaccine antigens or post-vaccination antibodies in breast milk during lactation.

METHOD OF APPLICATION AND DOSESS

Method of administration

The vaccine is administered in a single dose of 0.5 ml intramuscularly. For children of the first years of life, vaccinations are carried out in the upper outer surface of the middle third of the thigh, for persons older than 2 years - in the deltoid muscle of the shoulder.

Before use, the syringe with the vaccine Prevenar ® 13 should be shaken well until a homogeneous suspension is obtained. Do not use if foreign particles are detected during inspection of the contents of the syringe, or the contents look different than in the "Description" section of this instruction.

Do not inject Prevenar ® 13 intravascular and intramuscular in the gluteal region!

If vaccination with Prevenar ® 13 is started, it is recommended to complete it also with Prevenar ® 13 vaccine. If the interval between injections of any of the above vaccination courses is forced to increase, additional doses of Prevenar ® 13 are not required.

Vaccination schedule

Age of start of vaccination	Vaccination schedule	Intervals and dosage
2 -6 months		Individual immunization: 3 doses with an interval of at least 4 weeks between injections. The first dose can be administered from 2 months. Revaccination once every 11-15 months. Mass immunization of children: 2 doses with an interval of at least 8 weeks between injections. Revaccination once every 11-15 months.
7-11 months		2 doses with an interval of at least 4 weeks between injections. Revaccination once in the second year of life
12-23 months		2 doses with an interval of at least 8 weeks between injections
2 years and older		once

Children previously vaccinated with Prevenar ®

Pneumococcal vaccination initiated with Prevenar ® 7-valent vaccine may be continued with Prevenar ® 13 at any stage of the immunization schedule.

Persons aged 18 and over

Prevenar ® 13 is administered once. The need for revaccination with Prevenar ® 13 has not been established. The decision on the interval between the administration of Prevenar ® 13 and PPV23 vaccines should be made in accordance with official guidelines.

Special patient groups

In patients after hematopoietic stem cell transplantation, an immunization series consisting of 4 doses of Prevenar ® 13 0.5 ml is recommended. The first series of immunization consists of three doses of the drug: the first dose is administered from the third to the sixth month after transplantation. The interval between injections should be 1 month. A booster dose is recommended 6 months after the third dose.

Premature babies are recommended to be vaccinated four times. The first series of immunization consists of 3 doses. The first dose should be administered at 2 months of age, regardless of the child's body weight, with an interval of 1 month between doses. The introduction of the fourth (booster) dose is recommended at the age of 12-15 months.

Elderly patients

The immunogenicity and safety of Prevenar ® 13 have been confirmed in elderly patients.

SIDE EFFECT

The safety of Prevenar ® 13 was studied in healthy children (4429 children/14267 vaccine doses) aged 6 weeks to 11-16 months and 100 children born prematurely (at term).< 37 недель гестации). Во всех исследованиях Превенар ® 13 применялся одновременно с другими вакцинами, рекомендованными для данного возраста.

In addition, the safety of Prevenar ® 13 was evaluated in 354 children aged 7 months to 5 years who had not previously been vaccinated with any of the pneumococcal conjugate vaccines. The most commonly reported adverse reactions were injection site reactions, fever, irritability, decreased appetite, and sleep disturbance. In older children, during the primary vaccination with Prevenar ® 13, a higher frequency of local reactions was observed than in children of the first year of life.

When 13 preterm infants (born at gestational age ≤ 37 weeks) were vaccinated with Prevenar ®, including severely preterm infants born at gestational age less than 28 weeks and children with extremely low body weight (≤ 500 g), the nature, frequency and severity of post-vaccination reactions did not differ from those in term infants.

Those aged 18 years and older had fewer side effects, regardless of previous vaccinations. However, the frequency of reactions was the same as in younger vaccinated patients.

In general, the frequency of side effects was the same in patients aged 18-49 years and in patients over 50 years of age, with the exception of vomiting. This side effect in patients aged 18-49 years was more common than in patients over the age of 50 years.

In adult patients with HIV infection, the same frequency of adverse reactions was noted as in patients aged 50 years and older, with the exception of fever and vomiting, which were observed very often and nausea, which was observed frequently.

In patients after transplantation of hematopoietic stem cells, the incidence of adverse reactions was the same as in healthy adults, with the exception of fever and vomiting, which were very common in patients after transplantation. Children and adolescents with sickle cell anemia, HIV infection, or after hematopoietic stem cell transplantation had the same frequency of adverse reactions as in healthy patients aged 2-17 years, with the exception of headache, vomiting, diarrhea, fever, fatigue, arthralgia and myalgias, which in such patients were found to be "very frequent".

The adverse reactions listed below are classified according to their frequency in all age groups as follows: very common (≥ 1/10), frequent (≥ 1/100, but< 1/10), нечастые (≥ 1/1000, но < 1/100), редкие (≥ 1/10000, но < 1/1000) и очень редкие (≤ 1/10000).

Adverse reactions identified in clinical studies Prevenar 13

Very common: hyperthermia; irritability; reddening of the skin, pain, induration or swelling of 2.5-7.0 cm in size at the injection site (after revaccination and / or in children aged 2-5 years); vomiting (in patients aged 18-49 years), drowsiness, sleep disturbance, loss of appetite, headache, generalized new or exacerbation of existing joint and muscle pain, chills, fatigue.

Frequent: hyperthermia above 39 ° C; pain at the injection site, leading to a short-term limitation of the range of motion of the limb; hyperemia, thickening or swelling of 2.5-7.0 cm at the injection site (after a series of primary vaccinations in children under 6 months of age), vomiting, diarrhea, rash.

Infrequent: skin redness, induration or swelling larger than 7.0 cm at the injection site; tearfulness, convulsions (including febrile convulsions), hypersensitivity reactions at the injection site (urticaria, dermatitis, itching)**, nausea.

Rare: cases of hypotonic collapse*, flushing of the face**, hypersensitivity reaction, including shortness of breath, bronchospasm, Quincke's edema of various localization, including swelling of the face**, anaphylactic / anaphylactoid reaction, including shock**, lymphadenopathy at the injection site.

Very rare: regional lymphadenopathy**, erythema multiforme**.

* - observed only in clinical studies of the vaccine Prevenar ® , but possible for Prevenar ® 13.

** - noted during post-marketing observations of the vaccine Prevenar ® ; they can be considered as quite possible for Prevenar ® 13.

Adverse events observed in other age groups can also occur in children and adolescents aged 5-17 years. However, they were not noted in clinical studies due to the small number of participants.

There were no significant differences in the incidence of side effects between previously vaccinated and unvaccinated adults with PPV23.

OVERDOSE

An overdose of Prevenar ® 13 is unlikely, as the vaccine is released in a syringe containing only one dose.

INTERACTIONS WITH OTHER DRUGS AND OTHER INTERACTIONS

Data on the interchangeability of Prevenar ® 13 with other pneumococcal conjugate vaccines are not available. With simultaneous immunization with Prevenar ® 13 and other vaccines, injections are made in different parts of the body.

Children aged 2 months - 5 years

Prevenar ® 13 is combined with any other vaccines included in the immunization calendar for children in the first years of life, with the exception of BCG. Simultaneous administration of Prevenar ® 13 vaccine with any of the following antigens, which are part of both monovalent and combined vaccines: diphtheria, tetanus, acellular or whole cell pertussis, haemophilus influenzae type b, polio, hepatitis A, hepatitis B, measles, mumps, rubella, chickenpox and rotavirus infection - does not affect the immunogenicity of these vaccines. Due to the higher risk of developing febrile reactions in children with convulsive disorders, including those with a history of febrile convulsions, as well as receiving Prevenar ® 13 simultaneously with whole cell pertussis vaccines, symptomatic administration of antipyretics is recommended. With the combined use of Prevenar ® 13 and Infanrix-hexa, the frequency of febrile reactions coincided with that for the combined use of Prevenar ® (PCV7) and Infanrix-hexa. An increase in the frequency of reporting seizures (with and without fever) and hypotonic-hyporesponsive episodes (HGE) was observed with the combined use of Prevenar ® 13 and Infanrix-hexa. The use of antipyretic drugs should be started in accordance with local recommendations for the treatment of children with convulsive disorders or children with a history of febrile seizures, and in all children who received Prevenar ® 13 simultaneously with vaccines containing a whole cell pertussis component.

Based on data from a post-marketing study of prophylactic use of antipyretics on the immune response to Prevenar ® 13 vaccine, it is suggested that prophylactic administration of acetaminophen (paracetamol) may reduce the immune response to the Prevenar ® 13 primary vaccination series. prophylactic use of paracetamol does not change. The clinical significance of these data is unknown.

Children and adolescents aged 6 - 17 years

Data on the use of the drug Prevenar ® 13 simultaneously with a vaccine against human papillomavirus infection, meningococcal conjugate vaccine, a vaccine against tetanus, diphtheria and whooping cough, tick-borne encephalitis are not available.

Persons aged 18-49 years

Data on the simultaneous use of the drug Prevenar ® 13 with other vaccines are not available.

Persons aged 50 and over

The vaccine Prevenar ® 13 can be used together with the trivalent inactivated seasonal influenza vaccine (DVT). With the combined use of Prevenar ® 13 and DVT vaccines, immune responses to DVT vaccine coincided with those obtained with DVT vaccine alone, immune responses to Prevenar ® 13 vaccine were lower than when using Prevenar ® 13 alone. The clinical significance of this fact is unknown. The frequency of development of local reactions did not increase with the simultaneous administration of Prevenar ® 13 with an inactivated influenza vaccine, while the frequency of general reactions (headache, chills, rash, loss of appetite, pain in the joints and muscles) increased with simultaneous immunization. Co-administration with other vaccines has not been studied.

SPECIAL INSTRUCTIONS AND PRECAUTIONS FOR USE

Given the rare cases of anaphylactic reactions associated with the use of any vaccine, the vaccinated patient should be under medical supervision for at least 30 minutes after immunization. Immunization sites should be provided with anti-shock therapy.

Vaccination of premature (as well as full-term) children should be started from the second month of life (passport age). When deciding whether to vaccinate a premature baby (born at term< 37 недель беременности), особенно имеющего в анамнезе незрелость дыхательной системы, необходимо учесть, что польза иммунизации против пневмококковой инфекции у данной группы пациентов особенно высока и не следует ни отказываться от вакцинации, ни переносить ее сроки. В связи с потенциальным риском апноэ, имеющимся при применении любых вакцин, первая вакцинация Превенар ® 13 недоношенного ребенка возможна под врачебным наблюдением (не менее 48 ч) в стационаре на втором этапе выхаживания.

As with other intramuscular injections, in patients with thrombocytopenia and / or other disorders of the blood coagulation system and / or in the case of treatment with anticoagulants, vaccination with Prevenar ® 13 should be carried out with caution, provided that the patient's condition is stabilized and hemostasis control is achieved. It is possible to administer the vaccine Prevenar ® 13 subcutaneously to this group of patients.

Prevenar ® 13 cannot prevent diseases caused by pneumococci of other serotypes, antigens of which are not included in this vaccine.

Children from high-risk groups under the age of 2 years should receive primary vaccination with Prevenar ® 13 according to age. In patients with impaired immunoreactivity, vaccination may be accompanied by a reduced level of antibody production.

Application of Prevenar ® 13 and PPV23

For the formation of immune memory, immunization against pneumococcal infection is preferably started with Prevenar ® 13 vaccine. The need for revaccination has not been determined. In high-risk individuals, PPV23 administration may be recommended in the future to expand serotype coverage. There are data from clinical trials of PPV23 vaccination 1 year later, as well as 3.5-4 years after Prevenar ® 13 vaccine. At an interval between vaccinations of 3.5-4 years, the immune response to PPV23 was higher without changes in reactogenicity.

For children vaccinated with Prevenar ® 13 who are at high risk (eg, sickle cell anemia, asplenia, HIV infection, chronic disease, or immune dysfunction), PPV23 is administered at least 8 weeks apart. Conversely, patients at high risk for pneumococcal disease (patients with sickle cell disease or HIV infection), including those previously vaccinated with one or more doses of PPV23, may receive at least one dose of Prevenar 13.

The decision on the interval between the administration of PPV23 and Prevenar ® 13 should be made in accordance with official recommendations. In a number of countries (USA) the recommended interval is at least 8 weeks (up to 12 months). If the patient has previously been vaccinated with PPV23, Prevenar ® 13 should be administered no earlier than 1 year later. In the Russian Federation, PCV13 vaccination is recommended for all adults over the age of 50 and patients at risk, with the PCV13 vaccine administered first, with a possible subsequent PPV23 revaccination at least 8 weeks apart.

Prevenar ® 13 contains less than 1 mmol sodium (23 mg) per dose, i.e. practically does not contain sodium.

Within the specified expiration date, Prevenar ® 13 is stable for 4 days at temperatures up to 25 °C. At the end of this period, the drug should either be used immediately or returned to the refrigerator. These data are not guidelines for storage and transport conditions, but may be the basis for a decision on the use of the vaccine in the event of temporary temperature fluctuations during storage and transport.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Prevenar ® 13 has no or negligible effect on the ability to drive and use machinery. However, some of the reactions listed in the "Side effect" section may temporarily affect the ability to drive a vehicle and potentially dangerous mechanisms.

Release form

Suspension for intramuscular injection 0.5 ml/dose.

5 syringes in a plastic package sealed with plastic wrap.

2 plastic packs and 10 sterile needles, together with instructions for use, in a cardboard box.

When packing at NPO Petrovax Pharm LLC:

0.5 ml in a 1 ml syringe made of transparent colorless glass (type I).

1 syringe and 1 sterile needle in a plastic package sealed with plastic wrap. 1 plastic package with instructions for use in a cardboard box.

Storage and transportation conditions

At temperatures from 2 to 8°C. Do not freeze.

Keep out of the reach of children.

Transport at temperatures between 2 °C - 25 °C. Do not freeze.

Transportation at temperatures above 2-8 °C is allowed for no more than five days.

Best before date

Do not use after the expiry date stated on the packaging.

Holiday conditions

Pack with 1 syringe - by prescription

Pack of 10 syringes - for medical institutions

Manufacturing company

Packed:

NPO Petrovax Pharm LLC, Russian Federation

142143, Moscow region, Podolsky district, s. Pokrov, st. Sosnovaya, 1

Consumer claims should be sent to:

1. Pfizer LLC

123112 Moscow, Presnenskaya nab., 10, BC Tower on Naberezhnaya (Block C)

Phone: (495) 287-5000 Fax: (495) 287-5300

2) NPO Petrovax Pharm LLC, Russian Federation

142143, Moscow region, Podolsky district, s. Pokrov, st. Sosnovaya, 1

Phone/fax: (495) 926-2107, e-mail: [email protected]

3) Federal Service for Surveillance in Healthcare (Roszdravnadzor):

109074, Moscow, Slavyanskaya sq., 4, building 1

Tel: (495) 698-4538; (499) 578-0230

Prevenar 13 instructions for use recommend using as a vaccine, which is an effective protection against any pneumococcal infection. This drug does not belong to the category of antibiotics and is not intended to suppress the virus in the human body, its purpose is much wider. When used, it helps the cells of the body to remember the causative agent of the infection, after which, with the possible penetration of the virus, the body will react with lightning speed and be able to provide reliable protection.

Pharmacological features

The Prevenar 13 vaccine is a suspension containing polysaccharides isolated from various types of streptococcus. A characteristic difference from existing analogues is the possibility of application to children, and from the first months after birth.

From the beginning of the second month of life, with the help of vaccination with a vaccine, babies become protected from infection with dangerous streptococcal infections. The use of various vaccination schemes forms an immune response in the form of protection with the formation of functional antibodies to vaccine serotypes.

The effectiveness of vaccination in the prevention of various diseases is as follows:

1. When carrying out prophylaxis against invasive diseases (in the USA) of a pneumococcal nature, a positive result was noted in 97% of cases.
2. In prevention against a bacterial type of pneumonia, the cause of which lies in the serotypes of Streptococcus pneumoniae, similar to the vaccine, is more than 87%.
3. The effectiveness of the vaccine in a child from two months to six months and from 12 to 15 months with acute otitis media caused by pneumococcal serotypes is 54%.

Thanks to prevention with vaccination with Prevenar 13, the number of sick children has dropped sharply. And those isolated cases when the disease is yo managed to develop, it proceeded easily, responded well to treatment and was not accompanied by severe yo lame complications.

The capabilities of the vaccine make it possible to provide an effective preventive effect against the development of bacterial infections due to its composition, which includes:

• polysaccharides;
• protein;
• sodium chloride in the form of saline;
• succinic acid;
• polysorbates.

The drug is produced by the American company Pfizer. This is an extensive pharmaceutical corporation with branches in many European countries. A medicinal product, which may indicate the country of origin of Russia or Ireland, is not considered a fake.

Method of carrying out

Prevenar 13 for injection is produced in a syringe tube for single use.

The vaccine is used as an intramuscular injection, and for children under 2 years old, an injection is made into the lateral surface of the thigh, closer to its front. For a child after two years, the deltoid muscle on the shoulder is chosen as the place for the introduction of the drug.

Before manipulation, the emulsion syringe must be shaken well to obtain a homogeneous composition. If foreign elements are found in the syringe or if the appearance of the emulsion does not match the intended sample, the contents are not used.

Instructions for use of the drug involves only its intramuscular injection. To ensure the correct conduct of the procedure, it is better to first determine the site of injection and the basic requirements for the implementation of the procedure.

The manufacturer prohibits the introduction of the vaccine into the buttocks, vein, does not recommend the use of intradermal administration and under the skin.

The syringe is equipped with a small needle. To ensure the effectiveness of the procedure, it is necessary to insert the entire needle into the muscle tissue.

The use of vaccination is considered one of the effective methods to reduce the number of patients with infection with pneumococcal infections. The danger of such infection lies in the possibility of serious complications that can lead to death.

Infections caused by pneumococcal microorganisms lead to the appearance of a disease in the form of bronchitis, pneumonia, otitis and many others, the nature of the development of which can cause great harm to the body. Available drugs that can suppress pneumococcal infections are losing their effectiveness every year. Their place is taken by new, more advanced ones, but pathogens of infectious diseases quickly get used to them.

As a result of ongoing research, physicians working in this direction have made disappointing conclusions that after a couple of decades, the ability to influence the pneumococcal microflora will be completely lost. If some developments by that time allow for better drugs, then they will most likely be inaccessible to most patients.

The main purpose of vaccination with Prevenar 13 is to prevent pneumococcal disease. The use of the vaccine from the first days provides protection against various pneumococcal microorganisms. Subsequently, the introduction of the vaccine helps to maintain immunity at the proper level, preventing the development of severe conditions.

The use of the vaccine is especially indicated in the following conditions:

1. Persons whose advanced age exceeds 60 years. The explanation for this is that in a weakened body, the immune system, after many years, poorly counteracts the penetration of the pathogen. In such patients, as in children, very often develop serious complications caused by the vital activity of pneumococcus.
2. Patients with diabetes.
3. Individuals diagnosed with cirrhosis of the liver.
4. HIV-infected patients.
5. The presence of chronic diseases affecting the lungs, heart and blood vessels, brain.

These categories of people are most susceptible to the action of pneumococcus, and their condition, weakened by repeated relapses, will allow infection to proceed most severely. If preventive measures are not taken in time in this situation, the disease can lead to death.

Infants are vaccinated from the 2nd month, and depending on individual indications, they can be repeated every year, according to the vaccination calendar.

Vaccination with the use of Prevenar 13 must be officially reasoned. This takes into account the severity of the disease in different age groups, as well as the variability of serotypes depending on the geographical location.

Why vaccinate

Many parents, especially from the wealthy segments of the population, are biased against vaccinations in general and do not see the point in vaccinating against pneumonia. Referring to the fact that they eat well, live in favorable conditions, do not contact with the sick and such diseases do not threaten them. However, this is not the only purpose of the Prevenar 13 vaccine, it increases the ability of immunity to fight pneumococcal infection with great success.

Pneumococcus bacteria belong to the genus Streptococcus, which can lead to a number of dangerous diseases:

• pneumonia, in which lung tissues become inflamed with the spread of the inflammatory process to the alveoli;
• acute otitis media;
• development of purulent meningitis;
• endocarditis in the form of inflammation of the inner heart membrane;
• pleurisy with damage to the superficial membrane of the lungs;
• arthritis.

pneumococcal infection in childrendevelops as a complication after any disease. In some cases, pneumococcal pneumonia is the result of yo no flu or SARS. Also, these microorganisms often serve as a factor exacerbation of the chronic form of bronchitis or otitis, affecting the acute form of the middle ear.

The instruction attached to the vaccine provides for several types of schedule for the administration of the drug.

Differences in the nature of the procedure depend on the following circumstances:

1. The age of the patient who is indicated for vaccination is taken into account.
2. The need for a vaccine, as many scientists believe that older children can not be vaccinated. Most of them had previously suffered many streptococcal diseases.
3. From the available indications, since a certain group of people is simply necessary to vaccinate, due to the existing predisposition to pathologies caused by pneumococci.

Each of the vaccination schedules has its own characteristics, which, although insignificant, you need to have an idea about them:

1. At the age of two to six months, the vaccine is administered as follows: using a three-fold injection of the drug, observing intervals of at least a month. It is allowed for a number of reasons to be vaccinated twice, but then the interval between them should last at least eight months. Revaccination is carried out between 11 and 15 months.
2. If a child is vaccinated at the age of seven to eleven months, then the vaccination is carried out twice with a break of one month. Revaccination is carried out once at the age of two.
3. After reaching the year and up to 23 years inclusive, the vaccine is administered only 2 times, and the second - not earlier than two months after the first vaccination.
4. After reaching two years, the vaccine is administered only once. This is the most accessible form, especially for those who travel abroad, for those who start attending a preschool or go to school.

To get rid of an unwanted reaction at the injection site, you can apply an iodine mesh to the body. As a rule, soreness and discomfort at the injection site disappear without a trace the next day.

The severity and type of side effects depend on the age group of the patient, as follows:

1. When using the Prevenar 13 vaccine, according to the instructions for use for children from 6 weeks to 5 years old, according to experts, you can observe a fever, tearfulness, irritability in a child, a seal with edema can form at the injection site, up to seven centimeters in size. More rarely, arm mobility may be limited and skin hyperemia may occur.
2. On the part of hematopoiesis, in very rare cases, regional lymphadenopathy may develop. The most common side effect at this age manifests itself as a skin reaction in the form of urticaria or dermatitis.
3. When vaccinating adults who have reached the age of fifty, edema and induration at the injection site, pain in this area, a slight limitation of arm mobility, and hyperthermia may occur more often. From the side of the nervous system, a headache may follow. The digestive system will respond to the vaccine with loss of appetite, diarrhea symptoms, nausea and vomiting. Patients may feel swelling of the face, bronchospasm.

The likelihood of developing side effects from the use of Prevenar 13 is low, however, the possibility of such a reaction of the body must be taken into account in order to quickly eliminate it.

The vaccine preparation is easily tolerated, even by young children. Despite all the benefits that can be obtained from vaccination, there are some contraindications when it is better not to use it.

Such states of the body can be considered:

• pregnancy and breastfeeding, since the effect on the fetus and the effect on the child from the action of the drug has not been studied;
• do not use vaccination in case of an allergic reaction to its previous use;
• it is contraindicated to use the vaccine with increased susceptibility to any component due to its composition (including the diphtheria type of anatoxin);
• for vaccination, the absence of an acute period of existing chronic pathologies is necessary; in case of relapse, it is recommended to postpone the procedure until a stable remission occurs.

According to the rules, it is recommended to administer the vaccine to a child between the ages of two months and five years. If vaccination has not been carried out, then it can be carried out at any age, which is especially important for people at risk with the possibility of developing bacterial infections.

Knowing your contraindications,it is necessary to warn the medical staff who vaccinates the population about them.

special instructions

Given the possibility of an anaphylactic reaction occurring, children after vaccination should be under medical supervision for half an hour. The place where the vaccine is administered must have facilities for anti-shock therapy.

If it is necessary to use a vaccine for weakened or premature babies who are more susceptible to contracting bacterial infections and are more difficult to tolerate, e yo carried out in a hospital and under the supervision of doctors for at least two days.

When administering a vaccine, it is necessary to take into account some circumstances on which the effectiveness of the drug and the absence of side effects depend.

These primarily include:

1. Before the procedure itself and immediately after it, you should not allow communication with patients. Since after the introduction of the vaccine in the body, a decrease in protective forces persists for some time, the presence of an already accomplished infection with viruses or other infections can lead to the development of complications.
2. After the vaccination, the baby can introduce new types of complementary foods no earlier than two to three weeks later. It has been noticed that an allergic reaction is more often caused by products that are unusual for a child, and not by an administered drug.
3. It is better to carry out the procedure before the weekend, which will allow you to lie down at home (in case of a severe reaction), and also protect you from contact with patients.
4. It is recommended not to leave the territory of the clinic for at least half an hour after the introduction of the vaccine. This will allow you to quickly get professional medical help in case of side effects.
5. Do not be afraid to take a shower, only baths are not recommended, where there is a possibility of infection. If there is such an opportunity, then it is better not to wet the injection site during the day.
6. After vaccinating a child, you can walk with him in the fresh air, bypassing crowded places and busy transport lines.

The cost of the drug and the conditions for dispensing from pharmacies

Prevenar 13 can be purchased at a pharmacy, a package containing one syringe tube is sold to the public only by prescription. With a pack of ten syringes, the situation is more complicated, it will not be sold in a pharmacy even with a prescription signed by a doctor. Such packaging is intended for medical offices and is purposefully supplied to medical institutions.

The average price in pharmacies for a vaccine for a package containing one syringe dose of Prevenar 13 in the amount of 0.5 ml is quite high and can be 1860 rubles and more. This cost of the vaccine is due to its effectiveness and long-term protection against many bacterial infections.

Every year the number of children suffering from pneumococcal bacterial diseases only increases. Pneumococcal diseases manifest themselves in the form of pneumonia, bronchitis, sepsis, tonsillitis and similar ailments. The pharmaceutical market annually replenishes pharmacy counters with new drugs, including those aimed at combating pneumococci. Despite this, getting rid of this type of bacterial infection is quite difficult. In addition to the fact that the pneumococcus bacterium is sufficiently resistant to the effects of various antibiotic drugs, it also adapts to their composition. This leads to the need to update the composition of drugs in order to be able to cure the developing disease.

In order to exclude the occurrence of pneumococcal diseases in children, measures have been taken to conduct annual vaccination. This is one of the best decisions in order to exclude the occurrence of serious ailments, which was made at the beginning of 2017. For vaccination against pneumococcal bacteria, a remedy such as Prevenar 13 is used. We will find out in detail how effective and safe this vaccine is for children.

Features of the vaccine "Prevenar 13"

The main purpose of the Prevenar vaccine number 13 is to protect the body from the spread of pneumococcus bacteria. A vaccine is not an antibiotic or a drug that can fight a bacterium. Prevenar is a vaccine that stimulates the body to develop immunity against pneumococcal infections.

The vaccine called "Prevenar 13" has the form of a suspension, which is based on polysaccharides of various types of pneumococcus. Polysaccharides are particles of pneumococcal microorganisms that are enhanced with diphtheria protein. The vaccine received an additional digital designation "13", since it is under this number that all types of pneumococcal serotypes are located, which contribute to the occurrence of serious pathologies in the body.

Most often, pneumococcal infection contributes to the development of complications in young children. The advantage of the Prevenar vaccine is that it is prescribed for babies from the first months of life. From the second month of life, all small children are vaccinated against pneumococcal infections.

The vaccine contains the following components:

1. Pneumococcal polysaccharides of the following types: 1,3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C and others.
2. diphtheria protein.
3. Sodium chloride or saline.
4. Succinic acid.
5. Polysorbate.

The manufacturer of the Prevenar 13 vaccine is the pharmaceutical company Pfizer, which is located in the United States. This is a huge organization that has its branches in various European countries. If the packaging of the vaccine indicates that the medication was manufactured in Ireland or Russia, then you should not think that this is a fake.

It's important to know! The composition of the vaccine must be known, since if the patient is allergic to any component, its administration is strictly prohibited.

Who should get vaccinated

Pneumococcal infections contribute to diseases such as pneumonia. Bronchitis, otitis and many others. Resistance to the composition of the drug in pneumococcal microorganisms only increases every year. Experts do not console with guesses that in a few decades there will be no opportunity to overcome pneumococcal microorganisms. If such drugs are produced (for the destruction of pneumococcus), then they will not be available to all segments of the population.

It's important to know! Vaccination is one of the most effective and alternative ways to reduce the number of patients with pneumococcal diseases. The danger of this type of bacteria lies in the fact that it contributes to the development of serious complications leading to death.

From what and for what purpose is vaccination carried out? The main purpose of the Prevenar 13 vaccine is to effectively protect the body from the onset of pneumococcal disease. Moreover, vaccination from the first days of life increases the level of protection against all types of bacterial infections. In the future, vaccination every year will only maintain immunity, while preventing the occurrence of serious bacterial complications.

In addition to the fact that the above categories of people have a tendency to develop pneumococcus, the course of bacterial infections will proceed in severe forms. If measures are not taken in a timely manner to improve the patient, then eventually a fatal outcome occurs.

It's important to know! Vaccinations are given for newborns from the second month of life, and may continue annually, as provided by the vaccination schedule.

What does the vaccination schedule look like?

The instruction for the use of the vaccine provides for several options for the schemes for the use of the drug. The following factors play a major role in these options:

1. Age category of patients for whom it is indicated to be vaccinated.
2. The need for vaccination. Scientists have come to the conclusion that children older than 3 years and adults under 60 do not need to be vaccinated. This category of people has already suffered many different bacterial infections, so the immune system does not need additional strengthening in the form of the introduction of an artificial bacterial microorganism.
3. From the relevant indications, since there are categories of people for whom the vaccine is indicated for the presence of signs of a predisposition to the occurrence of ailments provoked by bacteria.

There are some differences for each version of the vaccination schedules. Let's consider these schemes in more detail.

1. For babies from 2 to 6 months, it is indicated to be vaccinated according to the following scheme: the vaccine is given three times, the interval between vaccinations should be at least 4 weeks. In case of impossibility to come for the next vaccination, you can do it twice, but with an interval of at least 8 months.
2. If the parents decide to vaccinate the baby at 7-11 months of age, the following scheme is carried out: immunization is performed twice, but with a pause of 4 weeks. You will need to undergo a single revaccination, which is carried out at the age of 2 years.
3. At the age of 1 year and up to 2 years, immunization is carried out in the amount of 2 times. Re-vaccination is carried out 8 months after the first.
4. From the age of 2, the vaccine is given only once. There is no need for revaccination. In the future, revaccination can be carried out once a year without age restrictions.

It's important to know! If the child was first vaccinated with Prevenar, which protects the body only against 7 types of pneumococcal bacteria, then repeated immunization can be performed with Prevenar 13.

How to properly inject "Prevenar 13"

The drug is produced in the form of a suspension, which is placed in a disposable syringe-tube. Outwardly, such a vaccine should have the form of a transparent liquid, therefore, in the presence of turbidity, its use should be excluded.

It's important to know! Before giving an injection, the vaccine in the syringe must be shaken. Inside the syringe should be a homogeneous consistency without impurities.

Previnar belongs to the category of those drugs that are not subject to freezing. If you notice that a medical worker is taking a medication out of the freezer, then such a remedy is unsuitable for use.

Instructions for use of the drug provides only intramuscular administration of the drug. It is important to read the instructions to find out where it is better to inject the drug.

• Babies under the age of two are recommended to inject the medication into the thigh. This is done in order to have the ability to apply a tourniquet in case of possible complications.
• For children over 2 years of age, it is required to administer the vaccine in the shoulder area. Usually this is the deltoid muscle, but each medical institution has its own rules.

It's important to know! The syringe has a needle, the length of which is insignificant, but it is important to inject all of it into the muscle in order to increase the effectiveness of the drug.

How the body reacts to the Prevenar 13 vaccine

The reaction of the body to the administration of the drug occurs in almost all cases. Prevenar is usually well tolerated by children, but the following side effects may develop:

1. In children and adults, there are such side effects from the nervous system as sleep disturbance, loss of appetite, headaches, fatigue and irritability.
2. The temperature rises very often. Usually the temperature is kept at 38-38.5 degrees, but in some cases it is possible to reach 39 degrees. Parents should control the temperature to avoid it rising above normal.
3. There are side effects on vaccination in the form of the occurrence of pain syndromes in the joints.
4. There are complaints of soreness at the injection site, movement of the arms and legs is limited, injection sites swell, and symptoms such as vomiting and diarrhea occur.
5. Rarely, after Prevenar, complications occur in the form of seals and swelling at the injection site up to 7 cm in size. Children become whiny and irritable.
6. There may be signs of enlarged lymph nodes.

It's important to know! For the speedy disappearance of reactions after the introduction of the vaccine, it is recommended to make an iodine mesh. Usually, the soreness of the injection site disappears by the next day.

What complications can occur

If side effects after vaccination do not disappear for more than 1 day, then it is necessary to inform the doctor. The occurrence of adverse reactions and complications does not always depend on the quality of the medication itself. Very often, the rules for storing the drug may be violated, the expiration date is not controlled, and low-quality antiseptic preparations are also used. After vaccination, the following complications may develop:

1. Allergy. The causes of allergic reactions are signs of intolerance to one of the constituent components of the vaccine.
2. The occurrence of Quincke's edema, as well as a complication in the form of anaphylactic shock. Rarely, cough and shortness of breath may occur.
3. Local complications include the occurrence of inflammatory reactions that form at the injection site.
4. The occurrence of seizures.
5. The temperature rises, there is weakness, headaches, body aches, joints.

Sometimes parents may suspect that the baby has an ARVI disease. To avoid the occurrence of side symptoms and complications after vaccination, the patient needs to be under the supervision of health workers for some time. In case of complications, the doctor prescribes symptomatic treatment.

It's important to know! Usually, 1-2 days before vaccination, health workers notify the need to take antiallergic drugs.

The presence of contraindications to the vaccination "Prevenar 13"

Vaccination with Prevenar is carried out as a preventive measure to exclude the development of ailments caused by pneumococcus. The vaccine is well tolerated, especially given the early age of infants. This drug has some contraindications, in the presence of which it is better to exclude the administration of the drug in order to avoid undesirable consequences and complications. These contraindications include:

• Pregnancy and lactation. Women are not recommended to be vaccinated, as the reaction to the fetus has not been studied, so the consequences can be unpredictable.
• It is forbidden to vaccinate if the previous vaccine provoked the occurrence of allergic symptoms.
• Do not administer the drug if there is hypersensitivity to at least one component of the vaccine.
• During vaccination, the patient must be healthy, therefore, in case of exacerbation of chronic or acute diseases, vaccination will need to be postponed.

It is recommended to vaccinate babies in the age category from 2 months to 5 years. If a person was not vaccinated in childhood, then he can be vaccinated at any age, especially if he is at risk of developing bacterial diseases.

It's important to know! Patients themselves must warn health workers who are engaged in immunization of the population about the presence of contraindications.

When vaccinating, it is important to know some recommendations. These recommendations include:

1. Prior to the start of immunization, as well as immediately after the introduction of the vaccine, it is recommended to avoid close contact with sick people. After the introduction of the vaccine, a decrease in immunity is observed, therefore, a patient who is known to be infected with viral or infectious diseases may encounter complicated symptoms after vaccination.
2. After the immunization is carried out, you can try the introduction of new types of complementary foods to the baby no earlier than a few weeks later. Most often, allergies after immunization may occur on supplements and complementary foods introduced into the diet, and not on the drug.
3. It is recommended to vaccinate on the eve of the weekend, which will avoid unwanted contact with sick people the next day.
4. After the administration of the drug, it is recommended to stay in the hospital for 0.5-1 hour. This is necessary in order to be able to provide emergency assistance to the patient in the event of side effects or complications.
5. You can wet the injection site, but it is recommended to do this under the shower, that is, running water, and not in the bathroom, where infection is possible. If possible, it is better not to wet the injection site during the day.
6. After vaccination, you can walk with the child. At the same time, it is important that such walks are in the fresh air, but not in cafeterias, shops and other establishments with a large crowd of people. The probability of catching a virus or infection in such places is 90%.

What questions often arise when vaccinating?

Patients who come to the hospital for immunization ask the following questions:

1. What is included in the vaccine? Is it live pneumococcus bacteria? The vaccine contains artificially grown and weakened strains of pneumococcus, so they are not able to provoke the disease.
2. What should I do to come to the hospital prepared for immunization? No special preparation is required for the Prevenar vaccination, but the most important thing is to arrive healthy and in a good mood. If the patient knows that he does not tolerate injections or medications, it is better to inform the doctor in advance. If in doubt, the patient is advised to be examined by a therapist and, if necessary, to be tested.
3. How long can a fever last after vaccination? Usually the temperature is kept at the level of 38-38.5 degrees. The duration of its maintenance does not exceed 2 days, but if it does not subside on the third day, then you should go to the hospital.
4. When should you not wait for the disappearance of side symptoms? In the event of adverse symptoms in severe form, it is recommended to immediately go to the hospital. Usually the most difficult forms of manifestation for vaccination are the occurrence of allergies. With Quincke's edema and with symptoms of anaphylactic shock, emergency assistance is required.
5. How often should I vaccinate with Previnar 13? Vaccination is carried out from one to 4 times, but it all depends on the age of the patient.

Nurses hear such questions every day from patients who came for vaccinations or brought their babies. The main thing that the patient needs to know is the high effectiveness of Prevenar 13, which reduces the possibility of bacterial diseases by 90%.

Prevenar 13: instructions for use and reviews

Latin name: Prevenar 13

ATX code: J07AL02

Active substance: polysaccharides of 13 pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, carrier protein CRM197

Manufacturer: Wyeth Pharmaceuticals Division of Wyeth Holdings Corporation (USA), Baxter Pharmaceuticals Solutions LLS (USA), Pfizer Ireland Pharmaceuticals (Ireland), NPO Petrovax Pharm LLC (Russia)

Description and photo update: 26.10.2018

Prevenar 13 is a vaccine (pneumococcal polysaccharide conjugated adsorbed, 13-valent) for the prevention of diseases caused by Streptococcus pneumoniae.

Release form and composition

Prevenar 13 is available as a suspension for intramuscular (IM) administration: a white solution with a homogeneous structure (0.5 ml each in a transparent glass syringe without color with a capacity of 1 ml: in a plastic package 1 syringe complete with 1 sterile needle, in 1 pack in a carton box; for medical institutions - 5 syringes in a plastic pack, 2 packs in a carton pack, complete with 10 sterile needles; 100 syringes in a plastic container).

0.5 ml (1 dose) suspension contains:

• active ingredients: pneumococcal conjugates (polysaccharide - CRM 197) - serotype polysaccharide 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F - 2.2 μg each, serotype 6B polysaccharide - 4, 4 mcg, CRM 197 carrier protein approximately 32 mcg;
• auxiliary components: polysorbate 80, aluminum phosphate, succinic acid, sodium chloride, water for injection.

Pharmacological properties

Prevenar 13 is a capsular polysaccharide vaccine of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. Each of them is individually conjugated to the diphtheria protein CRM 197 and adsorbed on aluminum phosphate. After the introduction of the vaccine, the immunomodulatory effect occurs on the basis of the production of antibodies in the body to each of the capsular polysaccharides of Streptococcus pneumoniae, providing specific protection against infections caused by pneumococcal serotypes included in the preparation.

Prevenar 13 contains 90% of the serotypes that cause the development of invasive pneumococcal infections (IPIs) that are resistant to antibiotics.

For pneumococcal conjugate vaccines, according to the recommendations of the World Health Organization, the equivalence of the immune response of the vaccine is determined by three criteria. The first criterion is the percentage of patients in whom the concentration of specific IgG antibodies has reached or exceeds 0.35 μg per 1 ml. The second criterion is SGK (geometric mean concentration) of Ig and OPA (opsonophagocytic activity) of bactericidal antibodies, where the OFA titer is equal to or greater than the ratio of 1 to 8. The third criterion is GMT (geometric mean titer). For adults, a protective level of anti-pneumococcal antibodies has not been established, so serotype-specific OFA (SGT) is used.

When conducting primary vaccination using three doses of Prevenar 13 in children under the age of 6 months, there is a significant increase in the level of antibodies to all vaccine serotypes. Against the background of the introduction of only two doses for serotypes 6B and 23F, the first criterion for the immune response of the vaccine is determined in a smaller percentage of children. At the same time, a pronounced booster response to revaccination is noted for all serotypes. For the formation of immune memory, the use of three and two doses for primary vaccination is indicated. In children of the second year of life, the secondary immune response to the booster dose is comparable for all 13 serotypes after a series of primary vaccinations using three and two doses of the vaccine.

Vaccination after 8 weeks of life of premature babies (gestation period up to 37 weeks), including those born with a gestation period of up to 28 weeks, after completing the full course, leads to the achievement of protective specific anti-pneumococcal antibodies and their OFA levels, which exceed the protective ones in 87-100% of vaccinated children to all 13 serotypes.

A single dose of Prevenar to 13 children from 5 to 17 years of age can give the necessary immune response to all Streptococcus pneumoniae polysaccharides that are part of the vaccine.

When compared with the Prevenar vaccine, the presence of additional (1, 3, 5, 6A, 7F, 19A) vaccine-specific serotypes in Prevenar 13 significantly increases its effectiveness.

After vaccination with Prevenar (according to the scheme, two doses in the first year of life and a single revaccination in the second year of life), with a coverage of 94% of children, the incidence of invasive pneumococcal infection (IPI) after 4 years reaches 98%. After switching to Prevenar 13, there is a trend towards a further decrease in the incidence of IPD. In children under the age of 2 years, this occurs in 76% of cases, at the age of 5-14 years - in 91%. There are no cases of IPD caused by serotype 5. In children aged 5 years and younger, serotype-specific efficacy against IPD for additional vaccine serotypes 3 and 6A ranges from 68 to 100%, respectively, and for serotypes 1, 7F and 19A was 91%.

The frequency of registration of IPD caused by serotype 3, against the background of the use of Prevenar 13, decreased by 68% in children under 5 years of age.

Switching to Prevenar 13 after the introduction of the Prevenar 2 + 1 vaccine, the incidence of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and serotype 6A is reduced by 95%, serotypes 1, 3, 5, 7F and 19A - by 89%.

In addition, with this transition in children from 1 month to 15 years of age, there is a decrease by 16% in the frequency of all cases of community-acquired pneumonia. Cases of community-acquired pneumonia with pleural effusion decreased by 53%, pneumococcal - by 63%. During the second year after the introduction of the Prevenar 13 vaccine, the incidence of community-acquired pneumonia caused by additional vaccine serotypes decreased by 74%.

In children under 5 years of age, vaccination with Prevenar 13 according to the 2 + 1 scheme reduces the number of hospitalizations with alveolar community-acquired pneumonia of any etiology by 32% and outpatient visits by 68%.

The effectiveness of the drug has been demonstrated in relation to vaccine-specific serotypes of the nasopharynx.

A serotype-specific decrease in the incidence of unvaccinated individuals can only be observed in countries in which mass immunization of the population is carried out for more than 3 years in compliance with the established scheme. In unvaccinated individuals 65 years of age and older, invasive pneumococcal infection occurs 25% less, caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F - decreased by 89% and serotypes 1, 3, 5, 6A, 7A, 19A - by 64%.

The incidence of infections caused by serotype 3 decreased by 44%, by serotype 6A by 95%, and by serotype 19A by 65%.

According to the results of clinical studies, the safety and immunogenicity of the drug has been demonstrated in patients aged 18 years and older, including those previously vaccinated with a 23-valent pneumococcal polysaccharide vaccine (PPV23). Immunological equivalence is observed for 12 common serotypes with PPV23. In addition, the unique serotype 6A and 8 serotypes shared with PPV23 demonstrated a higher immune response to the Prevenar 13 vaccine.

In patients aged 70 years and older after a single vaccination more than 5 years ago with PPV23, revaccination with Prevenar 13 gives a more pronounced immune response.

The administration of two doses of Prevenar to 13 patients with sickle cell anemia aged 6 to 18 years with an interval of 6 months gives a high immune response.

The introduction of the first dose of human immunodeficiency virus (HIV)-infected children and adults who have not previously received pneumococcal vaccine leads to an increase in IgG levels of GBS and OFA. The introduction with an interval of 6 months of the second and third doses of the vaccine allows you to achieve a higher immune response than with a single vaccination.

Hematopoietic stem cell transplantation is associated with a high risk of pneumococcal infection. Therefore, patients older than 2 years who underwent allogeneic hematopoietic stem cell transplantation (HSCT), with complete or satisfactory partial hematological remission in the case of lymphoma and myeloma, are shown vaccination with three doses of Prevenar 13 with an interval of 1 month. Vaccination begins 3–6 months after HSCT. 6 months after the third dose, a booster (fourth) dose of the vaccine is administered. One month after the fourth dose of Prevenar 13, a single dose of PPV23 is recommended.

Indications for use

According to the instructions, Prevenar 13 is indicated in patients from 2 months of age and older for the prevention of pneumococcal infectious diseases caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, including invasive forms such as meningitis, severe pneumonia, sepsis, bacteremia, and non-invasive forms such as community-acquired pneumonia, otitis media.

Vaccination is carried out according to the approved terms within the framework of the national calendar of preventive vaccinations and at an increased risk of developing pneumococcal infection.

High-risk conditions for pneumococcal disease include immunodeficiency (including human immunodeficiency virus infections), immunosuppressive therapy for cancer, anatomical and functional asplenia, cochlear implant (including planned surgery), cerebrospinal fluid leakage, chronic diseases of the cardiovascular system, lungs, kidneys and (or) liver, diabetes mellitus, bronchial asthma, convalescent period of meningitis, acute otitis media or pneumonia, infection with Mycobacterium tuberculosis.

In addition, the risk of developing pneumococcal infection is increased in tobacco smokers, patients over the age of 50, frequently and long-term ill children, premature babies, who are in organized groups of people (including boarding schools, orphanages, army groups).

Contraindications

• acute period of infectious, non-infectious and chronic diseases (until complete recovery or the onset of a period of remission);
• severe generalized allergic reactions, anaphylactic shock and other hypersensitivity reactions with previous administration of Prevenar 13 or Prevenar;
• individual intolerance to the components of the drug.

Instructions for use Prevenar 13: method and dosage

You can not inject the drug intravascularly and / m into the gluteal region.

The suspension is injected intramuscularly, in children of the first years of life - into the upper outer surface of the middle third of the thigh, older than 2 years - into the deltoid muscle of the shoulder.

Shake the contents of the syringe well before use. You can use the drug if, during visual inspection, the suspension has a homogeneous structure. If there are foreign particles in the contents of the syringe, Prevenar 13 should not be used.

A single dose for patients of any age is 0.5 ml.

It is important to note that if vaccination was started with a pneumococcal polysaccharide conjugated adsorbed, 13-valent vaccine, then it is recommended to complete it with the same vaccine. If vaccination is started with 7-valent Prevenar, it can be continued with Prevenar 13 at any stage of the immunization schedule.

If the interval between the introduction of the vaccine is increased for objective reasons, the introduction of additional doses of Prevenar 13 is not required.

For individual immunization of children aged 2-6 months, a 3 + 1 scheme is used: the first dose is administered at the age of 2 months, then with an interval of at least 1 month between injections, the second and third doses are administered. Revaccination is a single dose at 11–15 months of age.

When carrying out mass immunization of children aged 2–6 months, a 2 + 1 scheme is used: 2 doses with an interval of at least 2 months between injections. Revaccination - a single injection of one dose at the age of a child of 11-15 months.

When immunizing children aged 7–11 months, a 2 + 1 schedule is used: 2 doses with an interval of at least 1 month between injections. Revaccination is a single dose at 11–15 months of age.

When vaccinating children aged 12–23 months, a 1 + 1: 2 dose schedule is used with an interval between injections of at least 2 months.

When vaccinating children aged 24 months and older, a single administration of one dose of the vaccine is used.

Patients aged 18 years and older are shown a single dose of the drug, the need for revaccination has not been established. The interval between the administration of Prevenar 13 and PPV23 vaccines is prescribed in accordance with officially established guidelines.

After transplantation of hematopoietic stem cells, patients are shown immunization, consisting of 4 doses of 0.5 ml of Prevenar 13, according to the scheme 3 + 1. The first dose is recommended to be administered from the 3rd to the 6th month after transplantation. The next two doses are administered with an interval between injections of 1 month. Revaccination - one dose 6 months after the third dose.

Vaccination of premature babies is carried out according to the scheme 3 + 1. The first dose should be administered at the age of 2 months, regardless of the child's body weight. Then, with an interval of 1 month between injections, 2 more doses of Prevenar 13 are administered. The fourth (booster) dose is recommended to be administered at the age of 12-15 months.

The use of Prevenar 13 in the elderly is shown, the safety and immunogenicity of the drug have been confirmed for this category of patients.

Side effects

• very often: at the injection site - reddening of the skin, swelling or induration up to 7 cm in diameter, painful sensation [in children 2-5 years old and (or) after revaccination]; headache, worsening sleep, drowsiness, loss of appetite, exacerbation of existing or the appearance of generalized new pain in the joints and muscles, chills, fatigue, vomiting (in patients aged 18–49 years); hyperthermia; irritability;
• often: pain at the injection site, causing a short-term limitation of the range of motion of the limb; an increase in body temperature above 39 ° C; swelling or induration 2.5-7 cm in diameter, hyperemia at the injection site (in children under 6 months of age after the primary vaccination series), rash, vomiting, diarrhea;
• infrequently: reactions at the injection site - redness of the skin, swelling or induration in diameter of more than 7 cm, individual intolerance (itching, urticaria, dermatitis); nausea, convulsions (including febrile convulsions), tearfulness;
• rarely: reactions at the injection site - lymphadenopathy; flushes to the face, cases of hypotonic collapse, hypersensitivity reaction (including bronchospasm, shortness of breath, Quincke's edema with localization in the face and other organs), anaphylactic or anaphylactoid reaction (including shock);
• very rarely: regional lymphadenopathy, erythema multiforme.

In adults previously vaccinated and unvaccinated with 23-valent pneumococcal polysaccharide vaccine, there were no significant differences in the incidence of adverse effects.

Overdose

Since Prevenar 13 is available in single dose syringes only, overdose is unlikely.

special instructions

Immunization is carried out in a specialized medical office, provided with anti-shock therapy. Due to the risk of developing anaphylactic reactions after injection, the patient's condition should be monitored within 0.5 hours.

Immunization against pneumococcal infection of a premature baby born at a gestational age of less than 37 weeks is necessary for infants in the first months of life, especially when the respiratory system is immature. Therefore, vaccination should not be postponed or refused. The procedure is carried out at the second stage of nursing in a hospital under close medical supervision of the child's condition within 48 hours after vaccination. The nature, severity of post-vaccination reactions and the frequency of their development during vaccination of premature babies (including very premature babies and those with extremely low body weight) do not differ from those in full-term babies.

With primary vaccination with Prevenar 13, the incidence of local reactions in older children is higher than in children of the first year of life.

Caution is advised when IM administration of the drug to patients with disorders of the blood coagulation system (including thrombocytopenia) or who are on anticoagulant therapy. Vaccination in this category of persons can be carried out only after achieving control of hemostasis and stabilization of their condition. If necessary, subcutaneous administration of the suspension is indicated.

This vaccine cannot be used to prevent pneumococcal infection caused by serotypes whose antigens are not present in Prevenar 13. Primary vaccination in children under 2 years of age from high-risk groups should be carried out only in accordance with age. In violation of immunoreactivity, the administration of the drug may cause a decrease in the level of antibody formation.

Immunization for the formation of immune memory against pneumococcal infection is recommended to start with a 13-valent vaccine. The need for revaccination has not been established. To expand serotype coverage in high-risk individuals, subsequent administration of PPV23 is possible.

Immunization of children at high risk (including those with sickle cell anemia, asplenia, HIV infection, immune dysfunction, chronic disease) after Prevenar 13 can be continued with the introduction after 2 months of PPV23.

Patients previously vaccinated with PPV23 (one or more doses) may receive at least one dose of the 13-valent vaccine.

The vaccine is stable at temperatures up to 25°C for 4 days (within the stated expiration date). This information is reported to make a decision on the use of the drug with temporary temperature fluctuations during storage or transportation. Transportation can be carried out at a temperature of 2–25 °C for no more than 5 days.

Influence on the ability to drive vehicles and complex mechanisms

After the direct administration of the vaccine, care should be taken when driving vehicles and mechanisms, since a temporary violation of psychomotor reactions is possible.

Use during pregnancy and lactation

The safety of using Prevenar 13 during pregnancy and lactation has not been established.

There is no information on the ingress of vaccine antigens or post-vaccination antibodies into breast milk.

Application in childhood

Shown for use in children aged 2 months.

Use in the elderly

The use of Prevenar 13 in the elderly is shown.

drug interaction

Information on the interchangeability of Prevenar 13 when vaccinated with other pneumococcal conjugate vaccines is not available. When immunized with Prevenar 13, simultaneous vaccination with other vaccines is allowed if they are administered in different parts of the body.

In children aged 2 months to 5 years, Prevenar 13 can be combined with any vaccines that are included in the immunization schedule for children in the first years of life, tuberculosis cream (BCG). Simultaneous administration of antigens that are part of monovalent and combined vaccines, such as tetanus, diphtheria, acellular or whole cell pertussis, polio antigens, antigens of Haemophilus influenzae (type b), hepatitis A or B, mumps, measles, rubella, chicken pox, rotavirus infections, the immunogenicity of Prevenar 13 and these vaccines is not affected.

In children with convulsive disorders (including a history of febrile convulsions), as well as with simultaneous administration with whole cell pertussis vaccines, the risk of developing febrile reactions increases. They should be advised symptomatic use of antipyretics.

There are no data on the possibility of simultaneous use of Prevenar 13 in patients aged 6–17 years with a meningococcal conjugate vaccine, a vaccine against human papillomavirus infection, tick-borne encephalitis, tetanus, diphtheria and whooping cough.

In patients 50 years of age or older, the 13-valent vaccine may be used in combination with the 3-valent inactivated seasonal influenza vaccine (DVT). At the same time, the immune response to the DVT vaccine does not change, and the immune response to Prevenar 13 decreases.

Analogues

Analogues of Prevenar 13 are Pneumo 23, Prevenar.

Terms and conditions of storage

Keep away from children.

Store at temperatures up to 2-8 °C, do not freeze.

Shelf life - 3 years.

Terms of dispensing from pharmacies

A package with 1 syringe is dispensed by prescription, a package of 10 syringes is supplied to medical institutions.