Prevenar 13 complications. Mode restrictions

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

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

Features of the Prevenar 13 vaccine

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

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

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

The vaccine contains the following components:

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

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

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

Who should get vaccinated?

Pneumococcal infections contribute to the occurrence of diseases such as pneumonia. Bronchitis, otitis media and many others. Resistance to the composition of the drug in pneumococcal microorganisms is only increasing every year. Experts are not consoled by guesses that in just a few decades there will be no opportunity to overcome pneumococcal microorganisms. If such drugs are produced (to destroy pneumococcus), they will not be available to all segments of the population.

It is important to know! Vaccination is one of the most effective and alternative ways to reduce the number of people suffering from pneumococcal diseases. The danger of this type of bacterium is that it contributes to the development of serious complications leading to death.

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

In addition to the fact that the above categories of people have a tendency to develop pneumococcus, bacterial infections will occur in severe forms. If measures to improve the patient’s health are not taken in a timely manner, death will ultimately occur.

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

What does the vaccination schedule look like?

The instructions for use of the vaccine provide several options for dosage regimens. The following factors play a major role in these options:

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

There are some differences between each type of vaccination regimen. Let's look at these schemes in more detail.

1. For babies from 2 to 6 months, it is recommended to undergo vaccination according to the following scheme: vaccination is done three times, the interval between vaccinations should be at least 4 weeks. If it is impossible to come for the next vaccination, you can do it twice, but with an interval of at least 8 months.
2. If parents decide to vaccinate their baby at 7-11 months of life, the following scheme is carried out: immunization is performed twice, but with a pause of 4 weeks. You will need to undergo a one-time revaccination, which is carried out at the age of 2 years.
3. At the age of 1 to 2 years, immunization is carried out 2 times. Repeated vaccination is carried out 8 months after the first.
4. From 2 years of age, vaccination is done only once. There is no need for revaccination. In the future, revaccination can be carried out once a year without age restrictions.

It is important to know! If the child’s first vaccination was given with Prevenar, which protects the body only from 7 types of pneumococcal bacteria, then repeated immunization can be performed with Prevenar 13.

How to give the Prevenar 13 injection correctly

The drug is produced in the form of a suspension, which is placed in a disposable syringe tube. Externally, such a vaccine should look like a clear liquid, so if there is any cloudiness, its use should be excluded.

It is important to know! Before giving the injection, the vaccine in the syringe must be shaken. The inside of the syringe should have a uniform consistency without impurities.

Previnar belongs to the category of those drugs that cannot be frozen. If you notice that a medical professional is taking a medication out of the freezer, then the medication is unsuitable for use.

The instructions for use of the drug provide for intramuscular administration of the drug only. It is important to read the instructions to find out where it is best to administer the drug.

• For children under two years of age, it is recommended to inject the medication into the thigh. This is done with the aim of being able to apply a tourniquet in case of possible complications.
• For children over 2 years of age, the vaccine must be administered in the shoulder area. Usually this is the deltoid muscle, but each medical institution has its own rules.

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

How the body reacts to the Prevenar 13 vaccine

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

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

It is important to know! To ensure that reactions disappear as quickly as possible after the vaccine is administered, it is recommended to make an iodine mesh. Typically, the pain at the injection site goes away within the next day.

What complications may arise

If adverse symptoms do not disappear for more than 1 day after vaccination, you should inform your doctor. The occurrence of adverse reactions and complications does not always depend on the quality of the medication itself. Very often, the rules for storing the drug may be violated, the expiration date is not controlled, and low-quality antiseptic drugs are used. After vaccination, the following complications may develop:

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

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

It is important to know! Typically, 1-2 days before vaccination, health workers notify about the need to take antiallergic medications.

Presence of contraindications to Prevenar 13 vaccination

Vaccination with Prevenar is carried out for preventive purposes to prevent the development of diseases caused by pneumococcus. The vaccine is tolerated quite well, especially considering the early age of the infants. This drug has some contraindications, in the presence of which it is better to exclude the medication in order to avoid undesirable consequences and complications. These contraindications include:

• Pregnancy and lactation period. Women are not recommended to get the vaccine as the reaction to the fetus has not been studied, so the consequences may be unpredictable.
• It is prohibited to vaccinate if the previous vaccine caused allergic symptoms.
• You cannot administer the drug if you have hypersensitivity to at least one component of the vaccine.
• During vaccination, the patient must be healthy, therefore, if chronic or acute diseases worsen, vaccination will need to be postponed.

It is recommended to vaccinate children in the age group from 2 months to 5 years. If a person was not vaccinated as a child, he can get vaccinated at any age, especially if he is at risk of developing bacterial diseases.

It is important to know! Patients should independently warn health workers involved in immunization of the population about the presence of contraindications.

When carrying out vaccination, it is important to know some recommendations. These recommendations include:

1. Before immunization, as well as immediately after the vaccine is administered, it is recommended to avoid close contact with sick people. After the vaccine is administered, a decrease in immunity is observed, so a patient known to be infected with viral or infectious diseases may experience complicated symptoms after vaccination.
2. After immunization has been completed, you can try introducing new types of complementary foods to your baby no earlier than a few weeks later. Most often, an allergy after immunization may occur to additives and complementary foods introduced into the diet, and not to the drug.
3. It is recommended to vaccinate on the eve of the weekend, which will avoid unwanted contact with sick people the next day.
4. After administration of the drug, it is recommended to remain on the hospital premises for 0.5-1 hour. This is necessary in order to be able to provide emergency assistance to the patient if side effects or complications occur.
5. You can wet the injection site, but it is recommended to do this in the shower, that is, with running water, and not in the bathroom, where infection can occur. If possible, it is better not to wet the injection site during the day.
6. After vaccination, you can go for walks with your child. At the same time, it is important that such walks take place in the fresh air, but not in cafeterias, shops and other establishments with large crowds of people. The probability of contracting a virus or infection in such places is 90%.

What questions often arise during vaccination?

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

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

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

Useful information about vaccination

In conclusion, it is worth noting some useful facts about the use of the drug “Previnar 13” for pneumococcal infections.

1. The dosage of the medication is strictly excluded, since the product is supplied in special disposable syringes of a certain dosage.
2. If the patient has signs of blood clotting, the vaccine should be administered under the supervision of a physician. For such patients, a decision may be made to administer the drug subcutaneously.
3. If the child was born premature, then you can think about using the medication no earlier than after 2 months.
4. Experts say that the Prevenar vaccine is quite well tolerated when used in combination with other medications.

In conclusion, it should be noted that Prevenar number 13 is the only way to save humanity from the occurrence of ailments provoked by bacterial microorganisms, in particular pneumococcus. Vaccination of babies from the first months of their life allows for reliable protection of the body from many bacterial diseases from an early age.

Hello!

A little background. From an early age, my son often gets sick. At 8 months old I was admitted to the hospital with bronchitis, and off we go... It got worse, because from the age of 2 I sent my child to kindergarten, and my son turned from being frequently ill to constantly ill...

Bronchitis, tonsillitis, sinusitis became our constant companions... And then also food allergies, hay fever, “thanks to” which any snot necessarily led to complications.

At 3 years old, after a month of coughing, we were admitted to the hospital for examination. By the way, we didn’t have a pediatrician and I had to curse her into hospitalization so that they could at least find out the cause of such a long-term illness. She said until recently that there was no wheezing. Only after I showed her the appointment sheet from the pediatric pulmonologist, who diagnosed us with bronchitis, did she give up. (Two months after discharge, I abandoned this unfortunate doctor.)

At the hospital we had a picture taken. The diagnosis - obstructive bronchitis - was confirmed. They prescribed me to take antibiotics, and after 7 days they started injecting me with others. Cured.

When the attending physician was preparing our discharge, she advised me to vaccinate my son with Prevenar-13 or Pneumo-23 so that it would protect the body from complications. At that time, I did not understand either vaccinations or medications. Her arguments were convincing, and when I visited my pediatrician after discharge, I told her about the doctor’s recommendation from the children’s hospital.

Our doctor (to be honest, it’s hard to call her a doctor) reacted to this as a call to action and sent us to the vaccination room. To my hesitant objections - “Maybe later?”, she answered - “What are you waiting for? Until you catch something else?”

Now, before giving a child any medicine, or even a vitamin (and there is nothing to say about vaccinations), I study the issue very carefully. I listen to the opinions of several pediatricians and specialists, weighing all the pros and cons. And at that time I was a leader in these matters, which I now very much regret..

My son was vaccinated. There was slight redness at the injection site, the child did not complain about anything.

A day after vaccination, the NIGHTMARE began! My son had a fever of 39.5, a red throat, a cough. The temperature was not brought down by either Nurofen or paracetamol. Only an injection given by emergency doctors helped improve the situation.

The doctor who came to the house (our pediatrician went on vacation) said with confidence that it was from the vaccine. She was shocked that we were allowed to do it only a few days after recovery. She was diagnosed with acute tracheitis.

A few more days later, when the temperature subsided, we went to see an ENT doctor. The diagnosis is acute bilateral catarrhal otitis media. And again antibiotics...

I hated our pediatrician for sending us for this vaccine. I hated myself for listening to her and being so irresponsible about my son’s health. But now, when two years have passed since my son was vaccinated against pneumococcal infection, I can confidently say that I do not regret that we did it. My only regret is that I didn’t give up on the would-be pediatrician sooner. I am sure that my son’s healthy and strengthened body would have responded more easily to this vaccine; he simply did not have enough time to recuperate..

Over the past two years, my son suffered from bronchitis twice (both times in the spring, the culprit was hay fever), the temperature did not rise above 38.3. (and this is much easier to tolerate than 39-plus, both by mother and child), there were no painful sore throats or otitis media.

Conjugate vaccines against pneumococcus (Prevenar 13 and Synflorix are registered in the Russian Federation) have been used in pediatric practice to prevent diseases caused by this pathogen since the early 2000s. These vaccines were invented in developed countries, and for many years they were used only there, they were tested in many studies (they “conducted experiments” on their children), then they were registered in the Russian Federation and became available in private centers in our country, for a fee, and only then , in 2014, were included in the national vaccination calendar of the Russian Federation (“free”, more precisely at the expense of compulsory health insurance).

COMPOSITION OF PREVENAR 13

THE SCHEDULE OF VACCINE ADMINISTRATION DEPENDS ON THE AGE OF THE CHILD:

1. From two to six months, the vaccine is administered according to the following scheme: three doses of the vaccine with an interval of at least four weeks between them. If there is a need to leave for a long time, then the vaccination can be done only twice, but there must be a gap of at least 8 months between the first and second vaccinations. Revaccination with Prevenar 13 in the first and second cases is done between 11 and 15 months.
2. If parents decide to vaccinate their child from 7 to 11 months, the administration regimen for Prevenar 13 changes slightly. Immunization is carried out twice with a slight interval of 4 weeks. Revaccination is done once every two years.
3. After 12 months and up to 23 months inclusive, the vaccine is given only twice. The second time it is done no earlier than 8 weeks after the first injection.
4. Starting from the age of two, the vaccine is given only once. There is no need for revaccination. This is the most convenient Prevenar 13 vaccination regimen, especially for those traveling abroad or for children who will soon go to kindergarten or school. The age of a person for vaccination is unlimited.

In addition to the conjugate pneumococcal vaccine Prevenar13, there is also a polysaccharide pneumococcal vaccine Pneumo-23

DIFFERENCE OF PREVENAR 13 FROM PNEUMO-23

I have often heard that mothers prefer the Pneumo-23 vaccine rather than Prevenar13 for pneumococcal infections, for these reasons:

• it is installed once
• introduced no earlier than two years
• costs less
• MAIN - protects against 23 types of pneumococcus (Prevenar - from 13)

But I adhere to the opinion of one experienced pediatrician that more does not mean better:

It should be understood that the quality of the immune response to conjugate vaccines is much higher, and the duration of the immune response is longer (5-7 years for conjugate vaccines, 3-5 years for polysaccharide ones). Therefore, and also because conjugate vaccines can be administered from 2 months of life, conjugate vaccines are considered the main method of vaccination against pneumococcus in pediatrics, and if polysaccharide vaccines are considered, it is only as an addition to conjugate vaccines, that is, they are recommended to be administered AFTER conjugate vaccines, and only in some children at particularly high risk. In addition, different strains of pneumococcus have different aggressiveness, and Prevenar 13 includes the most aggressive strains, and Pneumo 23 includes both aggressive and relatively “harmless” strains. Therefore, the number of strains in itself is not an indicator of quality; the principle “the more the better” does not apply here.

If you decide to vaccinate your child against pneumococcus, please do it ONLY FOR COMPLETELY HEALTHY CHILDREN! Take the OBC and OAM to make sure of this. And after vaccination, also protect children from possible infection with viruses for about two weeks, because the immune response does not occur immediately after vaccinations. And before doing this, be sure to consult with doctors in different fields - pediatricians, immunologists. After all, what is good for one child may be absolutely contraindicated for another.

You can read my review of the Sovigripp flu vaccine, which is being given free of charge in clinics this year

You can read my review of the VAXIGRIP vaccination and how the last epidemiological season went after it.

Health to you and your children.

Are vaccinations necessary? I, like many mothers, am concerned about the health of my child, and I approach the issue of vaccination very seriously. When my child was invited to the clinic for vaccination, I had a question: should I get a pneumococcal vaccination and what negative consequences might there be?

This vaccination is relatively new for our country; just a few years ago it was included in the mandatory vaccination calendar. Before this, it could be done at a medical facility for a fee. centers

After talking with a pediatrician and surfing the Internet, I collected some information about Prevenar 13 which I will share with you.

The Prevenar vaccine, it can be called differently - pneumococcal, is a vaccine for the prevention of pneumococcal infections (pneumonia, otitis, meningitis caused by pneumococcus)

The vaccine is called Prevenar 13 because it contains 13 serotypes of antigens, respectively, Prevenar 7 has seven serotypes, Prevenar 23 has 23 serotypes.

Prevenar vaccination schedule

There are several Prevenar vaccination regimens; they differ in the number of vaccinations for children of different ages.

The longest and most complex vaccination schedule for children starting to be vaccinated from 2-6 months. It includes 4 injections of the drug. The first three doses (vaccination) are given at least one month apart. The fourth (revaccination) once every 11-15 months.

The complexity of this scheme is that at this age there are quite a few other vaccinations, for example, a rather complex DPT, and when vaccinating according to this vaccination schedule, you will have to combine Prevanar + DPT, Prevenar-hepatitis, the load on the child’s immune system will increase and it may be more difficult for him to tolerate them.

If you start vaccinating a child aged 7-11 months, then you will need to get three vaccinations of the drug, the first two doses with an interval of at least a month between injections. Revaccination once.

Vaccination after one to two years, contains two doses, two months apart

And finally, if you get vaccinated after two years, then the vaccination is given once.

Prevenar 13 is combined with any vaccines included in the vaccination schedule for children in the first two years of life.

Prevenar is administered intramuscularly, for children exclusively in the thigh, for children over two years old in the shoulder, The drug cannot be injected into the buttock .

Prevenar contraindications Do not get vaccinated during periods of various colds and exacerbations of chronic diseases. This vaccination is also not given if the child has difficulty with diphtheria toxoid (DTP).

Prevenar vaccination side effects

no matter what pediatricians say, that Prevenar is very easily tolerated, this is a little wrong; like all vaccinations, it has side effects

Temperature increase

Pain, swelling at the injection site

Sleep disturbance, tearfulness, irritability

Muscle pain

To minimize side effects, you need to prepare for vaccination, especially if your child is allergic. Within two days before vaccination, you need to give your child an antiallergic drug (Fenistil, Zyrtec, Suprastin) in the morning and evening, and on the day of vaccination, the day before.

Vaccination experience

My child was vaccinated with Prevenar 13 at the clinic; the vaccine was produced in Ireland and packaged in Russia by NPO Petrovax Pharm.

The full name of the vaccine is: pneumococcal polysaccharide vaccine, conjugated, adsorbed, thirteen-valent

The vaccine package contains a syringe with a pre-dose of the drug. This is very remarkable because it completely eliminates the mistaken administration of a larger dose of the drug.

They vaccinated once, I waited until the child was two years old.

My daughter tolerated the vaccination well (before the vaccination I gave her Zodak). Prevenar was administered in the afternoon and before bed the child complained that his leg hurt, but at the injection site everything was calm. Well, I was excited, a little more than usual, and slept and tossed and turned.

The Prevenar vaccination is needed to protect a small child from pneumonia and otitis media. Using my child as an example, I can say that we got vaccinated in February and now, ugh, ugh, she hasn’t suffered from otitis media during this time, and before the vaccination she got a little cold, and she’s always complaining about her ears.

I did not regret agreeing to the Prevenar vaccination.

I will be glad if the information I collected will help you decide whether Prevenar is worth taking and whether this vaccination is necessary.

Thanks to everyone who read my review.

Pneumococcal infection involves infection and development of the disease due to the microbe Streptococcus pneumoniae. The name of the pathogen comes from the most common disease it causes - pneumonia. However, pneumococcus often causes not only pneumonia, but also some other, no less serious diagnoses. Bacterial infection, or activation of saprophytic forms of streptococcus can lead to otitis, sinusitis, meningitis, endo- and pericarditis, arthritis, and pleurisy. Pneumococcus plays a significant role in the structure of morbidity in young children, sometimes causing deaths.

In the vast majority of cases, pneumococcal infection is secondary - it occurs as a complication of another infectious disease. Often occurs against the background of influenza, measles and other acute respiratory viral infections (ARVI).

Of the 10 pneumonia diseases in childhood, 9 are of pneumococcal etiology. Half of the cases of acute otitis in children are also pneumococcal infections. The disease occurs with complications and threatens not only the child’s health, but also his life. It is impossible to avoid infection using standard measures to prevent bacterial diseases. The source of infection can be a patient or a carrier of pneumococci. The route of infection is airborne or contact. There are many conditions conducive to infection: close contacts in crowded groups, the cold season, weakening of the body’s defenses due to a previous infection, and others. Vaccination remains the only way to prevent the disease.

Mechanism of action of the vaccine and indications

The Prevenar13 vaccine is a one-of-a-kind drug that has no analogues. The immune response is formed after the first stage of vaccination. And revaccination allows you to consolidate the result and achieve the creation of lasting immunity to pneumococcus.

In addition to children, vaccination is recommended for certain categories of the adult population - patients with chronic somatic diseases, patients with immunodeficiency conditions, and older patients. That is, patients who have a high risk of developing complications from any infectious disease.

Features of application

Vaccination with Prevenar13 begins at 2 months of age and involves 3 stages of vaccine administration with an interval of 1 month; in the second year of life, a single revaccination is performed.

If you deviate from the specified schedule, the vaccination plan is formed individually and depends on the age at which the vaccine was started.

The following vaccination schedules exist:

• vaccination started after 7 months: two stages of vaccination with an interval of 1 month; single revaccination in the second year of life;
• vaccination started after 12 months: one stage of vaccination and one stage of revaccination with an interval of 2 months;
• vaccination started after 24 months: one stage of vaccination; revaccination is not required.

Advantages and application experience

Clear advantages include the fact that this is the only vaccine that allows immunization of children under one year of age. Researchers note the effect of collective immunization - when a certain number of children are vaccinated, the total number of cases of the disease in a population in a limited area decreases. This means that the risks for those who have not received the vaccine are also reduced. The vaccine allows you to develop immunity to several serotypes of an infectious agent at once.

Prevenar13 is used in 90 countries. In Russia, this drug is included in the National Calendar of Preventive Vaccinations, which means that the vaccine is approved by the Ministry of Health, and some categories of the population can be given an injection under compulsory medical insurance. There is extensive world experience in using the vaccine, indicating isolated cases of side effects and high safety.

As for the combined administration of the Prevenar13 vaccine, it is allowed with any of the vaccines of the National Preventive Vaccination Calendar with the exception of BCG-M.

Children's vaccination rules

• It is necessary to avoid contact with infectious patients for several days before and after vaccination. It must be remembered that for some diseases the incubation period can last up to a week. Otherwise, the development of symptoms may coincide with the day of injection.
• It is not recommended to try new foods or come into contact with known allergens before or after vaccination.

There are no restrictions on walks and entertainment with your child. It is worth refraining from communicating with peers during ARVI epidemics. If there are chronic diseases, before vaccination an additional consultation with a pediatrician is necessary, who will be able to assess the risks and decide on the possibility of vaccination.

Manufacturer: Pfizer USA

PBX code: J07AL02

Farm group:

Release form: Liquid dosage forms. Suspension for injection.

General characteristics. Compound:

Active ingredients: Pneumococcal conjugates (polysaccharide - CRM197): 2.2 µg 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 oligosaccharide serotype 18C, 2.2 μg polysaccharide serotype 19A, 2 .2 µg polysaccharide serotype 19F, 2.2 µg polysaccharide serotype 23F, ~32 µg carrier protein CRM197.

Excipients: aluminum phosphate (in terms of aluminum), sodium chloride, succinic acid, polysorbate 80, water for injection.

Pharmacological properties:

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, 9V, 14, 18C, 19A, 19F and included in the vaccine 23F pneumococcal serotypes.

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 ³ 0.35 μg/ml; geometric mean concentrations (GMC) of immunoglobulins and opsonophagocytic activity (OPA) of bactericidal antibodies (GMA titer ³ 1:8 and geometric mean titers (GMT)). For adults, the protective level of antipneumococcal antibodies has not been determined and a serotype-specific SPA (SST) is used.

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

Immune response using three or two doses in a 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 serotypes of the vaccine was observed.

After the administration of two doses during the primary vaccination of Prevenar® 13, 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 ³ 0.35 μg/ml was determined in a smaller percentage of children. At the same time, a pronounced booster response to revaccination was noted for all serotypes. The formation of immune memory is 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 babies (born at gestational age<37 недель), включая глубоко-недоношенных детей (родившихся при сроке гестации <28 недель), начиная с возраста двух месяцев, отмечено, что уровень защитных специфических противопневмококковых антител и их ОФА после законченного курса вакцинации достигали значений выше защитных у 87-100 % привитых ко всем тринадцати включенным в вакцину серотипам.

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

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

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

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

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

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

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

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

Immunogenicity of the Prevenar® 13 vaccine in adults.Clinical studies of Prevenar® 13 provide immunogenicity data in adults aged 18 years and older, including persons aged 65 years and older and those previously vaccinated with one or more doses of polysaccharide pneumococcal 23-valent vaccine (PPV23) within 5 years prior to enrollment into the study. Each study included healthy adults and immunocompetent patients with chronic diseases in the compensation stage, including concomitant pathologies that form an increased susceptibility to pneumococcal infection (chronic cardiovascular diseases, chronic lung diseases, including asthma; and chronic diseases, including alcoholic lesions), and adults with social risk factors - smoking and alcohol abuse. The immunogenicity and safety of Prevenar® 13 has been demonstrated in adults aged 18 years and older, including patients previously vaccinated with PPV23. Immunological equivalence was established 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. In adults aged 18-59 years, opsonophagocytic activity FHT (OPA FHT) to all Prevenar® 13 serotypes were not lower than those in adults aged 60-64 years. Moreover, individuals aged 50–59 years had a statistically higher immune response to 9 of 13 serotypes compared to individuals aged 60–64 years.

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

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® 13 administration demonstrated immunological equivalence for 12 common serotypes compared with the response to PPV23, with an immune response to Prevenar® 13 for 10 common serotypes and serotype 6A. was statistically significantly higher compared to the response to PPV23. Prevenar® 13 gives a more pronounced immune response compared to revaccination with PPV23.

Immune response in special groups of patients.Patients with the conditions described below are at increased risk of pneumococcal infection.

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

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

Hematopoietic stem cell transplantation.Children and adults who underwent allogeneic hematopoietic stem cell transplantation (HSCT), aged ≥ 2 years with complete hematological remission of the underlying disease or with satisfactory partial remission in the case of 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.

Indications for use:

Prevention of pneumococcal infections, including invasive (including bacteremia, 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 onwards without age restrictions:

As part of the national calendar of preventive vaccinations;

In individuals at increased risk of developing pneumococcal infection.

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

Directions for use and dosage:

Method of administration. The vaccine is administered in a single dose of 0.5 ml intramuscularly. For children of the first years of life, vaccinations are carried out in the upper-outer surface of the middle third of the thigh, for persons over 2 years old - in 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.

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

If Prevenar ® 13 vaccination has begun, 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, additional doses of Prevenar ® 13 are not required.

Vaccination scheme

Age at which vaccination began	Vaccination scheme	Intervals and dosage
2 -6 months	or	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 every 11-15 months. Mass immunization of children: 2 doses with an interval of at least 8 weeks between administrations. Revaccination once every 11-15 months.
7-11 months		2 doses with an interval of at least 4 weeks between administrations. Revaccination once in the second year of life
12-23 months		2 doses with an interval of at least 8 weeks between administrations
2 years and older		One time

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

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

Special groups of patients. In patients after hematopoietic stem cell transplantation, a series of immunizations 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.

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

Features of application:

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

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 baby (born at term< 37 недель беременности), особенно имеющего в анамнезе незрелость дыхательной системы, необходимо учесть, что польза иммунизации против пневмококковой инфекции у данной группы пациентов особенно высока и не следует ни отказываться от вакцинации, ни переносить ее сроки. В связи с потенциальным риском апноэ, имеющимся при применении любых вакцин, первая вакцинация Превенар® 13 недоношенного ребенка возможна под врачебным наблюдением (не менее 48 ч) в стационаре на втором этапе выхаживания.

As with other intramuscular injections, in patients with thrombocytopenia and/or other coagulation disorders and/or in the case of treatment with anticoagulants, Prevenar® 13 vaccination should be administered with caution, provided that the patient's condition is stabilized and hemostasis is controlled. Subcutaneous administration of the Prevenar® 13 vaccine to this group of patients is possible.

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

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 develop 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 vaccine 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, i.e. it contains virtually no sodium.

Within the specified shelf life, Prevenar® 13 remains stable for 4 days at temperatures up to 25 °C. At the end of this period, the drug should either be used immediately or returned to the refrigerator. These data 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.Prevenar® 13 has no or negligible effect on the ability to drive a car and use equipment. However, some reactions listed in the “Side Effects” section may temporarily affect the ability to drive a vehicle and operate potentially dangerous machinery.

Side effects:

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 (at term< 37 недель гестации). Во всех исследованиях Превенар® 13 применялся одновременно с другими вакцинами, рекомендованными для данного возраста.

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 were injection site reactions, fever, irritability, 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.

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

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 to 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 hematopoietic stem cell transplant patients, 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 transplant patients. 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, and , 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), нечастые (≥ 1/1000, но < 1/100), редкие (≥ 1/10000, но < 1/1000) и очень редкие (≤ 1/10000).

Adverse reactions identified in clinical studies of Prevenar® 13

Very common: hyperthermia; irritability; skin redness, pain, thickening or swelling measuring 2.5-7.0 cm at the injection site (after revaccination and/or in children aged 2-5 years); (in patients aged 18 - 49 years), drowsiness, sleep deterioration, loss of appetite, generalized new or exacerbation of existing joint and muscle pain, bronchospasm, Quincke's edema of various localizations, including facial swelling**, anaphylactic/anaphylactoid reaction, including shock **, lymphadenopathy in the area of ​​the injection site.

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

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

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

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.

Interaction with other drugs:

There is no data on the interchangeability of Prevenar® 13 with other pneumococcal conjugate vaccines. When immunizing with Prevenar® 13 and other vaccines at the same time, injections are made into 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 children in the first years of life, with the exception of BCG. Simultaneous administration of the Prevenar® 13 vaccine with any of the following antigens included in both monovalent and combined vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, polio, hepatitis A, hepatitis B, measles, mumps, rubella , chickenpox and rotavirus infection - does not affect the immunogenicity of these vaccines. Due to the higher risk of 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 Infanrix-hexa were used together, the frequency of febrile reactions coincided with that for the combined use of Prevenar® (PCV7) and Infanrix-hexa. An increased incidence of reported seizures (with and without fever) and hypotensive-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.

Post-marketing data from a post-marketing study of prophylactic antipyretics on the immune response to Prevenar® 13 vaccine suggest that prophylactic administration of acetaminophen (paracetamol) may reduce the immune response to the primary Prevenar® 13 vaccination series. Immune response to Prevenar® 13 booster vaccination at 12 months at the prophylactic use of paracetamol does not change. The clinical significance of these data is unknown.

Children and adolescents aged 6 - 17 years.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.

Persons aged 18-49 years.There are no data on the simultaneous use of Prevenar 13 with other vaccines.

Persons 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 vaccine were similar to those obtained with DVT vaccine 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:

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

Overdose:

An overdose of Prevenar® 13 is unlikely because the vaccine is dispensed in a syringe containing only one dose.

Storage conditions:

At temperatures from 2 to 8 °C. Do not freeze. Keep out of the reach of children. Transport at temperatures between 2 °C - 25 °C. Do not freeze. Transportation at temperatures above 2-8 °C is allowed for no more than five days. Shelf life - 3 years. Do not use after the expiration date stated on the package.

Vacation conditions:

On prescription

Package:

Suspension for intramuscular administration 0.5 ml/dose.0.5 ml per 1 ml syringe made of transparent, colorless glass (type I).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 packaging at NPO Petrovax Pharm LLC: pabout 0.5 ml in a 1 ml syringe made of transparent, colorless glass (type I).1 syringe and 1 sterile needle in a plastic package sealed with plastic film. 1 plastic package together with instructions for use in a cardboard box.