Pneumovox 23 (Vaccine pneumococcal, polyvalent) - instructions for use, dose, side effects, contraindications

Streptococcus pneumoniae polysaccharides (according to the Danish nomenclature serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) of 25 μg of each serotype.

Excipients:

Sodium chloride 4.5 mg, phenol 1.25 mg, water for injection up to 0.5 ml.

Description:A clear, colorless liquid.

Pharmacotherapeutic group:MIBP vaccine

ATX: & nbsp

J.07 Vaccines

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

Pharmacodynamics:

Characteristics of the preparation

The Pnevmovax® 23 vaccine (a vaccine for the prevention of pneumococcal infections, multivalent) includes a mixture of highly purified capsular polysaccharides from the 23 most common and invasive serotypes Streptococcus pneumoniae. The 23-valent vaccine contains approximately 90% of serotypes that cause invasive pneumococcal infections in developed and developing countries. In accordance with scientific publications in Russia, the most common serotypes are 3, 6B, 14, 19F and 23F. Serotypes, which are most often the cause of an invasive drug-resistant pneumococcal infection, are 6B, 19F, 19A, 23F.

The Pneumovax® 23 vaccine is produced using 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 main causes of pneumonia, bacteremia, meningitis and otitis media.

Strains S. pneumoniae, drug-resistant, are becoming more common in the US and other regions of the world. It is reported that in some regions more than 35% of pneumococcal strains are resistant to penicillin.Many penicillin-resistant pneumococci are also resistant to other antimicrobial agents (eg, erythromycin, trimethoprim-sulfamethoxazole and cephalosporins of broad spectrum), which once again underscores the importance of vaccine prophylaxis for pneumococcal infection.

Immunogenicity

It was found that purified capsular polysaccharides of pneumococci cause the production of antibodies that effectively protect against pneumococcal infection. In clinical studies of the polyvalent vaccine, the immunogenicity of each of the 23 capsule antigens included in the vaccine was confirmed.

Protective levels of antibodies to the 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 do not depend on the participation of T-lymphocytes. Because of this, in children under 2 years of age whose 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 individuals (for example, in children), the decrease in the level of antibodies can occur more quickly. Limited (in number) published data show that antibody levels may decline more rapidly in the elderly (over 60). These results show that in order to provide permanent protection, revaccination may be required (see "INDICATIONS FOR APPLICATION", subsection "Revaccination").

A study of the prevalence of serotypes in the US pneumonia screening system for the control and prophylaxis of diseases showed a 57% protective effect of vaccination against invasive infections caused by serotypes included in the vaccine in people older than 6 years; 65-84% efficacy in patients with special groups (eg, individuals with diabetes, coronary heart disease, congestive heart failure, chronic lung disease, 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,because the groups of each disease failed to recruit a sufficient number of unvaccinated patients. The results of the study suggest that vaccination can provide protection for at least 9 years from the moment of receiving the first dose.

Another study demonstrated a decrease in efficacy with an increase in time after vaccination, especially in very elderly people (over 85 years of age).

Indications:

The Pneumovax® 23 vaccine is designed to prevent pneumococcal infection caused by pneumococcal types whose antigens are part of the vaccine. The vaccine is administered to persons aged 50 years and older, as well as individuals over 2 years of age with an increased risk of developing pneumococcal infections.

Immunocompetent persons:

- Scheduled vaccination of persons aged 50 years and older.

- Persons older than 2 years with chronic cardiovascular diseases (including congestive heart failure and cardiomyopathy), chronic lung diseases (including chronic obstructive pulmonary disease and emphysema), or diabetes mellitus.

- Persons older than 2 years, suffering from alcoholism, chronic liver disease (including cirrhosis of the liver) or with the outflow of cerebrospinal fluid.

- Persons older than 2 years with functional or anatomical asplenia (including sickle-cell anemia and splenectomy).

- Persons older than 2 years living in special environmental conditions or special social conditions (including the peoples of the Far North).

Immunocompromised persons:

- Persons older than 2 years, including those suffering from HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, a common malignancy, chronic renal failure or nephrotic syndrome, persons receiving immunosuppressive chemotherapy (including corticosteroids), and recipients after transplantation of bone brain or organ transplantation (for patients from special groups, see "SPECIAL INSTRUCTIONS", subsection "Vaccination deadlines").

Revaccination

- Usually booster vaccine Pnevmovaks® 23 immunocompetent persons previously vaccinated with 23-valent polysaccharide vaccine is not recommended.

- Nevertheless, single booster vaccine Pnevmovaks® 23 recommended for persons 2 years of age and older, who are at highest risk of serious pneumococcal infection and thosewho can quickly reduce the level of antipnevokokkovyh antibodies, provided that it has been at least five years since the first dose of pneumococcal vaccine was introduced. The group with the highest risk of pneumococcal infections includes people with functional or anatomical asplenia (for example, sickle-cell anemia or after splenectomy), persons suffering from HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, a common malignant tumor, chronic renal disease insufficiency, nephrotic syndrome, or with other conditions associated with immunosuppression (eg, bone marrow transplantation or organ transplantation), and individuals receiving immunity (including long courses of systemic corticosteroids) (see section "SPECIAL INSTRUCTIONS", subsection "Timing of vaccination").

- In children 10 years and younger, classified as at high risk for severe pneumococcal infections (for example, children with functional or anatomical asplenia, including sickle-cell anemia or after splenectomy, or in the presence of conditions,related to the rapid decrease in the level of antibodies after primary vaccination, including nephrotic syndrome, renal failure, or after kidney transplantation), vaccination with Pneumovax® 23 vaccine may be considered three years after the introduction of the previous dose of Pneumovax® 23 vaccine.

- If the previous vaccination status is unknown, patients in the high-risk group of pneumococcal infections should be vaccinated with pneumococcal vaccine.

- All persons 65 years of age or older who were not vaccinated for 5 years (and were in the age group under the age of 65 at the time of vaccination) should receive another dose of the Pneumovax® vaccine 23. Since the data on the safety of the pneumococcal vaccine when it is administered are three or more times, are inadequate, additional vaccination after the second dose of the vaccine is usually not recommended.

- Persons who are 2 years of age and older who are at greatest risk for serious pneumococcal infections and previously vaccinated with conjugated pneumococcal vaccine are recommended to be vaccinated with Pneumovax® 23.The interval between the administration of the conjugated pneumococcal vaccine and the administration of the Pneumovax® 23 vaccine should be at least 8 weeks.

Contraindications:

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

- Strong reaction or post-vaccination complication to previous administration.

- Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination. Scheduled vaccinations are carried out 2-4 weeks after recovery or during the period of convalescence or remission. With mild acute respiratory viral infections, acute intestinal diseases and other diseases accompanied by temperature hanging, vaccinations are carried out immediately after the temperature normalization.

- Any febrile respiratory illness or other acute infections are the reason for postponing vaccination with Pneumovax® 23, unless the doctor believes that such a delay entails an even greater risk.

Carefully:

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

Pregnancy and lactation:Not studied.

Dosing and Administration:ONLY FOR INTRAIMENTAL OR SUBORDINAL INTRODUCTION!

Do not administer intravenously or intradermally!

Before administration, the contents of the vial or syringe are checked for 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 into the deltoid muscle or lateral surface of the mid-thigh), while observing the necessary precautions to avoid intravascular injection.

To prevent the transmission of infectious agents 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.

Introduction of the vaccine supplied in the vial

The contents of the vial are completely poured into a syringe containing no preservatives, antiseptics and detergents.

Introduction of the vaccine supplied in the pre-filled syringe

The prefilled syringe is intended for single administration only. Enter the entire contents of the syringe.

Special patient groups

Children

The Pneumovox® 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 make up the polysaccharide vaccine.

Elderly patients

Clinical studies of the Pneumovox® 23 vaccine, in which persons aged 65 years and older participated, were conducted before and after registration of the drug. In the largest of these studies, Pnevmovax® 23 vaccine safety measures when used in adults aged 65 years and over (n = 629) was compared with the safety of Pneumovax® 23 when administered to adult patients in the age group 50 to 64 years (n = 379). Participants in this study were outpatients, and the prevalence of age-related chronic diseases was expected. Clinical data did not allow to reveal the increased frequency and severity of adverse reactions in people over the age of 65 compared with those in patients in the 50-64 age group.However, since the tolerance of older people to medical interventions may not be the same as that of younger patients, the higher frequency and / or severity of reactions in some elderly people can not be ruled out.

Postmarketing reports were received in which it was noted that some debilitated elderly people with several concomitant diseases had serious adverse events and a complication of the clinical course of the existing diseases after vaccination.

Side effects:In the clinical study of the Pneumovax® 23 vaccine, vaccinated and revaccinated adult patients participated for the first time, including 379 persons aged 50-64 years and 629 persons aged 65 years and over.

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

Reactions at the injection site occurred within three days after vaccination and usually disappeared on the fifth day after vaccination.

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

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

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

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

Below are the undesirable reactions that were observed during clinical trials and / or post-marketing period.

The frequency of unwanted reactions was determined as follows: very often (≥1/10), often (≥1 / 100, but <1/10), infrequently (≥1 / 1000, but <1/100), rarely (≥1 / 10000 , but <1/1000), very rarely (<1/10000), is unknown (the frequency of these unwanted reactions can not be determined from the available data, since they were obtained voluntarily from a population of unknown quantitative composition).

Violations of the blood and lymphatic system

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

Immune system disorders

Unknown: anaphylactoid reactions, Quincke's edema, serum sickness.

Disturbances from the nervous system

Unknown: febrile convulsions, Guillain-Barre syndrome, headache, paresthesia, radiculoneuropathy.

Disorders from the gastrointestinal tract

Unknown: nausea, vomiting.

Disturbances from the skin and subcutaneous tissues

Unknown: rash, urticaria, erythema multiforme.

Disturbances from musculoskeletal and connective tissue

Unknown: arthralgia, arthritis, myalgia.

General disorders and disorders at the site of administration

Often: fever (<38.8 ° C) and the following reactions at the site of administration: erythema, local compaction, tenderness, sensitivity, edema, warmth.

Rarely: phlegmon at the injection site †.

Unknown: asthenia, chills, fever, decreased mobility of the extremity into which the injection was made, malaise, peripheral edema^††.

Laboratory and instrumental data

Unknown: increase in the level of C-reactive protein.

* in patients who had other hematologic diseases;

** in patients with stabilized idiopathic thrombocytopenic purpura;

† with a rapid appearance after the introduction of the vaccine;

†† of the extremity into which the injection was made.

Overdose:

Data on cases of overdose are absent.

Interaction:

Use with other vaccines

Pneumococcal vaccine can be administered concomitantly with a vaccine for the prevention of influenza (which is injected into the other arm). Such administration does not lead to an increase in the incidence of side effects or a decrease in the intensity of the immune response to administration of each vaccine.

Pneumococcal vaccine can be administered simultaneously (in one day) with other vaccines (with the exception of vaccines for the prevention of tuberculosis) in different parts of the body using different syringes.(Information on the interval between the introduction of conjugated pneumococcal vaccine and the introduction of the Pneumovax® 23 vaccine is presented in the section "Indications for use", subsection "Revaccination").

Special instructions:

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

If the administration of the Pneumovax® 23 vaccine is administered to persons receiving immunosuppressive therapy, serum antibody levels may be lower than expected and there may be a lack of immune response to pneumococcal antigens (see the "Vaccination Terms" subsection).

Intradermal administration can cause severe local side effects.

As with any vaccine, vaccination with Pneumovax® 23 may not result in the complete protection of all vaccinated.

Vaccination with Pneumovax® 23 may not be effective in preventing infection resulting from fracture of the base of the skull or leakage of cerebrospinal fluid into the external environment.

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

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

Duration of vaccination

For some diseases, the pneumococcal vaccine should be administered at least two weeks before the scheduled splenectomy.

When planning cancer chemotherapy or other options for immunosuppressive therapy (for example, in patients with Hodgkin's disease or those who have a bone marrow transplant or organ transplant), the interval between vaccination and the onset of immunosuppressive therapy should be at least two weeks. Vaccination during chemotherapy or radiation therapy should be avoided. Pneumococcal vaccine can be administered several months after completion of chemotherapy or radiotherapy of tumor diseases.

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

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

Persons with asymptomatic or clinically expressed HIV infection should be vaccinated as soon as possible after the establishment of the diagnosis.

Effect on the ability to drive transp. cf. and fur:

The impact of the vaccine on the ability to drive vehicles and work with mechanisms has not been studied.

Form release / dosage:

Solution for intramuscular and subcutaneous administration, 1 dose.

Packaging:

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

For 0.5 ml (1 dose) in a disposable syringe with a capacity of 1.5 ml of Type I glass with a Luer-Lock adapter, a protective styrene-butadiene cap connected to a plastic lid and a piston covered with a bromobutyl stopper.1 disposable syringe with a stainless steel needle (or without a needle), placed in a contoured package. 1 contour pack is placed in a pack of cardboard with instructions for use. 10 contour mesh packages are placed in a pack of cardboard with instructions for medical use.

Storage conditions:

Store at a temperature of 2 to 8 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003441

Date of registration:02.02.2016

Expiration Date:02.02.2021

The owner of the registration certificate:Merck Sharp and Doum B.V.Merck Sharp and Doum B.V. Netherlands

Manufacturer: & nbsp

MERCK SHARP & DOHME, Corp. USA

Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.

Information update date: & nbsp14.12.2017

Illustrated instructions

Instructions

Pneumovax® 23 (Vaccine pneumococcal, polyvalent) (Pneumovax® 23)