In 2014, a new Pneumococcal vaccination appeared in the National Calendar of the Russian Federation. It protects the human body from the disease caused by Streptococcus.
Vaccination against infection Is not only prevention, but also protection against complications. Vaccination makes it easier to tolerate any kind of ailment that affects the respiratory tract. It reduces the risk of chronic ailments.
At the beginning of the 20th century, the term "pneumococcal infection" appeared in medical practice. Various dangerous diseases are hidden under this name. All of them develop due to the ingestion of pneumococci. The most serious diseases provoked by infection are acute otitis media, arthritis, pneumonia, pleurisy.
Among this list there are ailments that lead to the death of the patient, and some of them can make a person disabled.
Pneumococci- these are microorganisms related to pathogenic elements. The habitat is the respiratory tract.
Doctors find them when examining the nasopharynx in babies. But they are not dangerous as long as the immune system is protected. These microorganisms attack a person when the immune system is weakened. For example, this situation occurs when a baby has suffered some kind of illness.
According to statistics, it is this infection that is considered the cause of death of children.
Babies from 6 months to 2 years old are extremely susceptible to infection. Until six months, the disease does not develop, since there are still specific antibodies in the blood that he received from his mother at birth.
The main symptoms of the disease are a sharp increase in body temperature up to 40 degrees. In addition, shortness of breath, severe cough, nasopharyngeal congestion appear. Older children complain of sore throat. Without proper treatment, the virus spreads to the lungs, brain and sinuses.
Treatment of meningococcal infection is complicated by the fact that the virus is not sensitive to most drugs. Even with a well-designed treatment plan, doctors cannot always save a patient. For this reason, they advise parents to get vaccinated.
Pneumococcus can be infected from sick people, and carriers of this virus. The bacteria carriers themselves are quite healthy, but along with sneezing they transmit harmful bacteria that live in the nasopharynx. The infection does not enter their respiratory tract, since there is a barrier organ. And its reproduction is prevented by the mucous membrane, secretion. However, due to the weakening of the immune system, the disease affects its carrier.
Vaccination against pneumococcal infection
In Russia, during vaccination, physicians can use two drugs - Prevenar 13 and Pnevmo 23. The first is seven-valent and is produced by American pharmacists. In its composition, the drug does not have live bacteria pneumoniae, it contains its polysaccharides. The drug contains 13 particles of pneumococcus.
In addition, the composition contains a diphtheria protein, which allows the drug to be in the body for a significant period. And aluminum hydroxide, keeping the injection fluid in one position.
Pneumo 23 was developed by physicians from France. From the name it is clear that the drug fights 23 types of infection serotypes at once. The composition contains inanimate bacteria, phenol, water, phosphate.
This is due to the fact that there are many microorganisms in the composition. And the baby is not able to cope with so many harmful bacteria. Pneumococcal vaccine Pneumo 23 is intended for adults.
Parents can protect their baby from infection by getting the vaccine. There are no other ways to protect yourself from the disease. During vaccination, non-viable pathogens enter the bloodstream. And the body begins to gradually respond to new bacteria. There is a release of a high leukocyte count. They are the ones who fight against harmful viruses.
It is easier and faster for the human body to cope with non-living bacteria. In the future, he does not need to fight a strong virus, as immunity to the pathogen appears. Even in case of illness, the child will bring it easier. The blood will already have developed immunity and antibodies to the virus.
Vaccination against pneumococcal infection in children
Children are given an injection without fail, but in private institutions the price of the vaccine starts at 1200 rubles. The injection is injected intramuscularly. For children under two years old, an injection is given in the thigh, namely in the upper place outside. After the onset of two years of age, the vaccine is injected into the shoulder joint, into the deltoid muscle tissue.
If the first vaccination was given with Prevenar 13, then revaccination is also carried out with it. It is important that the medication is designed only for the child's body. And when vaccinating an adult is not used.
During the first series, the vaccine forms an immune response in the body. Indeed, according to the calendar, a baby from 2 months old needs three vaccinations with a difference of 45 days. This allows antibodies to be synthesized in the blood. After the revaccination, a secondary immunization is formed. Its effect lasts for life.
The dosage of the drug for one vaccination is 0.5 mg according to the instructions.
Vaccination against pneumococcal infection in adults
The microorganism Pneumococcus in adults is rare. But when infected, the course of the disease is much more complicated than that of babies. For this reason, doctors recommend pneumococcal vaccination for adults.
The disease provoked by pneumococcus is treatable with various drugs belonging to the antibacterial group. But in recent years, healthcare professionals have begun to notice that the virus has become less sensitive to current medications. And it takes doctors a considerable amount of time to select the right drug.
The only effective way to protect yourself from the disease is to administer the vaccine.
Pneumococcal vaccination for adults is done only once, using the drug Pnevmo 23. If a person is at risk, then it is necessary to be vaccinated every five years.
How to prepare for vaccination
Before vaccination, certain rules must be followed. On the day of vaccination, the patient should not show signs of a cold. For this reason, you must first pass blood and urine tests. When an adult knows about the presence of chronic diseases, then before giving a vaccine, they must be treated, before remission occurs.
Vaccination is required when the day of a healthy child is announced in the clinic. This is necessary in order to reduce the risk of contact with sick children. Signs of infection may appear only after a few days and give a complication to the reaction. It is important that vaccinations are given completely free of charge.
Vaccination schedule
The vaccine against pneumococcal infection can be combined with other forms of vaccination. Therefore, there is no exact timetable for the procedure, but it does not have BCG compatibility. The injection site is chosen by the doctor, since there are no strict restrictions.
Vaccination schedule:
- from 2 to 6 months - the drug is injected into the body three times;
- from 7 months up to 2 years - the vaccination is done twice, with an interval of 45 days;
- children from 2 years of age are vaccinated once.
The drug begins to act from the first minutes of ingestion.
Vaccination reaction
Children tolerate vaccination quite calmly, and there are no local reactions.
After vaccination, the patient can observe:
- decreased appetite;
- drowsiness;
- children often have moodiness;
- irritability;
- increased body temperature;
- induration or redness at the injection site;
- pain after the injection.
Most often, these reactions occur in a small number of patients. And this is due to the individual characteristics of the structure of the body. According to statistics, all side effects disappear within a day.
Contraindications
During vaccination, only high-quality drugs are used. Therefore, the vaccination can be done without fear for life and health. Due to the high-tech characteristics of medicines, there are no serious contraindications.
The main prohibition is the patient's individual intolerance to the components of medicines. At the time of vaccination, the person must be completely healthy. Pregnant women should refuse vaccination in the first three months of gestation. During the period of exacerbation of chronic diseases, vaccination is not carried out.
Possible complications
The vaccine has not only harmless side effects, but can also provoke the development of serious complications.
The most common negative consequences are:
- allergy-Quincke's edema, urticaria;
- convulsions;
- nausea;
- vomit;
- diarrhea;
- anaphylactic shock.
For any of the listed ailments, you should consult a doctor. Since the symptoms can lead to serious consequences.
The doctor will make a complete diagnosis and prescribe a competent treatment. In case of complications, re-vaccination is not carried out.
Doctor Komarovsky's opinion on pneumococcal vaccination
Harmful pneumococcal bacteria can provoke the development of the disease meningitis. This is a rather severe pathology that leads to coma, and subsequently to the death of the patient. At best, after recovery, neurological problems will appear.
In addition, pneumonia is dangerous for children under 2 years of age. They mainly affect the lungs and respiratory tract. And otitis media is extremely dangerous for a baby's hearing. But all this can be completely prevented if the child is vaccinated on time. Dr. Komarovsky believes the pneumococcal vaccine is safe.
Pneumo 23: instructions for use and reviews
Latin name: Pneumo 23
ATX code: J07AL02
Active substance: vaccine for the prevention of pneumococcal infections
Producer: Sanofi Pasteur (France)
Description and photo update: 26.10.2018
Pneumo 23 is a vaccine for the prevention of pneumococcal infection.
Release form and composition
Dosage form - solution for intramuscular and subcutaneous administration: clear, colorless liquid [1 dose (0.5 ml) in a 1 ml glass syringe with a chlorobromobutyl plunger and a fixed needle closed with a protective cap; each syringe is placed in a closed cell package (blister), 1 package in a cardboard box].
Composition of 1 dose of the vaccine:
- active substances: purified capsular polysaccharides of Streptococcus pneumoniae 23 serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20 , 22F, 23F, 33F - 0.025 mg each;
- additional components: sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injection, phenol (preservative).
Pharmacological properties
Pharmacodynamics
The active ingredient of the drug is purified polysaccharides of 23 serotypes of Streptococcus pneumoniae pneumococcus, which is at least 90% of all serotypes that can cause invasive pneumococcal infections.
The nature of the immune response to vaccine administration is T-independent. In children under 2 years of age, it is characterized by low immunogenicity and the absence of the effect of revaccination after repeated injections.
Specific immunity develops 2-3 weeks after vaccination.
According to the immunogenicity studies of Pnevmo 23, the overall epidemiological efficiency in preventing the development of infections caused by serotypes contained in the vaccine is 57%.
The effectiveness of immunization in patients with various diseases:
- diabetes mellitus - 85% (95% CI - 50–95%);
- anatomical asplenia - 77% (95% CI - 14–95%);
- chronic lung diseases - 65% (95% CI - 26–83%);
- congestive heart failure - 69% (95% CI - 17–88%);
- ischemic heart disease - 73% (95% CI - 23–90%).
Efficiency in immunocompetent elderly patients (over the age of 65 years) - 75% (95% CI - 57–85%).
According to studies, the effectiveness does not decrease as the time after vaccination increases: after 5–8 years it is about 71% (95% CI - 24–89%), after 9 years or more - 80% (95% CI - 16–95 %).
The epidemiological efficacy of Pneumo 23 was not determined in chronic renal failure, cirrhosis, alcoholism, leukemia, lymphoma, myeloma and sickle cell anemia, which is due to the small sample size in these groups.
Antibody titers ≥ 300 ng / ml after immunization were achieved in at least 84% of the subjects for 21 serotypes out of 22, of which 100% of the vaccinated - for 16 stereotypes, in 65% - for the 9N stereotype. In addition, due to serotype 6B in the vaccine, the production of antibodies to serotype 6A was also stimulated: in 90% of non-immune patients, at least two-fold seroconversion was achieved, with an average increase in antibody titer of 5.4 times.
Pneumo 23, according to research data, is ineffective for infections caused by pneumococcal serotypes, which are not present in the vaccine (95% CI of epidemiological effectiveness - from -73 to 18%; p ~ 0.15).
Indications for use
According to the instructions, Pneumo 23 is used in people at risk for the specific prevention of pneumococcal pneumonia and generalized pneumococcal infections caused by the Streptococcus pneumoniae serotypes presented in the vaccine.
The risk group includes:
- elderly people over the age of 65;
- persons with a weakened immune system: nephrotic syndrome, chronic renal failure, lymphoma, Hodgkin's disease, multiple myeloma, sickle cell anemia, absence or dysfunction of the spleen, oncohematological diseases, organ transplantation;
- people with chronic diseases: diabetes mellitus, cirrhosis, alcoholism, lung disease, cardiovascular disease, etc.;
- patients with cerebrospinal fluid leakage;
- patients with HIV infection (including asymptomatic);
- people who are in special institutions for the care of the disabled or the elderly, or work in conditions of an increased risk of pneumococcal infections or their complications, or are in organized groups (living in hostels, military personnel, students).
Contraindications
- children under 2 years old;
- exacerbation of chronic diseases;
- acute diseases (both infectious and non-infectious);
- an allergic reaction to the previous administration of the pneumococcal vaccine or to any of the components contained in the vaccine.
Instructions for use Pneumo 23: method and dosage
Vaccine Pneumo 23 is intended for subcutaneous or intramuscular administration. The more preferred route is intramuscular. It is forbidden to inject the drug into the vascular bed, therefore, before injecting the solution, make sure that the needle does not enter the blood vessel. To do this, the piston needs to be pulled back a little and inspect the syringe barrel, there should be no blood in it.
For primary immunization, one dose of Pnevmo 23 (0.5 ml) is administered.
With revaccination, a single administration of a single dose is also indicated.
The vaccine must be warmed to room temperature before administration, after being removed from the refrigerator for a few minutes.
Shake the drug immediately before injection.
Within 30 minutes after administration, the patient must be under medical supervision. The office should be provided with anti-shock therapy.
Between the injections of Pneumo 23 or Pneumo 23 and any other pneumococcal polysaccharide vaccine, intervals of at least 3 years should be observed.
Side effects
Pneumo 23, like any other biologically active drug, often causes:
- soreness, swelling, redness, or induration at the injection site. These reactions are moderately expressed and pass quickly;
- an increase in body temperature (in some cases more than 39 ° C) on the day of vaccination lasting up to 24 hours.
In very rare cases, pronounced local reactions occur. They develop, as a rule, in people with a high level of antipneumococcal antibodies, are reversible, pass without any complications and consequences.
In individual cases, it is possible: inflammation of the subcutaneous tissue at the injection site, headache, increased fatigue, malaise, myalgia, arthralgia, lymphadenopathy, urticaria, rash, Quincke's edema, anaphylactic reaction, including shock, febrile convulsions.
There are isolated reports of the occurrence of peripheral edema of the limb into which the vaccine was injected.
The patient should be warned that all adverse reactions, including those not listed in the instructions, must be reported to the attending physician.
Overdose
The vaccine is administered by a medical professional in a hospital setting. The syringe contains only one dose, so overdose is not possible.
special instructions
If splenectomy or immunosuppressive therapy (eg, chemotherapy) is required, vaccination should be given at least 2 weeks in advance.
If the vaccine is administered during immunosuppressive therapy, the immune response decreases, so vaccination should be postponed until the end of the course of treatment. The exception is people with chronic immunodeficiency (for example, with HIV infection) - in this case, the introduction of Pneumo 23 is still recommended, even when expecting a decrease in the immune response.
Due to the increased risk of hematoma formation when administered intramuscularly, the drug is used with extreme caution in patients with bleeding disorders (hemophilia or thrombocytopenia) and people receiving anticoagulants. In children with hemophilia, the risk of bleeding is increased with intramuscular injection, therefore, the Pneumo 23 vaccine should be injected subcutaneously into the area where you can press the site of infection, with the support of coagulation factors.
Influence on the ability to drive vehicles and complex mechanisms
No studies have been conducted on the effect of Pnevmo 23 on the ability to drive vehicles and other mechanisms.
Application during pregnancy and lactation
It is not known whether the components of the drug are excreted in breast milk.
In each case, the doctor makes the decision on vaccination individually, after assessing the real danger of pneumococcal infection and the possible risks associated with the introduction of Pneumo 23. The use of the drug is possible only if clearly necessary, if the benefit to the woman outweighs the potential risks to the fetus / child.
Childhood use
Pneumo 23 can be used to vaccinate children from 2 years of age. In children under 2 years of age, the nature of the immune response to the administration of the drug is characterized by low immunogenicity and lack of effect during revaccination.
Use in the elderly
Elderly people over 65 years of age are at risk of developing pneumococcal pneumonia and generalized pneumococcal infections, therefore, at this age, vaccination with Pneumo 23 is recommended for specific prophylaxis.
Drug interactions
On the same day as Pnevmo 23, it is allowed to administer other vaccines, but with different syringes and in different parts of the body, with the exception of the vaccine for the prevention of tuberculosis.
Immunosuppressive drugs reduce the immune response to the vaccine, therefore, vaccination is recommended after the end of immunosuppressive therapy.
The patient should be informed about the need to inform the doctor about all medications taken that coincide with vaccination or preceding immunization.
Analogs
The analogues of Pneumo 23 are: Pneumovax 23, Prevenar, Prevenar 13, Synflorix.
Terms and conditions of storage
Shelf life is 2 years.
Store in a dark place at a temperature of 2–8 ° С. Do not freeze. Keep out of the reach of children.
Vaccination plays an important role in the prevention of diseases caused by pneumococcal infection. After all, no one can avoid contact with these bacteria.
In this article we will discuss a vaccine for the prevention of pneumococcal infection - Pneumo 23, which is suitable for both children and adults. What kind of vaccine is this, indications and contraindications for its use, actions after vaccination, what reaction of the body to it is considered the norm and whether this drug has analogues - let's find out.
Why is pneumococcal infection dangerous?
Pneumococcal infection, which unites a group of diseases caused by a special subspecies of streptococcus - pneumococcus, is considered extremely common among people of all ages. This is due to the rather easy transmission of this type of microbes (infection occurs by airborne droplets) and the resistance of pneumococci to many antibiotics.
Pneumococci are the most common cause of the following diseases:
The danger of pneumococcus is also associated with the frequent development of carriage, when the infection can be on the mucous membranes of the host person for a long time, without causing him severe forms of the disease, but when talking or sneezing, bacteria are released into the air and infect others. In families where children attend preschool institutions, cases of pneumococcal infection are recorded in 60% of adults.
It is almost impossible not to meet pneumococcus in an adult leading an active lifestyle, or a child attending any educational institution. To effectively prevent the disease or the carriage of pneumococcal infection, vaccination with the drug "Pnevmo 23" is used.
What kind of vaccine "Pneumo 23"
The pneumococcal vaccine "Pnevmo 23" is produced in France. The Sanofi Pasteur plant (this is the manufacturer "Pnevmo 23") is part of the Sanofi-Aventis group, whose enterprises are considered one of the leaders in the immunobiological drugs market. The form of the vaccine is a disposable individual syringe containing 1 dose of "Pneumo 23".
The composition of the vaccine allows for the development of active immunity against twenty-three serological types of pneumococcus (the vaccine contains polysaccharides of 23 serotypes and a phenolic buffer solution).
One vaccination syringe "Pneumo 23", according to the instructions, contains 0.5 ml of the drug, which is one vaccination dose for all ages.
Instructions
In order to get vaccinated against pneumococcal infection, you should visit the local doctor of the polyclinic (or the doctor of the private vaccination office), who will determine the general state of health and the need for vaccination. Also, the doctor will conduct an examination, measure body temperature, evaluate general blood and urine tests to make sure that the person is completely healthy at the time of vaccination.
No special preparation is required from the patient himself before vaccination, but it is not advisable to vaccinate on an empty stomach and after exhausting physical activity, and it is also not recommended to visit the pool or sauna on the day of vaccination and do massage or cosmetic procedures on the limb where the Pneumo 23 vaccine was injected. ". The place of injection of the drug is chosen by the physician - it is either the shoulder or the hip. The route of administration is intramuscular or subcutaneous injection.
The drug is allowed to be administered simultaneously with other vaccinations (especially often done together with DPT in children or with the influenza vaccine in adults), except for the BCG vaccine. Immunity after vaccination will be developed no earlier than a month later, therefore, this point must be taken into account when choosing the timing of vaccination - in order for the body to develop immunity and fully resist pneumococci during a period of increased incidence of respiratory infections, the vaccination must be done 4 weeks before the start of the alleged epidemic ...
Indications for vaccination "Pneumo 23"
Long-term scientific research has confirmed a high degree of protection of the human body vaccinated with this vaccine from most of the most dangerous pneumococci. The effectiveness of the drug "Pnevmo 23" for adults and children was assessed by reducing the incidence rate: the development of bronchitis and pneumonia in the vaccinated contingent of people can be avoided in almost 90% of cases, and in those vaccinated who still got respiratory infections, only mild forms of the disease were noted ...
"Pneumo 23" is not included in the mandatory vaccination schedule, so it is done at will or depending on the indications for persons aged 2 years and older. Vaccination against pneumococcal infection is recommended for all those who have high risks of contracting any kind of pneumococcus and getting serious complications, and these are the following categories of patients.
Contraindications for the introduction of "Pneumo 23"
Contraindications existing for the Pneumo 23 vaccine can be divided into absolute and relative. An absolute contraindication, in which the vaccine cannot be administered under any circumstances, is an allergy to any component of the drug. Relative contraindications for the use of "Pneumo 23" include:
During pregnancy, the introduction of "Pneumo 23" is allowed only in the third trimester of pregnancy by the decision of the doctor, when there is a high risk of illness of the expectant mother (for example, on the eve of the autumn-winter season with the flu vaccine); a nursing mother has no contraindications for vaccination, vaccine components do not penetrate into the mother's milk.
There is an opinion that a contraindication for vaccination against pneumococcus is a previous pneumonia, because if a person has been ill with pneumonia and developed immunity, then why, in this case, the Pneumo 23 vaccination is needed, and from what it can protect. But this is an erroneous statement, because after the transferred pneumococcal infection, there will be immunity to 1-2 types of microbes, while the introduction of the vaccine will develop protection against all 23 of the most dangerous pneumococci.
What to do after vaccination "Pneumo 23"
After vaccination, you must not leave the medical facility for at least half an hour. This time is needed so that in the event of an acute local or general reaction to the Pnevmo 23 vaccination, the necessary medical assistance is provided on time. But in general, 95% of people after vaccination do not experience any unpleasant sensations or changes in their state of health, so the concerns of those planning to be vaccinated with Pneumo 23 about how the vaccine is tolerated are usually unfounded.
After vaccination, a child can walk and visit educational institutions in the same regime without restriction.
Possible reactions and complications after vaccination
In 5% of cases, there may be local reactions to the vaccine (burning sensation, redness, painful sensation or induration at the injection site). These unpleasant symptoms usually resolve within 24 hours after the injection. As general reactions, an increase in temperature after vaccination with "Pneumo 23" is described, but the post-vaccination temperature usually quickly normalizes on its own or against the background of a single dose of antipyretic drugs.
Vaccine manufacturers point to a negligible likelihood of such complications after vaccination "Pnevmo 23" as swollen lymph nodes, pain in the joints, the appearance of a skin rash, the development of anaphylactic allergic reactions to the vaccine. Such complications are rather exceptions, since this vaccine, in the vast majority of cases, is well tolerated. But the patient must be aware of all the possible consequences after the introduction of Pneumo 23, and be ready to see doctors in the event of any change in the state of health after vaccination, be it local changes, or a general deterioration in well-being.
Revaccination "Pneumo 23"
When using the drug "Pneumo 23" for the prevention of pneumococcal infection, the vaccination scheme consists of a single injection of vaccination (primary immunization), which provides protection for 5 years. A repeated injection of the drug (revaccination) is prescribed after 5 years, and sometimes after 3 years or even earlier by the decision of the doctor in the following cases:
- patients with severe immunodeficiency (absence of a spleen, HIV infection);
- persons at risk for bronchopulmonary, renal and heart diseases;
- people over 65;
- smokers;
- children over 10 years old with an established diagnosis of sickle cell anemia are also recommended earlier revaccination "Pneumo 23".
Analogs "Pnevmo 23"
In addition to the French vaccine "Pneumo 23", there are analogues of immunobiological preparations against pneumococcal infection. Similar vaccines are produced:
- USA - Prevenar;
- Belgium - Sinflorix.
The drug "Prevenar" provides the development of immunity to 7 or 13 (depending on the type of vaccine) serotypes of pneumococcus, "Synflorix" - to 10, while "Pneumo 23" - to 23 types of microbe (10 of them are considered "adults" after all more often the adult population is sick, 13 - children). Another advantage of "Pnevmo 23" is its price - it is much lower than that of "Sinflorix" and especially "Prevenar".
The only drawback of "Pnevmo 23" is the age at which this vaccine can be used. If the American and Belgian vaccines can be administered starting from six weeks of a child's life, then the French vaccine is allowed only for use in children over two years old - that is, Pneumo 23 is not suitable for the prevention of pneumococcal diseases in newborns.
The proven safety and high clinical effect of the Pneumo 23 vaccine makes this drug indispensable as a specific prophylaxis of pneumococcal diseases for a wide range of people, since the immunity developed after vaccination makes it possible to get sick less often and more easily, use less antibiotics for treatment, and live a normal, non-isolated life in the period of the rise of respiratory infections.
Active substance
Pneumococcal conjugates (polysaccharide-CRM 197) (pneumococcal polysaccharide conjugate vaccine (absorbed))
Release form, composition and packaging
Suspension for intramuscular injection white, homogeneous.
| 1 dose (0.5 ml) | |
| pneumococcal conjugates (polysaccharide-CRM 197) | |
| 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 | 2.2 μg |
| carrier protein CRM 197 | ~ 32 μg |
Excipients: aluminum phosphate - 0.5 mg (in terms of aluminum - 0.125 mg), - 4.25 mg, succinic acid - 0.295 mg, polysorbate 80 - 0.1 mg, water d / i - up to 0.5 ml.
0.5 ml - syringes with a capacity of 1 ml made of transparent colorless glass (1) - plastic packages (1) complete with a sterile needle - cardboard packs.
0.5 ml - syringes with a capacity of 1 ml made of transparent colorless glass (5) - plastic packages (2) complete with sterile needles (10 pcs.) - cardboard packs.
pharmachologic effect
Vaccine for the prevention of pneumococcal infections. Prevenar13 vaccine is a capsular polysaccharide of 13 pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, individually conjugated with diphtheria protein CRM 197 and adsorbed on aluminum phosphate.
Immunological properties
Administration of Prevenar 13 vaccine induces the production of antibodies to capsular polysaccharides Streptococcus pneumoniae, thereby providing specific protection against infections caused by pneumococcal serotypes included in the vaccine 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
According to the WHO recommendations for new conjugated pneumococcal vaccines, the equivalence of the immune response of the vaccine 13 was determined according to three criteria: the percentage of patients who achieved a concentration of specific IgG antibodies ≥0.35 μg / ml; geometric mean concentrations (SGC) and opsonophagocytic activity (OFA) of bactericidal antibodies (OFA titer ≥1: 8 and geometric mean titers (SGT)). For adults, the protective level of antipneumococcal antibodies has not been determined and serotype-specific OPA (SGT) is used.
Prevenar 13 vaccine includes up to 90% of serotypes that cause invasive pneumococcal infections (IPIs), incl. resistant to antibiotic treatment.
Immune response using three or two doses in a primary vaccination series
After the introduction three doses Prevenar 13 vaccines during primary vaccination of children under 6 months of age showed a significant increase in the level of antibodies to all serotypes of the vaccine.
After the introduction two doses during the primary vaccination with Prevenar 13 as part of the mass immunization of children of the same age group, a significant increase in antibody titers to all components of the vaccine is also noted; 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. Immune memory formation has been shown for both of the above vaccination regimens. Secondary immune response to a booster dose in children of the second year of life when used three or two doses in the primary vaccination series are comparable for all 13 serotypes.
When vaccinating premature babies (born at gestational age<37 недель), включая глубоко недоношенных детей (родившихся при сроке гестации <28 недель), начиная с возраста 2 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 13 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 1 дозу пневмококковой 7-валентной конъюгированной вакцины, а также ранее не вакцинированные дети и подростки в возрасте от 10 до 17 лет, получив по 1 дозе вакцины Превенар 13, продемонстрировали иммунный ответ на все 13 серотипов, эквивалентный таковому у детей 12-15 месяцев, вакцинированных 4 дозами препарата Превенар 13.
A single injection of Prevenar vaccine to 13 children aged 5-17 years is able to provide the necessary immune response to all serotypes of the pathogen that are part of the vaccine.
Vaccine efficacy Prevenar 13
Invasive pneumococcal infection (IPI)
After the introduction of the Prevenar vaccine in the 2 + 1 regimen (2 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 incidence of IPI caused by vaccines was noted -specific serotypes. After switching to Prevenar 13, a further decrease in the incidence of IPI caused by vaccine-specific additional serotypes was noted, from 76% in children under 2 years of age to 91% in children aged 5–14 years.
Serotype-specific efficacy against IPI for additional serotypes of Prevenar 13 vaccines 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 serotype 5 IPD. After Prevenar 13 was included in national immunization programs, the registration rate of serotype 3 IPD decreased by 68% (95% CI 6-89%) in children under 5 years of age. In a case-control study performed in this age group, a 79.5% reduction in the incidence of IPI caused by serotype 3 was shown (95% CI 30.3-94.8).
Otitis media (CO)
After the introduction of Prevenar vaccination, followed by switching to Prevenar 13 according to the 2 + 1 scheme, a 95% decrease in the incidence of CO caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and serotype 6A was revealed, as well as an 89% decrease the frequency of CO caused by serotypes 1, 3, 5, 7F and 19A.
Pneumonia
When switching from Prevenar to Prevenar 13, there was a 16% decrease in the incidence of all cases of community-acquired pneumonia (CAP) 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 вакцины Превенар 13 отмечено 74% снижение частоты ВБП, вызванных 6 дополнительными серотипами вакцины Превенар 13. У детей в возрасте младше 5 лет после внедрения вакцинации препаратом 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 efficacy of Prevenar 13 has been demonstrated in reducing the carriage of vaccine-specific serotypes in the nasopharynx, both common with Prevenar vaccine (4, 6B, 9V, 14, 18C, 19F, 23F), and 6 additional (1, 3, 5, 6A, 7A, 19A) and related serotype 6C.
A population effect (serotype-specific reduction in the incidence of unvaccinated individuals) has been observed in countries where Prevenar 13 has been used in mass immunization for more than 3 years with high vaccination coverage and adherence to the immunization schedule. In 13 persons 65 years and older who were not vaccinated with Prevenar, a decrease in IPI by 25% was demonstrated, while IPI caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F decreased by 89%, and 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 Prevenar 13 vaccine in adults
Clinical studies of Prevenar 13 provide immunogenicity data in adults aged 18 and over, including those aged 65 and over and those who have previously received 1 or more doses of the polysaccharide pneumococcal 23-valent vaccine (PPV23) 5 years prior to inclusion into the study. Each study included healthy adults and immunocompetent patients with chronic diseases in the stage of compensation, including comorbidities that form an increased susceptibility to pneumococcal infection (chronic cardiovascular diseases, chronic lung diseases, including asthma; kidney disease and diabetes mellitus, chronic liver disease, including alcohol damage), and adults with social risk factors - smoking and alcohol abuse. The immunogenicity and safety of Prevenar 13 has been demonstrated in adults 18 years of age and older, including patients previously vaccinated with PPV23. Immunological equivalence was established for 12 common serotypes with PPV23. In addition, for 8 serotypes common with PPV23 and for serotype 6A, which is unique for Prevenar 13 vaccine, a statistically significantly higher immune response to Prevenar 13 was demonstrated. serotypes of the Prevenar 13 vaccine were not lower than those in adults aged 60-64 years. Moreover, individuals aged 50-59 years old showed a statistically higher immune response for 9 out of 13 serotypes compared to people aged 60-64 years.
Clinical efficacy of Prevenar 13 vaccine has been demonstrated in a randomized, double-blind, placebo-controlled CAPITA trial (over 84,000 patients) for community-acquired pneumococcal pneumonia (CAP) in adults aged 65 years and older: 45% for the first episode of CAP caused by overlapping serotypes Prevenar 13 (invasive and non-invasive); 75% for invasive infections caused by serotypes covered by Prevenar 13.
Immune response in adults previously vaccinated with PPV23
In adults aged 70 years and older, once vaccinated with PPV23 ≥5 years ago, administration of Prevenar 13 demonstrated immunological equivalence for 12 common serotypes compared with the response to PPV23, with 10 common serotypes and serotype 6A being the immune response to Prevenar 13 was statistically significantly higher compared to the response to PPV23. Prevenar 13 gives a more pronounced immune response compared to revaccination with PPV23.
Immune response in special patient populations
Patients with the conditions described below are at increased risk of pneumococcal infection.
Sickle cell anemia
In an open-label, noncomparative 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 вакцины Превенар 13 при двукратной иммунизации с интервалом 6 месяцев приводило к статистически значимо высокому иммунному ответу (СГК IgG к каждому серотипу, определяемые методом иммуноферментного анализа (ИФА), и ОФА СГТ к каждому серотипу). После ведения второй дозы иммунный ответ был сопоставим с таковыми после первой дозы препарата.
HIV infection
HIV-infected children and adults with CD4 count ≥200 cells / μL (average 717.0 cells / μL), viral load<50 000 копий/мл (в среднем 2090.0 копий/мл), с отсутствием активных СПИД-ассоциированных заболеваний и ранее не получавшие вакцинации пневмококковой вакциной, получали 3 дозы вакцины Превенар 13. Показатели IgG СГК и ОФА были достоверно выше после первой вакцинации препаратом 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 препаратом Превенар 13.
Hematopoietic Stem Cell Transplant
Children and adults who underwent allogeneic hematopoietic stem cell transplant (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 vaccine 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 the general recommendations, a single dose of PPV23 was administered 1 month after the fourth dose of Prevenar 13. The titers of functionally active antibodies (OPA SGT) were not determined in this study. The administration of the Prevenar 13 vaccine caused an increase in FGC serotype-specific antibodies after each dose. The immune response to the booster dose of Prevenar 13 vaccine was significantly higher for all serotypes compared to the response to the primary immunization series.
Indications
- prevention of pneumococcal infections, including invasive (including meningitis, bacteremia, sepsis, severe pneumonia) and non-invasive (community-acquired pneumonia and otitis media) forms of diseases caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F from 2 months of age onwards without age limit:
- within the framework of the national calendar of preventive vaccinations;
- in persons of groups at increased risk of developing pneumococcal infection.
Vaccination is carried out within the framework of the national calendar of preventive vaccinations in accordance with the approved terms, as well as for persons at risk for the development of pneumococcal infection: with immunodeficiency states, incl. HIV infection, cancer, receiving immunosuppressive therapy; with anatomical / functional asplenia; with a cochlear implant installed or planned for this operation; patients with leaking cerebrospinal fluid; with chronic diseases of the lungs, cardiovascular system, liver, kidneys and diabetes mellitus; patients with bronchial asthma; premature babies; persons who are in organized groups (orphanages, boarding schools, army groups); convalescents of acute otitis media, meningitis, pneumonia; long-term and often ill children; patients infected with mycobacterium tuberculosis; all persons over 50; tobacco smokers.
Contraindications
- hypersensitivity to the previous administration of Prevenar 13 or Prevenar (including anaphylactic shock, severe generalized allergic reactions);
- hypersensitivity to diphtheria toxoid and / or excipients;
- acute infectious or non-infectious diseases, exacerbations of chronic diseases. Vaccination is carried out after recovery or during remission.
Dosage
The vaccine is administered in a single dose of 0.5 ml / m. For children of the first years of life, the vaccine is injected into the upper-outer surface of the middle third of the thigh, persons over 2 years old - 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, when examining the contents of the syringe, foreign particles are detected, or the contents look different than in the section "Dosage form, composition and packaging".
Do not inject Prevenar 13 intravascularly and intramuscularly into the gluteal region!
If vaccination with Prevenar 13 is started, it is recommended to complete it also with Prevenar 13. If the interval between injections of any of the above courses of vaccination is forced to increase, the introduction of additional doses of Prevenar 13 is not required.
Vaccination schedule
| Age at initiation of vaccination | Vaccination schedule | Intervals and dosage |
| 2-6 months | 3+1 or 2+1 |
Individual immunization: 3 doses with an interval of at least 4 weeks between injections. The first dose can be administered from 2 months. Revaccination once at 11-15 months. Mass immunization of children: 2 doses with an interval of at least 8 weeks between injections. Revaccination once at 11-15 months. |
| 7-11 months | 2+1 | 2 doses with an interval of at least 4 weeks between injections. Revaccination once in the second year of life |
| 12-23 months | 1+1 | 2 doses with an interval of at least 8 weeks between injections |
| 2 years and older | 1 | Once |
Children previously vaccinated with Prevenar
Vaccination against pneumococcal infection, started with Prevenar 7-valent vaccine, can be continued with Prevenar 13 vaccine at any stage of the immunization schedule.
Persons aged 18 and over
Prevenar 13 is administered once. The need for revaccination with Prevenar 13 has not been established. The decision on the interval between administration of Prevenar 13 and PPV23 vaccines should be made in accordance with official guidelines.
Special patient groups
Have patients after hematopoietic stem cell transplantation a series of immunizations is recommended, consisting of 4 doses of Prevenar 13 0.5 ml each. The first series of immunizations consists of the administration of 3 doses of the drug: the first dose is administered from the 3rd to the 6th month after transplantation. The interval between injections should be 1 month. It is recommended that the booster dose be administered 6 months after the third dose.
Premature babies four times vaccination is recommended. The first series of immunizations consists of 3 doses. The first dose should be administered at the age of 2 months, regardless of the child's body weight, with an interval of 1 month between doses. The introduction of the fourth (booster) dose is recommended at the age of 12-15 months.
The immunogenicity and safety of Prevenar 13 vaccine have been confirmed for elderly patients.
Side effects
The safety of Prevenar 13 vaccine has been studied in healthy children (4429 children / 14 267 doses of vaccine) aged 6 weeks to 11-16 months and 100 children born prematurely (at term<37 недель гестации). Во всех исследованиях Превенар 13 применялся одновременно с другими вакцинами, рекомендованными для данного возраста.
In addition, the safety of Prevenar 13 vaccine was assessed in 354 children aged 7 months to 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 disturbance. 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 vaccinated with Prevenar, 13 premature babies (born at a gestational age of ≤37 weeks), including deeply premature babies born at a gestational age of less than 28 weeks and children with extremely low body weight (≤500 g), did not differ in the nature, frequency and severity of post-vaccination reactions from those of full-term babies.
Individuals aged 18 and over had fewer side effects regardless of previous vaccinations. However, the frequency of development of reactions was the same as in vaccinated younger ones.
In general, the incidence of side effects was the same in patients aged 18–49 years and in patients over 50 years old, 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.
In adult patients with HIV infection, the frequency of adverse reactions was the same as in patients aged 50 years and older, with the exception of fever and vomiting, which were very common and nausea, which was often observed.
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 after hematopoietic stem cell transplantation had the same frequency of adverse reactions as in healthy patients aged 2-17 years, with the exception of headache, vomiting, diarrhea, fever, fatigue , arthralgias and myalgias, which were found in these patients as "very frequent".
The adverse reactions listed below are classified according to the frequency of their occurrence in all age groups as follows: very often (≥1 / 10), often (≥1 / 100, but<1/10), нечасто (≥1/1000, но <1/100), редко (≥1/10 000, но <1/1000) и очень редко (≤1/10 000).
Adverse reactions identified in clinical trials of Prevenar vaccine 13
Often: hyperthermia; irritability; redness of the skin, pain, induration or swelling of 2.5-7 cm in size at the injection site (after revaccination and / or in children aged 2-5 years); vomiting (in patients aged 18–49 years), drowsiness, poor sleep, poor appetite, headache, generalized new or exacerbation of existing joint pain and muscle pain, chills, fatigue.
Often: hyperthermia above 39 ° C; soreness at the injection site, leading to a short-term limitation of the range of motion of the limb; hyperemia, induration or edema 2.5-7 cm in size at the injection site (after a series of primary vaccinations in children under 6 months of age), vomiting, diarrhea, rash.
Infrequently: skin redness, induration or swelling larger than 7 cm at the injection site; tearfulness, convulsions (including febrile convulsions), hypersensitivity reactions at the injection site (urticaria, dermatitis, pruritus) **, nausea.
Rarely: cases of hypotonic collapse *, flushing of the face **, hypersensitivity reactions, including dyspnea, bronchospasm, Quincke's edema of various localization, including facial edema **, anaphylactic / anaphylactoid reaction, including shock **, lymphadenopathy at the injection site.
Very rarely: regional lymphadenopathy **, erythema multiforme **.
* observed only in clinical trials of Prevenar vaccine, but possible for Prevenar 13 vaccine.
** were noted during post-marketing observations of Prevenar vaccine; they can be considered as quite possible for Prevenar 13 vaccine.
Adverse events observed in other age groups can also occur in children and adolescents aged 5-17 years. However, in clinical trials, they were not noted due to the small number of participants.
There were no significant differences in the incidence of side effects in adults previously vaccinated and unvaccinated with PPV23.
Overdose
An overdose of Prevenar 13 vaccine is unlikely because the vaccine is dispensed in a syringe containing only one dose.
Drug interactions
There is no data on the interchangeability of Prevenar 13 with other pneumococcal conjugate vaccines. With simultaneous immunization with Prevenar 13 and other vaccines, injections are made in different parts of the body.
Children aged 2 months-5 years
Prevenar 13 is combined with any other vaccines included in the immunization schedule for children in the first years of life, with the exception of BCG. Simultaneous administration of 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, polio, hepatitis A, hepatitis B, measles, mumps, rubella, chickenpox and rotavirus - does not affect the immunogenicity of these vaccines. Due to the higher risk of developing febrile reactions, children with seizure disorders, incl. with a history of febrile seizures, and those receiving Prevenar 13 at the same time as whole-cell pertussis vaccines, symptomatic antipyretic drugs are recommended. With the combined use of Prevenar 13 vaccines and the frequency of febrile reactions coincided with that for the combined use of Prevenar (PCV7) and Infanrix-hexa vaccines. An increase in the frequency of seizures (with and without an increase in body temperature) and hypotonic-hyporesponsive episodes (HGE) was observed with the combined use of Prevenar 13 and Infanrix-hexa vaccines. Antipyretic drugs should be started in accordance with local recommendations for the treatment of children with seizure disorders or children with a history of febrile seizures, and in all children who received Prevenar 13 at the same time as vaccines containing whole-cell pertussis component.
According to a post-marketing study of the prophylactic use of antipyretics to the immune response to the Prevenar 13 vaccine, it is assumed that the prophylactic administration of acetaminophen () may reduce the immune response to a series of primary vaccinations with Prevenar 13. Immune response to revaccination with Prevenar 13 at 12 months with prophylactic use paracetamol does not change. The clinical significance of these findings is unknown.
Children and adolescents aged 6-17
There are no data on the use of Prevenar 13 simultaneously with the vaccine against human papillomavirus infection, conjugated meningococcal vaccine, tetanus, diphtheria and pertussis vaccine, tick-borne encephalitis.
Persons aged 18-49
There are no data on the simultaneous use of Prevenar 13 with other vaccines.
Persons aged 50 and over
Prevenar 13 can be used in conjunction with seasonal inactivated trivalent influenza vaccine (DVT). With the combined use of the Prevenar 13 and DVT vaccines, the immune responses to the DVT vaccine coincided with the responses obtained with the DVT vaccine alone, the immune responses to the Prevenar 13 vaccine were lower than with the use of Prevenar 13 alone. The clinical significance of this fact is unknown. The incidence of local reactions did not increase with the simultaneous administration of Prevenar 13 with an inactivated influenza vaccine, while the frequency of general reactions (headache, chills, rash, loss of appetite, pain in joints and muscles) increased with simultaneous immunization. Concomitant use with other vaccines has not been studied.
special instructions
Taking into account the rare cases of anaphylactic reactions that occur with the use of any vaccine, the vaccinated patient should be under medical supervision for at least 30 minutes after immunization. Immunization sites should be provided with anti-shock therapy.
Vaccination of premature (as well as full-term) babies should be started from the second month of life (passport age). When deciding whether to vaccinate a premature baby (born at term<37 недель беременности), особенно имеющего в анамнезе незрелость дыхательной системы, необходимо учесть, что польза иммунизации против пневмококковой инфекции у данной группы пациентов особенно высока и не следует ни отказываться от вакцинации, ни переносить ее сроки. В связи с потенциальным риском апноэ, имеющимся при применении любых вакцин, первая вакцинация препаратом Превенар 13 недоношенного ребенка возможна под врачебным наблюдением (не менее 48 ч) в стационаре на втором этапе выхаживания.
Like other intramuscular injections, patients with thrombocytopenia and / or other disorders of the blood coagulation system and / or in the case of anticoagulant treatment, vaccination with Prevenar 13 should be carried out with caution, provided that the patient's condition is stabilized and hemostasis control is achieved. Perhaps s / c administration of the vaccine Prevenar 13 to this group of patients.
Prevenar 13 cannot prevent 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 the primary vaccination with Prevenar 13 according to their age. In patients with impaired immunoreactivity, vaccination may be accompanied by a reduced level of antibody production.
Application of Prevenar 13 and PPV23
For the formation of immune memory, immunization against pneumococcal infection is preferable to start with the Prevenar 13 vaccine. The need for revaccination has not been determined. In high-risk groups, PPV23 may be recommended later to expand serotype coverage. There are data from clinical studies of vaccination with PPV23 after 1 year, and also after 3.5-4 years after vaccine Prevenar 13. With an interval between vaccinations of 3.5-4 years, the immune response to PPV23 was higher without changes in reactogenicity.
Children who are vaccinated with Prevenar 13 and are at high risk (for example, those with sickle cell disease, asplenia, HIV infection, chronic illness, or immune dysfunction) are given PPV23 at intervals of at least 8 weeks. In turn, patients who are at high risk of pneumococcal infection (patients with sickle cell disease or HIV infection), including patients previously vaccinated with one or more doses of PPV23, may 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 guidelines. 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 who have reached the age of 50 and for patients at risk, with the PCV13 vaccine being administered first, followed by a possible subsequent revaccination with PPV23 at intervals of at least 8 weeks.
Prevenar 13 contains less than 1 mmol sodium (23 mg) per dose, i.e. practically does not contain sodium.
Within the specified shelf life, Prevenar 13 is stable for 4 days at temperatures up to 25 ° C. At the end of this period, the drug should either be used immediately or returned to the refrigerator. These data are not guidelines for storage and 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.
Influence on the ability to drive vehicles and use mechanisms
Prevenar 13 has little or no effect on the ability to drive and use machinery. However, some of the reactions mentioned in the "Side effects" section may temporarily affect the ability to drive a vehicle and potentially dangerous machinery.
Pregnancy and lactation
The safety of the vaccine during pregnancy and breastfeeding has not been established.
There are no data on the use of Prevenar 13 vaccine during pregnancy.
There is no data on the release of vaccine antigens or post-vaccination antibodies in breast milk during lactation.
Terms of dispensing from pharmacies
1-syringe pack is available by prescription.
A pack with 10 syringes is intended for healthcare institutions.
Storage conditions and periods
The drug should be stored out of the reach of children at a temperature of 2 to 8 ° C; do not freeze. Shelf life is 3 years. Do not use after the expiration date printed on the package.
Transportation conditions
Transport at temperatures between 2 ° C – 25 ° C. Do not freeze. Transportation at temperatures above 2-8 ° C is allowed for no more than 5 days.
Formula, chemical name: there is no data.
Pharmacological group: immunotropic agents / vaccines, sera, phages and toxoids.
Pharmachologic effect: immunomodulatory, immunostimulating.
Pharmacological properties
The vaccine for the prevention of pneumococcal infections contains purified polysaccharides of the Streptococcus pneumoniae serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) that cause invasive pneumococcal infections in developing and developed countries. In 2 - 3 weeks after immunization, specific immunity develops. The immune response is T-independent, characterized by no booster effect with repeated injections, and low immunogenicity in patients under two years of age.
Indications
Specific prophylaxis in persons at risk of generalized pneumococcal infections and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes.
Dosage and administration of the vaccine for the prevention of pneumococcal infections
The vaccine for the prevention of pneumococcal infections is administered intramuscularly or subcutaneously. Do not inject into vessels. Before the introduction, it is necessary to make sure that the needle does not enter the vessel; for this, the syringe plunger is pulled slightly towards itself, as a result of which blood should not appear in the syringe. The drug is used as a primary immunization and as a revaccination. Dosages depend on the trade form of the drug. Any unused vaccine residue should be disposed of in accordance with national regulations.
The risk group for pneumococcal disease includes the following categories of people: persons who have chronic diseases (for example, lung disease, cardiovascular disease, alcoholism, diabetes mellitus, cirrhosis); people 65 years of age and older; patients with a weakened immune system (impaired function or absence of the spleen, Hodgkin's disease, multiple myeloma, sickle cell anemia, lymphoma, oncohematological diseases, nephrotic syndrome, chronic renal failure, organ transplantation); patients with cerebrospinal fluid leakage; patients with HIV infection (with clinical manifestations and asymptomatic); people working in conditions that increase the risk of pneumococcal infections or their complications; people who are in special institutions for the care of disabled or elderly patients; persons who are in organized groups (military personnel, students living in hostels).
It is recommended that the vaccine be given at least two weeks before starting immunosuppressive treatment (chemotherapy and others) or removing the spleen. The immune response to the vaccine can be reduced during immunosuppressive treatment, therefore it is recommended to postpone the vaccination until the end of the course. But vaccination of patients with chronic immunodeficiency (eg, HIV infection) is recommended, although the immune response may be limited.
When the vaccine is administered, it is necessary to have anti-shock therapy available. Medical supervision of the patient is required for at least half an hour after the administration of the vaccine.
Contraindications for use
Hypersensitivity (including to the previous administration of pneumococcal vaccine), exacerbation of chronic diseases, acute infectious and non-infectious diseases.
Restrictions on use
Blood clotting disorders (thrombocytopenia, hemophilia), taking anticoagulants (increased risk of hematoma formation with intramuscular injection).
Application during pregnancy and lactation
The use of the vaccine during pregnancy is not recommended due to limited experience with the vaccine in pregnant women. It is not known whether the vaccine passes into breast milk. The decision to vaccinate women during pregnancy and breastfeeding should be made only if there is a real risk of pneumococcal infection, when the expected benefit to the mother is higher than the possible risk to the fetus or child.
Side effects of the vaccine for the prevention of pneumococcal infections
Local reactions: swelling, soreness, induration, redness, peripheral edema of the limb, inflammation of the subcutaneous tissue, the development of pronounced local reactions is possible.
Others: fever, asthenia, myalgia, chills, headache, fatigue, malaise, lymphadenopathy, rash, arthralgia, allergic reactions (angioedema, urticaria, febrile convulsions, anaphylactic reaction, including shock).
Interaction of the vaccine for the prevention of pneumococcal infections with other substances
Before giving the vaccine, the patient should inform the doctor about taking any medications. The drug can be injected simultaneously (on the same day) with other vaccines (except vaccines for the prevention of tuberculosis) in different parts of the body using different syringes. Immunosuppressive drugs reduce the immune response to the vaccine. Certolizumab pegol does not suppress the humoral immune response to the vaccine.
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