Vaccine against pneumococcal infection instruction. Prevenar - instructions for the use of pneumococcal vaccine, indications and contraindications, analogues

Pneumo 23 is a vaccine for the prevention of pneumococcal infection.

Release form and composition

Dosage form - solution for intramuscular and subcutaneous administration: a clear, colorless liquid [1 dose (0.5 ml) in a 1 ml glass syringe with a chlorobromobutyl plunger and a fixed needle closed with a protective cap; each syringe is placed in a closed cell package (blister), 1 package in a cardboard box].

Composition of 1 dose of the vaccine:

• active substances: purified capsular polysaccharides of Streptococcus pneumoniae 23 serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20 , 22F, 23F, 33F - 0.025 mg each;
• additional components: sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injection, phenol (preservative).

Pharmacological properties

Pharmacodynamics

The active ingredient of the drug is purified polysaccharides of 23 serotypes of Streptococcus pneumoniae pneumococcus, which is at least 90% of all serotypes that can cause invasive pneumococcal infections.

The nature of the immune response to vaccine administration is T-independent. In children under 2 years of age, it is characterized by low immunogenicity and the absence of the effect of revaccination after repeated injections.

Specific immunity develops 2–3 weeks after vaccination.

According to the immunogenicity studies of Pnevmo 23, the overall epidemiological effectiveness in preventing the development of infections caused by serotypes contained in the vaccine is 57%.

The effectiveness of immunization in patients with various diseases:

• diabetes mellitus - 85% (95% CI - 50–95%);
• anatomical asplenia - 77% (95% CI - 14–95%);
• chronic lung diseases - 65% (95% CI - 26–83%);
• congestive heart failure - 69% (95% CI - 17–88%);
• ischemic heart disease - 73% (95% CI - 23–90%).

Efficiency in immunocompetent elderly patients (over the age of 65 years) - 75% (95% CI - 57-85%).

According to studies, the effectiveness does not decrease as the time after vaccination increases: after 5–8 years it is about 71% (95% CI - 24–89%), after 9 or more years - 80% (95% CI - 16–95 %).

The epidemiological efficacy of Pneumo 23 in chronic renal failure, cirrhosis, alcoholism, leukemia, lymphoma, myeloma and sickle cell anemia was not determined, which is due to the small sample size in these groups.

Antibody titers ≥ 300 ng / ml after immunization were achieved in at least 84% of the subjects for 21 serotypes out of 22, of which 100% of the vaccinated - for 16 stereotypes, in 65% - for the 9N stereotype. In addition, due to serotype 6B in the vaccine, the production of antibodies to serotype 6A was also stimulated: in 90% of non-immune patients at least two-fold seroconversion was achieved, with an average increase in antibody titer of 5.4 times.

Pneumo 23, according to research data, is ineffective for infections caused by pneumococcal serotypes, which are not present in the vaccine (95% CI of epidemiological effectiveness - from -73 to 18%; p ~ 0.15).

Indications for use

According to the instructions, Pneumo 23 is used in people at risk for the specific prevention of pneumococcal pneumonia and generalized pneumococcal infections caused by Streptococcus pneumoniae serotypes presented in the vaccine.

The risk group includes:

• elderly people over the age of 65;
• persons with a weakened immune system: nephrotic syndrome, chronic renal failure, lymphoma, Hodgkin's disease, multiple myeloma, sickle cell anemia, absence or dysfunction of the spleen, oncohematological diseases, organ transplantation;
• people with chronic diseases: diabetes mellitus, cirrhosis, alcoholism, lung disease, cardiovascular disease, etc.;
• patients with leaking cerebrospinal fluid;
• patients with HIV infection (including asymptomatic);
• people who are in special institutions for the care of the disabled or the elderly, or work in conditions of an increased risk of pneumococcal infections or their complications, or are in organized groups (living in hostels, military personnel, students).

Contraindications

• children under 2 years of age;
• exacerbation of chronic diseases;
• acute diseases (both infectious and non-infectious);
• an allergic reaction to the previous administration of the pneumococcal vaccine or to any of the components contained in the vaccine.

Instructions for use Pneumo 23: method and dosage

Vaccine Pneumo 23 is intended for subcutaneous or intramuscular administration. The more preferred route is intramuscular. It is forbidden to inject the drug into the vascular bed, therefore, before the injection of the solution, make sure that the needle does not fall into blood vessel... To do this, the piston must be pulled back a little and inspect the syringe barrel, there should be no blood in it.

For primary immunization, one dose of Pnevmo 23 (0.5 ml) is administered.

With revaccination, a single administration of a single dose is also indicated.

The vaccine must be warmed to room temperature before administration, keeping it for a few minutes after being removed from the refrigerator.

Shake the drug immediately before injection.

Within 30 minutes after injection, the patient must be under medical supervision. The office should be provided with anti-shock therapy.

Between the injections of Pneumo 23 or Pneumo 23 and any other pneumococcal polysaccharide vaccine, intervals of at least 3 years should be observed.

Side effects

Pneumo 23, like any other biologically active drug, quite often calls:

• soreness, swelling, redness, or induration at the injection site. These reactions are moderately expressed and pass quickly;
• an increase in body temperature (in some cases more than 39 ° C) on the day of vaccination lasting up to 24 hours.

In very rare cases, pronounced local reactions occur. They usually develop in people with high level antipneumococcal antibodies, are reversible, pass without any complications and consequences.

In individual cases, it is possible: inflammation of the subcutaneous tissue at the injection site, headache, increased fatigue, malaise, myalgia, arthralgia, lymphadenopathy, urticaria, rash, Quincke's edema, anaphylactic reaction, including shock, febrile convulsions.

There are isolated reports of the occurrence of peripheral edema of the limb into which the vaccine was administered.

The patient should be warned that all adverse reactions, including those not listed in the instructions, must be reported to the attending physician.

Overdose

The vaccine is administered by a healthcare professional under conditions medical institutions... The syringe contains only one dose, so overdose is not possible.

special instructions

If splenectomy or immunosuppressive therapy (such as chemotherapy) is required, vaccination should be given at least 2 weeks in advance.

If the vaccine is administered during immunosuppressive therapy, the immune response decreases, so vaccination should be postponed until the end of the course of treatment. The exception is people with chronic immunodeficiency (for example, with HIV infection) - in this case, the introduction of Pneumo 23 is still recommended, even when expecting a decrease in the immune response.

Due to the increased risk of hematoma formation with intramuscular injection the drug is used with extreme caution in patients with bleeding disorders (hemophilia or thrombocytopenia) and people receiving anticoagulants. In children with hemophilia, the risk of bleeding is increased with intramuscular injection, therefore, the Pneumo 23 vaccine should be injected subcutaneously into the area where you can press the site of infection, with the support of coagulation factors.

Influence on the ability to drive vehicles and complex mechanisms

No studies have been conducted on the effect of Pnevmo 23 on the ability to drive vehicles and other mechanisms.

Application during pregnancy and lactation

Are the components of the drug released from breast milk, unknown.

In each case, the doctor makes a decision on vaccination individually, after assessing the real danger of pneumococcal infection and the possible risks associated with the introduction of Pneumo 23. The use of the drug is possible only if clearly necessary, if the benefits to the woman outweigh the potential risks to the fetus / child.

Childhood use

Pneumo 23 can be used to vaccinate children from 2 years old. In children under 2 years of age, the nature of the immune response to the administration of the drug is characterized by low immunogenicity and no effect during revaccination.

Use in the elderly

Elderly people over 65 years old are at risk of developing pneumococcal pneumonia and generalized pneumococcal infections, therefore, at this age, vaccination with Pneumo 23 is recommended for specific prophylaxis.

Drug interactions

On the same day as Pnevmo 23, it is allowed to administer other vaccines, but with different syringes and in different parts of the body, with the exception of the vaccine for the prevention of tuberculosis.

Immunosuppressive drugs reduce the immune response to vaccine administration, therefore, vaccination is recommended after the end of immunosuppressive therapy.

The patient should be informed about the need to inform the doctor about all medications taken that coincide in time with vaccination or preceding immunization.

Analogs

The analogues of Pneumo 23 are: Pneumovax 23, Prevenar, Prevenar 13, Synflorix.

Terms and conditions of storage

Shelf life is 2 years.

Store in a dark place at a temperature of 2–8 ° С. Do not freeze. Keep out of the reach of children.

J.07 Vaccines

J.07.A.L Vaccine for the prevention of pneumococcal infection

Characteristics of the drug

The Pneumovax® 23 vaccine (vaccine for the prevention of pneumococcal infections, polyvalent) contains a mixture of highly purified capsular polysaccharides from 23 of the most common and invasive serotypes Streptococcus pneumoniae. The 23-valent vaccine contains approximately 90% of the serotypes that cause invasive pneumococcal infections in developed and developing countries. According to scientific publications in Russia, serotypes 3, 6B, 14, 19F and 23F are most common. The serotypes most commonly associated with invasive drug-resistant pneumococcal infections are 6B, 19F, 19A, 23F.

The Pneumovax® 23 vaccine is produced according to technology developed in the research laboratories of Merck Sharp and Dome.

Immunological properties

Pneumococcal infection is one of the leading causes of death worldwide and one of the leading causes of pneumonia, bacteremia, meningitis and otitis media.

Strains S. pneumoniae drug resistant drugs are becoming more common in the United States and other regions of the world. In some regions, more than 35% of pneumococcal strains are reported to be resistant to penicillin. Many penicillin-resistant pneumococci are also resistant to other antimicrobial drugs (e.g. erythromycin, trimethoprim-sulfamethoxazole, and cephalosporins wide range actions), which once again emphasizes the importance of vaccine prevention of pneumococcal infection.

Immunogenicity

The purified capsular polysaccharides of pneumococci have been found to induce the production of antibodies that effectively protect against pneumococcal infection. In clinical studies of a multivalent vaccine, the immunogenicity of each of the 23 types of capsular antigens included in the vaccine has been confirmed.

Protective levels of antibodies to type-specific capsular antigens of pneumococci usually appear by the third week after vaccination. Bacterial capsular polysaccharides stimulate the production of antibodies mainly through mechanisms that are independent of the involvement of T lymphocytes. As a result, in children under the age of 2 years, whose the immune system is still immature, the immune response to most types of pneumococcal capsular antigens is usually weak or unstable.

Duration of acquired immunity

After the introduction of pneumococcal vaccine, serotype-specific antibody levels decrease after 5-10 years. In some groups of people (for example, in children), the decrease in antibody levels may occur faster. Limited (in number) published data indicate that antibody levels may decline more rapidly in the elderly (over 60). These results indicate that revaccination may be required to ensure continued protection (see section "INDICATIONS FOR USE", subsection "Revaccination").

The US Centers for Disease Control and Prevention Pneumococcal Pneumococcal Surveillance Study of Serotype Prevalence showed 57% protective efficacy against invasive infections caused by vaccine serotypes in individuals over 6 years of age; 65-84% efficacy in patients special groups (for example, people with diabetes, ischemic disease heart, congestive heart failure, chronic illness lungs and anatomical asplenia); and 75% efficacy in immunocompetent individuals over 65 years of age.

The effectiveness of the vaccine has not been confirmed for some groups of immunocompromised patients, since it was not possible to recruit a sufficient number of unvaccinated patients for each disease group. The results of the study suggest that vaccination can provide protection for at least 9 years from the date of the first dose.

Another study showed a decrease in efficacy with increasing time after vaccination, especially in very elderly people (over 85 years).

The Pneumovax® 23 vaccine is intended for the prevention of pneumococcal infection caused by types of pneumococcus, the antigens of which are included in the vaccine. The vaccine is given to people aged 50 and over, as well as to people over 2 years old with an increased risk of developing pneumococcal infections.

Immunocompetent persons:

Routine vaccination of people aged 50 and over.

Persons over 2 years of age with chronic cardiovascular disease (including congestive heart failure and cardiomyopathy), chronic lung disease (including chronic obstructive pulmonary disease and emphysema), or diabetes mellitus.

Persons over 2 years old, suffering from alcoholism, chronic liver disease (including cirrhosis of the liver) or with leakage of cerebrospinal fluid.

Persons over 2 years of age with functional or anatomical asplenia (including sickle cell disease and splenectomy).

Persons over 2 years old, living in special environmental conditions or special social conditions (including the peoples of the Far North).

Immunocompromised persons:

Persons over 2 years old, including those suffering from HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, common malignant tumor, chronic renal failure or nephrotic syndrome, persons receiving immunosuppressive chemotherapy (including corticosteroids), as well as recipients after bone marrow transplant or organ transplantation (for patients from special groups, see the section "SPECIAL INSTRUCTIONS" subsection "Timing of vaccination").

Revaccination

Usually revaccination of 23 immunocompetent persons previously vaccinated with the 23-valent polysaccharide vaccine with the Pneumovax® vaccine is not recommended.

However, a single revaccination with Pneumovax® 23 vaccine is recommended for people 2 years and older who are at greatest risk of serious pneumococcal infections, and for those who can quickly decrease their antipneumococcal antibody levels, provided that at least five years have passed since then. how the first dose of pneumococcal vaccine was introduced. People with functional or anatomical asplenia (for example, sickle cell anemia or after splenectomy), people with HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, advanced malignant tumor, chronic renal insufficiency, nephrotic syndrome, or other conditions associated with immunosuppression (for example, bone marrow transplants or organ transplants), and persons receiving immunosuppressive chemotherapy (including long courses of systemic corticosteroids) (see the "SPECIAL INSTRUCTIONS" section, subsection " Terms of vaccination ").

Children 10 years of age or younger who are at high risk of severe pneumococcal infections (eg, children with functional or anatomical asplenia, including sickle cell disease, or after splenectomy, or with conditions associated with a rapid decline in antibody levels after primary vaccination, including nephrotic syndrome renal failure or after kidney transplantation), the question of revaccination with Pneumovax® 23 vaccine may be considered three years after the administration of the previous dose of Pneumovax® 23 vaccine.

If the prior vaccination status is unknown, patients at high risk of developing pneumococcal infections should receive the pneumococcal vaccine.

All persons 65 years of age and older who have not been vaccinated for 5 years (and were in age group under 65 years of age at the time of vaccination) should receive another dose of Pneumovax® 23. Since there is insufficient data on the safety of pneumococcal vaccine given three or more times, additional vaccination after the second dose of vaccine is generally not recommended.

For persons aged 2 years and older who are at greatest risk of serious pneumococcal infections and who have previously been vaccinated with conjugated pneumococcal vaccine, revaccination with Pneumovax® 23 vaccine is recommended. The interval between the administration of the conjugated pneumococcal vaccine and the administration of Pneumovax® 23 vaccine should be at least 8 weeks.

Hypersensitivity to any component of the vaccine. In case of an acute anaphylactoid reaction to any component of the administered vaccine, a solution of epinephrine (1: 1000) should be available for immediate administration.

A strong reaction or post-vaccination complication to the previous administration.

Acute infectious and non-communicable diseases, exacerbation of chronic diseases are temporary contraindications for vaccinations. Routine vaccinations are carried out 2-4 weeks after recovery or during the period of convalescence or remission. For mild acute respiratory viral infections, acute intestinal diseases and other diseases accompanied by a temperature rise, vaccinations are carried out immediately after the temperature has returned to normal.

Any febrile respiratory illness or other acute infections are a reason to postpone vaccination with Pneumovax® 23, unless, in the opinion of the doctor, such a delay entails an even greater risk.

Caution should be exercised when administering the vaccine to persons receiving immunosuppressive therapy, persons with severe forms of impairment of cardiovascular and / or pulmonary functions (see the "SPECIAL INSTRUCTIONS" section).

Do not administer intravenously or intradermally!

Before the introduction, the contents of the vial or syringe are checked for the presence of mechanical particles and discoloration. The Pneumovax® 23 vaccine is a clear, colorless liquid. The Pneumovax® 23 vaccine is administered in a volume of 0.5 ml subcutaneously or intramuscularly (preferably in the deltoid muscle or the lateral surface of the middle part of the thigh), while observing necessary measures precautions to avoid intravascular administration.

To prevent transmission of pathogens from one person to another, it is important to use a separate sterile syringe and needle for each individual patient.

Dilution or reconstitution of the drug is not required.

Administration of the vaccine supplied in a vial

The contents of the vial are completely drawn into a syringe that does not contain preservatives, antiseptics and detergents.

Administration of the vaccine supplied in a pre-filled syringe

The pre-filled syringe is for single administration only. The entire contents of the syringe are injected.

Special patient groups

Children

The Pneumovax® 23 vaccine is not used in children under 2 years of age, because children of this age group do not develop an effective immune response to the capsular antigens that are part of the polysaccharide vaccine.

Elderly patients

Clinical studies of the Pneumovax® 23 vaccine, in which persons aged 65 years and older took part, were carried out before and after the registration of this drug. In the largest of these studies, the safety performance of Pneumovax® 23 vaccine when used in adults aged 65 years and older (n \u003d 629) was compared with the safety of Pneumovax® 23 when administered to adult patients aged 50 to 64 years (n \u003d 379) ... The participants in this study were outpatients and the prevalence of age-related chronic disease was expected. Clinical data did not reveal an increased frequency and severity of adverse reactions in persons over the age of 65 compared to those in the group of 50-64 years. However, since the tolerance of older people for medical intervention may not be the same as that of younger patients, higher frequency and / or more severe reactions in some older people cannot be ruled out.

Post-marketing reports were received indicating that some frail elderly with multiple comorbidities had severe adverse events and complications following vaccination. clinical course existing diseases.

The incidence of injection site reactions in first-time vaccinated and revaccinated patients was 72.8% and 79.6%, respectively, in persons aged 50 to 64 years and 52.9% and 79.3%, respectively, in persons aged 65 years and older. The frequency of occurrence of reactions at the injection site in the older age group of boosters was comparable to the frequency observed in the younger age group of boosters.

Injection site reactions appeared within three days after vaccination and usually disappeared by the fifth day after vaccination.

The incidence of systemic reactions in first-time vaccinated and revaccinated patients was 48.8% and 47.4%, respectively, in persons aged 50 to 64 years and 32.1% and 39.1%, respectively, in persons aged 65 years and older.

The incidence of established vaccine-associated systemic reactions in first-time vaccinated and revaccinated patients was 35.5% and 37.5%, respectively, in persons aged 50 to 64 years, and 21.7% and 33.1%, respectively, in persons aged 65 years and older.

The frequency of occurrence of systemic and vaccine-associated systemic reactions in the older age group of boosters was comparable to the frequency observed in the younger age group of boosters.

Among the most common systemic adverse events were asthenia / fatigue, myalgia, and headache. Symptomatic treatment led to complete recovery in most cases.

Below are the adverse reactions that were observed during clinical research and / or in the post-registration period.

The frequency of adverse reactions was determined as follows: very often (≥1 / 10), often (≥1 / 100, but<1/10), нечасто (≥1/1000, но <1/100), редко (≥1/10000, но <1/1000), очень редко (< 1/10000), неизвестно (частоту данных нежелательных реакций невозможно установить из имеющихся данных, поскольку они были получены добровольно от населения неизвестного количественного состава).

Blood and lymphatic system disorders

Unknown: hemolytic anemia *, leukocytosis, lymphadenitis, lymphadenopathy, thrombocytopenia **.

Immune system disorders

Not known: anaphylactoid reactions, Quincke's edema, serum sickness.

Nervous system disorders

Unknown: febrile seizures, Guillain-Barré syndrome, headache, paresthesia, radiculoneuropathy.

Gastrointestinal disorders

Unknown: nausea, vomiting.

Skin and subcutaneous tissue disorders

Unknown: rash, urticaria, erythema multiforme.

Musculoskeletal and connective tissue disorders

Unknown: arthralgia, arthritis, myalgia.

General disorders and disorders at the injection site

Very common: fever (< 38,8°С) и следующие реакции в месте введения: эритема, местное уплотнение, болезненность, чувствительность, отек, прилив тепла.

Rare: injection site cellulitis †.

Not known: asthenia, chills, fever, decreased mobility of the injected limb, malaise, peripheral edema ††.

Laboratory and instrumental data

Not known: Increased C-reactive protein levels.

* in patients with other hematological diseases;

** in patients with stabilized idiopathic thrombocytopenic purpura;

† with rapid onset after vaccine administration;

†† limb injected into.

There are no data on cases of overdose.

Use with other vaccines

The pneumococcal vaccine can be given at the same time as the flu vaccine (given in the other hand). Such administration does not lead to an increase in the frequency of side effects or a decrease in the intensity of the immune response to the administration of each of the vaccines.

Pneumococcal vaccine can be given at the same time (on the same day) with other vaccines (excluding vaccines to prevent tuberculosis) in different parts of the body using different syringes. (Information about the interval between the administration of the conjugated pneumococcal vaccine and the administration of the Pneumovax® 23 vaccine is presented in the section "Indications for use", subsection "Revaccination").

Vaccination with Pneumovax® 23 vaccine will not protect against diseases caused by pneumococci of those capsule types that are not included in this vaccine.

If Pneumovax® 23 vaccine is administered to persons receiving immunosuppressive therapy, the level of serum antibodies may be lower than expected and there may be a lack of immune response to pneumococcal antigens (see subsection "Timing of vaccination").

Intradermal administration can cause severe local adverse reactions.

As with any vaccine, vaccination with Pneumovax® 23 may not lead to complete protection of all vaccinated.

Vaccination with Pneumovax® 23 may be ineffective in preventing infection resulting from a fracture of the base of the skull or leakage of cerebrospinal fluid into the environment.

In patients whose condition requires the administration of penicillin (or other antibiotics) to prevent pneumococcal infection, such prevention should not be stopped after vaccination with Pneumovax® 23.

Special attention should be paid and appropriate precautions should be taken when administering Pneumovax® 23 to persons with severe forms of cardiovascular and / or pulmonary dysfunction.

Terms of vaccination

For some diseases, the pneumococcal vaccine must be given at least two weeks before elective splenectomy.

When planning chemotherapy for cancer or other immunosuppressive therapy (for example, in patients with Hodgkin's disease or in those who are about to have a bone marrow transplant or organ transplant), the interval between vaccination and initiation of immunosuppressive therapy should be at least two weeks. Vaccinations during chemotherapy or radiation therapy should be avoided. The pneumococcal vaccine can be given several months after the completion of chemotherapy or radiation therapy for tumor diseases.

In Hodgkin's disease, after intensive chemotherapy (in combination with or without radiation therapy), the immune response to vaccination can be reduced for two years or more.

In some patients, within two years after completing chemotherapy or other immunosuppressive therapy options (with or without radiation therapy), there is a significant improvement in the immune response, especially with an increase in the interval between the end of treatment and the introduction of pneumococcal vaccine.

Individuals with asymptomatic or clinically significant HIV infection should be vaccinated as soon as possible after the specified diagnosis is made.

The effect of the vaccine on the ability to drive vehicles and operate machinery has not been studied.

Solution for intramuscular and subcutaneous administration, 1 dose.

0.5 ml (1 dose) in a colorless glass bottle with a capacity of 3 ml. The bottle is sealed with a silicone-coated bromobutyl stopper, under an aluminum roll-in and closed with a snap-off plastic cap with first opening control. 1 bottle of vaccine is placed in a cardboard box with instructions for medical use.

0.5 ml (1 dose) in a 1.5 ml disposable syringe made of type I glass with a Luer-Lock adapter, a protective styrene-butadiene cap connected to a plastic cap, and a plunger covered with a bromobutyl stopper. 1 disposable syringe with a stainless steel needle (or without a needle), placed in a blister pack. 1 contour package is placed in a cardboard box with instructions for use. 10 blisters are placed in a cardboard box with instructions for medical use.

Store at temperatures from 2 to 8 ° C, protected from light.

Keep out of the reach of children.

Do not use after the expiration date printed on the package.