PREVENAR® 13 (vaccine pneumococcal polysaccharide conjugated adsorbed, thirteen-valent) (Prevenar® 13)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of pneumococcal infectionsVaccine for the prevention of pneumococcal infections
Dosage form: & nbspsuspension for intramuscular injection
Composition:

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 the diphtheria CRM protein197 and adsorbed to aluminum phosphate.

COMPOSITION

Composition per single dose (0.5 ml):

Active substances:

Pneumococcal conjugates (polysaccharide-CRM197):

Polysaccharide serotype 1 2.2 μg

Polysaccharide serotype 3 2.2 μg

Polysaccharide serotype 4 2.2 μg

Polysaccharide serotype 5 2.2 μg

Polysaccharide serotype 6A 2.2 μg

Polysaccharide serotype 6B 4.4 μg

Polysaccharide serotype 7F 2.2 μg

Polysaccharide serotype 9V 2.2 μg

Polysaccharide serotype 14 2.2 μg

The oligosaccharide serotype of 18C is 2.2 μg

Polysaccharide serotype 19A 2.2 μg

Polysaccharide serotype 19F 2.2 μg

Polysaccharide serotype 23F 2.2 μg

Carrier protein CRM197 ~ 32 μg

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: & nbsp

J.07   Vaccines

J.07.A.L   Vaccine for the prevention of pneumococcal infection

Pharmacodynamics:

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

According to WHO recommendations for new conjugated pneumococcal 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 ≥ 0.35 μg / ml; average geometric concentrations (SGS) of immunoglobulins and opsonophagocyte activity (OFA) of bactericidal antibodies (OFA titer ≥ 1: 8 and average geometric titres (CGT)).For adults The protective level of anti-pneumococcal antibodies is not defined and the serotype-specific OFA (CGT) is used.

The Prevenar® 13 vaccine contains up to 90% of the serotypes that cause invasive pneumococcal infections (IPI), including antibiotic-resistant ones.

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

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

After the introduction two doses with 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 μg / ml was detected in a smaller percentage of children. At the same time, a pronounced booster response to revaccination for all serotypes was noted. The formation of immune memory is indicated for both of the above vaccination schemes. Secondary immune response to a revaccinating dose in children of the second year of life the use of 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 deep premature infants (born at a gestation period of <28 weeks), starting at the age of two months, it was noted that the level of protective specific antiepneumococcal antibodies and their OPA after the completed vaccination course reached values ​​above protective in 87-100% grafted 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 pneumococcal 7-valent conjugate vaccine, as well as previously unvaccinated children and adolescents aged 10 to 17 years, one dose of Prevenar® 13 vaccine, demonstrated an immune response to all 13 serotypes, equivalent to that in children 12-15 months old, vaccinated with four doses of Prevenar® 13.

The single administration of Prevenar® 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.

Effectiveness of Prevenar®13

Invasive pneumococcal infection (IPI)

After the introduction of Prevenar® in a 2 + 1 schedule (two doses in the first year of life andrevaccination once in the second year of life) in four years with a 94% coverage of vaccination, 98% (95% CI: 95; 99) caused by vaccine-specific serotypes. After the transition to Prevenar® 13, there was a further decrease in the frequency of IPI caused by vaccine-specific additional serotypes from 76% in children younger than 2 years of age to 91% of children aged 5-14 years.

The serotype-specific efficacy against IPI for the additional serotypes 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), but there were no cases of IPI caused by serotype 5. After the inclusion of Prevenar® 13 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 and the subsequent transition to Prevenar® 13 in the 2 + 1 regimen, the incidence of CO caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and serotype 6A was reduced by 95%, and by 89% decrease in the frequency of CO caused by serotypes 1, 3, 5, 7F and 19A.

Pneumonia

When switching from Prevenar® to Prevenar® 13, there was a 16% reduction in the incidence of all community-acquired pneumonia (PFS) in children aged 1 month to 15 years. 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 Prevenar® 13, a 74% reduction in the incidence of PFS caused by 6 additional serotypes of Prevenar® 13 was noted. 68% (95% CI: 73%) of children under 5 years after the introduction of Prevenar® 13 vaccination ; 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

Prevenar® 13 has been shown to reduce the carrier burden in the nasopharynx of vaccine-specific serotypes, in common with 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 observed 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.In unvaccinated Prevenar®, 13 individuals 65 years of age or older have experienced a 25% reduction in IPI, while FTIs caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F have decreased by 89% and 64% 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 provide data on immunogenicity 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 polysaccharide pneumococcal 23-valent vaccine (PPV23) 5 years before enrollment in the study. In each study there were healthy adults and immunocompetent patients with chronic diseases in the compensation stage, including concomitant pathology that formed 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 Prevenar® 13 is demonstrated for adults 18 years of age and older, including patients previously vaccinated with PPV23. Immunological equivalence is established for 12 common seroprevalence-23 serotypes. In addition, for a total of 8 serotypes common to the PRV23 and serotype 6A, unique to the Prevenar® 13 vaccine, a statistically significantly higher immune response to Prevenar® 13 was demonstrated. In adults 18-59 years of age, the CGT of opsonophagocytic activity (OFA CGT) to all 13 Prevenar® 13 serotypes were no less than those of adults aged 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, CAPITA study (more than 84,000 patients) for community-acquired pneumococcal pneumonia (PPP) in adults 65 years and older: 45% for the first runway episode caused by serotypes overlapping Prevenar® 13 (invasive and non-invasive); 75% for invasive infections caused by serotypes overlapping Prevenar® 13.

Immune response in adults previously vaccinated with PPV23

In adults 70 years and older, once vaccinated with PPV23 ≥ 5 years ago, the administration of Prevenar® 13 demonstrated immunological equivalence for 12 common serotypes compared with response to PPV23, with this for 10 common serotypes and serotype 6A, the immune response to Prevenar® 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 old with sickle cell anemia previously vaccinated with one or more doses of PPV23 at least 6 months before inclusion

the study showed that the administration of the first dose of Prevenar® 13 with double immunization at 6-month intervals resulted in a statistically significant high immune response (IgG SGS for each serotype determined by ELISA and OFA CGT 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 a CD4 count ≥ 200 cells / μL (an average of 717.0 cells / μl), a viral load <50,000 copies / ml (an average of 2,090.0 copies / ml), with no active AIDS-associated diseases and not previously vaccinated with pneumococcal vaccine, 3 doses of Prevenar® 13 were obtained. IgG SGA and OFA values ​​were significantly higher after the first vaccination of Prevenar® 13 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 (TGSC) aged ≥ 2 years with complete hematologic remission of the underlying disease or with satisfactory partial remission in the case of lymphoma and myeloma received three doses of Prevenar® 13 at intervals of at least 1 month between doses.

The first dose of the drug was administered 3-6 months after TSCC. A fourth (booster) dose of Prevenar® 13 was administered 6 months after the third dose. In accordance with general recommendations, a single dose of PPV23 was administered at 1 month after the fourth dose of Prevenar® 13. The titers of the functionally active antibodies (OFA CGT) were not determined in this study. Introduction Prevenar® 13 caused an increase in SGS 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:

- 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 life and then without age restrictions:

- within 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, in t.ch. 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 lung diseases, cardiovascular system, liver, kidney and diabetes mellitus; patients with bronchial asthma; premature infants; persons who are in organized collectives (orphanages, boarding schools, army collectives); convalescent acute convalescent otitis media, meningitis, pneumonia; long and often sick children; patients infected with mycobacteria tuberculosis; to all persons over 50; tobacco smokers.

Contraindications:

- Hypersensitivity to prior 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 performed after recovery or during remission.

Pregnancy and lactation:

The safety of the vaccine during pregnancy and breastfeeding has not been established. Data on the use of Prevenar® 13 during pregnancy are not available. There are no data on the isolation of vaccine antigens or postvaccinal antibodies with breast milk during lactation.

Dosing and Administration:

Method of administration

The vaccine is given in a single dose of 0.5 ml intramuscularly. Children of the first years of life are vaccinated in the upper-outer surface of the middle third of the thigh, persons older than 2 years - 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 "Description" section of this manual.

Do not administer Prevenar® 13 intravascularly and intramuscularly to the gluteal region!

If Prevenar® 13 is vaccinated, 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

Age of vaccination

Vaccination schedule

Intervals and dosage

2 -6 months

3+1

or

2+1

Individual immunization: 3 doses with an interval of at least 4 weeks between administrations. The first dose can be administered from 2 months.

Revaccination once in 11-15 months.

Mass immunization of children: 2 doses with an interval of not less than 8 weeks between administrations. Revaccination once in 11-15 months.

7-11 months

2+1

2 doses with an interval of at least 4 weeks between administrations. Revaccination once in the second year of life.

12-23 months

1+1

2 doses with an interval of not less than 8 weeks between administrations.

2 years and older

1

Once

Children previously vaccinated with Prevenar®

Vaccination against pneumococcal infection initiated by the 7-valent Prevenar® vaccine may be continued with Prevenar® 13 at any stage of the immunization schedule.

Persons aged 18 years and over

Prevenar® 13 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 0.5 ml is recommended. The first series of immunizations consists of the administration 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 revaccination dose is recommended to be administered 6 months after the administration of the third dose.

Preterm infants are recommended a four-time 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.

Side effects:

Prevenar® 13 vaccine safety was studied in healthy infants (4,429 children / 14,267 vaccine doses) between the ages of 6 weeks and 11-16 months and 100 babies born prematurely (<37 weeks gestation). In all studies Prevenar® 13 was used 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 Prevenar® was vaccinated, 13 premature infants (born at gestational age ≤ 37 weeks), including deeply premature babies born less than 28 weeks of gestation and children with extremely low body weight (≤ 500 g), the 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 the development of the reactions was the same as that of the vaccinated 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 to 49 years was more common than in patients over the age of 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, which were very frequent and nausea, which 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 frequent in patients after transplantation. 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 met as "very frequent".

The adverse reactions listed below are classified according to their frequency in all age groups as follows: very frequent (≥ 1/10), frequent (≥ 1/100, but <1/10), infrequent (≥ 1/1000, but <1/100), rare (≥ 1/10000, but <1/1000) and very rare (<1/10000).

Undesirable reactions identified in clinical trials Prevenar® 13

Very Frequent: hyperthermia; irritability; redness of the skin, soreness, constriction or swelling of 2.5-7.0 cm at the injection site (after revaccination and / or in children aged 2-5 years); vomiting (in patients aged 18 to 49 years), drowsiness, sleep deterioration, worsening of appetite, headache,generalized new or exacerbation of existing pains in the joints and muscle pains, chills, fatigue.

Frequent: hyperthermia above 39 °C; soreness at the injection site, resulting in a short-term restriction of limb movements; hyperemia, compaction or edema of 2.5-7.0 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, densification or swelling of more than 7.0 cm at the injection site; tearfulness, convulsions (including febrile convulsions), hypersensitivity reactions at the injection site (hives, dermatitis, pruritus) **, nausea.

Rare: 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 rare: regional lymphadenopathy **, erythema polyforma **.

* - have been observed only in clinical studies of Prevenar® vaccine, but are also possible for Prevenar® 13.

** - were observed in post-marketing surveillance of Prevenar® vaccine; 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, 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.

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

Interaction:

Data on the interchangeability of Prevenar® 13 on 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 schedule for infants of the first years of life, with the exception of BCG. 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 a type b, poliomyelitis, hepatitis A, hepatitis B, measles, mumps, rubella, chicken pox and rotavirus infection - does not affect the immunogenicity of these vaccines. Due to the higher risk of febrile reactions to children with convulsive disorders, including those with a history of febrile convulsions, and also receiving Prevenar® 13 concurrently 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 Infanrix-hexa. An increase in the frequency of seizure reporting (with and without body temperature increase) and hypotonic-hypo-responsive episodes (GGE) was observed with the joint use of Prevenar® 13 and Infanrix-hexa. 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 Prevenar® 13 concurrently with vaccines containing the whole-cell pertussis component.According to a post-marketing study on the prophylactic use of antipyretic agents for an immune response to the introduction of 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 immune response to Prevenar® 13 revaccination at 12 months at preventive use of paracetamol does not change. The clinical significance of this data is not known.

Children and adolescents aged 6 to 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 absent.

Persons aged 18-49 years

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

Persons aged 50 years and over

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 Prevenar® 13 alone.The clinical significance of this fact is unknown. The incidence of local reactions did not increase with the simultaneous administration of Prevenar® 13 with the inactivated influenza vaccine, while the frequency of general reactions (headache, chills, rash, loss of appetite, pain in joints and muscles) increased with simultaneous immunization. Simultaneous use with other vaccines has not been investigated.

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

Like other intramuscular injections, patients with thrombocytopenia and / or other disorders of the blood coagulation system and / or in case of anticoagulant treatment, vaccination Prevenar® 13 should be performed with caution, provided that the patient's condition is stabilized and hemostasis control is achieved. Subcutaneous administration possible vaccines Prevenar® 13 to this group of patients.

Prevenar® 13 can not 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 according to their age. In patients with impaired immunoreactivity, vaccination may be accompanied by a decreased level of antibody formation.

Application Prevenar® 13 and WPV23

For the formation of immune memory, immunization against pneumococcal infection is preferable to begin with the Prevenar® 13. 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 least 8 weeks apart. 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 introduction of PRV23 and the Prevenar® 13 vaccine 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 Russia, vaccination of PKV13 is recommended for all adults who have reached the age of 50 years and for patients at risk, the PKV13 vaccine being administered first with possible subsequent revaccination of PPV23 at intervals of not less than 8 weeks.

Prevenar® 13 contains less than 1 mmol sodium (23 mg) per dose, i.e., practically free of sodium.

Within the indicated shelf life, Prevenar® 13 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 the storage and transport conditions, but may be the basis for a decision on the use of the vaccine in the case of temporary fluctuations in temperature during storage and transport.
Effect on the ability to drive transp. cf. and fur:Prevenar® 13 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.
Form release / dosage:Suspension for intramuscular injection 0.5 ml / dose.

Packaging:

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 plastic wrap. 1 plastic bag together with instructions for use in a cardboard box.

5 syringes in a plastic bag sealed with a polyethylene film.

2 plastic bags and 10 sterile needles together with instructions for use in a cardboard pack.

When packing at OOO NPO Petrovax Pharm:

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 plastic wrap. 1 plastic bag together with instructions for use in a cardboard box.

Storage conditions:

At a temperature of 2 to 8 ° C. Do not freeze. Keep out of the reach of children.

Transport at a temperature of 2 ° C to 25 ° C. Do not freeze.

Transportation is allowed at temperatures above 2-8 ° C for not more than five days.

Shelf life:

3 years.

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

Leave conditions

Packing with 1 syringe - prescription

Packing with 10 syringes - for treatment and prophylactic institutions.

Terms of leave from pharmacies:On prescription
Registration number:LP-000798
Date of registration:03.10.2011 / 04.10.2016
Expiration Date:Unlimited
The owner of the registration certificate: Pfizer Inc. Pfizer Inc. USA
Manufacturer: & nbsp
Representation: & nbspPfizer LtdPfizer LtdUSA
Information update date: & nbsp20.06.2017
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