Active substanceVaccine for the prevention of typhoid feverVaccine for the prevention of typhoid fever
Dosage form: & nbspLiophilizate for the preparation of a solution for subcutaneous administration.
Composition:

Vaccine is an inactivated with ethyl alcohol lyophilized microbial cells S. typhi Tu-2 No. 4446.

1 ml contains 5 billion microbial cells. Preservative - phenol no more than 0,05%.

Solvent - sodium chloride isotonic solution for injection 0.9%.

Description:

Vaccine - amorphous powder of white color.

Solvent - Clear, colorless liquid.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07   Vaccines

Pharmacodynamics:

Immunological properties

Two-fold administration of the drug protects 65% of those vaccinated against typhoid fever within 2 years.

Indications:

Prevention of typhoid fever from 18 years of age.

Priority vaccination is subject to:

- population living in a territory with a high incidence of typhoid fever;

- population living on the territory in chronic aquatic epidemics of typhoid fever;

- persons engaged in the field of public amenities (workers,service sewerage networks, facilities and equipment, as well as enterprises for sanitary cleaning of populated areas - collection, transport and disposal of domestic waste);

- persons working with live cultures of typhus;

- persons departing for hyperendemic regions of the country, as well as contact regions in epideptic sites.

According to epidemic indications, vaccinations are carried out at the threat of an epidemic or an outbreak (natural disasters, major accidents at the water and sewerage network), as well as during the epidemic, with mass immunization of the population in the threatened area.

Contraindications:

1. Acute infectious and non-infectious diseases. Exacerbation of chronic diseases - inoculation is carried out not earlier than a month after recovery (remission).

2. Chronic diseases of the liver and biliary tract.

3. Chronic kidney disease.

4. Diseases of the endocrine system.

5. Diseases of the cardiovascular system: rheumatism, heart defects, myocarditis, hypertension.

6. Bronchial asthma and other severe allergic diseases.

7. Systemic diseases of connective tissue.

8. Infectious and non-infectious diseases of the central nervous system: the presence in the anamnesis of diseases accompanied by convulsions.

9. Diseases of the blood, malignant neoplasms.

10. Pregnancy.

In order to identify contraindications, the doctor on the day of vaccination conducts a survey and examination of the vaccine with mandatory thermometry. If necessary, conduct appropriate laboratory examination.

After the introduction of the typhoid vaccine, routine vaccinations with other drugs are carried out not earlier than 1 month later.

The vaccinations are recorded in the established registration forms with the date of vaccination, dose, manufacturer, serial number, response to vaccination when treatment.

Dosing and Administration:

Vaccination is carried out 2 times with an interval of 25-35 days in a dose:

1 vaccination - 0.5 ml;

2 vaccination 1.0 ml;

revaccination spend in 2 years in a dose of 1.0 ml.

The drug is injected with a syringe subcutaneously into the subscapular area.

Immediately before inoculation into a vial with typhoid vaccine atwear 5 ml of solvent - sodium chloride isotonic solution for injection 0.9%. The contents of the ampoule are mixed by gentle shaking. The dissolution time should not exceed 1 min.Dissolved drug should be a uniform suspension of light gray color without flakes and foreign inclusions.

A resuspended vaccine that is stored in compliance with asepsis rules can be used within 2 hours.

Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules.

Reaction to administration

After the introduction of the vaccine, general and local reactions may develop.

General reaction appears after 5-6 hours and is expressed by fever, malaise, headache. Its duration, as a rule, does not exceed 48 hours.

Local reaction characterized by the appearance of skin hyperemia, pain, the formation of infiltrate, which disappear after 3-4 days.

Before mass vaccination, the vaccine must be administered to a limited group (40-50) of people subject to vaccination, equivalent in age and health condition to the majority of the vaccinated.

The reaction is taken 24 hours after inoculation.

An increase in temperature to 37.5 ° C inclusive is regarded as a weak reaction, from 37.6 to 38.5 ° C as an average reaction and from 38.6 ° C and higher as a strong one.

Redness without infiltration and infiltration up to 25 mm in diameter is regarded as a weak reaction, an infiltrate with a diameter of 26 to 50 mm inclusive - as an average reaction and an infiltrate with a diameter of more than 50 mm, as well as an infiltrate with the presence of lymphangitis and lymphadenitis as a strong reaction.

Subject to strict adherence to these instructions, a series of vaccines may be used for subsequent vaccinations if strong and medium temperature reactions and strong local reactions were detected after 24 hours in no more than 7%, or if the average temperature and local responses were detected by no more than 12 % of vaccinated. In the latter case, when calculating the percent, the cases of strong temperature and local reactions are also taken into account.

Given the possibility of shock (in the rarest of cases, especially sensitive individuals), it is necessary to ensure medical supervision of the vaccinated for 30 minutes. Places of vaccination should be equipped with anti-shock therapy.

Side effects:Absent.
Special instructions:

Not suitable for use:

- The drug, the integrity of the packaging is broken (cracked ampoules).

- The drug is unmarked.

- A drug with altered physical properties (discoloration, consistency), if there are extraneous inclusions.

- The drug has expired.

Form release / dosage:Lyophilizate for the preparation of a solution for subcutaneous administration (complete with a solvent).
Packaging:

A vaccine of 1 ml in ampoules, a 5 ml solvent in an ampouleax.

The kit consists of one ampoule of vaccine and one ampoule of the solvent.

5 sets in a pack with instructions for use and an ampoule knife or scarifier ampoule.

Storage conditions:

A drug keep in accordance with SP 3.3.2.1248-03, at a temperature of 2 to 8 ° C, out of reach of children.

Transport in accordance with SP 3.3.2.1248-03, at a temperature of 2 to 8 ° C.

Shelf life:Shelf life of the vaccine is 3 years, the solvent is 5 years.
Terms of leave from pharmacies:For hospitals
Registration number:P N000661 / 01
Date of registration:18.03.2009
Expiration Date:Unlimited
The owner of the registration certificate:St. Petersburg Research Institute of Vaccines and Serums and the enterprise for the production of bacterial preparations FSUE FMBASt. Petersburg Research Institute of Vaccines and Serums and the enterprise for the production of bacterial preparations FSUE FMBA
Manufacturer: & nbsp
Representation: & nbspSt. Petersburg Research Institute of Vaccines and Serums and the enterprise for the production of bacterial preparations FSUE FMBASt. Petersburg Research Institute of Vaccines and Serums and the enterprise for the production of bacterial preparations FSUE FMBA
Information update date: & nbsp02.01.2017
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