Mentsevax® ACWY (Mencevax® ACWY)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of meningococcal infectionsVaccine for the prevention of meningococcal infections
Dosage form: & nbsplyophilizate for the preparation of a solution for subcutaneous administration
Composition:

1 dose of vaccine contains:

Name of components

Content in a single dose *

Active substances:

Purified polysaccharide N. meningitidis group A

50 μg

Purified polysaccharide N. meningitidis group C

50 μg

Purified polysaccharide N. meningitidis groups W135

50 μg

Purified polysaccharide N. meningitidis groups Y

50 μg

Excipients:

Sucrose

12.6 mg (for vials of 1 dose)

3.87 mg (for 10-dose vials)

Trometamol

0.1 mg

* To compensate for losses during the restoration of the vaccine and to ensure the content of the declared quantities of active substances in the injected dose during the packing of the vaccine, 25% excess of the vaccine components is poured into the vials.

1 dose (0.5 ml) of the solvent contains:

Name of components

The content in a single dose (0.5 ml)

Sodium chloride

4.5 mg

Water for injections

up to 0.5 ml

Phenol

1,25 mg (only for bottles of 10 doses)
Description:

Amorphous mass or white powder.

Mentsevseks® ACWY complies with WHO requirements for biological preparations and for meningococcal polysaccharide vaccines.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07.A   Vaccines for the prevention of bacterial infections

J.07.A.H   Vaccine for the prevention of meningitis

Pharmacodynamics:

Mentseks® Vaccine ACWY is purified lyophilized polysaccharide antigens of meningococci Neisseria meningitidis serogroups A, C, W135 and Y.

Mentseks® Vaccine ACWY causes the production of bactericidal antibodies against meningococcus serogroups A, C, W135 and Y.

Immunogenicity of the vaccine Mentsevseks® ACWY were evaluated 1 month after vaccination (530 vaccinated persons). According to the results of the evaluation, the percentage of people with a titer of bactericidal antibodies> 1: 8 was not less than 85.8%; percentage of patients responding to vaccination (the answer was defined as seroconversion with a serum bactericidal antibody 1: 8 serum threshold, for initially seronegative individuals, or as a four-foldthe increase in serum bactericidal antibody titer after vaccination compared to the titers before vaccination in initially seropositive subjects) was not less than 72.3%; the level of seroconversion in persons seronegative at the time of vaccination was not less than 81.8%.

The quantitative determination of serum bactericidal antibodies was performed by GlaxoSmithKline using a rabbit complementarity test system (rSBA).

Data Studies conducted in people with a deficiency of late components of the complement system (31 participants) and those who underwent bone marrow transplantation (44 participants) demonstrated that Mentseks vaccination® ACWY provides a sufficient immune response. In patients with a deficiency of late components of the complement system, the mean geometric antibody titer for the meningococcal antigen Neisseria meningitidis serogroup A was 26.8 μg / ml, serogroup C - 19.2 μg / ml, serogroup W135 - 16.4 μg / ml and serogroups Y - 30,7 mkg / ml after 13 weeks after vaccination. Among the patients who underwent bone marrow transplantation, in 62-84% of patients the concentration of antibodies to polysaccharide A was ≥ 2.0 μg / ml, and 76-84% of individuals had a concentration of antibodies to the polysaccharide C ≥ 2.0 μg / ml after one month after vaccination.

Efficiency

The effectiveness of the Mentseks vaccine® ACWY More than 1.68 million children and adults between the ages of 2 and 29 were proven during the mass vaccination campaign in the Neisseria meningitidis in Burkina Faso. During the mass vaccination campaign, 32 cases of meningitis due to Neisseria meningitidis serogroup A, and 3 cases of meningitis caused by Neisseria meningitides serogroups W135.

The duration of the immune response

An evaluation of the duration of the immune response formed after the administration of the Mentseks® vaccine ACWY adolescents and adults 11 up to 55 years, within 5 years after vaccination. The results of this evaluation showed that 5 years after vaccination, the antibody titer for meningococcus serogroups A and C remained at a level of ≥1: 8 in at least 74.3% and 71.2% of those vaccinated with Mentsex® ACWY, respectively. While two years after the vaccination, seroprotection for meningococcal serogroups W135 and Y remained only in 24% and 44% of individuals, respectively. Taking into account the received data on seroprotection for meningococcal serogroups W135 and Y, which are a surrogate measure of the level of protection provided by vaccination, it is recommended to revaccinate individuals with a high risk of infection meningococcal infection caused by meningococcus serogroups A, C, W135 and Y.

The content of serum bactericidal antibodies was determined in the laboratories of the RNU, Great Britain, using a complementary rabbit complement test system (rSBA).

In contrast to data on persistence rSBA- MenA, limited data obtained using the method of quantification based on human complement (hsba) one year after vaccination, show a decrease in titers bactericidal serum antibodies against meningococcus serogroup A. Clinical significance of reducing titers hsba- MenAnd antibodies are unknown, and analysis of current data suggests the expediency of conducting early revaccination in people at high risk of contact with meningococcal infection.

Indications:

Prevention of meningitis and other forms of meningococcal infection caused by meningococcus serogroups A, C, W135 and Y in children from 2 years of age, adolescents and adults.

Vaccination is primarily recommended for people who are at high risk of infection living in areas endemic for this infection,or visiting those areas; Persons at high risk of infection (children from preschool institutions, students in grade 1-2 schools, adolescents from organized groups, united in living in hostels, children from family hostels, housed in inadequate sanitary and hygienic conditions). Immunization is also shown to medical personnel of infectious departments of hospitals.

Contraindications:

- Hypersensitivity to any component of the vaccine; reaction hypersensitivity to the previous administration of a polysaccharide meningococcal vaccine;

- acute infectious and non-infectious diseases, exacerbation of chronic diseases. Vaccinations are carried out 2-4 weeks after recovery or during the period of convalescence / remission.

With mild acute respiratory viral infections and acute intestinal diseases, vaccinations are carried out immediately after the temperature normalization.

Pregnancy and lactation:

Currently, there is insufficient data on the use of this vaccine in pregnant women. Introduction of Mentseks® ACWY Pregnant women are only allowed in cases where the potential benefit exceeds the potential risk to the fetus.

There is insufficient data on the use of the vaccine in women during lactation.

Mentseks® Vaccine ACWY should be given to nursing women if necessary, when the possible benefit exceeds the potential risk for the child.

Dosing and Administration:

Vaccination schedule

The vaccine is administered once in a dose of 0.5 ml. It is possible to carry out revaccination of persons with a high risk of infection with meningococcal infection caused by meningococcal serogroups A, C, W135 and Y. The need for revaccination is determined in accordance with the established requirements for immunoprophylaxis and taking into account the data on the duration of the immune response.

Method of administration

The vaccine should only be administered subcutaneously!

The vaccine is reconstituted before use with the applied solvent at a rate of 0.5 ml per dose. The bottle is shaken thoroughly until the content is completely dissolved within 1 minute. The vaccine after reconstitution should be clear, colorless and should not contain visible mechanical inclusions. The vaccine is not used if the reconstituted solution looks different, as well as in the presence of foreign particles or when the color changes.

After reconstitution in a disposable vial of the lyophilisate with a solvent, the vaccine should be used immediately.

It is allowed to store the solution in a vial containing 10 doses, at a temperature of 2 to 8 ° C not more than 8 hours. The solution should be protected from direct sunlight.

A new sterile needle should be used to administer the drug. When using the vaccine in multi-dose packs, new syringes and needles should be used each time to withdraw the drug.

The drug should be removed from the bottle with strict adherence to aseptic rules.

Mentseks® Vaccine ACWY under no circumstances should not be administered intravenously!

Side effects:

Clinical Trials Data

Mentsevseks® vaccine safety profile ACWY based on recent clinical trials in which the vaccine was introduced 530 patients.

The adverse events presented below were recorded during the 48 h after vaccination and are listed by the body systems and in accordance with the frequency of occurrence. Frequency of occurrence is defined as follows: Often (≥ 1/10), often (≥1 / 100 and <1/10), infrequently (≥ 1/1 000 and <1/100).

Frequency of occurrence of undesirable phenomena

From the side of metabolism and nutrition

Often: loss of appetite.

From the nervous system

Very often: irritability, drowsiness, headache.

Infrequently: dizziness.

From the gastrointestinal tract

Often: nausea, vomiting, diarrhea.

From the musculoskeletal and connective tissue

Often: myalgia.

General reactions and reactions at the site of administration

Very often: pain and redness in place injections, a sense of fatigue.

Often: swelling at the injection site, fever.

Post-registration data

From the immune system: allergic reactions (including anaphylactic and anaphylactoid reactions).

From the skin and subcutaneous fat: urticaria, rash, swelling of Quincke.

From the side of the musculoskeletal and connective tissue: arthralgia, hypertonia muscles.

General reactions and reactions at the site of administration: flu-like syndrome, chills.

Overdose:

During post-marketing surveillance, cases of a vaccine overdose (up to a tenfold excess of the recommended dose) were reported. The undesirable effects of an overdose were similar to those observed when the recommended dose was administered.

Interaction:

Mentseks® Vaccine ACWY can be administered concomitantly with other vaccines, while vaccines are administered to different parts of the body in individual str.eggOh.

Mentseks® Vaccine ACWY Do not mix in the same syringe with other vaccines.

Special instructions:

Mentsevseks vaccine® ACWY does not protect against diseases caused by meningococci belonging to other serogroups other than A, C, W135 and Y.

When administered to persons with impaired immunity, the vaccine may not induce an effective immune response.

Revaccination with vaccines containing the polysaccharide of meningococcus serogroup C can cause a less pronounced immune response to the polysaccharide of meningococcal serogroup C, compared to the primary vaccination.

For people at high risk of infection with meningococcal infection caused by meningococcus serogroups A, C, W135 and Y, it is recommended to consider the need for revaccination in accordance with the established requirements for immunoprophylaxis and taking into account the data on the duration of the immune response.

Vaccinations should be preceded by careful collection of anamnesis, especially about previous vaccinations and the possibility of unforeseen complications, as well as physical examination and thermometry.

After the introduction of Mentseks vaccine® ACWY, as well as after the injection of other vaccines, anaphylactic reactions can rarely develop, and therefore the vaccine should be under medical supervision for at least 30 minutes after vaccination, and the place of vaccination should be provided with anti-shock therapy.

After vaccination, or sometimes in front of it, fainting or severe weakness is possible as a psychological reaction to injection. Before vaccination it is important to make sure that the patient will not get injured in the event of a syncope.

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

Research on the impact of Mentseks® vaccine ACWY on the management of vehicles or the ability to work with moving mechanisms was not carried out. However, an undesirable effect can not be predicted based on the pharmacological properties of the active substance. Nevertheless, the condition of the patient and the spectrum of adverse events of the vaccine in the post-vaccination period after the administration of Mentseks® ACWY should be taken into account in determining the patient's ability to perform tasks that require motor, cognitive skills and decision-making.

Form release / dosage:Lyophilizate for the preparation of a solution for subcutaneous administration.
Packaging:

For 1 dose of vaccine in bottles (neutral glass, type I according to Eur. F.), sealed with a plug of synthetic butyl rubber and an aluminum cap under break-in, equipped with a protective plastic lid, complete with a solvent of 0.5 ml in ampoules (neutral glass, type I according to Eur.F.). One by one a vial of vaccine, one ampoule with a solvent in the blister. One blister with instructions for use in a cardboard pack.

1 dose of the vaccine in bottles (neutral glass, type I according to Eur.F.), sealed with a plug of synthetic butyl rubber and an aluminum cap for running in, equipped with a protective plastic lid complete with 0.5 ml solvent in bottles (neutral glass, type I according to Hept. F.). One vial with a vaccine, one vial with a solvent in the blister pack. One blister with instructions for use in a cardboard pack.

1 dose of the vaccine into bottles (neutral glass, type I according to Eur.F.), sealed with a plug of synthetic butyl rubber and an aluminum cap for running in, equipped with a protective plastic lid complete with 0.5 ml solvent in syringes (neutral glass,type I according to Hept. F.) with 1 or 2 needles in protective plastic caps or without needles. One bottle with a vaccine, one syringe with a solvent with 1 or 2 Needles or without a needle in the blister. One blister with instructions for use in a cardboard pack.

1 dose of vaccine in bottles (neutral glass, type I according to Hept. F.), sealed with a plug of synthetic butyl rubber and an aluminum cap for running in, equipped with a protective plastic lid. For 100 bottles together with 5-10 instructions for use in a cardboard box.

0.5 ml solvent in bottles (neutral glass, type I according to Hept. F.), sealed with a cork made of synthetic butyl rubber and an aluminum cap for running in, equipped with a protective plastic lid. 100 bottles in a cardboard box.

For 10 doses of the vaccine in bottles (neutral dark glass, type I according to Eur. F.), sealed with a cork made of synthetic butyl rubber and an aluminum cap for running in, equipped with a protective plastic lid. For 50 bottles together with 1-5 instructions for use in a cardboard box.

5 ml of solvent in bottles (neutral glass, type I according to Hept. F.), sealed with a plug of synthetic butyl rubber and an aluminum capunder the break-in, equipped with a protective plastic lid. 50 bottles in a cardboard box.

Storage conditions:

Lyophilizate (vaccine) should be stored at a temperature of 2 to 8 ° C. Freezing is allowed.

Solvent Store at a temperature of 2 to 25 ° C. Do not freeze.

Vaccine complete with a solvent keep at a temperature of 2 to 8 ° C. Do not freeze. Keep the vaccine and thinner out of the reach of children.

Transportation conditions

Lyophilizate (vaccine) transport at a temperature of 2 to 8 ° C. Freezing is allowed.

Solvent transport at a temperature of 2 to 25 ° C. Do not freeze.

Vaccine complete with a solvent transport at a temperature of 2 to 8 ° C. Do not freeze.

Shelf life:

Vaccine - 3 of the year.

Solvent - 5 years.

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

Expiration date is the last day of the month indicated on the package.

Terms of leave from pharmacies:On prescription
Registration number:П N015356 / 01
Date of registration:21.10.2008
The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia
Manufacturer: & nbsp
Representation: & nbspGlaxoSmithKline Trading, ZAOGlaxoSmithKline Trading, ZAO
Information update date: & nbsp16.12.2015
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