Vaccine meningococcal group A polysaccharide dry (Vaccinum meningococcium gruppae A polysaccharidicum siccum)

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:
Purified capsular specific polysaccharide of strain N.meningitidis serogroup A # 208 -
250 mcg.
Excipient: lactose monohydrate - 10 mg.
Does not contain preservatives.
1 ampoule contains 5 doses for children from 9 years, adolescents and adults or 10 doses for children from 1 year to
8 years inclusive.
It comes complete with a solvent - sodium chloride solvent for the preparation of dosage forms for injection 0.9%.
Description:

Amorphous mass in the form of a tablet or loose powder from white to a whitish-gray color.Reconstituted drug: colorless or yellowish solution.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp
  • Meningococcus A antigen polysaccharide purified
    • Pharmacodynamics:

    The introduction of the vaccine leads to an intensive increase in the blood of vaccinated specific antibodies, providing, after 1 week, immunity to meningococcal infection caused by meningococcus serogroup A.

    Immunity persists for 3 years after vaccination. Revaccination is carried out if necessary not earlier than 3 years after the first immunization.

    Indications:
    Prevention of generalized forms of meningococcal infection caused by meningococcus serogroup A, in children from 1 year, adolescents and adults.
    Vaccination is recommended in endemic regions, as well as in the case of an epidemic caused by group A meningococci.
    Vaccine prophylaxis is carried out by all contact persons in the centers of meningococcal infection (cohabiting family members, persons of institutions where there is cohabitation, pupils and personnel of preschool institutions, persons who have established contact with nasopharyngeal secrets of the patient).
    When a meningococcal epidemic is threatened with an epidemic, the vaccine is primarily indicated for people at increased risk of infection (children from 1.5 years to 8 years old, first-year students of secondary and higher education institutions, as well as persons from different territories of the Russian Federation, countries near and far abroad and united by living together in hostels).
    When the morbidity rate rises (over 20 per 100,000 population), vaccination of the population with a coverage of at least 85% is recommended.
    Contraindications:
    1. Hypersensitivity to lactose, an allergic reaction to the previous administration of meningococcal vaccine.
    2. Acute diseases (infectious and non-infectious); exacerbation of chronic diseases. Vaccinations are carried out not earlier than 1 month after recovery (remission). In the outbreaks, vaccination is allowed after normalizing the temperature.
    3. Chronic diseases in the stage of decompensation.
    4. Malignant neoplasms, blood diseases.
    5. Pregnancy and the period of breastfeeding.
    Pregnancy and lactation:Contraindicated in the introduction of the vaccine during pregnancy and lactation (safety of use in pregnant and lactating women has not been studied, no controlled clinical trials have been conducted).
    Dosing and Administration:
    The drug is administered once subcutaneously in the scapular region or in the upper third of the shoulder. In a vial of vaccine, 2.5 ml of the solvent supplied with the vaccine-sodium chloride chloride is used to prepare dosage forms for injection of 0.9% (taken from a solvent ampoule with a graduated syringe). The dissolution time should not exceed 1 minute. The dissolved vaccine should be clear, free of any particles, inclusions or sediment.
    The vaccine dose for children from 1 year to 8 years inclusive is 0.25 ml (25 μg); at the age of 9 years, adolescents and adults -0.5 ml (50 μg).

    Precautions for use.

    Vaccinations are carried out in the focus of meningococcal infection not earlier than 3 days after the end of chemoprophylactic measures.

    Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules. The dissolved vaccine is not subject to storage.

    The preparation is not suitable for use in ampoules with broken integrity or marking, with a change in physical properties (color, transparency), expired shelf life, improper storage.

    In order to identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccine with mandatory thermometry.

    Side effects:
    The introduction of a vaccine may cause a part of the vaccine to produce a weak and short reaction. Local reaction is expressed in skin hyperemia (up to 25% of vaccinated) and pain in the area of ​​administration of the vaccine. Its duration does not exceed two days. A part of the vaccinated 6-8 hours after vaccination may increase the temperature, usually up to 37.1-37.5 ° C, followed by normalization after 24 hours. The frequency of temperature reactions exceeding 37.5 ° C, should not be more than 5%.
    Given the possibility of anaphylactic shock, it is necessary to provide medical supervision of the vaccinated within 30 minutes after the administration of the drug. Places of vaccination should be equipped with anti-shock therapy.
    Overdose:Not installed.
    Interaction:
    The vaccine can be administered concomitantly with inactivated vaccines of the National calendar of prophylactic vaccinations (as well as inactivated vaccines of the calendar for epidemiological indications) with different syringes in different parts of the body.
    Effect on the ability to drive transp. cf. and fur:No information.
    Form release / dosage:
    Lyophilizate for the preparation of a solution for subcutaneous administration.
    Packaging:
    Vaccine - 250 mcg polysaccharide meningococcal group A in the ampoule. Solvent (sodium chloride solvent for the preparation of dosage forms for injection 0.9%) - 5 ml in the ampoule. Issued in the kit. The kit consists of 1 ampoule of vaccine and 1 ampoule of the solvent.
    For 5 sets with instructions for use and a scarifier ampoule or a knife ampoule (if necessary) in a pack of cardboard.
    Storage conditions:
    In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C in a place inaccessible to children. Do not freeze.
    Conditions of transportation. In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Short-term (no more than 7 days) transportation of the vaccine is allowed at a temperature of no higher than 25 ° C. Do not freeze.
    Shelf life:
    2 years. The drug with expired shelf life is not subject to application. Expiration date is the last day of the month indicated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000302
    Date of registration:27.04.2010 / 11.12.2014
    Expiration Date:27.04.2015
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp12.01.2017
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