Interaction of fromilid uno with alcohol. Can I take Clarithromycin and alcohol? Industrial release form

call the most frequent bacterial infection human, according to WHO estimates, it causes 1.2 million deaths per year, more than 40% of deaths in children 0-5 years old - community-acquired pneumonia in Russia 1.5 million per year, pneumococci cause 76% of them in adults and up to 90 % - in children under 5 years of age, including those complicated by pleurisy and destruction. Vaccination against pneumococcal infection has significantly reduced the incidence of pneumococcal infection.

Efficacy of pneumococcal conjugate vaccines

Already the first results of using the Prevenar vaccine showed that it prevents 83% of meningitis caused by vaccine serotypes. For all radiographically confirmed pneumonias, the decrease in incidence was 20.5%, and for pneumonia of any etiology, the frequency of hospitalizations decreased from 11.5 to 5.5 cases per 1000 children (by 52.4%), and the frequency of outpatient visits to a doctor - from 99.3 to 58.5 cases per 1000 children (by 41.1%).

According to the CDC, mass vaccination with Prevenar reduced the incidence of bacteremic forms of pneumococcal infection in children aged 0-4 years, caused by pneumococci included in the vaccine, from 81.9 to 1.7 per 100,000. vaccine serotypes (from 16.8 to 21.7), but the total number of bacteremia decreased by 4 times - from 98.7 to 23.4 per 100,000.

The incidence of pneumococcal meningitis has also changed significantly. In the United States, in children 0-2 years old, it decreased from 2000 to 2004. from 7.7 to 2.6, and mortality from 0.37 to 0.18 per 100,000, i.e. 1600 cases of meningitis of this etiology were prevented in 4 years. In Spain, the incidence of pneumococcal meningitis (per 100,000 children aged 0-5 years) has decreased by 54% due to vaccination, from 6.14 in 2001 to 2.86 in 2006.

Mass vaccination of children early age formed collective immunity: in the USA, bacteremic pneumonias became less common both in unvaccinated children aged 5-15 years (by 38%) and in adults (by 47% at the age of 15-45 years, by 20% in 45-65 year olds), and 36% in persons over 65 years of age. The incidence of pneumococcal meningitis has also decreased by 33%, and the mortality of persons over 65 years of age - by 44%.

The pneumococcal vaccine protects against 80% of strains of pneumococcus with intermediate and 100% with high resistance to penicillin.

With a 57% decrease in the incidence of otitis media caused by vaccine serotypes, the overall impact of vaccination was significantly lower (6-9%) due to the persistence of the incidence caused by other pathogens and the increase in the incidence of otitis media caused by other pneumococcal serotypes (by 33%). More pronounced decrease in recurrent otitis media (by 16%) and severe forms requiring tympanostomy (by 25%). The carriage of vaccine serotypes has been halved, but other serotypes are taking their place, so that overall effect turns out to be not so significant.

The pneumococcal vaccine Prevenar is also successfully combined with influenza, and this combination (in autumn Influvac + Prevenar twice with an interval of 4-8 weeks) in children 18-72 months of age Led (compared to the control who received HBV) to a decrease in the frequency of febrile respiratory episodes during epidemiological season by 25%, while only Influvak - by 13%. At the same time, the reduction in confirmed cases of influenza in the Influvac + Prevenar group and only Influvac was similar (51 and 52%), the level of reduction in the frequency of otitis media did not differ significantly (57 and 71%). Outside the influenza season, the differences between the experimental and control groups were not significant.

Although the cost of a conjugate vaccine is significant, mass vaccination in the US has a significant economic impact. Total estimates of direct health system costs associated with hospitalizations and outpatient visits for pneumonia of any etiology for children younger age declined from average annual values ​​of $688.2 million between 1997 and 1999 to $376.7 million in 2004 (a decrease of 45.3%, i.e. approximately $310 million). Taking into account the decrease in the incidence at all ages under the influence of vaccination of children, the economic effect is assessed as significant.

Latin name: Prevenar, Prevenar 13
ATX code: J07AL02
Active substance: Pneumococcal
conjugates
Manufacturer: Pfizer, USA
Pharmacy leave condition: On prescription
Price: from 1898 to 2021 rub.

"Prevenar 13" together with "Prevenar" - vaccines that are used against pneumococcal infection (the causative agent of pneumonia, meningitis and other ailments) for vaccinating children from 2 months to 5 years.

Indications for use

Vaccination with "Prevenar" is carried out in order to prevent the occurrence of diseases provoked by the pathogen - Streptococcus pneumoniae, these include:

  • Sepsis
  • Otitis media (acute stage)
  • Glomerulonephritis
  • Erysipelas skin
  • Pneumonia
  • Scarlet fever
  • bacteremia
  • Meningitis.

Composition

The drug is based on pneumococcal conjugates, which are represented by polysaccharides of a number of serotypes: 4 (2 μg), 6B (4 μg), 9V (2 μg), 14 (2 μg), 18C (2 μg), 19F (2 μg), 23F (2 μg), as well as CRM 197 carrier protein (20 μg).

Additional components: aluminum phosphate at a dosage of 0.5 mg, sodium chloride at a dose of 4.5 mg, and purified water (0.5 ml).

The new vaccine Prevenar 13 contains 7 serotypes in common with Prevenar along with the CRM197 carrier protein.

An additional six pneumococcal serotypes of the Prevenar 13 vaccine are: 1, 3, 5, 6A, 7F, 19A, which are co-conjugated with CRM₁₉₇ (diphtheria protein), adsorbed using aluminum sulfate.

Additional components of the Prevenar 13 vaccine include: sodium chloride, aluminum phosphate, polysorbate, succinic acid, and purified water.

Medicinal properties

The vaccine used to prevent pneumococcal infection includes active components, which are represented by pneumococcal polysaccharides. These components are obtained during laboratory research from Gram-positive microorganisms - Streptococcus pneumoniae, they are conjugated with a carrier protein of the diphtheria group (CRM197), adsorbed in aluminum phosphate.

Some time after the introduction of the vaccine, the process of producing antibodies directly to the capsular-type polysaccharides of Streptococcus pneumoniae of a number of serotypes is launched, as a result of which it is possible to provide a specific immune response to the infections provoked by them.

The use of the drug "Prevenar 13" for the purpose of vaccinating children of two months of age allows stimulating the work of the child's immunity, as a result of which it is possible to form an immune response after the first vaccination procedure, as well as revaccination. After the first three vaccinations, as well as the next revaccination procedure, a significant increase in the antibody level is observed. "Prevenar 13" stimulates the production of functional cells - antibodies to the serotypes included in this drug.

In patients aged 2-5 years, the formation of cells - antibodies to the serotypes of this drug occurs after the first vaccination. The immune response in this group of children is practically the same as in those babies who have passed the first stage of immunization.

Vaccination with Prevenar 13 can be carried out as a preventive measure to prevent diseases of an infectious origin, as well as otitis media in acute stage. Can be combined with IPV (polio), DPT.

Vaccines have the same safety index and level of immunogenicity, so the transition from one drug to another is possible at any stage of the vaccination procedure. In addition, Prevenar 13, in addition to 6 other serotypes, allows you to increase protection. child's body from IPI.

Release form

Price: from 1898 to 2021 rubles.

The vaccine against pneumococcal infection is produced in the form of a suspension of a rich whitish hue, intended for intramuscular injection, homogeneous. A slight cloudy sediment is allowed in the suspension. The vaccine is released in syringes for single use, in a cardboard package there may be 1 or 5 pieces.

Mode of application

The vaccine is given intramuscularly directly into the lateral area in the upper thigh (recommended for children under 2 years of age). For babies from 2 years old, the vaccine is given in the deltoid muscle (shoulder region). A single dose for vaccination is 0.5 ml.

Immediately before inoculation, the syringe with the solution must be shaken until a homogeneous suspension is formed.

The vaccine "Prevenar 13" along with "Prevenar" is not intended for intravenous administration.

Children aged 2 months. - It is recommended to vaccinate for 5 years, taking into account the vaccination schedule. How many months to vaccinate a child, the pediatrician determines.

For children from 2 to 6 months

Children under six months of age are vaccinated three times during primary vaccination, the interval between vaccinations is at least 1 month. It is also possible to carry out two vaccinations during the primary immunization with a break of 2 months. Pediatricians usually recommend that the first vaccine be given to the child at 2 months. Then the second stage of vaccination (revaccination) is carried out once at 11-15 months. The scheme carried out is recommended for immunization of children against infections caused by pneumococci. How many months to undergo revaccination, it is better to agree with the pediatrician.

For children from six months in the case of the first vaccination

Babies 7 months old — 11 months do two vaccinations with a break of 1 month. A one-time revaccination is carried out in the second year of a child's life.

children preschool age from 2 to 5 years, the vaccine is given once.

From pneumococcal infection

If the vaccination is carried out primarily using Prevenar, a drug with similar characteristics, Prevenar 13, can be used during subsequent vaccination. It should be borne in mind that vaccination can only be completed with the drug "Prevenar 13". With a forced extension of the recommended interval between the administration of the drug, additional vaccination against pneumococcal infection is not needed.

During pregnancy and

The drug is not intended for immunization of adults. No information is available on the safety of this vaccine during pregnancy or breastfeeding.

Contraindications

Children should not be vaccinated in the following cases:

  • Excessive sensitivity to the components of the drug, as well as diphtheria toxoid
  • Viral infections and non-infectious diseases
  • Acute course of chronic diseases.

Precautionary measures

The reaction to vaccination may be different, therefore, in order to avoid complications after vaccination, it is worth staying under the supervision of a pediatrician for half an hour. Further control over the child's condition is carried out by parents at home.

It should be borne in mind that the children's pneumococcal vaccine does not stimulate the protection of the child's body against streptococcus serotypes.

The vaccine is not prescribed for vaccination in children who have serious disorders of the blood coagulation process, while intramuscular administration is not indicated. The possibility of vaccination in a particular case is determined by the attending physician when the expected benefit significantly exceeds possible risks for the health of the child, which are due to the introduction of the drug.

Impaired immunoreactivity, which is observed during immunosuppressive therapy for HIV, can provoke a decrease in the production of antibodies to vaccine components. The issue of vaccinating a child who is at high risk is decided during a consultation with a pediatrician.

The contents of the injection syringe must not be mixed with other vaccines (eg polio, DTP) or placed in other containers.

Cross-drug interactions

You can administer the pneumococcal vaccine on the same day with other types of vaccines (except BCG). The list includes Hemophilus influenzae, live DTP, poliomyelitis (drops), Infanrix, vaccination takes place according to the established immunization schedule. The introduction of the drug is best done in different parts of the skin.

Side effects

Usually the vaccine is well tolerated by children, but after the child has been vaccinated, both local and general reactions can be observed:

  • Redness
  • Local swelling of the skin, induration
  • Pain (local reaction)
  • Hyperthermia (temperature rises above 38 ° C and lasts for a long time)
  • lethargy
  • Sleep quality disorder
  • Nervous excitability

Along with such signs, complications can be observed, namely, violations of the hematopoietic system, the central nervous system, the lymphatic system, the functioning of the digestive tract: lymphadenopathy, loss of appetite, hypersensitivity, stool change, convulsive states, urge to vomit.

If you got up heat body after having been vaccinated, it is necessary to give the child an antipyretic drug. The child's body temperature may rise for the first few days after vaccination.

Overdose

The probability of an overdose with Prevenar is very low, complications are unlikely, since the drug is produced in a syringe containing a dosage for one use.

Terms and conditions of storage

The shelf life of Prevenar is 3 years.

Analogues

Sanofi Pasteur, France
average price- 1322 rubles.

"Pneumo 23" is used to prevent the occurrence of ailments provoked by pneumococci. The main active ingredient of the drug is Vaccinum antipneumococcum. One dose of the vaccine (0.5 ml) is dispensed in a syringe placed in a cardboard box.

Pros:

  • A good remedy for the prevention of pneumococcal infection
  • You can vaccinate with the polio vaccine, DPT
  • Vaccination is indicated for children diagnosed with diabetes mellitus.

Minuses:

  • High price
  • Vaccination with the drug "Pneumo 23" is carried out from the third year of a child's life
  • Local allergic reactions after vaccination are not excluded, fever body during the first few days.

Synflorix

GlaxoSmithKline, Belgium
Price from 1500 to 1680 rubles.

"Synflorix" is indicated for the vaccination of infants from 6 weeks of age to 5 years of age in order to prevent invasive diseases provoked by streptococcus serotypes. Synflorix is ​​combined with IPV (poliomyelitis), DTP. Produced as a suspension for intramuscular injections, each package contains a syringe with a dose for one use.

Pros:

  • "Synflorix" is indicated for vaccination of babies from two months of age
  • Complications and local allergic reactions are rare.

Minuses:

  • After vaccination, body temperature may rise slightly
  • Vaccination up to 2 years
  • Quite problematic to find in the pharmacy network.

Producer: "NPO Petrovax Pharm" Russia

ATC code: J07AL02

Farm group:

Release form: Liquid dosage forms. Suspension for injection.



General characteristics. Composition:

Composition per dose (0.5 ml):
Active substances:
Pneumococcal conjugates (polysaccharide - CRM197):

  • Serotype 1 polysaccharide 2.2 mcg
  • Serotype 3 polysaccharide 2.2 mcg
  • Serotype 4 polysaccharide 2.2 mcg
  • Serotype 5 polysaccharide 2.2 mcg
  • Polysaccharide serotype 6A 2.2 mcg
  • Polysaccharide serotype 6B 4.4 mcg
  • Polysaccharide serotype 7F 2.2 mcg
  • Polysaccharide serotype 9V 2.2 mcg
  • Serotype 14 polysaccharide 2.2 mcg
  • Oligosaccharide serotype 18C 2.2 mcg
  • Polysaccharide serotype 19A 2.2 mcg
  • Polysaccharide serotype 19F 2.2 mcg
  • Polysaccharide serotype 23F 2.2 mcg
  • Carrier protein CRM197 ~32 µg

Excipients:
aluminum phosphate - 0.5 mg (in terms of aluminum 0.125 mg), sodium chloride - 4.25 mg, succinic acid - 0.295 mg, Polysorbate 80 - 0.1 mg, water for injection - up to 0.5 ml.

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


Pharmacological properties:

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

According to the WHO recommendations for new pneumococcal conjugate vaccines, the equivalence of the immune response when using the Prevenar® 13 and Prevenar® vaccines was assessed using a combination of three independent criteria: the percentage of patients who reached the concentration of specific IgG antibodies of 0.35 µg/ml; geometric mean concentrations of immunoglobulins (IgG GMC) and opsonophagocytic activity of bactericidal antibodies (OFA titer 1:8). The introduction of Prevenar® 13 causes the development of an immune response to all 13 vaccine serotypes, equivalent according to the above criteria to the vaccine Prevenar®. For adults, a protective level of anti-pneumococcal antibodies has not been determined and serotype-specific OFA is used.

The vaccine Prevenar® 13 includes up to 90% of all serotypes that cause invasive pneumococcal infections(IPI), including those resistant to antibiotic treatment. Observations conducted in the USA since the introduction of the 7-valent conjugate vaccine Prevenar® suggest that the most severe cases of invasive disease are associated with the action of the serotypes included in Prevenar® 13 (1, 3, 7F and 19A), in particular serotype 3 directly associated with necrotizing pneumonia.

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

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

After the introduction of two doses during the primary vaccination of Prevenar® 13 as part of the mass immunization of children in the same age group, there is also a significant increase in antibody titers to all components of the vaccine, but the level of IgG0.35 μg / ml for serotypes 6B and 23F was determined in a smaller percentage of children. At the same time, the concentration of antibodies after the introduction of the booster dose of Prevenar® 13, compared with the concentration of antibodies before the introduction of the booster dose, increased for all 13 serotypes. The formation of immune memory is shown for both of the above vaccination schemes. The secondary immune response to a booster dose in children of the second year of life when using three or two doses in a series of primary vaccinations is comparable for all 13 serotypes. Prevenar® 13 contains seven serotypes in common with Prevenar® vaccine and the CRM197 carrier protein. The comparative identity of both vaccines in terms of immunogenicity and safety profile allows switching from Prevenar® to Prevenar® 13 at any stage of child vaccination, and the additional 6 serotypes in Prevenar® 13 provide wider protection against IPD.

Indications for use:

Prevention of diseases caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (including bacteremia, pneumonia and acute) in children aged 2 months - 5 years.
prevention of pneumococcal diseases (including pneumonia and invasive diseases) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in adults aged 50 years and older.


Important! Get to know the treatment

Dosage and administration:

The vaccine is administered intramuscularly - into the anterolateral surface of the thigh (for children under 2 years old) or into the deltoid muscle of the shoulder (for persons over 2 years old), in a single dose of 0.5 ml.
Before use, the Prevenar® 13 vaccine syringe must be shaken well until a homogeneous suspension is obtained. Do not use if foreign particles are detected during inspection of the contents of the syringe, or the contents look different than in the Description section of this instruction.
Do not inject Prevenar® 13 intravenously, intradermally and intramuscularly into the gluteal region!:

Vaccination schedule:
Age from 2 to 6 months::
A series of three primary vaccinations: 3 doses of Prevenar® 13 are administered with intervals between injections of at least 1 month. The first dose can be administered to children from the age of 2 months. Revaccination is carried out once every 11-15 months. The scheme is used in the implementation of individual immunization of children against pneumococcal infection.

A series of two primary vaccinations: administer 2 doses of Prevenar® 13 with an interval between injections of at least 2 months. The first dose can be administered to children from the age of 2 months. Revaccination is carried out once every 11-15 months. The scheme is used in the implementation of mass immunization of children against pneumococcal infection.

For children who have not been vaccinated in the first 6 months of life, the introduction of Prevenar® 13 is carried out according to the following schemes:
Age from 7 to 11 months: two doses with an interval between injections of at least 1 month. Revaccination is carried out once in the second year of life.
Age from 12 to 23 months: two doses with an interval between injections of at least 2 months.
Age 2 to 5 years (inclusive): once If vaccination is started with Prevenar® 13, it is recommended that it be completed with Prevenar® 13 as well.

If you are forced to increase the interval between injections of any of the above vaccination courses, the introduction of additional doses of Prevenar® 13 is not required.
Children previously vaccinated with Prevenar®
Pneumococcal vaccination initiated with Prevenar® 7-valent vaccine may be continued with Prevenar® 13 at any stage of the immunization schedule.

Persons over 50
In adults, including patients previously vaccinated with pneumococcal polysaccharide vaccine, Prevenar® 13 is administered as a single dose.
The need for revaccination has not been established.

Application Features:

Given the rare cases of anaphylactic reactions, the vaccinated patient after vaccination should be under medical supervision for at least 30 minutes. Immunization sites should be provided with anti-shock therapy.

When deciding to vaccinate a child with severe prematurity (28 weeks' gestation), especially those with a history of respiratory immaturity, it must be taken into account that the benefits of immunization against pneumococcal infection in this group of patients are especially high and vaccination should not be refused or tolerated. terms. However, due to the potential risk of apnea associated with the use of any vaccine, the first vaccination with Prevenar® 13 is recommended in a hospital under medical supervision (at least 48 hours).

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

Prevenar® 13 provides protection only against those serotypes of Streptococcus pneumoniae that are included in its composition, and does not protect against other microorganisms that cause invasive diseases, pneumonia or otitis media. In patients with impaired immunoreactivity, vaccination may be accompanied by a reduced level of antibody formation.

There is limited evidence that Prevenar® 13's precursor, the seven-valent vaccine Prevenar®, elicits an adequate immune response in children under 6 months of age with sickle cell anemia, with a safety profile similar to that of Prevenar® in non-vaccinated children. high risk groups.

Currently, there are no data on the safety and immunogenicity of the vaccine in patients at high risk for invasive pneumococcal infections (for example, in patients with congenital or acquired spleen dysfunction, HIV infection, malignant tumors, after transplantation of a strain of hematopoietic stem cells, nephrotic syndrome). The decision to vaccinate high-risk patients should be made on an individual basis.

High-risk children under 2 years of age should be primed with Prevenar® 13 according to age. When children 2 years of age or older who are at high risk (eg, sickle cell anemia, asplenia, HIV infection, chronic disease, or immunological dysfunction) and who have previously received courses of Prevenar® 13 vaccination are given 23 -valent pneumococcal polysaccharide vaccine, the interval between vaccines should be at least 8 weeks.

Immunization against pneumococcal infection in adults is desirable to start with Prevenar® 13.

Due to the fact that the cause of the development of otitis media can be a variety of pathogens (viruses, bacteria, fungi, mixed infections), and not just pneumococci included in Prevenar® 13 serotypes, the estimated preventive efficacy of Prevenar® 13 against otitis media may be less expressed in comparison with the efficiency for invasive diseases.

Due to the higher risk of developing febrile reactions, children with convulsive disorders, including those with a history of febrile seizures, and also receiving Prevenar® 13 concomitantly with whole cell pertussis vaccines, it is recommended prophylactic prescription antipyretics.

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

Side effects:

The safety of Prevenar® 13 has been studied in healthy children (4429 children/14267 vaccine doses) aged 6 weeks to 11-16 months. In all studies, Prevenar® 13 was used simultaneously with other vaccines recommended for this age.
In addition, the safety of Prevenar® 13 was evaluated in 354 children aged 7 months and over. up to 5 years of age who have not previously been vaccinated with any of the pneumococcal conjugate vaccines.
The most commonly reported adverse reactions were injection site reactions, fever, irritability, decreased appetite, and sleep disturbance.
In older children, during the primary vaccination with Prevenar® 13, a higher frequency of local reactions was observed than in children of the first year of life.

Individuals aged 65 years and older had fewer side effects, regardless of previous vaccinations. However, the frequency of reactions was the same as in the younger population.

The adverse reactions listed below are classified by organs and systems, as well as in accordance with the frequency of their manifestation in all age groups.

The frequency of adverse reactions was determined 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 research Prevenar® 13 in children
General and local reactions:

Very common: hyperthermia up to 39 ° C; irritability; hyperemia of the skin, pain, induration or swelling of 2.5-7.0 cm in size at the injection site; drowsiness, deterioration of sleep.
Frequent: hyperthermia above 39 ° C; soreness at the injection site, leading to a short-term limitation of the range of motion of the limb.
Infrequent: hyperemia of the skin, induration or edema larger than 7.0 cm at the injection site; tearfulness.
Rare: cases of hypotonic, hypersensitivity reactions at the injection site (urticaria, itching) *; flushes of blood to the face *.

Blood and lymphatic system:

Nervous system:

Gastrointestinal tract:

* - noted during post-marketing observations of the vaccine Prevenar®; can be considered as possible for Prevenar® 13.
Adverse reactions identified in clinical studies of Prevenar® 13 in adults

Gastrointestinal tract:

The immune system:

Skin and subcutaneous tissue:

General and local reactions:

In general, there were no significant differences in the incidence of side effects in adults previously vaccinated with 23-valent pneumococcal polysaccharide vaccine and not vaccinated with this vaccine.

The frequency of development of local adverse reactions was the same for people aged 50-59 years and people over 65 years old when vaccinated with Prevenar® 13, and the number of local adverse reactions did not increase when vaccinated simultaneously with inactivated influenza vaccine.

The frequency of common vaccine systemic reactions was higher when Prevenar 13 was co-administered with inactivated influenza vaccine compared with inactivated influenza vaccine alone ( headache, rash, decreased appetite, joint and muscle pain) or Prevenar® 13 alone (headache, fatigue, chills, decreased appetite and joint pain).

Interaction with other drugs:

Data on the interchangeability of Prevenar® and Prevenar® 13 with non-CRM197-based pneumococcal conjugate vaccines are not available.

With simultaneous vaccination with Prevenar® 13 and other vaccines, injections are made in different parts of the body.

Children aged 2 months to 5 years
Prevenar® 13 is combined with any other vaccines included in the immunization schedule for children in their first years of life. Prevenar® 13 can be administered to children simultaneously (on the same day) with any of the following antigens, which are part of both monovalent and combined vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated polio, hepatitis B, measles, mumps, rubella and chickenpox- without changes in reactogenicity and immunological parameters.

Persons aged 50 and over
Prevenar® 13 can be administered simultaneously with a trivalent inactivated influenza vaccine.
Co-administration 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 not infectious diseases exacerbation of chronic diseases. Vaccination is carried out after recovery or during remission.

PREGNANCY AND BREASTFEEDING
There are no data on the use of Prevenar® 13 during pregnancy. It is not known whether Prevenar® 13 is excreted in breast milk.

Overdose:

An overdose of Prevenar® 13 is unlikely because the vaccine comes 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.

Leave conditions:

On prescription

Package:

Suspension for intramuscular injection 0.5 ml/dose. 0.5 ml in a 1 ml syringe made of transparent colorless glass (type I).

5 syringes in a plastic package sealed with plastic wrap. 2 plastic packs and 10 sterile needles, together with instructions for use, in a cardboard box.

When packing NPO Petrovax Pharm LLC, Russian Federation:
1 syringe and 1 sterile needle in a plastic package sealed with plastic wrap. 1 plastic package with instructions for use in a cardboard box.


Vaccine against pneumococcal infection

Pneumococcal disease includes a group of serious diseases such as meningitis, bacteremia and pneumonia, as well as milder but more common diseases such as sinusitis and otitis media. The causative pathogen Streptococcus pneumoniae is often present as colonies in the human nasopharynx, from where it spreads, as a rule, by airborne droplets. Infants and young children are believed to be the main reservoir of this pathogen, with varying degrees of nasopharyngeal carriage ranging from 27% in developed countries to 85% in developing countries.

There are over 90 serotypes of S. pneumoniae. The distribution of disease-causing serotypes varies with age, clinical manifestations disease, severity of course, geographic location and time. Prior to the introduction of pneumococcal conjugate vaccines, serotypes 6-11 were associated with 70% or more of invasive pneumococcal disease (IPI) occurring in children worldwide. IPI is usually defined as a disease associated with the shedding of pneumococcus from normally sterile human blood or following spread of the pathogen by blood flow from other parts of the body, such as in meningitis or septic arthritis; this does not extend to places such as the middle ear, where the infection spreads directly from the nasopharynx.

Most diseases are sporadic. Outbreaks of pneumococcal disease are uncommon, but can occur in closed communities, such as nursing homes, children's day hospitals, and other institutions of this kind.

However, large outbreaks of meningitis caused by serotype 1 have been reported in the African meningitis belt. Of the 8.8 million children under 5 who died in 2008, WHO estimates that 476 000 (333 000 – 529 000) deaths were due to pneumococcal disease. Morbidity and mortality rates are higher in developing than in economically developed countries; most deaths occur in Africa and Asia.

In Europe and the USA, S. pneumoniae is estimated to cause approximately 30-50% community-acquired pneumonia(SAR) requiring hospitalization of adults.

In many countries, the routine use of pneumococcal conjugate vaccines has drastically reduced the incidence of IPD, and in some areas, IPD caused by vaccine serotypes of the bacterium has virtually disappeared, even among age groups that were not targeted by the immunization program (herd immunity effect).

S.pneumoniae is a gram-positive encapsulated diplococcus. The polysaccharide capsule of the bacterium is an essential virulence factor in more than 90 pneumococcal serotypes, which are defined based on differences in the composition of this capsule. In general, infection-induced immunity is serospecific, but cross-protection among related serotypes can occur. While a wide variety of serotypes cause non-invasive diseases such as otitis media and sinusitis, serotypes 1, 5, 6A, 6B, 14, 19F, and 23F commonly cause IPD in children under 5 years of age. Serotypes 1, 5 and 14 together across all regions are associated with 28-43% of FDI and 30% of FDI in 20 of the world's poorest countries; serotypes 23F and 19F are responsible for 9-18% of IPD cases worldwide. Serotype 18C is widespread in regions with a large number high-income countries (i.e. Europe, North America and Oceania). Some serotypes, such as 6B, 9V, 14, 19A, 19F and 23F, are probably more associated with drug resistance than others.

Laboratory diagnosis of S. pneumoniae based on isolation of the virus by culture can be performed in most clinical microbiology laboratories, although pre-treatment with antibiotics, improper sample handling and transport, or use of inappropriate culture media may result in failure of isolation of the microorganism. Some of the observed geographic variation in serotype prevalence may be due to factors including differences in patient selection, frequency of use and quality of blood culture media, pneumococcal immunization programs, and antibiotic policy.

Pneumococcal infection can affect various systems organism, which causes the occurrence of a certain number of disease syndromes. Although temporary colonization on the nasopharyngeal mucosa, which is the primary site of infection, rarely becomes diseased, certain pneumococcal serotypes can occasionally enter the blood stream, causing bacteremia and possibly infection of secondary organs such as the brain, leading to meningitis. In other cases, the direct spread of the pathogen from the nasopharynx can cause diseases such as otitis media or sinusitis. Pneumonia often occurs when pneumococcus is inhaled from the nasopharynx. When the occurrence of pneumonia is associated with bacteremia, the disease is classified as IPD.

Due to the high reliability of microbiological diagnosis, the incidence of IPD is often used as an estimate of the incidence of acute pneumococcal infection in general. On average, about 75% of IPD cases and 83% of pneumococcal meningitis cases occur in children under 2 years of age, but these rates vary considerably, as does the prevalence of cases in age group up to 2 years. Between 8.7% and 52% of cases of pneumonia occur in infants under 6 months of age.

The case fatality rate for IPD can be high, ranging from 20% for septicemia to 50% for meningitis in developing countries. Mortality rates are highest among young children. Even in industrialized countries total score mortality in pneumococcal bacteremia can reach 15-20% among adults and 30-40% among the elderly, despite appropriate antibiotic therapy and intensive treatment. Among those who have recovered from meningitis, 58% of cases have long-term neurological consequences, such as hearing loss, mental disorders and movement disorders and seizures.

Risk factors for pneumonia, including pneumococcal pneumonia in infants and young children, are lack of breastfeeding, alimentary violations, indoor air pollution. In addition to the high incidence among children under the age of 2 years, the risk of pneumococcal infection is increased among the elderly (over 65 years of age) and among those who abuse alcohol and tobacco. This risk is also increased among people with chronic diseases such as cardiovascular disease, lung disease, diabetes or asplenia, or other conditions that suppress the immune system, such as advanced HIV infection.

The development of resistance to commonly used antibiotics such as penicillin, macrolides, cephalosporins and co-trimoxazole is a serious problem in some parts of the world. However, as a result of the widespread introduction of immunization against pneumococcal infection, there has been a decrease in the circulation of drug-resistant strains.

A definitive diagnosis of pneumococcal infection can be made by isolating the organism from blood or other normally sterile body components such as cerebrospinal fluid, but etiologic diagnosis is problematic in cases of pneumococcal pneumonia that is not accompanied by bacteremia.

Vaccines have been used to prevent pneumococcal infections for over 30 years. There are currently two different types of pneumococcal vaccines on the market:

(1) 23-valent pneumococcal polysaccharide vaccine (PPV23), which has been available since 1980, and

(2) two pneumococcal conjugate vaccines available on the market since 2009,

Prevenar (instruction for the vaccine)

Recently, among mothers, the fashion for a vaccine has gone Prevenar. Parents are sure that after this vaccine their children are not afraid of otitis media, meningitis, etc. Usually no one even tries to read the instructions before vaccination. For those who care about what they inject their child as part of the vaccine Prevenar publish instructions. Be sure to read up on the side effects of the drug.

The choice must be informed!

suspension for intramuscular injections 0.5ml/dose 1dz

Wyeth Pharmaceutical Division of Wyeth Holdings Corporation (USA)

International non-proprietary name

Released by prescription

  • Pneumococcal conjugates (polysaccharide + CRM197):
  • Polysaccharide serotype 6B
  • Polysaccharide serotype 9V
  • Polysaccharide serotype 14
  • Oligosaccharide serotype 18C
  • Polysaccharide serotype 19F
  • Polysaccharide serotype 23F
  • Polysaccharide serotype 9V 2 mcg
  • Polysaccharide serotype 14 2 mcg
  • Polysaccharide serotype 18C 2 mcg
  • Polysaccharide serotype 23F 2 mcg
  • Serotype 4 polysaccharide 2 mcg
  • Polysaccharide serotype 6B 4 mcg
  • Polygosaccharide serotype 18C 2 mcg
  • Polysaccharide serotype 19F 2 mcg
  • Polysaccharide serotype 23F 2 mcg

    The introduction of the vaccine causes the production of antibodies to the capsular polysaccharides of Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, providing specific protection of the body from the infections they cause. In children of the first year of life, starting from 2 months of age, using various vaccination schedules, the formation of a protective immune response after a series of primary vaccinations and a secondary immune response to the last dose, i.e. during revaccination. After the introduction of three doses at the primary vaccination and subsequent revaccination, a significant increase in the level of antibodies was noted. In children aged 2 to 5 years, a pronounced formation of antibodies to all vaccine serotypes is observed after a single injection, while the immune response almost coincided with that in children of the first two years of life after a series of primary immunizations.

    Hypersensitivity during the previous administration of the vaccine, hypersensitivity to excipients and / or diphtheria toxoid; acute infectious and noncommunicable diseases, exacerbation of chronic diseases (in these cases, vaccination is carried out after recovery or in remission).

    General and local reactions: reaction at the injection site (redness, induration / swelling, pain / soreness); hyperthermia from 38°C and above (per rectum measurement), irritability, drowsiness, restless sleep, tearfulness, swelling/induration of the injection site and redness of more than 2.4 cm, soreness at the injection site, leading to a short-term restriction of the range of motion of the limb, hyperthermia> 39°C (measurement per rectum), episodes of hypotension-hyporeactivity, hypersensitivity reactions at the injection site ( dermatitis, itching, urticaria). Hematopoietic and lymphatic system: regional lymphadenopathy. Immune system: hypersensitivity reactions, including anaphylactic shock, angioedema, Quincke's edema, bronchospasm, dyspnea. Nervous system: convulsions, including febrile convulsions. Gastrointestinal tract: vomiting, diarrhea, loss of appetite. Skin and subcutaneous tissue: urticaria, erythema multiforme.

    The vaccine can be administered to children simultaneously (on the same day) with other vaccines included in the National Immunization Schedule (with the exception of BCG), as well as with Hemophilus influenzae type b (Hib) vaccine and Infanrix hexavalent vaccine, according to the prescribed immunization schedule. Vaccines must always be administered in different parts of the body. Prevenar is supplied in a ready-to-use syringe, the contents of which should not be transferred to another container and mixed with others. medicines.

    Symptoms: increased side effects. Treatment: symptomatic.

    Method of application and dosage

    The vaccine is administered only intramuscularly in the anterolateral surface of the thigh (children under 2 years old) or in the deltoid muscle of the shoulder (children over 2 years old). Do not administer Prevenar intravenously!

    The need for any additional dose after each of the above immunization schedules has not been established.

    Prevenar is not for use in adults. There are no data on the safety of Prevenar during pregnancy and lactation. Vaccine administration should be delayed if the patient has acute illness accompanied by moderate or severe hyperthermia.

    In the event of the development of possible rare cases of anaphylactic reactions within at least 30 minutes after the introduction of the vaccine, the patient should be under appropriate medical supervision. Due to the potential risk of apnea, it should be possible to observe the patient's condition for 48-72 hours during the primary vaccination series in children under 28 weeks of age, especially in cases of immature respiratory organs in history.

    Prevenar does not provide protection against serotypes of Streptococcus pneumoniae that are not included in the vaccine, as well as against other microorganisms that cause invasive diseases or otitis media.

    During revaccination, a slight decrease in the content of antibodies to Hib was described, while maintaining a protective level. A non-permanent decrease in response to pertussis antigens as well as to inactivated polio vaccine (IPV) has been described. Limited data are available on the co-administration of Prevenar with the measles, mumps and rubella vaccine and the varicella vaccine.

    Prevenar should not be given to children with thrombocytopenia or other bleeding disorders for whom intramuscular injections are contraindicated, unless the potential benefit of the vaccine far outweighs the risk of the vaccine. The use of the Prevenar vaccine cannot replace standard diphtheria immunization. The CRM197 carrier protein is a genetically modified non-toxic form of diphtheria toxin.

    HIV infection or other causes, there may be a decrease in the formation of antibodies in response to vaccination. There are no data yet on the safety and immunogenicity of the vaccine in children from other high-risk groups for invasive pneumococcal disease (for example, children with hereditary or acquired splenic dysfunction, HIV infection, malignant neoplasms, nephrotic syndrome). The decision to vaccinate high-risk children should be made on an individual basis.

    Antipyretic prophylaxis is recommended for all children receiving Prevenar in conjunction with whole cell pertussis vaccines because of the increased risk of febrile reactions; as well as children with convulsive disorders, including a history of "febrile" convulsions.

    Store at a temperature of 2 to 8 gr. C. Do not freeze.

    Prevenar (or Prevnar) is one of Wyeth's most widely used vaccines in the world and was recently acquired by Pfizer.

    The semivalent conjugate vaccine Prevnar (or Prevenar) is designed to protect against seven strains of pneumococci. It was developed by Wyatt and licensed in the United States of America and over 70 other countries. However, this vaccine does not include two serotypes (types 1 and 5) that cause a significant proportion of pneumococcal infections in developing countries.

    Wyatt has also completed trials of a nine-valent conjugate vaccine including serotypes 1 and 5.

    The 7-valent vaccine Prevenar (Prevnar) is also used in Russia. According to the manufacturer, it protects against 7 strains of pneumococcus and is intended for the prevention of diseases caused by Streptococcus pneumoniae, including sepsis, meningitis, pneumonia, bacteremia and acute otitis media in children aged 2 months to 5 years.

    But the Prevnar (Prevenar) vaccine is banned in the Netherlands

    The Dutch authorities have temporarily banned the use of Pfizer's Prevnar (Prevenar) vaccine for the prevention of pneumococcal infections after three children died within 10 days of vaccination.

    A representative of the Netherlands Health Institute RIVM said that on average, 5 to 10 deaths are recorded among children after vaccination with Prevenar. The exact causes of death of children are still unknown. An investigation is underway.

    Pfizer spokesperson Gwen Fischer said preliminary results from the company's own investigation found no link between the deaths of children and vaccinations. The company announced a temporary "quarantine" for the use of this batch of vaccine (about 110,000 doses).

    Vaccination Prevenar 13 - what is it for, what vaccination scheme for children is provided for in the instructions for use?

    To date, vaccination of the population is one of the most powerful ways prevention set dangerous diseases. In addition to mandatory (scheduled) vaccinations, additional ones are sometimes used, as a rule, in the case of epidemic indications. Until recently, these included vaccination against pneumococcal infection. Since 2015, she has been included in national calendar vaccination, but its use is advisory. Today, the most popular vaccine is Prevenar, which is considered the most effective.

    Vaccine Prevenar 13 against pneumococcal infection

    The composition and form of release of the vaccine

    The vaccine contains a number of pneumococcal conjugates, or rather, 13. This is the name of artificial molecules that combine two particles with different properties, that is, the vaccine is “not live”. One dose of the drug (0.5 ml) contains hybrid molecules - polysaccharides of serotypes 1, 2, 3, 4, 5, 6, 7, 9, 14, 19, 23, serotype 18 oligosaccharide and carrier protein.

    The Prevenar vaccine also contains excipients:

  • aluminum salt of phosphoric acid;
  • sodium chloride;
  • succinic acid;
  • polysorbate;
  • water.
  • What does Prevenar protect against?

    Many parents see no point in vaccinating their child "against pneumonia". However, this is not the only indication of the drug. What else does Prevenar protect against? This vaccine activates immunity against pneumococcal (Streptococcus pneumoniae) infection.

    Pneumococci are bacteria of the genus Streptococcus, which cause a lot of dangerous diseases. Among them:

  • pneumonia - inflammation lung tissue with damage to the alveoli;
  • acute otitis media;
  • purulent meningitis;
  • endocarditis (damage to the inner lining of the heart);
  • pleurisy (inflammation of the pleura - the surface layer of the lungs);
  • arthritis.
  • In children, pneumococcal infection is usually a complication of some disease. Sometimes pneumococcal pneumonia is diagnosed when the child has had SARS or the flu. These bacteria often cause exacerbations chronic bronchitis. Also, otolaryngologists note the occurrence of otitis media caused by Streptococcus pneumoniae against the background of rhinitis.

    Who is vaccinated?

    Vaccination is indicated for several population groups. Consider the cases in which the Prevenar vaccine is prescribed for babies:

    • all children over the age of 2 months;
    • premature babies;
    • frequently ill children;
    • children with chronic diseases diabetes, asthma, work disorders of cardio-vascular system, HIV-infected.
    • Adults are not usually vaccinated. This is due to the fact that they have an immune system that inhibits pneumococci as soon as they enter the body. However, among the adult population, there are several risk groups that are indicated for vaccination:

    • The elderly. In developed countries, people over the age of 65 are required to be vaccinated.
    • Patients with extensive liver damage (cirrhosis), endocrine diseases (diabetes mellitus), kidney disorders, cardiovascular abnormalities.
    • Those who have blood pathologies (sickle anemia).
    • HIV-infected.
    • Persons who are constantly forced to stay in crowded places.
    • There are few contraindications for this vaccine. These include:

    • individual intolerance to one of the components of the drug;
    • acute phase of SARS, influenza;
    • childhood infectious diseases (chickenpox, measles, etc.).
    • Also, Prevenar should not be vaccinated if the child feels unwell, has a slightly elevated temperature. In addition, do not get vaccinated if the baby has an exacerbation of a chronic illness.

      The child is vaccinated in the clinic or, at the request of the parents, in a private medical office. The vaccine is sold in a sealed package, so you can buy it at a pharmacy.

      According to the instructions, the suspension should be shaken before administration to get rid of possible sediment. Do not administer the vaccine if the solution is cloudy or has a different white color. Consider the scheme of administration of the drug, as well as the dosage depending on the age of the children.

      Prevenar is administered intramuscularly. Consider where exactly the injection is made:

    • Babies under the age of 2 years - in the anterolateral surface of the thigh, since it is in this place that there are fewer nerve endings and adipose tissue that prevents active absorption of the drug.
    • It is not recommended to administer the drug to infants in the gluteal muscle in order to avoid damage to the sciatic nerve.
    • Babies older than 2 years old are injected into the deltoid muscle of the shoulder.
    • The manufacturer warns that the vaccine should not be administered intravenously.
    • If Prevenar is co-administered with pertussis vaccine, prophylactic use of antipyretics is recommended, as there is a possibility of febrile reactions.

      Scheme and terms of vaccination of the child

      The schedule and timing of vaccination with Prevenar are based on official recommendations. If the child is not more than six months old, the schedule implies a 3-fold injection of the vaccine and subsequent revaccination. Babies from six months to a year are vaccinated twice. Children older than 13 months are vaccinated 1 or 2 times according to a different schedule. The table shows all options for administering the vaccine.

      Premature babies, babies up to 28 weeks, as well as those who have a history of the diagnosis of "underdevelopment of the respiratory system", should be observed after vaccination for at least 2-3 days. This is associated with the risk of sleep apnea.

      How to prepare your baby for vaccination?

      Preparation for vaccination is not required. Usually, before administering the vaccine, the doctor examines the child, measures the temperature. If no deviations are found, the baby is vaccinated.

      However, some pediatricians recommend taking a blood test before vaccination to make sure that there are no hidden secrets in the child's body. inflammatory processes. Since Prevenar 13 can cause allergies, children with allergies are advised to prepare more thoroughly - start taking antihistamines three days before the procedure and the same amount of time to continue drinking them after it.

      How is the vaccination tolerated by the child?

      Any vaccination can cause an inadequate reaction from the body. Vaccination Prevenar 13 is no exception. At the same time, pediatricians note that in most cases, vaccination is well tolerated. However, it is worthwhile to find out what side effects from Prevenar 13, as well as possible complications.

      Consider the normal reaction of the body, why complications may arise, and how to behave in case of atypical symptoms.

      Normal reaction and side effects

      Prevenar is a modern pneumococcal vaccine that provides the formation of antibodies to all 13 serotypes. During this period (about a week), slight malaise and soreness at the injection site are possible. Such reactions of the body are considered quite normal and happen infrequently. An increase in temperature is noted in 1% of the vaccinated, a local reaction - in 5%.

      It is worth remembering other possible side effects of the vaccine. How long does it take for them to show up? As a rule, if there are no problems within three days after vaccination, you can breathe easy.

      Consider the likely side effects, as well as the right actions for parents:

    1. Sleep disturbance, irritability, loss of appetite. Worth the wait difficult period- the child's appetite and sleep will improve.
    2. Increasing the temperature to 39-40°C. In this case, the use of antipyretics - Paracetamol or Ibuprofen is recommended.
    3. Soreness at the injection site, complaints of restriction in the movement of the arm or leg. You can lubricate this area with Traumeel, Heparin, Troxevasin. You will have to consult a doctor if the problem has not disappeared on the third day.
    4. Seal at the injection site, tissue edema exceeding 7 cm in diameter. Pediatricians recommend lubricating this area with drugs to dissolve the tumor.
    5. Nausea. Absorbent agents are shown - Enterosgel, Polysorb, Smekta.
    6. Possible Complications

      They talk about complications after vaccination if you have to go to the doctors to stop the symptoms. Complications can occur for various reasons - a poor-quality vaccine, a violation of the rules for administering the drug, or an individual reaction of the body.

      Consider possible problems:

      1. An allergic reaction in the form of skin manifestations - a rash, itchy pink spots all over the body or in some areas. Similar situations arise when any component of the vaccine is intolerant.
      2. Anaphylactic shock, Quincke's edema, suffocation - this is also an allergic reaction that affects the respiratory system.
      3. Inflammation of the tissues at the injection site - swelling, induration, hyperemia.
      4. Seizures.
      5. Fever, joint pain, headache, weakness. All these symptoms resemble the onset of a viral disease.

      After vaccination, it is advisable not to leave the walls of the clinic for half an hour. This must be done if there is a possibility of allergic reaction. Further, it is important to monitor the condition of the child at home and, if necessary, call a doctor.

    7. For three days after the procedure, it is better not to take the child to public places. This is necessary in order to avoid infection with SARS, which can complicate the adaptation period and lead to unpredictable consequences. At the same time, it is allowed to walk with the baby on the street.
    8. If the baby receives complementary foods, a new product should not be introduced into his diet a week before and within 7 days after vaccination.
    9. With an increase in temperature and a local reaction (redness, thickening of tissues at the injection site), you can give the baby an antipyretic and antihistamine.
    10. If necessary, you can choose an analogue of the vaccine with an almost identical composition. Among them are the following:

      vseprorebenka.ru

      Pneumococcal vaccine "Pneumo 23"

      Sanofi Pasteur, France

    11. Release form: 1 syringe / 1 dose / 0.5 ml.
    12. Vaccination schedule: once for children from two years and adults.
    13. Revaccination not earlier than 3 years.

      Instructions for use

      Registration certificate holder:

      SANOFI PASTEUR, S.A. (France)

      ATX code: J07AL01 (Pneumococcus, purified polysaccharides antigen)

      Active ingredient: pneumococcal polysaccharide vaccine

      Ph.Eur. European Pharmacopoeia

      solution d / w / m and s / c injections 0.5 ml / 1 dose: syringes 1 dose

      reg. No: P N011092 dated 07/02/10 - Indefinitely

      Release form, composition and packaging

      Streptococcus pneumoniae polysaccharides (23 serotypes; 25 mcg of each serotype)

      1 dose - syringes (1) - contour plastic packaging (1) - cardboard packs.

      Clinico-pharmacological group: Vaccine for the prevention of diseases caused by Streptococcus pneumoniae

      Pharmacotherapeutic group: MIBP vaccine

      The scientific information provided is general and cannot be used to make a decision on the possibility of using a particular medicinal product.

      pharmachologic effect

      Highly purified polyvalent vaccine. It is a purified polysaccharide 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. Causes the formation of immunity to the specified serotypes of Streptococcus pneumoniae. Immunity is acquired 10-15 days after a single vaccination and persists for at least 5 years. After the introduction of this vaccine, seroconversion occurs in at least 90% of vaccinated individuals.

      Prevention of pneumococcal infections, especially infections respiratory tract, in persons from risk groups, starting from 2 years of age.

      The vaccine is administered s / c or / m. Primary vaccination is carried out with one dose of this vaccine once. Revaccinations are carried out every five years. The interval between revaccinations may be shortened in individuals at high risk or in patients receiving immunosuppressants.

      Possible weakness, a slight increase in body temperature, chills, headache (duration - no more than 24 hours); local reactions - redness, mild soreness or induration at the injection site.

      Contraindications for use

      Pronounced reaction to the previous administration of the vaccine; pneumococcal vaccination or previous pneumococcal infection (caused by one of the serotypes contained in the vaccine) up to 5 years before the planned vaccination with this vaccine.

      Use during pregnancy and lactation

      Although there is no evidence of adverse effects on the fetus when using this vaccine during pregnancy, vaccination of pregnant women at risk is not recommended.

      Vaccination is especially indicated for patients with sickle cell anemia, as well as those with asplenia who have undergone splenectomy or before splenectomy.

      With revaccination carried out earlier than the due date, severe local reactions may occur.

      In connection with the possibility of developing serious adverse reactions (such as the Arthus phenomenon), contraindications should be strictly observed during vaccination, and the benefits of vaccination should be evaluated. At the same time, it should be taken into account that the determination of the effectiveness of pneumococcal vaccination was carried out only in individuals from risk groups.

      Immunosuppressive therapy may reduce or completely suppress the immune response to the introduction of this vaccine.

      IN last years In the world there is an ambiguous attitude towards vaccinations. Despite the fact that universal vaccination against certain diseases has led to their almost complete disappearance, the ranks of opponents mandatory vaccinations are growing. This is facilitated by the widespread misconceptions regarding vaccination.

      Unknown infection is the main danger

      Intestinal infections, shaft tick-borne encephalitis and southern infections brought by Russians from vacations—such are the medical results of the summer.

      One of the most eminent infectious disease specialists in Russia, Academician Viktor Maleev, spoke about our smallest, but no less dangerous enemies.

      The national calendar of preventive vaccinations includes far from the most complete list vaccines in the world. When compiling it, a great many factors are taken into account, and not the last role.

      Comprehensive response to colds and flu

      With the onset of the cold season, the incidence of acute respiratory infections increases annually. viral infections(ARVI), influenza and other respiratory tract infections, at the peak of cold weather, acquiring epidemic proportions.

      SYNFLORIX™ vaccine for the prevention of pneumococcal infection (polysaccharide antigen) and untyped hemophilic infection, conjugated, adsorbed (SYNFLORIX™ pneumococcus eliminated polysaccharides antigen and Haemophilus influenzae, conjugated)

      GlaxoSmithKline Biologicals s.a. J07A L52

      susp. d / in. 1 vial dose monodose. 0.5 ml, No. 1

      susp. d / in. 1 dose syringe 0.5 ml, with 2 needles, No. 1

      susp. d / in. 1 dose syringe 0.5 ml, with needle, no. 1

      1 dose (0.5 ml) contains: 1 mcg of pneumococcal polysaccharide serotypes 1 1.2, 5 1.2, 6B 1.2, 7F 1.2, 9V 1.2, 14 1.2, 23F 1.2 and 3 µg each of pneumococcal polysaccharide serotypes 4 1.2, 18C 1.3 and 19F 1.4.

      1 adsorbed on aluminum phosphate - 0.5 mg Al 3+;

      3 conjugated with tetanus toxoid protein ≈ 8 mcg;

      No. UA/15363/01/01 from 08/15/2016 to 08/15/2021 By prescription DC

      Date added: 01/17/2018

      In the 2016 Compendium guide for this drug, the following information was provided

      1 adsorbed on aluminum phosphate - 0.5 mg Al 3+;

      2 protein D conjugated (obtained from a non-type strain haemophilus influenzae) ≈ 13 μg;

      4 protein-conjugated diphtheria toxoid≈ 5 µg.

      epidemiological data. The 10 pneumococcal serotypes included in this vaccine represent the major disease-causing serotypes in Europe, accounting for approximately 56-90% of invasive pneumococcal infections (IPIs) in children aged<5 лет. В этой возрастной группе серотипы 1; 5 и 7F является причиной 3,3-24,1% ИПИ в зависимости от страны и исследуемого периода.

      Pneumonia of various etiologies is the leading cause of childhood morbidity and mortality worldwide. Prospective studies have found that Streptococcus pneumoniae in 30-50% was the likely cause of pneumonia.

      Acute otitis media (AOM) is a common childhood disease of various etiologies. Bacteria may be responsible for 60-70% of clinical episodes of AOM. Streptococcus pneumoniae and untyped strain haemophilus influenzae are the most common causes of bacterial CCA worldwide.

      Effectiveness in clinical studies. In a multicentre, double-blind, cluster-randomized, phase III/IV controlled clinical trial in Finland (FinIP), children were randomized into 4 groups, according to two infant vaccination regimens: 2+1 (3rd and 5th month followed by booster dose at month 11) or 3+1 (months 3, 4, and 5 followed by a booster dose at month 11) to receive either Synflorix™ (2/3 clusters) or control vaccines against hepatitis (1/3 clusters). In tour cohorts (advance vaccination by age), children aged 7-11 months received the first dose of SYNFLORIX™ vaccine or a control vaccine against hepatitis B, in accordance with a two-dose regimen, followed by a booster dose, and children aged 12-18 months at the first vaccinations received two doses of SYNFLORIX™ vaccine or hepatitis A control vaccine. The median follow-up period from the first vaccination was 24-28 months for invasive disease, diagnosed nosocomial pneumonia, and outpatient antimicrobial treatment. During the cluster study, infant follow-up was up to 21 months to assess the effect on nasopharyngeal carriage.

      In a multicenter, randomized, double-blind, phase III clinical trial (Otitis Media and Pneumonia Clinical Trial - COMPAS), healthy infants aged 6-16 weeks received SYNFLORIX™ or a hepatitis B control vaccine at 2; 4 and 6 months followed by SYNFLORIX™ or hepatitis A control vaccine at 15-18 months of age.

      FDI. Cohort of infants aged<7 мес на момент зачисления

      Vaccine efficacy (in the FinIP study) or vaccine efficacy (in the COMPAS study) has been demonstrated in the context of preventing culture-confirmed cases of IPD due to vaccine pneumococcal serotypes (Table 1).

      Table 1 Prevention of IPI in infants who received at least 1 dose of SYNFLORIX™ vaccine (total cohort of vaccinated infants)

      EV, vaccine efficacy in a clinical trial of a vaccine (FinIP) or vaccine efficacy in a clinical trial (COMPAS); CI - confidence interval.

      1 During the FinIP study, other serotypes causing IPD included 7F (1 case in Synflorix™ 2+1 clusters), 18C, 19F, and 23F (1 case each in control clusters). During the COMPAS study, serotypes 5 (2 cases), 18C (4 cases) and 23F (1 case) were also detected in the control group in addition to serotypes 6B and 14. 2 Two groups of control infant clusters were pooled. 3p<0,0001. 4 p=0,0009.

      5 93.0% (95% CI 74.9–98.9; 2/14) regardless of primary regimen.

      Pneumonia. Efficacy of SYNFLORIX™ for the prevention of community-acquired pneumonia (CAP) of likely bacterial etiology was demonstrated in a per-protocol cohort (immunized with less than three doses of the primary regimen) (p≤0.002), as the primary target of the COMPAS study during a follow-up period of 38 weeks from study entry: 22.0% (95% CI 7.7-34.2) 240 cases/10295 subjects in the Synflorix™ arm compared with 304 cases/10201 subjects in the control arm.

      CAP of probable bacterial etiology was defined as radiologically confirmed cases of CAP or alveolar consolidation/pleural effusion on chest x-ray or without alveolar infiltrates, but with a CRP level ≥40 mg/l.

      The effectiveness of the vaccine in preventing CAP, probably of bacterial etiology with the presence of alveolar consolidation or pleural effusion, was 25.7% (95% CI 8.4-39.6) and in the prevention of clinically suspected CAP with referral for chest x-ray was 6.7 % (95% CI 0.7-12.3).

      In the FinIP study, the vaccine was 26.7% (95% CI 4.9-43.5) effective in reducing the incidence of hospital-diagnosed pneumonia in the 3+1 regimen for infants and 29.3% (95% CI 7.5- 46.3) according to the 2 + 1 scheme for babies. For round vaccination, vaccine efficacy was 33.2% (95% CI 3.0-53.4) in the cohort of children aged 7-11 months and 22.4% (95% CI -8.7 to 44.8) in a cohort of children aged 12-18 months.

      OSO. The efficacy of the vaccine in preventing AOM was assessed in the COMPAS study (Table 2).

      Table 2. CCA vaccine efficacy 1 in the COMPAS trial (according to protocol 2: 5989 participants)

      1 First episode; 2 follow-up period for a maximum of 40 months, starting from the 2nd week after the 3rd dose of the primary vaccination course; 3 are not statistically significant by a predefined test (one-tailed p=0.032). However, in all vaccinated cohorts, the effect of the vaccine in the context of clinical episodes of ACA was 19% (95% CI 4.4-31.4).

      In another multicenter, randomized, double-blind study (POET) conducted in the Czech Republic and Slovakia, infants received an 11-valent investigational vaccine (11Pn-PD) containing 10 serotypes of Synflorix™ (together with serotype 3, which has been shown to be effective), or a control vaccine according to the vaccination schedule at 3, 4, 5 and 12-15 months. The effectiveness of the vaccine is presented in table. 3.

      Table 3. OCA 1 vaccine efficacy in the POET study (according to protocol 2: 4907 participants)

      1 All episodes; 2 follow-up period for a maximum of 24 months, starting from the 2nd week after the 3rd dose of the primary vaccination course.

      In the POET study, the effectiveness of the 11Pn-PD vaccine in preventing the first episode of NCA due to vaccine serotypes was 52.6% (95% CI 35.0-65.5). The specific efficacy of serotypes against the first episode of CCA caused by serotypes 6B, 14 19F and 23F has been demonstrated.

      Effects on Antimicrobial Use

      In the total cohort of vaccinated infants in the FinIP study, Synflox™ vaccination reduced amoxicillin outpatient use by 7.9% (95% CI 2.0-13.4) in the 3+1 infant regimen and 7.5% (95% CI 0 ,9-13,6) - according to the 2 + 1 scheme for babies.

      Effect on nasopharyngeal carriage (NFN). The effect of SYNFLORIX™ vaccination on NFN was studied in the FinIP studies (5092 participants) and in the COMPAS study (1921 participants). In both studies, SYNFLORIX™ significantly reduced the carriage of vaccine serotypes (combined and singly 6B, 19F and 23F) with a tendency to increase after booster vaccination in the carriage of non-vaccine serotypes or serotypes that are not part of the NFN vaccine, resulting in reduction in total pneumococcal carriage.

      Post-registration pharmacovigilance. In Brazil, Synflorix™ was included in the National Immunization Program (NIP) in March 2010 for neonatal use in a 3+1 schedule with a round immunization program for children under 2 years of age. The case/control study reported a significant reduction in bacteriological or PCR-verified IPD from any vaccine serotype (83.8%; 95% CI 65.9–92.3) and IPD from serotype 19A (82. 2%, 95% CI 10.7-96.4).

      In Finland, SYNFLORIX™ was included in the NIP in September 2010 for use in newborns on a 2+1 schedule without a tour program. We assessed the relative reduction in the incidence of IPI in children aged ≤5 years during the first 3 years after the introduction of IPI. Before and after the introduction of the comparator NPI, there is a significant reduction in the incidence of any bacteriologically confirmed IPD (80%; 95% CI 72–85), IPI of any vaccine serotype (92%; 95% CI 86–95), and IPI due to serotype 19A (62%; 95% CI 20-85).

      Data on immunogenicity

      Immunological efficacy comparable to PCV7. In a direct comparison study with PCV7, the immunological efficacy of the SYNFLORIX™ vaccine was demonstrated to be comparable to PCV7. established by ELISA for all serotypes except 6B and 23F. For serotypes 6B and 23F, respectively, 65.9 and 81.4% of children vaccinated at age 2; 3 and 4 months reached the antibody detection threshold for ELISA 1 month after the third dose of SYNFLORIX™ compared to 79.0% and 94.1%, respectively, after three doses of PCV7.

      Immunogenicity in infants aged 6 weeks-6 months.

      . The immunogenicity of the Synflorix™ vaccine was evaluated in various clinical studies in Africa, Asia, Europe and America according to different schemes (6-10-14 weeks, 2-3-4, 3-4-5 or 2-4-6 months) . In many clinical studies, revaccination was performed.

      Primary vaccination schedule including 2 doses. In a clinical study, the immunogenicity of SYNFLORIX™ was evaluated following a 2- or 3-dose primary vaccination schedule. Although there was no significant difference between the two groups in terms of the proportion of subjects reaching the antibody threshold for ELISA, a lower proportion of subjects reaching the OPA threshold was observed for some vaccine serotypes, as well as for cross-reactive serotype 19A in subjects who used 2 -dose primary scheme. In both regimens, a response to revaccination was observed, indicating immunological preparation, for each vaccine serotype and serotype 19A.

      Immunogenicity in unvaccinated infants and children ≥7 months of age (round vaccination). During studies in pre-vaccinated children aged 7-11 months (using the 2+1 schedule) and children aged 12 months to 5 years (using the 2-dose regimen), the level of GMC antibodies determined by ELISA and OPA GMT for all vaccines serotypes and cross-reactive serotype 19A was identical to or higher than the level induced by the 3-dose primary series in infants.

      Immunogenicity in preterm infants. The immunogenicity of the Synflorix™ vaccine was assessed in very preterm and preterm infants (gestation period - 27-30 and 31-36 weeks, respectively), as well as in full-term infants (3 primary doses in 2; 4; 6 months with revaccination at 15-18 months) .

      After primary vaccination, for each vaccine serotype, the proportion of individuals with ELISA antibody concentrations ≥0.20 μg/mL and OPA titers ≥8 was identical, regardless of the degree of term.

      active immunization of infants and children aged 6 weeks to 5 years to prevent serotype pneumococcal disease Streptococcus pneumoniae 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F and cross-reactive serotype 19A (including sepsis, meningitis, pneumonia, bacteremia, and CCA), as well as infections caused by untyped haemophilus influenzae.

      the vaccine is administered intramuscularly.

      Children aged 6 weeks to 6 months

      Primary 3 dose schedule. The recommended vaccination schedule for optimal protection is 4 doses of 0.5 ml each. The primary regimen for infants consists of 3 doses, with the first dose usually administered at 2 months of age, with an interval of at least 1 month between doses. The first dose can be given as early as 6 weeks of age; The 4th dose is recommended not earlier than 6 months after the 3rd dose, preferably at the age of 12-15 months.

      Previously unvaccinated children over 6 months of age and children aged:

    14. 7-11 months: the vaccination schedule includes 2 doses of 0.5 ml with an interval of at least 1 month between doses; 3rd dose is recommended in the second year of life at least 2 months apart;
    15. 12 months-5 years: The vaccination schedule includes 2 doses of 0.5 ml with an interval of at least 2 months between doses.
    16. Individuals receiving their first dose of Synflorix™ are advised to complete the full course of immunization with Synflorix™.

      hypersensitivity to the active and excipients of the vaccine or to any carrier protein.

      As with other vaccines, administration of Synflorix™ should be delayed in individuals with acute febrile illness. However, the presence of mild, minor manifestations of infectious diseases, such as a cold, is not a reason to postpone vaccination.

      Approximately 22,500 healthy children and 137 preterm infants who received approximately 64,000 doses of SYNFLORIX™ vaccine during their primary vaccination participated in clinical trials. Approximately 19,500 healthy children and 116 preterm infants received a booster dose of SYNFLORIX™ during their second year of life. Safety was also assessed in 435 children aged 2-5 years, of whom 285 received 2 doses of Synflorix™. In all studies, the vaccine was used simultaneously with other vaccines recommended for children.

      In neonates, the most common adverse reactions after primary vaccination were injection site redness and irritability (41% vs. 55%). After administration of the booster dose, the most common adverse reactions were pain at the injection site and irritability (51% and 53%, respectively). Most of these reactions were mild to moderate in severity and did not last long.

      With the introduction of subsequent doses of the vaccine according to the primary vaccination schedule, no increase in the frequency or severity of adverse reactions was noted.

      Reactogenicity was higher in children simultaneously vaccinated with a whole-cell vaccine for the prevention of whooping cough.

      Reactogenicity was similar in both children under 12 months of age and over 12 months of age, except for pain at the injection site (39% under 12 months of age and >58% of children over 12 months of age). After vaccination with a booster dose in children over 12 months of age, injection site reactions (rash and abnormal crying) are more likely than in infants at primary vaccination.

      Adverse reactions (for all age groups) that have been reported are divided into categories depending on the frequency of occurrence: very often (≥1 / 10); often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10 000, <1/1000), очень редко (<10 000).

      compendium.com.ua

      Vaccination against pneumococcal infection Prevenar

      ATTENTION! do not administer intravenously

      Instructions for use of the vaccine Prevenar (short)

      The pneumococcal polysaccharide conjugated adsorbed vaccine includes seven active substances, which are pneumococcal polysaccharides obtained from gram-positive bacteria Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F, individually conjugated with diphtheria carrier protein CRM197, and adsorbed on aluminum phosphate.

      Vaccine to prevent pneumococcal infections

      The introduction of the Prevenar vaccine causes the production of antibodies to the capsular polysaccharides of Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, providing specific protection of the body against the infections they cause.

      In children of the first year of life, starting from 2 months of age, using various vaccination schedules, the formation of a protective immune response after a series of primary vaccinations and a secondary immune response to the last dose, i.e. during revaccination. Prevenar induces the formation of functional antibodies to all vaccine serotypes.

      In children aged 2 to 5 years, a pronounced formation of antibodies to all vaccine serotypes is observed after a single injection of Prevenar, while the immune response almost coincided with that in children of the first two years of life after a series of primary immunizations.

      Prevention of diseases caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteremia and acute otitis media) in children aged 2 months to 5 years.

      Hypersensitivity with previous administration of Prevenar, hypersensitivity to excipients and / or diphtheria toxoid; acute infectious and non-infectious diseases, exacerbation of chronic diseases (in these cases, vaccination is carried out after recovery or in remission).

      Dosage and administration

      The vaccine is administered only intramuscularly in the anterolateral surface of the thigh (children under 2 years old) or in the deltoid muscle of the shoulder (children over 2 years old).

      1 dose once

      The safety of Prevenar has been studied in healthy children aged 6 weeks to 18 months. In all cases, Prevenar was used simultaneously with other recommended childhood vaccines. The most common adverse reactions were soreness at the injection site and fever (fever).

      During revaccination, cases of rapidly passing pain at the injection site (36.5%), as well as cases of short-term limitation of the range of motion of the limb due to pain at the injection site (18.5%) were most often observed.

      Older children who received the vaccine once had a higher incidence of local reactions than children under 1.5 years of age, but these reactions were short-lived.

      Several cases of overdose of Prevenar are described, as well as the introduction of a subsequent dose earlier than prescribed. Adverse reactions observed in overdose were consistent with those observed with the recommended single doses of Prevenar.

      Interaction with other medicinal products and other forms of interaction

      Prevenar can be administered to children simultaneously (on the same day) with other vaccines included in the National Immunization Schedule (with the exception of BCG), as well as with Hemophilus influenzae type b (Hib) vaccine and Infanrix hexavalent vaccine, according to the prescribed immunization schedule. Vaccines must always be administered in different parts of the body.

      0.5 ml of the drug in disposable syringes made of transparent colorless borosilicate glass.

      Conditions of transportation and storage

      At temperatures from 2 to 8 0C.

      Shelf life: 3 years

      For detailed information on the use of the drug Prevenar, see the full instructions for medical use.

      What does the Prevenar vaccine protect against?

      Pneumococcal infection complicates the course of bronchitis, meningitis, otitis media, sinusitis and pneumonia. Reliable prophylaxis is required to avoid serious health consequences. Modern pediatrics is well aware of the Prevenar vaccination: what vaccination saves from is detailed in the instructions. Doctors perform immunization in a hospital, after examining the child for colds. Learn about all the advantages and disadvantages of the American medicine for the prevention of pneumonia and the French counterpart.

      Instructions for pneumococcal vaccination Prevenar

      Many specialists in the field of pediatrics have heard about the innovative drug Prevenar, some strongly recommend making a choice in favor of this preventive vaccination. The description of the drug says that the active ingredient is pneumococcal polysaccharides from gram-positive bacteria. It is necessary to introduce a dose of the drug - an artificial infection from it will provoke the production of antibodies. After such an interaction, the body of an adult and a child receives protection against pneumococcal infection and its consequences.

      The medical calendar indicates when preventive vaccination is required. The actions of doctors are indicated in the WHO standards - the preventive vaccination schedule. To ensure stable immunity, it is required to administer the medicine several times at different ages. What is the Prevenar vaccine for? Among the indications, it is necessary to highlight the prevention of the following diagnoses:

      The pneumonia vaccine called Prevenar is given in childhood. Single serving - 0.5 ml. This dose is enough not to cause side effects, but to ensure the stability of antibodies. If it is necessary to vaccinate a child under 6 months of age, the Prevenar vaccination scheme is offered to choose from:

    17. triple primary vaccination with a temporary break of 1 month;
    18. double vaccination against pneumonia with a limitation of 2 months;
    19. the first dose of the drug can be administered up to 2 months of life, and revaccination is best done up to a year.
    20. Such a pneumococcal vaccine is a guarantee of health, the ability to avoid fatal diagnoses and not put the life of a small child at risk. If infants have not completed Prevenar or Pneumo 23, the sequence of actions is as follows:

    • primary vaccination in the period of 7-11 months with a time interval of 1 month. Revaccination - at 2 years;
    • in 1-2 years, carry out a double vaccination with a time interval of 2 months;
    • single injection of Prevenar at the age of 2-5 years.
    • Who is the manufacturer of Prevenar 13

      The pneumococcal vaccine is highly effective, while it is not a development of domestic pharmacology. Serial production of the drug is carried out by the American manufacturer Pfizer (USA). The drug is expensive, not available to all families with small children. A worthy alternative was the Pneumo 23 vaccine - a budget version of French production.

    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 This is not only prevention, but also protection against complications. Vaccination makes it easier to tolerate any type 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. Under this name, various dangerous diseases are hidden. All of them develop due to the ingestion of pneumococci. The most severe diseases provoked by infection are acute otitis, 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 are pathogenic micro-organisms. 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 the baby has suffered some kind of disease.

    According to statistics, this infection is considered the cause of death in children.

    Babies from 6 months to 2 years are extremely susceptible to infection. Until six months, the disease does not develop, since specific antibodies are still present in the blood, which 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, there is shortness of breath, a strong cough, nasal congestion. Older children complain of pain in the 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 the patient. For this reason, they advise parents to vaccinate.

    Pneumococcus can be contracted 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, doctors can use two drugs for vaccination - Prevenar 13 and Pneumo 23. The first is heptavalent and is produced by American pharmacists. In its composition, the drug does not have live pneumoniae bacteria, it contains its polysaccharides. The drug contains 13 particles of pneumococcus.

    In addition, the composition contains diphtheria protein, which allows the drug to remain in the body for a significant period. And aluminum hydroxide, keeping the injection liquid in one position.

    Pneumo 23 was developed by doctors from France. From the name it is clear that the drug fights immediately with 23 types of infection serotypes. The composition contains non-living bacteria, phenol, water, phosphate.

    This is due to the fact that the composition contains many microorganisms. And the baby is not able to cope with so many harmful bacteria. The pneumococcal vaccine Pneumo 23 is intended for adults.

    Parents can protect their baby from infection by getting vaccinated. There is no other way to protect yourself from the disease. When vaccinated, non-viable pathogens enter the bloodstream. And the body begins to gradually respond to new bacteria. There is a release of a high rate of leukocytes. They are the ones who fight malware.

    It is easier and faster for the human body to cope with non-living bacteria. Subsequently, he does not need to fight a strong virus, since immunity to the pathogen appears. Even in case of illness, the child will bring it more easily. In the blood, immunity and antibodies to the virus will already be developed.

    Pneumococcal vaccine for children


    An injection is mandatory for children, but in private institutions the price of the vaccine starts at 1,200 rubles. The injection is administered intramuscularly. For children under two years old, the injection is made in the thigh, namely in the upper place outside. After the age of two, the vaccine is injected into the shoulder joint, into the deltoid muscle tissue.

    If the first vaccination was made 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.

    The vaccine in the first series forms an immune response in the body. After all, according to the calendar, a baby from 2 months is required to do three vaccinations with a difference of 45 days. This allows antibodies to be synthesized in the blood. After 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.

    Pneumococcal vaccine for adults


    The microorganism Pneumococcus rarely occurs in adults. But when infected, the course of the disease is much more complicated than in babies. For this reason, pneumococcal vaccination is recommended by doctors for adult patients.

    The disease provoked by pneumococcus can be treated with various drugs belonging to the antibacterial group. But in recent years, medical professionals have begun to notice that the virus has become less sensitive to current medications. And it takes doctors a significant amount of time to select the right drug.

    The only effective way to protect yourself from the disease is to administer a vaccine.

    Pneumococcal vaccination for adults is done only once, the drug Pneumo 23 is used. If a person is at risk, then you need to be vaccinated every five years.

    How to prepare for vaccination


    Before vaccination, certain rules must be observed. 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 making a vaccine, it is necessary to treat them, before the onset of remission.

    It is required to vaccinate 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 done completely free of charge.

    Vaccination Schedule


    The pneumococcal vaccine may be combined with other forms of vaccination. Therefore, there is no exact schedule for conducting, but it does not have compatibility with BCG. The injection site is chosen by the doctor, as 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 vaccine is given 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 entering the body.

    Reaction to vaccination


    Children tolerate vaccination quite calmly, and there are no local reactions.

    After vaccination, the patient can observe:

    • decrease in appetite;
    • drowsiness;
    • children often have moodiness;
    • irritability;
    • increase in body temperature;
    • hardening or redness at the injection site;
    • pain after 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


    When vaccinating, only high-quality preparations are used. Therefore, 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 individual intolerance of the patient to the components of medicines. At the time of vaccination, the person must be completely healthy. Pregnant women in the first three months of gestation should refuse to be vaccinated. During the period of exacerbation of chronic diseases, vaccination is not carried out.

    Possible Complications


    The vaccine not only has harmless side effects, but can also cause serious complications.

    The most common side effects 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. If complications occur, re-vaccination is not carried out.

    Doctor Komarovsky's opinion on pneumococcal vaccination


    The harmful bacteria pneumococcal can trigger the development of meningitis. This is a rather severe pathology, which leads to coma, and subsequently to the death of the patient. At best, after recovery, neurological problems will appear.

    In addition, it is dangerous for children under 2 years of age to get pneumonia. They affect the lungs and airways to a large extent. And otitis is extremely dangerous for the hearing of the baby. But all this can be prevented if the child is vaccinated on time. Dr. Komarovsky believes that the pneumococcal vaccine is safe.

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