Vaccine Prevenar 13 in Moscow - vaccination against pneumococcal infection

Prevenar 13 — Pneumococcal polysaccharide vaccine, conjugated, adsorbed, thirteen-valent Registration number: LP-000798 Tradename: Prevenar 13 Group name: Vaccine for the prevention of pneumococcal infections Dosage form: Suspension for intramuscular administration Manufacturer country: Pfizer, Ireland Exploratory survey: not required Vaccine cost: RUB 3,900 (examination before vaccination is paid additionally) Applicable: For adults and children Conditions for dispensing from pharmacies: Package with 1 syringe - according to prescription, package with 10 syringes - for medical institutions Analogue of this vaccine: Vaccine "Synflorix"

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DESCRIPTION OF THE MEDICINE

The Prevenar 13 vaccine is a capsular polysaccharide of 13 pneumococcal serotypes: 1, 3,4,5, 6A, 66, 7F, 9U, 14, 18C, 19A, 19F and 23F, individually conjugated to the diphtheria protein CRM197 and adsorbed on aluminum phosphate.

Appearance: Homogeneous white suspension.

PREVENAR 13 is manufactured in accordance with WHO guidelines for the production and quality control of pneumococcal conjugate vaccines.

Pharmacological group

Pneumococcal purified polysaccharide conjugated antigen. ATX code: J07AL02

Immunological properties

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

According to WHO recommendations for new conjugate pneumococcal vaccines, the equivalence of the immune response of Prevenar 13 was determined according to three criteria: the percentage of patients who achieved a concentration of specific IgG antibodies of ~ 0.35 μg/ml; geometric mean concentrations (GMC) of immunoglobulins and opsonophagocytic activity (o FA) of bactericidal antibodies (GMA titer ~ 1:8 and geometric mean titers (GMT)). For adults, the protective level of antipneumococcal antibodies has not been determined and a serotype-specific OPA (SP) is used.

The Prevenar 13 vaccine includes up to 90 serotypes. causing invasive pneumococcal infections (IPI), including those resistant to antibiotic treatment.

Immune response following a three or two dose primary vaccination series.

After three doses of Prevenar 13 were administered during the primary vaccination of children under 6 months of age, a significant increase in the level of antibodies to all vaccine serotypes was observed. After the administration of two doses during the primary vaccination of Prevenar13, as part of the mass immunization of children of the same age group, a significant increase in antibody titers to all components of the vaccine was also observed; for serotypes 6B and 23F, an IgG level of ~ 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 indicated for both of the above vaccination regimens. The secondary immune response to a booster dose in children of the second year of life using three or two doses in the primary vaccination series is comparable for all 13 serotypes.

When vaccinating premature infants (born at a gestational age of <37 weeks), including very premature infants (born at a gestational age of <28 weeks), starting at the age of two months, it was noted that the level of protective specific anti-pneumococcal antibodies and their OPA after the completed course vaccinations reached values above protective in 87-100 vaccinated to all thirteen serotypes included in the vaccine.

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, and previously unvaccinated children and adolescents aged 10 to 17 years who received one dose of Prevenar 13 vaccine, demonstrated immune response to all 13 serotypes, equivalent to that in children 12-15 months vaccinated with four doses of Prevenar 13.

A single administration of Prevenar to 13 children aged 5-17 years is able to provide the necessary immune response to all serotypes of the pathogen included in the vaccine.

Immunogenicity of the vaccine in adults

In adults aged 60-64 years who have not previously received the polysaccharide pneumococcal 23-valent vaccine (PPV23), after administration of Prevenar 13 or PPV23 vaccines, and in adults aged 50-59 years who received one dose of Prevenar 13 vaccine, immunological equivalence for 12 serotypes common to PPV23. In addition, for 8 serotypes common to PPV23 and for serotype 6A, unique to the Prevenar 13 vaccine, a statistically significantly higher immune response to Prevenar 13 was demonstrated.

The immune response to Prevenar 13 in people aged 50–59 years for all 13 serotypes was equivalent to that of adults aged 60–64 years. Moreover, individuals aged 50–59 years had a statistically higher immune response to 9 of 13 serotypes compared to individuals aged 60–64 years.

Immune response in adults previously vaccinated with PPV23

In adults aged 70 years and older vaccinated with a single dose of PPV23 ~5 years ago, Prevenar administration demonstrated noninferiority for 12 common serotypes compared with the response to PPV23, while for 10 common serotypes and serotype 6A the immune response to Prevenar 13 was statistically significantly higher compared to the response to PPV23.
Prevenar 13 has been shown to produce a stronger immune response compared to booster vaccination with PPV23. Demonstrated clinical efficacy of Prevenar 13 in the randomized, double-blind, placebo-controlled CAPPA trial (more than 84,000 patients) against community-acquired pneumococcal pneumonia (CAP) in adults aged 65 years and older: 45 against first episode of CAP caused by serotypes overlapped by Prevenar 13 (invasive and non-invasive); 75 for invasive infections caused by serotypes overlapped by Prevenar 13.

Immune response in special patient groups

Patients with the conditions described below are at increased risk of pneumococcal infection. The clinical significance of the immune response induced by Prevenar 13 in patients in these groups is currently unknown.

Sickle cell anemia. In an open-label, non-comparative study conducted in France, Italy, UK, USA, Lebanon, Egypt and Saudi Arabia in 158 children and adolescents aged ~6 and <18 years with sickle cell disease, previously vaccinated with one or more doses of PPV23 for at least 6 years months before inclusion in the study showed that the administration of the first dose of Prevenar 13 with double immunization with an interval of 6 months led to a statistically significant high immune response (SGC IgG to each serotype, determined by enzyme-linked immunosorbent assay (ELISA), and SGT of opsonophagocytic activity (about FA SGT ) to 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 of ~200 cells/mil (average 717.0 cells/μl), viral load <50,000 copies/ml (average 2090.0 copies/ml), and no active AIDS-associated diseases and who had not previously received vaccination with pneumococcal vaccine, received 3 doses of Prevenar 13. The IgG SGC and OFA levels were significantly higher after the first vaccination with Prevenar 13 compared to the pre-vaccination level. At the second and third doses (6 and 12 months later), a higher immune response developed than after a single vaccination with Prevenar13.

Hematopoietic stem cell transplantation. Children and adults who underwent allogeneic hematopoietic stem cell transplantation (HSCT), 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 with an interval of at least 1 month 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 general recommendations, a single dose of PPV23 was administered 1 month after the fourth dose of Prevenar 13. Functionally active antibody titers (FAA FAT) were not determined in this study. Administration 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.

Vaccination at the Amel Dental clinic

Patients choose us because:

We always have high-quality certified foreign-made vaccines in stock;
we carry out vaccinations, adhering to the national and international vaccination calendar;
we have equipped a specially separate room for waiting and vaccination;
vaccination is carried out by specially trained specialists who, in addition to professional skills, have extensive experience working with children;
Before vaccination, each patient undergoes a mandatory examination by a doctor (generalist, pediatrician);
the doctor monitors the patient’s condition before, during and after vaccination;
After vaccination, the doctor draws up a schedule for the next vaccinations and gives recommendations to the patient.

At Amel Dental you can get one Prevenar vaccination or undergo complex vaccination in accordance with the vaccination calendar. To do this, you need to make an appointment with a doctor, and he will draw up an individual vaccination schedule and conduct all the necessary examinations.

COMPOUND

Composition per 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 9U - 2.2 μg;
Polysaccharide serotype 14 - 2.2 μg;
Oligosaccharide serotype 18C - 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 - O, 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.

METHOD OF APPLICATION AND DOSAGE

Do not administer Prevenar 13 intravascularly or intramuscularly into the gluteal region!

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

Before use, the syringe with the Prevenar 13 vaccine must be shaken well until a homogeneous suspension is obtained. Do not use if inspection of the contents of the syringe reveals foreign particles, or the contents look different than those described in the “Description” section of these instructions.

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

VACCINATION SCHEME

Age at which vaccination began	Vaccination scheme	Intervals and dosage
2 months – 6 months	3+1 or 2+1	Individual immunization: 3 doses or with an interval of at least 4 weeks between doses. 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+1	2 doses at least 4 weeks apart. between injections. Revaccination once in the second year of life
12-23 months	1+1	2 doses at least 8 weeks apart. between injections
2 years and older	1	One time

Vaccination for children previously vaccinated with Prevenar

Vaccination against pneumococcal disease started with the 7-valent Prevenar vaccine can be continued with Prevenar 13 at any stage of the immunization regimen.

Vaccination for people over 18 years of age

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.

Vaccination of special groups of patients

In patients after hematopoietic stem cell transplantation, an immunization series consisting of 4 doses of Prevenar 13, 0.5 ml each, 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 administrations should be 1 month. A booster dose is recommended to be administered 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. A fourth (booster) dose is recommended at 12–15 months of age.

Vaccination of elderly patients

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

Synflorix, Prevenar, Prevenar-13, Pneumo-23 - what's the difference?

Synflorix and Prevenar 13 are close analogues of the Prevenar vaccine. The Prevenar vaccine has been used longer, it includes the 7 most common serotypes of streptococcus, Synflorix - 10, Prevenar-13 - respectively, 13.
Synflorix and Prevenar-13 are produced in Russia under an agreement with the Pfizer concern and are included in the national vaccination calendar.
The Prevenar vaccine is produced in the USA.
All three vaccines can be used to vaccinate children under 2 years of age.

As for Pneumo-23, this vaccine is intended for vaccination of children from 2 years of age and protects against the 23 most common serotypes of streptococcus. This vaccine is produced in France.

SIDE EFFECTS

In healthy children

The safety of the Prevenar 13 vaccine was studied in healthy children (4429 children/14267 vaccine doses) aged from 6 weeks to 11-16 months and 100 children born prematurely (less than 37 weeks of gestation). In all studies, Prevenar 13 was administered concomitantly with other vaccines recommended for a given age.

In addition, the safety of the Prevenar 13 vaccine was assessed in 354 children aged 7 months - 5 years who had not previously been vaccinated with any of the pneumococcal conjugate vaccines. The most common adverse reactions are decreased appetite and sleep disturbances. In older children, during primary vaccination with Prevenar 13, a higher frequency of local reactions was observed than in children of the first year of life.

In premature babies

When Prevenar was vaccinated in 13 premature infants (born at a gestational age of up to 37 weeks), including very premature infants born at a gestational age of less than 28 weeks and children with extremely low body weight (up to 500 g), the nature, frequency and severity of post-vaccination reactions did not differ from those in full-term children.

In adults

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

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

Adult patients with HIV infection had the same incidence of adverse reactions as patients aged 50 years and older, with the exception of fever and vomiting, which were very common, and nausea, which was common. in patients after hematopoietic stem cell transplantation, the incidence of adverse reactions was the same as in healthy adult patients, with the exception of fever and vomiting, which were very common in patients after transplantation. Children and adolescents with sickle cell disease, HIV infection, or hematopoietic stem cell transplant had the same incidence of adverse reactions as healthy patients aged 2-17 years, with the exception of headache, vomiting, diarrhea, fever, fatigue, arthralgia and myalgia, which were considered “very frequent” in such patients.

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

Adverse reactions identified in clinical studies of Prevenar 13

Possible side effects

Hyperthermia (or hyperthermia above 39 OS);
Irritability;
Redness of the skin;
Pain or tenderness at the injection site - hypersensitivity reactions at the injection site (urticaria, dermatitis, itching);
Induration or swelling measuring 2.5-7.0 cm at the injection site;
Vomit;
Drowsiness;
Deterioration of sleep;
Loss of appetite, headache;
Generalized new or exacerbation of existing pain in the joints and muscle pain;
Chills;
Fatigue;
hyperemia;
Diarrhea;
Rash;
Tearfulness;
Seizures (including febrile seizures);
Nausea;
anaphylactic and anaphylactoid reaction;
regional lymphadenopathy;
erythema multiforme;
regional lymphadenopathy;
erythema multiforme.

Adverse events observed in other age groups may 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 in adults previously vaccinated and not vaccinated with PPV23.

Why is the Prevenar vaccine included in the vaccination schedule?

Prevenar is a vaccine designed to prevent pneumococcal infections.
Pneumococcus is “responsible” for 30% of all pneumonia, and such pneumonia is severe and with complications (such as pleurisy, lung abscess, pericarditis, arthritis, sepsis).

Children under 5 years of age are at risk for pneumococcal pneumonia. Pneumococcus causes from 30% to 60% (according to various sources) of childhood otitis media.

Pneumococcal infection is a common cause of meningitis and sepsis in children and adolescents.

INTERACTIONS WITH OTHER MEDICINES AND OTHER TYPES OF INTERACTIONS

There are no data on the interchangeability of Prevenar 13 with other pneumococcal conjugate vaccines. When immunizing with Prevenar13 and other vaccines at the same time, injections are given in different parts of the body

Use of other vaccines at the age of 1 month - 5 years

Prevenar 13 is combined with any other vaccines included in the immunization schedule for children in the first years of life. Simultaneous administration of the Prevenar 13 vaccine with any of the following antigens included in both monovalent and combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated polio, hepatitis A, hepatitis B, measles, mumps, rubella , chickenpox and rotavirus infection do not affect the immunogenicity of these vaccines. Due to the higher risk of febrile reactions in children with seizure disorders, including a history of febrile seizures, and those receiving Prevenar 13 concomitantly with whole-cell pertussis vaccines, symptomatic administration of antipyretics is recommended. When Prevenar 13 and Infarix-hexa were used together, the frequency of febrile reactions coincided with that for the combined use of Prevenar (PCV7) and Infarix-hexa. An increased incidence of reported seizures (with and without fever) and hypotonic hyporesponsive episodes (HHE) was observed when Prevenar 13 and Infanrix-hexa were used together. Antipyretic medications should be initiated in accordance with local treatment guidelines for children with seizure disorders or a history of febrile seizures and in all children receiving Prevenar 13 concomitantly with vaccines containing whole cell pertussis.

According to a post-marketing study of the prophylactic use of antipyretics on the immune response to the Prevenar 13 vaccine, it is assumed that the prophylactic administration of acetaminophen (paracetamol) may reduce the immune response to the primary Prevenar 13 vaccination series. The immune response to Prevenar 13 revaccination at 12 months with the prophylactic use of paracetamol did not is changing. The clinical significance of these data is unknown.

Use of other vaccines between 6 and 17 years of age

There are no data on the use of Prevenar 13 simultaneously with the vaccine against human papillomavirus infection, meningococcal conjugate vaccine, tetanus, diphtheria and pertussis vaccine, and tick-borne encephalitis.

Use of other vaccines between 18 and 49 years of age

There are no data on the simultaneous use of Prevenar 13 with other vaccines.

Use of other vaccines in people aged 50 years and older

Prevenar 13 can be used in conjunction with trivalent inactivated seasonal influenza vaccine (DVT). When Prevenar 13 and DVT were used in combination, immune responses to DVT were similar to those obtained with DVT alone, and immune responses to Prevenar 13 were lower than with Prevenar 13 alone. The clinical significance of this finding is unknown. The incidence of local reactions did not increase with simultaneous administration of Prevenar 13 with inactivated influenza vaccine, while the incidence of general reactions (headache, chills, rash, loss of appetite, joint and muscle pain) increased with simultaneous immunization. Concomitant use with other vaccines has not been studied.

Contraindications

Only a doctor can decide whether Prevenar is suitable for a child to be vaccinated

Prevenar vaccination is contraindicated if there is a history of an allergic reaction to any component of the vaccine, as well as in the following cases:

Hypersensitivity reactions to previous administration of Prevenar drugs (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).
If an acute or exacerbation of a chronic disease occurs, the child receives a deferment until complete recovery or a period of remission. The pediatrician determines the required duration of delay from vaccinations, guided primarily by the risk of complications. In most cases, the delay is about 1 month. In case of meningococcal meningitis and other severe diseases of the nervous system, vaccinations are postponed for a longer period - up to six months from the onset of the disease.
The main contraindications to vaccination, which provide grounds for medical withdrawal from vaccinations, are strong reactions and post-vaccination complications after the administration of the previous dose of the vaccine. A strong reaction is understood as an increase in body temperature above 40 °C with the occurrence of swelling and redness at the site of vaccine administration over 8 cm in diameter, severe allergic reactions, anaphylactic shock, the development of infectious diseases and damage to individual body systems.

SPECIAL INSTRUCTIONS AND WARNINGS

Given the rare incidence of anaphylactic reactions with any vaccine, the vaccinated patient should be under medical supervision for at least 30 minutes after immunization. Immunization sites must be provided with anti-shock therapy. Vaccination of premature (as well as full-term) children should begin from the second month of life (passport age). When deciding whether to vaccinate a premature infant (born <37 weeks of gestation), especially one with a history of respiratory immaturity, it is necessary to take into account that the benefits of immunization against pneumococcal infection in this group of patients are especially high and vaccination should not be withheld or delayed. its timing. Due to the potential risk of apnea. available when using any vaccines, the first vaccination of Prevenar 13 for a premature baby is possible under medical supervision (at least 48 hours) in a hospital during the second stage of nursing. As with other intramuscular injections, in patients with thrombocytopenia and/or other coagulation disorders and/or those receiving anticoagulant treatment, Prevenar 13 vaccination should be administered with caution, provided that the patient's condition is stabilized and hemostasis is controlled. Subcutaneous administration of the Prevenar13 vaccine to this group of patients is possible. Prevenar 13 does not provide prevention of diseases caused by pneumococci of other serotypes, the antigens of which are not included in this vaccine. There is evidence that the predecessor of the Prevenar 13 vaccine, the seven-valent Prevenar vaccine, causes an adequate immune response in children 8 to 6 months of age with sickle cell anemia, the safety profile of the Prevenar vaccine in them is similar to the safety profile in vaccinated people not belonging to high-risk groups. High-risk children under 2 years of age should receive an age-appropriate primary vaccination with Prevenar 13. In patients with impaired immunoreactivity, vaccination may be accompanied by a reduced level of antibody formation.

Application of Prevenar 13 and PPV23

To form immune memory, it is preferable to start immunization against pneumococcal infection with the Prevenar 13 vaccine. The need for revaccination has not been determined. For individuals at high risk, PPV23 may be subsequently recommended to expand serotype coverage.

There are data from clinical studies of PPV23 vaccination after 1 year, as well as 3.5-4 years after the Prevenar 13 vaccine. With 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 disease, asplenia, HIV infection, chronic disease, or immune dysfunction), PPV23 is administered at least 8 weeks apart. In turn, patients at high risk of pneumococcal disease (patients with sickle cell disease or HIV infection), including patients previously vaccinated with one or more doses of PPV23, can receive at least one dose of Prevenar 13 vaccine.

The decision on the interval between administrations of PPV23 and Prevenar 13 should be made in accordance with official recommendations. In some 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 50 years of age and patients in risk groups, and the PCV13 vaccine is administered first, with possible subsequent revaccination with PPV23 at an interval of at least 8 weeks.

Prevenar 13 contains less than 1 mmol sodium (23 mg) per dose, meaning it is virtually sodium-free.

Within the specified shelf life, Prevenar 13 remains stable for 4 days at temperatures up to 25C. At the end of this period, the drug should either be used immediately or returned to the refrigerator. These data do not constitute instructions for storage and transportation 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 transportation.

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

There is no information on the effect of the drug on the ability to drive a car and use equipment.

Reviews of Prevenar

It should be noted that the Prevenar vaccine, reviews of which are found in large numbers on various forums, causes a lot of controversy and doubt. Of course, for many parents such prevention seems very attractive, but some of them are completely unsure of its effectiveness. Moreover, users often consider such vaccinations to be the cause of side effects and even mortality among children.

You can also find reviews from doctors about Prevenar online. Experts have very different opinions about this vaccine. While some describe positive results of vaccination, others point to certain facts, for example, that the drug does not contain serotypes 1 and 5, which mainly cause pneumococcal infections. In addition, it is reported that this vaccine is temporarily banned in some countries, such as the Netherlands.

Users often say that private clinics persuade them to undergo vaccination. At the same time, there are sometimes reports of the development of side effects in the form of increased body temperature. Basically, reviews of Prevenar 13 contain information that vaccination is successful, without the development of undesirable manifestations. Parents say that they strictly followed all the doctors’ recommendations and always maintained the established interval between vaccinations. After this, children get sick less, and they calmly attend kindergarten and other public places.

RELEASE FORM

Suspension for intramuscular administration 0.5 ml/dose.

Equipment

0.5 ml in a 1 ml syringe made of transparent, colorless glass (type 1). 1 syringe and 1 sterile needle in a plastic package sealed with plastic film. 1 plastic package together with instructions for use in a cardboard box;
5 syringes in a plastic package, sealed with plastic film;
2 plastic packages and 10 sterile needles along with instructions for use in a cardboard box;
When packaged at NPO Petrovax Pharm LLC: 0.5 ml in a 1 ml syringe made of transparent colorless glass (type 1). 1 syringe and 1 sterile needle in a plastic package sealed with plastic film. 1 plastic package together with instructions for use in a cardboard box.

MANUFACTURER

Wyeth Pharmaceuticals Division of Wyeth Holdings Corporation, USA 401 North Middletown Road, Purple River, New York 10965, SSD;
Baxter Pharmaceutical Solutions LLC, USA 927 South Curry Nike, Bloomington, IN 47403, USA;
Pfizer Ireland Pharmaceuticals, Ireland Grange Castle Business Park, Clondalkin, Dublin 22. Ireland;
LLC "NPO Petrovax Pharm", Russian Federation 142143, Moscow region, Podolsky district, village. Pokrov, st. Sosnovaya, 1;
Packaged by: Wyeth Pharmaceuticals, United Kingdom New Lane, Havant, Hampshire, P09 2NG, United Kingdom or NPO Petrovax Pharm LLC, Russian Federation 142143, Moscow region, Podolsk district, p. Pokrov, st. Sosnovaya, 1

CLAIMS

Consumer complaints should be sent to:

Representative office of Pfizer H Corporation. Si. Pi. Corporation, 123317 Moscow, Presnenskaya embankment, 10, Business Center "Tower on Naberezhnaya" (Block C) Phone: +7 (495) 287-5000, fax: +7 (495) 287-5300;
LLC "NPO Petrovax Pharm", Russian Federation 142143, Moscow region, Podolsky district, village. Pokrov, st. Sosnovaya, 1 Tel./fax: +7 (495) 926-2107, e-mail;
Federal Service for Surveillance in Healthcare (Roszdravnadzor): 109074, Moscow, Slavyanskaya Square, 4, building 1 Tel.: +7 (495) 698-4538; +7 (499) 578-0230.