Instruction for use: Prevenar 13

Dosage form: Suspension for intramuscular injection

Active substance: Vaccinum antipneumococcum

ATX

J07AL02 Pneumococcal purified polysaccharide antigen conjugated

Pharmacological group:

Vaccines, serums, phages and toxoids

The nosological classification (ICD-10)

A16 Tuberculosis of respiratory organs, not confirmed bacteriologically or histologically

A40.3 Septicemia caused by Streptococcus pneumonia

B24 Disease caused by human immunodeficiency virus [HIV], unspecified

B95.3 Streptococcus pneumonia

C80 Malignant neoplasm without specification of localization: Malignant tumor; Malignant neoplasm; Malignant neoplasms of different localization; Malignant tumors; Eton-Lambert syndrome; Locally prevalent forms of malignant neoplasms; Metastatic ascites; Metastatic ascites; Cerebellar degeneration in tumors; Hereditary cancers; Metastatic tumors; Cancer ascites; Solid tumors

D73.0 Hypersplenism

D84.9 Unspecified Immunodeficiency: Pneumonia in immunodeficient states; Autoimmune disease; Autoimmune diseases; Severe immunodeficiency; immune deficiency; Immunodeficiency; immunodeficiency diseases; Immunodeficiency states due to surgery; Immunotherapy for cancer; Immunomodulation; Infections in patients with weakened immune systems; Correction of immune deficiency; Correction of immunodeficiencies; Correction of a weakened immune system; Correction of a weakened immunity in immunodeficient states; Violation of immunity; Violation of the immune status; Immune System Disorders; Primary immunodeficiency; Maintaining immunity; Lowering the body's defenses; Lowering the immunity; Lowering the immunity of colds and infectious diseases; The decrease of the immune status; Lowered resistance to infections; Lowered resistance to infections and colds; Lowered resistance; Immunosuppression; Predisposition to colds; acquired immune deficiencies; Radiation immunodeficiency; The development of immunodeficiency; Immune dysfunction syndrome; immunodeficiency syndrome; primary immunodeficiency syndrome; Reducing the body's defenses; Immunosuppression; Reduced immune defense; Reducing local immunity; Reducing the total body resistance; The decrease in cell-mediated immunity; Reduced resistance to infections in children; Reducing the body's resistance; Reduced resistance; reduced immunity; Status immunodeficiency; Stimulation of the processes of nonspecific immunity; Heavy selective secondary immunodeficiency; immunity Oppression; Primary immunodeficiency

E14 Diabetes mellitus, unspecified: Severe vascular complication of diabetes: Diabetes; Diabetic asthenia; Thyroid dysfunction; Diabetes; Obesity in the background of diabetes

G00.1 Pneumococcal meningitis: Recurrences of pneumococcal meningitis

G96.0 Spread of cerebrospinal fluid [CSF]

H66.9 Otitis media, unspecified: Chronic otitis media; Otitis; Average otitis media; Middle ear infection; Otitis media in children

I99 Other and unspecified disorders of the circulatory system: angiopathy; Arterial angiopathy; Atherosclerotic angiopathy; Hemodynamic right heart defects; Hemodynamic defect of the right heart; coronary angiopathy; Infringement of blood circulation; Violation of circulation; Violation microcirculation in organs and tissues; Peripheral circulatory disorders; Disorders of the peripheral circulation in the extremities; circulatory failure; Hemodynamic instability occlusion of arteriovenous origin; Acute circulatory failure; Psevdostenokardicheskie state; Psevdostenokardicheskoe disorder; circulatory disorder; Cardiovascular diseases; Vascular insufficiency; Thrombosis arteriovenous shunt; Thrombosis with prosthetic heart valves; Deterioration of blood circulation in the pelvic organs; Functional failure of the cardiovascular system; Functional disorders of the cardiovascular system; Chronic arterial insufficiency; Chronic heart failure; Age-related vascular disease; The risk of thrombosis

J13 Pneumonia caused by Streptococcus pneumonia: Pneumonia streptococcal; Pneumococcal pneumonia; Infections of pneumococcal etiology, especially respiratory tract; Pneumococcal infections

J18 Pneumonia without specification of pathogens: Alveolar pneumonia; Community-acquired pneumonia atypical; Community-acquired pneumonia non-pneumococcal; Pneumonia; Inflammation of the lower respiratory tract; Inflammatory lung disease; Shared pneumonia; Respiratory and lung infections; Infections of the lower respiratory tract; Cough with inflammatory diseases of the lungs and bronchi; Croupous pneumonia; Nosocomial pneumonia; Exacerbation of chronic pneumonia; Acute community-acquired pneumonia; Acute pneumonia; Focal pneumonia; Pneumonia abscessing; Pneumonia bacterial; Pneumonia croupy; Pneumonia of focal; Pneumonia with difficulty in sputum discharge; Pneumonia in AIDS patients; Pneumonia in children; Septic pneumonia; Chronic Obstructive Pneumonia; Chronic pneumonia; Lymphoid interstitial pneumonia

J45 Asthma: Asthma of physical effort; Asthmatic conditions; Bronchial asthma; Bronchial asthma of light course; Bronchial asthma with difficulty in sputum discharge; Bronchial asthma of severe course; Bronchial asthma physical effort; Hypersecretory asthma; The hormone-dependent form of bronchial asthma; Curbing asthma attacks with bronchial asthma; Non-allergic bronchial asthma; Night Asthma; Exacerbation of bronchial asthma; Attack of bronchial asthma; Endogenous forms of asthma; Night attacks of asthma; Cough with bronchial asthma

J98.9 Respiratory disorder, unspecified: Hypoventilation; Hypoventilation of the lungs; Hypoxemia; Medicinal damage of the lungs; Disturbances from the respiratory center; Functional disorders of the respiratory system; Arterial hypoxemia; Toxic changes in the lung at elevated oxygen pressure

K76.9 Liver disease, unspecified: Change in liver function in heart failure; Restoration of impaired liver function; Severe liver function disorders; Hepatitis; Hepatosis; Hepatopathy; Liver dysfunction; Diseases of the liver; Impaired liver function; Dysfunction of the liver; Infringements of function of a liver of an inflammatory etiology; Functional liver failure; Functional disorders of the liver; Chronic liver disease; Chronic diffuse liver disease; Enterogenic diseases of the gallbladder and liver

N28.9 Kidney and ureter's disease, unspecified: Disturbance of ureter function; Autoimmune kidney damage; Kidney Diseases; Infringement of a renal blood flow; Impaired renal function; Impaired renal function; Nondiabetic nephropathy; Insufficiency of excretory function of the kidneys; Nephrogenic osteopathy; Nephropathic syndrome; Nephropathy of minimal changes; Maintaining kidney function; Chronic kidney disease; Megaloureter

P07.3 Other cases of prematurity: Preterm infants; Preterm neonatal; Dysbiotic disorder of the intestine in premature infants; Exercising preterm infants; Premature baby

R54 Age-related disease: External signs of aging; Age-related eye disease; Age-related visual impairment; Age-related vascular disease; Age constipation; Age-related changes in visual acuity; Age-related changes in the brain involutional; Age-related disorders; Age-related hearing loss; gerontological practice; senile dementia; Deficiency of calcium and vitamin D3 in the elderly; cerebral vascular disease and age-related; involutionary depression; involutional depression; Correction of metabolism in middle and old age; Malnutrition in elderly and senile age.; senile dementia; senile dementia; senile depression; senile colpites; senile psychosis; Syndrome of age involution; Hearing loss age; Aging; Brain Aging; The aging of the organism; senile dementia; senium; Senile involutional psychosis; senile psychosis; Memory impairment in elderly patients; Conduct disorders in the elderly

R78.8.0 * Bacteremia: Persistent bacteraemia; Bacteremia

Y43.4 Adverse reactions in the therapeutic use of immunosuppressive agents: Treatment with immunosuppressants

Z23.8 The need for immunization against another single bacterial disease

Z29.1 Prophylactic immunotherapy: Vaccination against viral infections; donor Vaccination; Vaccination and revaccination; Vaccination of newborns; Vaccination against hepatitis B; Immunization; Correction of the immune status; Therapeutic and prophylactic immunization; Preventive immunization; Specific immunoprophylaxis; Stimulation of the processes of nonspecific immunit

Z54 recovery period: The recovery period; The recovery period after illness; Recovery; The recovery from the flu and colds; Recovery after illness; The lack of mineral salts in the period of convalescence; The period of recovery after illness; The period of recovery after illness and surgery; The period of recovery after a serious illness; The period of convalescence after illness; rehabilitation period; rekovalestsentsii period after infectious diseases; decubation; The period of convalescence after surgery and infectious diseases; The period of convalescence after prolonged infections; The period of convalescence after serious diseases; The period of convalescence after severe infections; Rehabilitation period; convalescent state; Convalescence after illness; Convalescence after infectious diseases; Convalescence after debilitating diseases; Convalescence after infectious diseases; Convalescence at an elevated blood loss; Status of convalescence after illness

Z72.0 Tobacco use: tobacco smoking, Smoking

Z96.2 Presence of otological and audiological implants

Composition

Suspension for intramuscular administration 1 dose (0.5 ml)

Active substances:

Pneumococcal conjugates (polysaccharide - CRM197):

Polysaccharide serotype 1 2.2 mkg

Polysaccharide serotype 3 2.2 mkg

Polysaccharide serotype 4 2.2 mkg

Polysaccharide serotype 5 2.2 mkg

Oligosaccharide serotype 6A 2.2 mkg

Polysaccharide serotype 6B 4.4 mkg

Polysaccharide serotype 7F 2.2 mkg

Polysaccharide serotype 9V 2.2 mkg

Polysaccharide serotype 14 2.2 mkg

Polysaccharide serotype 18C 2.2 mkg

Polysaccharide serotype 19A 2.2 mkg

Polysaccharide serotype 19F 2.2 mkg

Polysaccharide serotype 23F 2.2 mkg

Carrier protein CRM 197 »32 mkg

Auxiliary substances: 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 of dosage form

Homogeneous suspension of white color.

Characteristic

The Prevenar® 13 vaccine is a capsular polysaccharide of 13 serotypes of pneumococcus: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, individually conjugated to diphtheria protein CRM197 and adsorbed on aluminum phosphate.

Pharmachologic effect

Mode of action - Immunomodulating.

Pharmacological (immunobiological) properties

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

According to WHO recommendations, for the new conjugated pneumococcal vaccines, the equivalence of the immune response of Prevenar® 13 vaccine was determined according to three criteria: the percentage of patients who reached the concentration of specific IgG antibodies ≥ 0.35 mkg / ml; (IgA) and opsonophagocytic activity (OFA) of bactericidal antibodies (OFA titer ≥1: 8 and average geometric titers (CGT).) The protective level of anti-pneumococcal antibodies and the serotype-specific OFA (CGT) are not defined for adults.

The Prevenar® 13 vaccine contains up to 90% of the serotypes that are the cause of invasive pneumococcal infections (IPI), incl. Resistant to antibiotic treatment.

Immune response when using three or two doses in a series of primary vaccinations. After the introduction of three doses of Prevenar® 13 vaccine, a significant increase in the level of antibodies to all serotypes of the vaccine was noted in the primary vaccination of children up to 6 months of age. After the introduction of two doses in the initial vaccination of Prevenar® 13, a significant increase in antibody titers to all components of the vaccine was also observed in the mass immunization of children of the same age group; for serotypes 6B and 23F, IgG ≥0.35 mkg / ml was detected in a smaller percentage of children. At the same time, a marked booster response to revaccination for all serotypes was noted. The formation of immune memory is indicated for both of the above vaccination schemes. The secondary immune response to the revaccinating dose in children of the second year of life, using three or two doses in a series of primary vaccinations, is comparable for all 13 serotypes.

At the time of vaccination of premature infants (born at the gestational age of <37 weeks), including deeply premature infants (born at the gestational age of <28 weeks), starting from the age of two months, it was noted that the level of protective specific antinepneumococcal antibodies and their OFA after the completed vaccination course Reached values above protective in 87-100% of those vaccinated to all thirteen included in the vaccine serotypes.

Immunogenicity in children and adolescents aged 5 to 17 years

Children aged 5 to <10 years who had previously received at least one dose of a pneumococcal 7-valent conjugate vaccine, as well as previously unvaccinated children and adolescents aged 10 to 17 years, received one dose of Prevenar® 13, Demonstrated an immune response to all 13 serotypes, equivalent to that in children 12-15 months, vaccinated with four doses of Prevenar® 13.

A single dose of Prevenar® vaccine to 13 children aged 5-17 years is able to provide the necessary immune response to all the serotypes of the pathogen that make up the vaccine.

The effectiveness of Prevenar® 13

Invasive pneumococcal infection (IPI). After the introduction of the Prevenar® vaccine in the 2 + 1 schedule (two doses in the first year of life and the revaccination once in the second year of life), after four years with 94% coverage, 98% (95% CI: 95, 99) Vaccine-specific serotypes. After switching to the Prevenar® 13 vaccine, there was a further decrease in the frequency of IPI caused by vaccine-specific additional serotypes, from 76% in children under 2 years old to 91% in children aged 5-14 years. Preventar® 13 serotypes for the additional serotypes of Prevenar® 13 in children <5 years old ranged from 68% to 100% (serotype 3 and 6A, respectively), and was 91% for serotypes 1, 7F, and 19A), with no observed Of cases of IPI caused by serotype 5. After the inclusion of Prevenar® 13 vaccine in national immunization programs, the frequency of registration of IPI 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 decrease in the incidence of IPI caused by serotype 3 by 79.5% (95% CI: 30.3-94.8).

Otitis media (CO). After the introduction of Prevenar® vaccination with the subsequent transition to Prevenar® 13 vaccine, a 95% reduction in the incidence of CO caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and serotype 6A was detected, as well as 89% reduction in CO frequency caused by serotypes 1, 3, 5, 7F and 19A.

Pneumonia. In the transition from the Prevenar® vaccine to the Prevenar® 13 vaccine, a 16 percent reduction in the incidence of all community-acquired pneumonia (PFS) in children aged 1 month to 15 years was noted. Cases of PLE with pleural effusion decreased by 53% (p <0.001), pneumococcal PFS decreased by 63% (p <0.001). In the second year after the introduction of the Prevenar® 13 vaccine, a 74% reduction in the incidence of PFS caused by 6 additional serotypes of the Prevenar® 13 vaccine was noted. 68% (95% CI) of children under 5 years after the introduction of Prevenar® 13 vaccine according to the 2 + 1 schedule : 73; 61) a decrease in the number of outpatient visits and 32% (95% CI: 39; 22) a decrease in the number of hospitalizations for alveolar VBP of any etiology.

Carrier and population effect. The efficacy of the Prevenar® 13 vaccine against the reduction of carriage in the nasopharynx of vaccine-specific serotypes, as well as those of the Prevenar® vaccine (4, 6B, 9V, 14, 18C, 19F, 23F) and 6 additional (1, 3, 5, 6A, 7A, 19A) and the related serotype 6C.

The population effect (a serotype-specific reduction in the incidence of unvaccinated individuals) has been noted in countries where Prevenar® 13 is used as part of mass immunization for more than 3 years, with high vaccination coverage and compliance with the immunization schedule. Unvaccinated vaccines Prevenar® 13 individuals 65 years of age and older demonstrated a 25% reduction in IPI, while FTIs caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F decreased by 89, and 64% decreased by IPI due to 6 additional Serotypes (1, 3, 5, 6A, 7A, 19A). The incidence of infections caused by serotype 3 decreased by 44%, serotype 6A - by 95%, serotype 19A - by 65%.

Immunogenicity of Prevenar® 13 in adults

Clinical studies of Prevenar® 13 vaccine provide immunogenicity data in adults 18 years of age and older, including those aged 65 years and those who have previously been vaccinated with one or more doses of a polysaccharide pneumococcal 23-valent vaccine (PPV23) 5 years before Inclusion in the study. In each study there were healthy adults and immunocompetent patients with chronic diseases in the compensation stage, including a concomitant pathology forming an increased susceptibility to pneumococcal infection (chronic cardiovascular diseases, chronic lung diseases including asthma, kidney and diabetes, chronic liver disease, Including alcohol abuse), and adults with social risk factors - smoking and alcohol abuse.

Immunogenicity and safety of the Prevenar® 13 vaccine is demonstrated for adults aged 18 years and older, including patients previously vaccinated with PPV23. Immunological equivalence is established for 12 common seroprevalence-23 serotypes. In addition, for the 8 common serotype 23 and serotype 6A, unique to the Prevenar® 13 vaccine, a higher statistically significant immune response to the Prevenar® 13 vaccine was demonstrated. The OFA CGT for all 13 serotypes of the Prevenar® 13 vaccine was not lower than that of adults At the age of 60-64 years. Moreover, persons aged 50-59 years gave a statistically higher immune response to 9 of 13 serotypes compared to people aged 60-64 years.

The clinical efficacy of Prevenar® 13 in a randomized, double-blind, placebo-controlled study of CAPITA (more than 84,000 patients) for community-acquired pneumococcal pneumonia (PAP) in adults 65 years of age and older: 45% for the first episode of serotiped- Overlapping vaccine Prevenar® 13 (invasive and non-invasive); 75% for invasive infections caused by serotypes overlapping with Prevenar® 13.

Immune response in adults previously vaccinated with PPV23. In adults 70 years and older, once vaccinated with PPV23> 5 years ago, the introduction of the Prevenar® 13 vaccine demonstrated immunologic equivalence for 12 common serotypes compared with the response to PPV23, with 10 immune serotypes and serotype 6A immune response to the Prevenar vaccine ® 13 was statistically significantly higher than the response to PPV23. Prevenar® 13 gives a more pronounced immune response compared to PPV23 revaccination.

Immune response in specific patient groups

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

Sickle cell anemia. In an open noncomparative study involving 158 children and adolescents aged> 6 and <18 years with sickle cell anemia previously vaccinated with one or more doses of PPV23 at least 6 months before enrollment, it was shown that the administration of the first dose of Prevenar® vaccine 13 with double immunization with an interval of 6 months resulted in a statistically significant high immune response (IgG SGS to each serotype, determined by ELISA, and OFA CGR for each serotype). After the second dose, the immune response was comparable to that after the first dose of the drug.

HIV infection. HIV-infected children and adults with CD4 count> 200 cells / μl (average 717 cells / μl), viral load <50,000 copies / ml (average 2090 copies / ml), with no active AIDS-associated diseases and previously not receiving Vaccination with pneumococcal vaccine, 3 doses of Prevenar® 13 were obtained. The IgG of SGS and OPA were significantly higher after the first vaccination with Prevenar® 13 vaccine compared to the pre-vaccination level. The second and third doses (at 6 and 12 months) developed a higher immune response than after a single vaccination with Prevenar® 13.

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

Indication of the Prevenar 13

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 and older without age restriction:

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

- in individuals at high risk of developing pneumococcal infection.

Vaccination is carried out within the framework of the national calendar of preventive vaccinations according to the approved terms, as well as to persons at risk for developing pneumococcal infection: with immunodeficient conditions, incl. HIV infection, oncological diseases receiving immunosuppressive therapy; With anatomical / functional aspiration; With the established 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 infants; Persons who are in organized collectives (orphanages, boarding schools, army collectives); Convalescent acute middle otitis media, meningitis, pneumonia; Long and often sick children; Patients infected with mycobacterium tuberculosis; To all persons over 50; Tobacco smoking.

Contraindications

Hypersensitivity reactions 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, exacerbation of chronic diseases (vaccination is carried out after recovery or during remission).

Application in pregnancy and breastfeeding

The safety of the vaccine during pregnancy and breastfeeding has not been established. Data on the use of the vaccine Prevenar® 13 during pregnancy are absent.

There are no data on the isolation of vaccine antigens or post-vaccination antibodies with breast milk during lactation.

Side effects

Prevenar® 13 vaccine safety was studied in healthy children (4,429 children / 14,267 doses of vaccine) between the ages of 6 weeks to 11-16 months and 100 babies born prematurely (<37 weeks gestation). In all studies, Prevenar® 13 was administered concomitantly with other vaccines recommended for this age. In addition, the safety of the Prevenar® 13 vaccine 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 frequent adverse reactions were reactions at the injection site, fever, irritability, decreased appetite, and disturbed sleep. In older children, with a primary vaccination with Prevenar® 13, a higher incidence of local reactions was observed than in children of the first year of life. When vaccinated with Prevenar® vaccine, 13 premature babies (born at gestation period <37 weeks), including deeply premature babies born less than 28 weeks gestation, and children with extremely low body weight (<500 g), the nature, frequency and severity of post-vaccination reactions Did not differ from those of full-term children. Persons aged 18 years and older had fewer side effects, regardless of previous vaccinations. However, the frequency of development of the reactions was the same as that of vaccines of a younger age.

In general, the incidence of adverse events was similar in patients aged 18-49 years and in patients older than 50 years, with the exception of vomiting. This side effect in patients aged 18-49 years was more common than in the age of over 50 years.

Adult patients with HIV had the same incidence of adverse reactions as in patients aged 50 years and older, with the exception of fever and vomiting that were very frequent, and nausea that was observed frequently. In patients after hematopoietic stem cell transplantation, the incidence of adverse reactions was similar to that in healthy adult patients, with the exception of fever and vomiting, which were very common in these patients. In children and adolescents with sickle cell disease, HIV infection or after hematopoietic stem cell transplantation, the same incidence of adverse reactions was observed as in healthy patients aged 2-17 years, with the exception of headache, vomiting, diarrhea, fever, fatigue, arthralgia And myalgia, which in such patients were very frequent.

Undesirable reactions identified in clinical trials of Prevenar® 13

The undesired reactions listed below are classified according to their frequency in all age groups as follows: very often (≥1 / 10); Often (≥1 / 100, but <1/10); Infrequently (≥1 / 1000, but <1/100); Rarely (≥1 / 10000, but <1/1000) and very rarely (<1/10000).

Very often hyperthermia; irritability; Redness of the skin, soreness, constriction or edema of 2.5-7 cm at the injection site (after revaccination and / or in children aged 2-5 years); Vomiting (in patients aged 18-49 years), drowsiness, worsening of sleep, worsening of appetite, headache, generalized new or exacerbation of existing pains in joints and muscle pains, chills, fatigue.

Often hyperthermia is above 39 ° C; Soreness at the injection site, resulting in a short-term restriction of limb movements; Hyperemia, compaction or edema of 2.5-7 cm at the injection site (after a series of primary vaccinations in children under 6 months of age), vomiting, diarrhea, rash.

Infrequent - redness of the skin, tightness or swelling of more than 7 cm at the injection site; Tearfulness, convulsions (including febrile convulsions), hypersensitivity reactions at the injection site (hives, dermatitis, pruritus) **, nausea.

Rarely, cases of hypotonic collapse *, flushing of blood to the face **, hypersensitivity reaction, including dyspnea, bronchospasm, Quincke edema of various locations, including facial edema **, anaphylactic / anaphylactoid reaction including shock **, lymphadenopathy in the injection site.

Very rarely - regional lymphadenopathy **, erythema polyforma **.

* Only observed in clinical trials of Prevenar® vaccine, but they are also possible for Prevenar® 13.

** Marked in post-marketing surveillance of Prevenar® vaccine; They can be considered as quite possible for the Prevenar® vaccine 13.

Adverse events observed in other age groups can also occur in children and adolescents aged 5-17 years. However, in clinical trials, they were not noted because of the small number of participants. Significant differences in the incidence of side effects in adults, previously vaccinated and unvaccinated PPV23, were not noted.

Interaction

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

Children 2 months - 5 years. Prevenar® 13 is compatible with any other vaccines included in the immunization schedule for infants of the first years of life, except for BCG. The simultaneous administration of Prevenar® 13 vaccine with any of the following antigens that are part of both monovalent and combination vaccines: diphtheria, tetanus, acellular or whole-cell pertussis, Haemophilus influenzae (type b), poliomyelitis, hepatitis A, hepatitis B, measles, mumps , Rubella, chicken pox and rotavirus infection - does not affect the immunogenicity of these vaccines. In connection with a higher risk of febrile reactions to children with convulsive disorders, incl. With febrile convulsions in the anamnesis, as well as receiving Prevenar® 13 together with whole-cell pertussis vaccines, symptomatic antipyretic agents are recommended. With the joint use of Prevenar® 13 and Infanrix hexa, the frequency of febrile reactions coincided with that for the joint use of Prevenar® (PCV7) and Infarriks-hexa vaccines. An increase in the frequency of seizure reporting (with and without body temperature increase) and hypotonic-hypo-responsive episodes (GGE) was observed when vaccines Prevenar® 13 and Infanrix-hex were combined. The use of antipyretic drugs should be initiated 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 the Prevenar® 13 vaccine concurrently with vaccines containing the whole-cell pertussis component.

According to a post-marketing study on the prophylactic use of antipyretics for the immune response when administering the Prevenar® 13 vaccine, it is suggested that the prophylactic administration of acetaminophen (paracetamol) may reduce the immune response to a series of primary vaccinations with Prevenar® 13. The vaccine Prevenar® 13 in 12 Month with the preventive use of paracetamol does not change. The clinical significance of these data is unknown.

Children and adolescents 6-17 years. Data on the use of Prevenar® 13 at the same time as the vaccine against human papillomavirus infection, conjugated meningococcal vaccine, tetanus, diphtheria and pertussis vaccine, tick-borne encephalitis are not available.

Persons 18-49 years. Data on concurrent use of Prevenar® 13 with other vaccines are not available.

Persons 50 years of age or older. The Prevenar® 13 vaccine can be used in conjunction with the trivalent inactivated seasonal influenza vaccine (DVT). With combined use of Prevenar® 13 and DVT vaccines, immune responses to the DVT vaccine were consistent with responses from a single DVT vaccine, immune responses to the Prevenar® 13 vaccine were lower than with the Prevenar® 13. Only the clinical significance of this fact is unknown .

The incidence of local reactions did not increase with the simultaneous administration of the Prevenar® 13 vaccine with the inactivated influenza vaccine, while the frequency of general reactions (headache, chills, rash, loss of appetite, joint and muscle pain) increased with simultaneous immunization. Simultaneous use with other vaccines has not been investigated.

Dosing and Administration

IM.

The vaccine is given in a single dose of 0.5 ml. Children of the first years of life are vaccinated in the upper part of the middle third of the thigh, persons over 2 years old in the deltoid muscle of the shoulder.

Prior to use, the syringe with the Prevenar® 13 vaccine should be well shaken until a homogeneous suspension is obtained. Do not use if foreign particles are detected when inspecting the contents of the syringe or the contents look different than in the section "Description of the dosage form".

Do not administer Prevenar® 13 intravascular and intramuscularly to the gluteal region.

If vaccination with Prevenar® 13 is started, it is recommended that it also be completed with Prevenar® 13. With a forced increase in the interval between injections of any of the above vaccination courses, the administration of additional doses of Prevenar® 13 is not required.

Vaccination schedule

Children previously vaccinated with Prevenar®. Vaccination against pneumococcal infection, initiated with the 7-valent Prevenar® vaccine, can be continued with Prevenar® 13 vaccine at any stage of the immunization schedule.

Persons aged 18 years and over. The Prevenar® 13 vaccine is administered once. The need for revaccination Prevenar® 13 is not established. The decision on the interval between the administration of Prevenar® 13 and PPV23 vaccines should be taken in accordance with official guidelines.

Special patient groups

In patients after hematopoietic stem cell transplantation, a series of immunizations consisting of 4 doses of Prevenar® 13 to 0.5 ml is recommended.

The first series of immunizations consists of the introduction of three doses of the drug: the first dose is administered from the third to the sixth month after transplantation. The interval between administrations should be 1 month. The revaccinating dose is recommended to be administered 6 months after the third dose.

Preterm infants are recommended 4-fold vaccination. The first series of immunizations consists of 3 doses. The first dose should be administered at the age of 2 months, regardless of the weight of the child 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. Immunogenicity and safety of the Prevenar® 13 vaccine have been confirmed for elderly patients.

Overdose

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

Special instructions

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

Vaccination of premature (as well as full-term) children should start from the second month of life (passport age). When deciding to vaccinate a premature baby (born at the time of <37 weeks gestation), especially having a history of immaturity of the respiratory system, it must be taken into account that the benefit of immunization against pneumococcal infection in this group of patients is particularly high, and neither vaccination nor transfer Its terms. Due to the potential risk of apnea from any vaccine, the first vaccination with Prevenar® 13 preterm infants is possible under medical supervision (at least 48 hours) in the hospital at the second stage of nursing.

Like other intravenous injections, patients with thrombocytopenia and / or other disorders of the blood coagulation system and / or anticoagulant treatment, 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 to this group of patients.

The Prevenar® 13 vaccine cannot prevent the prevention of diseases caused by pneumococci of other serotypes whose antigens are not included in this vaccine. Children from high-risk groups under 2 years of age should be vaccinated with Prevenar® 13 vaccine in accordance with their age. In patients with impaired immunoreactivity, vaccination may be accompanied by a lower level of antibody formation.

Use of the Prevenar® 13 and PPV23 vaccines

For the formation of immune memory, immunization against pneumococcal infection should preferably begin with the Prevenar® 13 vaccine.

The need for revaccination is not defined. Individuals from high-risk groups to expand coverage of serotypes may subsequently be recommended to introduce PPV23. There are data from clinical trials of vaccination of PPV23 in 1 year, and also after 3.5-4 years after Prevenar® 13. With an interval between vaccinations of 3.5-4 years, the immune response to PPV23 was higher without changes in reactogenicity.

Children vaccinated with Prevenar® 13 and belonging to a high-risk group (eg, sickle-cell anemia, asplenia, HIV infection, chronic disease or immune dysfunction), PPV23 should be injected at intervals of at least 8 weeks. In turn, patients who are at high risk of pneumococcal disease (patients with sickle cell anemia or HIV infection), including patients 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 PRV23 and the Prevenar® 13 vaccine should be taken 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, the Prevenar® 13 vaccine should not be given more than 1 year later.

In the Russian Federation, the vaccination of pneumococcal 13-valent vaccine (PKV13) is recommended for all adults who have reached the age of 50 years and patients at risk, the PKV13 vaccine being administered first with possible subsequent revaccination of PPV23 with an interval of not less than 8 weeks. Prevenar® 13 contains less than 1 mmol sodium (23 mg) per dose, i.e. Practically does not contain sodium.

Within the indicated shelf life, the Prevenar® 13 vaccine remains stable for 4 days at a temperature of 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 guidance on storage and transport conditions, but may be the basis for deciding on the use of the vaccine in the case of temporary fluctuations in temperature during storage and transport.

Influence of drugs on the ability to drive a vehicle or potentially dangerous mechanisms. The Prevenar® 13 vaccine has little or no 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 the IM introduction, 0.5 ml / dose. For 0.5 ml in a 1 ml syringe made of clear, colorless glass (type I).

1 syringe and 1 sterile needle in a plastic bag sealed with a PE film. 1 plastic packaging is placed in a cardboard box. 5 syringes in a plastic bag sealed with a PE film. 2 plastic bags and 10 sterile needles are placed in a cardboard box.

When packing at OOO NPO Petrovax Farm. For 0.5 ml in a 1 ml syringe made of clear, colorless glass (type I). 1 syringe and 1 sterile needle in a plastic bag sealed with a PE film. 1 plastic packaging is placed in a cardboard box.

Manufacturer

1. Wyeth Pharmaceuticals Division of Wyeth Holdings Corporation, USA. 401, North Middletown Road, Pearl River, New York, 10965, USA.

2. Baxter Pharmaceutical Solutions Solutions, USA. 927 South Curry Pike, Bloomington, IN 47403, USA.

Packed with:

Wyeth Pharmaceuticals, United Kingdom. New Lane, Havant, Hampshire, P09 2NG, United Kingdom.

Or OOO NPO Petrovax Pharm. 142143, the Russian Federation, Moscow Region

Claims of consumers should be sent to: 1. OOO Pfizer. 123112, Moscow, BC "Tower on the Embankment" (Block C).

2. OOO NPO Petrovax Pharm, the Russian Federation.

Conditions of supply of pharmacies

Packing with 1 syringe - according to the prescription; Packing with 10 syringes - for medical and preventive institutions.

Storage conditions of the drug Prevenar 13

At a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

Shelf life of the drug Prevenar 13

3 years.

Do not use after the expiry date printed on the package.