Instructions for medical use

medicine

Pneumovax 23

pneumococcal polysaccharide vaccine

Tradename

Pneumovax 23 pneumococcal polysaccharide vaccine

International nonproprietary name

Dosage form

Solution for injection, 0.5 ml/1 dose

Compound

One bottle (0.5 ml) of vaccine contains

active substance - pneumococcal polysaccharide consisting of 23 Danish pneumococcal serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F 25 mcg of each serotype

Excipients - sodium chloride, phenol, water for injection

Description

Transparent colorless solution

Pharmacotherapeutic group

Antibacterial vaccines. Antipneumococcal vaccines. Pneumococcal purified polysaccharide antigen

ATX code J07AL01

Pharmacological properties

Pharmacokinetics

Since Pneumovax 23 is a vaccine, pharmacokinetic studies have not been conducted.

Pharmacodynamics

Pneumovax 23 is a vaccine used for active immunization against pneumococcal diseases caused by 23 serotypes Streptococcus pneumonia(1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F). The vaccine is prepared from purified pneumococcal capsular polysaccharide antigens derived from 23 serotypes that cause approximately 90% of invasive pneumococcal diseases.

Immunobiological properties

The presence of type-specific humoral antibodies in the blood serum usually suggests the presence of effective protection against infectious diseases caused by Streptococcus pneumonia. An increase in antibody levels of ≥ 2-fold after vaccination was associated with the effectiveness of multivalent pneumococcal polysaccharide vaccines in clinical studies. However, the concentration of anticapsular antibodies required to protect against pneumococcal infection caused by any specific capsular antigen has not been established. The majority of persons ≥ 2 years of age (85 to 95%) respond to vaccination by producing antibodies to most or all of the 23 pneumococcal polysaccharides contained in the vaccine. Bacterial capsular polysaccharides induce antibody formation primarily by a T cell-independent mechanism and cause insufficient or inconsistent antibody formation in older children< 2 лет.

Antibodies are detectable in the third week after vaccination, but their levels decline within 3 to 5 years after vaccination; some groups may experience a more rapid decline (eg, children and the elderly). The protective level of serum antibodies produced to capsular polysaccharide antigens after vaccine administration varies from more than 100 to 300 ng/ml depending on the serotype.

In clinical studies examining the immune response to a single dose of the Pneumovax 23 vaccine in adults (50-64 years and ≥ 65 years), unvaccinated or who received one vaccination more than 3-5 years ago, the ratios of antibody titers of each serotype before and after vaccination were established ( on the 30th day after receiving the vaccine): 0.60 and 0.94, respectively, in the group over 65 years of age and 0.62 and 0.97, respectively, in the group of 50-64 years of age.

The clinical significance of the lower antibody production observed after booster vaccination compared with vaccination is unknown.

Efficiency

The effectiveness of multivalent pneumococcal polysaccharide vaccine in pneumococcal pneumonia and bacteremia has been established in randomized controlled clinical trials. The study was conducted among men aged 16 to 58 years who were at high risk for the incidence of pneumococcal pneumonia and bacteremia. The criterion for effectiveness was the incidence of pneumococcal diseases caused by a specific serotype. Protective efficacy against pneumococcal pneumonia (the primary endpoint in these studies) was 76.1% when using 6-valent (1,2,4,8,12F, and 25 serotypes) Streptococcus pneumonia) and 91.7% when using the 12-valent vaccine (1,2,3,4,6A,8, 9N,12F,25, 7F, 18C, and 46 serotypes of Streptococcus pneumonia). In studies involving people eligible for the vaccine, such as those with diabetes, chronic heart disease, lung disease, or anatomical asplenia, vaccine effectiveness was reported to be between 50 and 70%.

One study found that vaccination had a significant protective effect against infectious diseases caused by several distinct serotypes Streptococcus pneumonia(1, 3, 4, 8, 9V and 14). For other serotypes, the number of cases in this study was too small to draw conclusions about specific protection against these serotypes.

In a clinical study of immunization of patients aged 2 to 25 years with sickle cell anemia, congenital asplenia (Ivemark syndrome) and splenectomy with a polyvalent pneumococcal polysaccharide vaccine containing 8 capsular polysaccharide antigen serotypes Streptococcus pneumonia(1,3,6,7,14,18,19 and 23), a lower incidence of bacterial pneumococcal diseases was noted compared to those not vaccinated.

Duration of immunity

One epidemiological study suggests that vaccination may provide protection for at least 9 years after the initial vaccine dose. After vaccination, the titer of antibodies produced for each specific serotype decreases over 5-10 years. Antibody titers decline more quickly in children and older people over 60 years of age. Revaccination may be required in these patient groups. However, after revaccination, the antibody titer may be lower if the interval between vaccinations exceeds 10 years, in particular in very elderly people (people aged ≥ 85 years).

Indications for use

Active immunization against pneumococcal infection caused by Streptococcus pneumonia serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20 , 22F, 23F, 33F) adults and children over 2 years old

Contingent of persons with an increased risk of morbidity who are subject to vaccination

• routine vaccination of people over 50 years of age
• adults and children over 2 years of age with chronic cardiovascular disease (including congestive heart failure and cardiomyopathy), chronic pulmonary disease (including chronic obstructive pulmonary disease and emphysema), diabetes mellitus, chronic liver disease (including cirrhosis) and alcoholism, functional or anatomical asplenia (including sickle cell disease and splenectomy) and symptoms of liquorrhea*
• adults and children over 2 years of age with reduced immunity (immunodeficiency conditions due to HIV, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, malignant tumors, chronic renal failure or nephrotic syndrome; caused by immunosuppressive chemotherapy (including corticosteroids); after an organ transplant or bone graft brain)

Vaccination is not carried out due to ineffectiveness:

• for the prevention of acute otitis media, sinusitis and other upper respiratory tract infections
• *for the prevention of pneumococcal pneumonia, in patients with liquorrhea caused by congenital injuries, skull fractures, or neurosurgical procedures.

Directions for use and doses

Immunization is carried out in the summer-autumn period.

Primary vaccination

Adults and children over the age of two years - one single dose of 0.5 ml is administered intramuscularly or subcutaneously into the deltoid muscle of the shoulder or into the middle third of the anterolateral thigh.

Features of use in chronic diseases not associated with immunosuppression

The decision on the need to vaccinate this category of people must be made based on an assessment of the immune status and characteristics of the course of the underlying disease.

Features of use in diseases associated with immunosuppression

It is recommended that the pneumococcal vaccine be given two weeks (preferably) before elective splenectomy or initiation of chemotherapy or other immunosuppressive therapy. Vaccination should be avoided during chemotherapy or radiation therapy.

After completing chemotherapy and/or radiation therapy for neoplastic disease, the immune response to vaccination may remain reduced. Vaccination should not be prescribed earlier than three months after completion of such therapy. A longer delay may be appropriate for patients receiving intensive or prolonged therapy.

Persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after diagnosis is confirmed.

Revaccination

One single dose of 0.5 ml is administered by intramuscular or subcutaneous injection into the area of ​​the deltoid muscle of the shoulder or into the lateral part of the mid-thigh.

The schedule and timing of vaccination (re-vaccination) are determined in accordance with local official recommendations. Routine revaccination should not be performed in immunocompetent patients. The issue of revaccination is decided individually depending on the level of antibodies in patients.

Revaccination may be considered for persons at increased risk of developing serious pneumococcal disease who received a pneumococcal vaccine at least five years ago, or for persons with a rapid decline in anti-pneumococcal antibody levels. Individuals at increased risk include patients with functional or anatomical asplenia (eg, splenectomy or sickle cell disease), HIV, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, malignancies, chronic renal failure, nephrotic syndrome. This group also includes people receiving immunosuppressive chemotherapy or people who have undergone organ or bone marrow transplantation. For patients at high risk of developing fatal pneumococcal disease, a booster vaccination after three years may be considered.

Revaccination after less than three years is not recommended due to the increased risk of adverse reactions. It has been established that the incidence of local adverse reactions, and in persons aged ≥ 65 years - some systemic adverse reactions, after revaccination is higher than after primary vaccination with a time interval between vaccine administration of three to five years.

Children

Revaccination in children 2 to 10 years of age should be considered only 3 years after vaccination if there is an increased risk of developing pneumococcal disease (eg, children with nephrotic syndrome, a removed spleen, or sickle cell disease).

For more detailed instructions for using the vaccine, see the recommendations of the National Calendar of the Republic of Kazakhstan.

Vaccine administration technique

The vaccine should be used as supplied and no dilution or reconstitution is required. It is necessary to conduct a visual inspection of the ampoule for integrity, color change, and sedimentation. If there are changes, such a vaccine cannot be administered.

The vaccine is administered intramuscularly (IM) or subcutaneously (SC).

Do not administer intravenously or intradermally.

Take precautions to ensure that the needle does not enter a blood vessel. Also, the vaccine should not be administered intradermally, since this route of administration is associated with an increased risk of developing local reactions.

Any unused product or waste should be disposed of in accordance with local biohazard disposal requirements.

Side effects

Clinical studies have found that the most common general systemic reactions to the vaccine were weakness, fatigue, myalgia and headache. To eliminate post-vaccination reactions, patients were given symptomatic treatment.

Aged people

In clinical studies, the total number of adverse reactions in patients aged 50-64 years at the site of vaccine administration during primary vaccination was 72.8%, and during revaccination 79.6%. In patients ≥ 65 years of age, the total number of adverse reactions at the vaccine injection site during primary vaccination was 52.9%, and during revaccination 79.3%.

Local adverse reactions to the vaccine appeared on the third day after vaccination and completely disappeared on the fifth day.

The total number of systemic adverse reactions during primary vaccination in patients aged 50-64 years was 48.8%, with revaccination 47.4%. In patients ≥ 65 years of age, the total number of systemic adverse reactions during primary vaccination was 32.1%, and during revaccination 39.1%.

The total number of adverse reactions associated with vaccination in patients aged 50 to 64 years with primary vaccination was 35.5%, with revaccination 37.5%. In patients ≥ 65 years of age, the total number of vaccine-related adverse reactions with primary vaccination was 21.7%, with revaccination 33.1%

Children

Clinical studies on the safety and effectiveness of Pneumovax 23 in children under two years of age have not been conducted. Use in this age category is not recommended, because the level of antibodies produced may be insufficient.

Side effects are distributed according to the frequency of their occurrence during clinical trials and use in the post-marketing period: very often (1/10); often (from 1/100 to<1/10); нечасто (от1/1,000 до <1/100); редко (1/10,000 до <1/1,000); очень редко (<1/10,000), неизвестно - (частота не может быть определена из имеющихся данных).

Often

Fever (£38.8°C)

- erythema, edema, pain, tenderness, swelling and local hyperthermia at the injection site

Rarely

Inflammation of the subcutaneous fatty tissue that developed at the site of vaccine administration in the immediate period after vaccination

Unknown

Asthenia, chills, limited mobility and peripheral edema of the injected limb, malaise

- hemolytic anemia in patients with other hematological disorders, leukocytosis, lymphadenitis, lymphadenopathy, thrombocytopenia in patients with idiopathic thrombocytopenic purpura with stable platelet levels

- anaphylactoid reactions, angioedema, serum sickness

Febrile seizures, Guillain-Barré syndrome, headache, paresthesia, radiculoneuropathy

Nausea, vomiting

Rash, urticaria, erythema multiforme

Arthralgia, arthritis, myalgia

Increased C-reactive protein levels

Contraindications

Hypersensitivity to any component of the vaccine

History of anaphylactic reaction to previous pneumococcal vaccine administration

Acute infectious disease or exacerbation of a chronic disease of moderate or severe severity

Children under 2 years old

- pregnancy and lactation

Drug interactions

The pneumococcal vaccine can be given at the same time as the influenza vaccine, using separate needles and different injection sites.

Pneumovax 23 and Zostavax (an antiviral vaccine for the prevention of herpes zoster) should not be administered simultaneously as such use resulted in decreased immunogenicity of the Zostavax vaccine in a clinical study. It is recommended to maintain a 4-week interval between the administration of these two vaccines.

There is no experience of simultaneous use with other vaccines.

special instructions

Administration of the vaccine should be delayed in cases of illness accompanied by severe fever or other active infection, unless delay may entail an even greater risk of pneumococcal disease.

As with any vaccine, adequate medications, including epinephrine (adrenaline), should be available for immediate use in the event of an acute anaphylactic reaction.

Patients with immunodeficiency conditions

As with any other vaccine, vaccination with Pneumovax 23 may not be effective in all recipients. In patients with immunodeficiency due to underlying conditions or treatment (eg, immunosuppressive therapy, chemotherapy, or radiation therapy for malignancy), the expected production of serum antibodies may not be observed after the first or second dose of the vaccine. Consequently, these patients may not have adequate protection against disease caused by pneumococcal disease.

In individuals receiving immunosuppressive therapy, the length of time for the immune response to recover varies depending on the disease and treatment. Improvements in the immune response were observed for two years after completion of chemotherapy or other immunosuppressive therapy (with or without radiation therapy) and with an increase in the interval between the end of treatment and administration of the pneumococcal vaccine.

Following administration of pneumococcal vaccine, appropriate antibiotic therapy to prevent pneumococcal infection should not be discontinued in immunocompromised patients. The duration of antibiotic therapy is determined by the attending physician in each clinical case.

Patients at increased risk of developing serious pneumococcal disease (eg, those who have had their spleen removed or who have received immunosuppressive therapy for any reason) should be counseled about the possible need for early antimicrobial therapy in the event of severe, acute illness accompanied by fever.

The pneumococcal vaccine may not be effective in preventing infection resulting from basal skull fracture, neurosurgical procedures, or exposure to cerebrospinal fluid.

Pregnancy and lactation

Animal studies are insufficient to determine the effectiveness and safety of vaccination in pregnant women. The Pneumovax 23 vaccine has not been evaluated in studies of the effect on intrauterine development and fetal pregnancy. Therefore, Pneumovax 23 should not be used during pregnancy, except in cases of obvious need, when the potential benefit justifies the potential risk to the fetus. Pneumovax 23 has not been evaluated in reproductive studies. It is not known whether this vaccine is excreted in breast milk.

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

There is no data indicating that Pneumovax 23 affects the ability to drive vehicles or operate machinery.

“Pneumo 23” is a vaccine that is used to prevent diseases that arise as a result of damage to the body by pneumococci. This is an immunostimulating agent; it is administered once to form immunity to the main serotypes of bacteria (23 serotypes). The drug is contraindicated in children under two years of age due to lack of immunogenicity. At this age, children do not develop stable immunity to pneumococci.

Vaccination that protects against infections caused by pneumococci is included in the vaccination calendar performed for preventive purposes to protect the population. First of all, children need vaccinations. To reduce the incidence of development among the population, two drugs are used in Russia. These are Prevenar and the Pneumo 23 vaccine. The instructions attached to each of them contain different information about the composition and vaccination schedule. These drugs have significant differences.

It is known that there are approximately 90 different serotypes of pneumococcus; vaccines contain only those that pose the most serious danger to humans.

Release form, components of the drug "Pneumo 23"

The drug is available in the form of an injection solution. The instructions for “Pneumo 23” are presented as highly purified. It contains various purified serotypes of Streptococcus pneumoniae, to which a person subsequently develops immunity.

The volume of one dose of the product is 0.5 ml of solution, intended for administration subcutaneously and intramuscularly. The vaccine contains 25 mcg of each serotype out of the 23 available, the total volume is 575 mcg. Additionally, the preservative phenol was used. Auxiliary ingredients include sodium phosphate and injection water.

The drug contains those serovars that are the most common in Europe. Most pneumococcal infections develop precisely because of their negative effects on the body (about 90%). These serotypes are resistant to many antibiotic drugs.

Pharmacological action of the drug "Pneumo 23"

Immunity is acquired ten days after the vaccine is administered, no later than the fifteenth day. It lasts for at least five years. The vaccine helps prevent the development of diseases that are characterized by severe disease. The instructions for “Pneumo 23” allow it to be used together with some other vaccines (medicines that are used to prevent influenza).

The drug prevents the occurrence of infectious processes of different localization, the causative agents of which are pneumococci. The effect of the vaccine is aimed at preventing diseases such as otitis media, meningitis, pneumonia and other diseases. The drug helps reduce the likelihood of developing sepsis.

Indications for use of the drug "Pneumo 23"

The vaccine is introduced into the body to prevent the development of infections that can be caused by pneumococci. The need for its use is greatest in representatives of risk groups, in those who have undergone splenectomy, or when this procedure is planned. Administration of the drug is indicated for nephrotic syndrome. It is worth getting vaccinated after 65 years, as well as in cases of weakened immunity and frequent hospitalization. “Pneumo 23” instructions for use recommends use for CSF leakage, dependence on nicotine and alcohol.

Vaccination is needed for patients with chronic bronchopulmonary diseases, those who suffer from diabetes, tuberculosis, and cirrhosis. Indications include diseases in which the composition of the blood changes, HIV, immunodeficiency states, severe neurological lesions, diseases in which the functioning of the cardiovascular system is disrupted. There are also medical indications for military personnel, soldiers, and boarding school residents.

It is believed that vaccination of a healthy child over six years of age is inappropriate. At this stage of life, children’s bodies can independently resist infectious diseases, since the immune system is already sufficiently developed. Typically, children over six years of age and adults are vaccinated only if there are appropriate indications, mainly if they are at risk.

Contraindications to taking the drug "Pneumo 23"

A contraindication is hypersensitivity to the composition of the drug, which could be detected after previous administrations of the drug. The vaccine is not used for severe allergic reactions. Contraindications include anti-pneumococcal vaccination, after which less than three years have passed, however, in such cases there may be exceptions. Children under two years of age are not vaccinated.

There is no data showing the effect of this procedure on fetal development, so pregnant women are vaccinated in rare cases and for special indications. “Pneumo 23” instructions for use prohibit the use of acute infectious diseases and non-infectious processes, and hyperthermia. If a chronic disease has worsened, immunization should be postponed until the health condition returns to normal.

During pregnancy, you should avoid using the vaccine in the first and second trimester. If there are serious indications, a vaccination may be given in the third trimester. “Pneumo 23” instructions recommend that in such cases it be administered under the close supervision of a doctor. After immunization, it is necessary to monitor changes in the patient's condition. Pregnant women are observed longer than other patients, for a minimum of three hours. During lactation there is no reason to interrupt breastfeeding.

Use and dosage of the drug "Pneumo 23"

The vaccine is administered subcutaneously or intramuscularly. The injection is made in the deltoid muscle area. If immunization is carried out for the first time, the product is used once. Revaccination is indicated after five years or later. An exception is made for patients undergoing immunosuppressive therapy and members of the risk group.

The vaccine is administered directly from the syringes in which the drug is packaged. “Pneumo 23” instructions prohibit administration by intravenous route. Vaccination is carried out exclusively in specialized medical institutions. The drug must be administered by a qualified specialist.

Inspection is a mandatory procedure before using the vaccine. If there are temporary contraindications, the vaccine is given later, when the identified symptoms disappear. As the instructions show, “Pneumo 23” has the ability to cause, therefore, patients who have been injected with the solution are observed for thirty minutes. If side effects develop, immediate treatment is necessary.

The specialist decides what scheme to use for vaccination. Not only during the first administration of the drug, but also during revaccination, the administration of one dose of the solution is indicated.

Side effects of the drug "Pneumo 23"

What negative reactions of the body can the Pneumo 23 vaccination lead to? The instructions indicate the likelihood of developing an allergy; some people may experience redness in their skin, and may experience slight soreness or a slight hardening in the area where the drug was injected. In rare cases, chills appear and body temperature rises slightly. Headache and asthenia may be present. All general reactions and functional disorders usually disappear about a day after their occurrence. People who received revaccination earlier than prescribed may experience severe local reactions. You should carefully study the instructions before use.

Drug interactions of the drug "Pneumo 23"

It is impossible to carry out therapy based on the use of immunosuppressive drugs when it is necessary to vaccinate using the Pneumo 23 vaccine. Instructions and reviews from doctors do not allow their combination due to a decrease in the immune response or its absence.

If you need to be immunized with several vaccines, you should ask your doctor about the possibility of combining them.

Precaution

Before you decide to get vaccinated, you need to make sure that it is really necessary. Do not ignore contraindications to Pneumo 23. The instructions and reviews contain information about the development of quite serious side effects. Possible reactions include the Arthus phenomenon. This vaccination must be taken seriously.

Cost of the drug "Pneumo 23"

The drug is sold in pharmacies. The instructions allow the purchase of the Pneumo 23 vaccine only with a doctor’s prescription. The price of the product is approximately 1300 rubles.

Analogues of the drug "Pneumo 23"

You can replace the vaccine with Prevenar 13 or Prevenar. The most optimal option is selected by the doctor, taking into account the patient’s health condition and the individual characteristics of his body. The Prevenar 13 product contains fewer serotypes than the Pneumo 23 vaccine, but, as patients report in their reviews, local negative reactions are more often observed after its use. For this reason, for many, the best option is the Pneumo 23 vaccine. The instructions for the drug "Prevenar 13" do not contain age restrictions. This drug is even administered to children under two years of age. The vaccine for vaccination is always selected together with a doctor.

Pneumococcal infections are caused by the microbe Streptococcus pneumonia. Pneumococcal bacteria in the human body inhabit the tissues of the nasal cavity, middle ear, larynx and lungs. They are the cause of pneumonia, otitis media, meningitis, sepsis. Many antimicrobial agents have been developed to combat pneumococci. However, the disease is easier to prevent than to treat. Pneumovax 23 is a pneumococcal vaccine, polyvalent for the prevention of pneumococcal infections.

Pneumovax 23 - vaccination: composition and release form

The Pneumovax 23 vaccine is used for the purpose of active immunization to prevent pneumococcal diseases. The drug is polyvalent. This means that it contains many active ingredients. Namely, capsular polysaccharides from 23 different strains of pneumococcus.

Pneumovax 23 is a drug for immunoprophylaxis of infections caused by bacteria of the pneumococcal group (photo: www.snap361.com)

The vaccine is available in vials. One vaccination dose is 0.5 ml. In addition to pneumococcal antigens, it contains excipients: sodium chloride solution, phenol and water for injection. Externally, the vaccine looks like a clear and colorless liquid.

Pharmacological action of vaccination

The Pneumovax 23 vaccine contains highly purified fragments of the cell wall of pneumococci. They are not virulent and cannot cause disease. However, they retain immunogenicity - the ability to provoke an immune response. In response to the entry of an antigen into the human body, the following immune reactions occur:

• A local inflammatory process occurs at the injection site, which activates the immune system. Immune response cells migrate to this area.
• They recognize the pathogen contained in the vaccine, absorb it and ferment it. Then they display fragments of the antigen on their surface so that it can be recognized by other cells.
• Lymphocytes recognize foreign substances and activate humoral immunity.
• As a result, antibodies are produced - proteins that bind the antigen and remove it from the body.

As a result of vaccination, immunological memory is formed. When a real infectious agent enters, the immune system reacts much faster. Antibodies are rapidly produced, preventing the development of the disease. Immunoglobulins, which are produced after immunoprophylaxis, circulate in human blood for years, providing protection against infection.

Indications and preparation for vaccine administration

The Pneumovax 23 vaccination is indicated for several population groups. Immunoprophylaxis is carried out to such immunocompetent persons:

• People over fifty years old.
• Children over two years of age who suffer from diabetes mellitus have diseases of the heart and pulmonary system with a chronic course.
• Individuals over two years of age who have a blood disorder, such as sickle cell anemia. People who have had surgery to remove their spleen.

• Avoid visiting public places several days before vaccination.
• Do not overload the digestive tract. It is necessary to eat light, thermally processed food.
• If necessary, buy an antipyretic drug.

If a child is subject to vaccination, then when visiting a medical facility, it is advisable to take his favorite toy.

Method of use of the Pneumovax 23 vaccine and dose

Before using the drug, the health worker checks the integrity of the packaging, the presence of labeling and the expiration date of the drug. The contents of the bottle should be transparent and colorless. The vaccine is injected into the deltoid muscle area or buttock. Before the injection, the doctor or paramedic must perform thermometry. The injection site is treated with an antiseptic solution. One vaccination dose contains half a milliliter of the active substance.

Important! After vaccination, doctors recommend staying in a medical facility for half an hour. Allergic reactions of the anaphylactic type occur predominantly during this period of time. This will make it possible to provide timely medical care.

Contraindications for administration of the Pneumovax 23 vaccine

There are contraindications to immunoprophylaxis with the vaccine. The drug should not be used for people who have had hypersensitivity reactions to vaccine components. If the patient is indicated for revaccination, but after the first administration of the drug there were post-vaccination complications, administration of the drug is prohibited. Relative contraindications include:

• The presence of an acute infectious process in the body. In this case, vaccination is postponed until stable remission is achieved.
• Diseases of the central and peripheral nervous system, accompanied by convulsive syndrome.

Doctor's advice. The presence of background allergic reactions and diseases does not prevent vaccination

Possible post-vaccination reactions and their treatment

There are several categories of post-vaccination reactions:

• General disorders: fever, weakness, peripheral edema.
• Digestive system: vomiting, nausea.
• Circulatory system: lymphadenopathy, lymphadenitis, thrombocytopenia, hemolytic anemia.
• Immune system: hypersensitivity reactions, serum sickness, angioedema.
• Musculoskeletal system: muscle weakness, myalgia, arthritis, arthralgia.

Arthritis and arthralgia - possible post-vaccination reactions (photo: www.health-styles.com.ua)

In rare cases, a post-injection abscess occurs at the injection site if the rules of asepsis and antisepsis are violated.

Treatment of post-vaccination reactions is carried out according to the symptoms that arise. For fever, take antipyretics. For hypersensitivity - antiallergic. Arthritis requires the use of anti-inflammatory drugs. If an abscess occurs, it is necessary to open the abscess and clean it of its contents.

Use of the vaccine for special groups of patients

No studies have been conducted on the use of the vaccine in pregnant women. Therefore, it is unknown what effects the drug may cause in this group of patients. Immunoprophylaxis with the Pneumovax 23 vaccine is prohibited for pregnant women. The product is also used with caution in nursing mothers. The vaccine is not recommended for use in children under two years of age. During this period, the immune system of babies is not yet able to adequately respond and develop a sufficient titer of antibodies against the capsular antigens of pneumococci.

The vaccine is used with caution in older people. At this age, as a rule, there are chronic diseases that affect the incidence of adverse reactions.

The opinion of doctors regarding immunoprophylaxis by vaccination is ambiguous. Most experts confirm the effectiveness of this method and recommend it. Their arguments are based on the following facts:

• There are many diseases for which there are no effective drugs, but they can be prevented by vaccinations.
• Most vaccines are not avirulent (they do not contain pathogens, but only their components). In this case, the possibility of the occurrence of a real disease is excluded.
• The incidence of serious complications with the present disease is much higher than the incidence of post-vaccination complications.

Opponents of vaccination say that the antigenic load on the body causes immunosuppression in young children. In addition, the introduction of foreign substances into a child’s body rarely goes unnoticed.

Vaccine storage conditions

The product for immunoprophylaxis of pneumococcal infections is stored in special refrigeration equipment at a temperature of two to eight degrees above zero. It is unacceptable for the product to be exposed to direct sunlight. The shelf life of the vaccine is two years. After its expiration, the drugs must be disposed of.

Vaccine analogues

There are other products on the pharmaceutical market for the prevention of respiratory tract infections. They vary depending on the number of serotypes of capsular antigens presented in the preparation. These include:

• Prevenar - contains antigens of seven serotypes of pneumococci.
• Prevenar 13 differs from the previous vaccine in a greater variety of serotypes.
• Synflorix is ​​a vaccine containing 10 serotypes of pneumococcus.

Prevenar 13 is a partial analogue of the Pneumovax 23 vaccine, containing antigens of 13 strains of pneumococci (photo: www.irecommend.ru)

There is no complete analogue of this vaccine on the pharmaceutical market.

One dose of the Pneumo 23 vaccine contains capsule purified polysaccharides Streptococcus pneumoniae twenty-three serotypes that provoke severe disease: 1-5 (inclusive), 6B, 7F, 8, 9 (N and V), 10 A, 11A, 12F, 14, 15B, 17F, 18C, 19 (A and F ), 20, 22F, 23F and 33F.

As an additional substance, the drug contains a phenolic buffer solution.

Release form

The vaccine is contained in individual packaging. The syringe contains one dose of 0.5 ml.

The syringe is packed in a cardboard box.

pharmachologic effect

This drug is a pneumococcal polyvalent vaccine, which is used for prophylactic purposes - to prevent pneumococcal infections of various localizations.

In particular, the vaccine is intended to prevent pneumonia, sepsis , . The Pneumo 23 vaccination promotes the formation in the body of Streptococcus pneumoniae, a bacteria specific to twenty-three serotypes.

After the Pneumo 23 vaccine has been administered once, a person has specific immunity for five years. The drug is widely used in children after reaching the age of two to prevent the development of pneumococcal infection in them.

Pharmacokinetics and pharmacodynamics

No data are provided on the pharmacokinetics of this drug.

This remedy can be combined with the administration of vaccines that are aimed at preventing influenza.

Indications for use

The use of Pneumo 23 is indicated to prevent the development of pneumococcal infection different localization. Recommended for use by children from the age of two.

The vaccine is recommended for anyone who has an increased risk of infection. Streptococcus pneumonia. In particular, this vaccination should be given to older people, children with weakened bodies, who are subject to frequent hospitalization.

People who abuse nicotine and alcohol, those who have weakened immunity, and leakage of cerebrospinal fluid are also at risk of contracting the infection.

Contraindications

Vaccination with the drug should not be given to people who have a history of reactions after receiving the pneumococcal vaccine.

Immunization is not carried out for people suffering from acute infectious and non-infectious diseases, hyperthermia. The vaccine should not be administered during a relapse of chronic diseases.

Vaccination is allowed only after the patient has entered stable remission or has fully recovered.

The drug should not be administered to people who have received a pneumococcal vaccine over the previous three years (with the exception of people at risk, as well as those who have received immunosuppressive treatment).

It should be taken into account that a recent pneumococcal infection is not a contraindication to the Pneumo 23 vaccination.

Side effects

After the patient receives Pneumo 23, he may develop some local negative reactions: the appearance of compaction, swelling, pain, hyperemia in the place where the drug was injected.

In most cases, such manifestations are moderate and disappear very quickly, and no specific treatment is required.

Very rarely (in isolated cases) during the use of Pneumo 23, severe local manifestations may develop, including Arthus phenomenon . All these side effects go away without additional treatment.

People whose bodies have a high content of antipneumococcal bacteria may develop hyperthermia, and sometimes, very rarely, the body temperature can rise to 39 degrees or higher.

There is information about isolated cases of arthralgia, adenopathy, skin rash and anaphylactoid reactions. If these or other undesirable manifestations develop, you should immediately inform your doctor.

Vaccination Pneumo 23, instructions for use (Method and dosage)

The instructions for Pneumo 23 stipulate that the vaccine is used parenterally. This solution must be administered directly from the syringe in which the product is packaged by the manufacturer.

The drug is administered subcutaneously or intramuscularly. Please note that it cannot be administered intravenously.

It is imperative that this vaccine is administered in a specialized medical facility by a qualified specialist.

Before receiving a dose of the vaccine, the patient must be examined by a specialist. If a person has a feeling of general weakness, hyperthermia, or exacerbation of chronic diseases, vaccination should be postponed.

After the drug has been administered, the person must remain under the supervision of a specialist for 30 minutes. If he develops anaphylactoid reactions, the patient is given emergency treatment.

The general scheme for using the vaccine is determined by the doctor. As a rule, during the first vaccination, one dose (0.5 ml) of Pneumo 23 is administered.

Revaccination expedient after at least three years. When revaccinating, a person should also receive one dose (0.5 ml) of the product.

Reduce the permissible interval (three years) between administration Pneumo 23 it is possible for people who have an increased risk of developing pneumococcal infection, as well as for those who have recently received immunosuppressive therapy.

Overdose

No data on overdose of Pneumo 23 was provided.

Interaction

There is no information about the significant interaction of Pneumo 23 with other drugs.

If there is a need to immunize with several vaccines at once, including Pneumo 23, you should definitely ask a specialist for information about their compatibility.

With simultaneous treatment with immunosuppressive drugs, the immune response is reduced.

Terms of sale

Can only be purchased with a doctor's prescription.

Storage conditions

The vaccine can only be stored and transported in its original packaging, and it is important to adhere to a temperature range of 2 to 8 degrees.

Pneumo 23 cannot be frozen.

Best before date

special instructions

This vaccine is especially indicated for people who suffer sickle cell anemia , as well as persons with asplenia ; those who have recently had a splenectomy or people who are about to undergo a splenectomy.

It should be noted that if revaccination is carried out earlier than the required period, the person may experience severe local side effects after the injection.

Since there is a possibility of severe side effects (in particular, the Arthus phenomenon), before administering the drug, you need to evaluate the benefits of vaccination and take into account all contraindications.

If a person is receiving immunosuppressive treatment, the immune response to Pneumo 23 may be suppressed.

One dose of the vaccine provides effective protection.

Analogs

Analogues of this vaccine are drugs, Prevenar 13 .

Only a doctor can choose the most optimal remedy after an individual consultation.

Prevenar 13 or Pneumo 23 - which vaccine is better?

The Prevenar 13 vaccine contains fewer serotypes than Pneumo 23. But reviews often contain information that when using Prevenar, local side effects occur more often.

At the same time, Prevenar 13, unlike Pneumo 23, can be administered to children up to two years of age. The attending pediatrician will tell you which vaccine is best to use to immunize a child.

The advisability of using these vaccines is described in more detail by specialists, for example, Dr. Komarovsky.

For children

Vaccination with this drug can be given to children from the age of two.

It is important to take into account all contraindications and consult a doctor.

During pregnancy and lactation

It is not recommended to administer the vaccine during the first and second trimesters. But if there are serious indications, immunization can be carried out in the third trimester of pregnancy under the close supervision of a doctor.

If a pregnant woman has been vaccinated, after administering the drug she should be under the supervision of a doctor for at least three hours.

Vaccination during lactation is acceptable. There is no need to interrupt