Tifivak (Lyophilisate) Instructions for Use

Marketing Authorization Holder

St. Petersburg Research Institute of Vaccines and Sera of the FMBA, FSUE (Russia)

ATC Code

J07AP03 (Purified typhoid bacterial polysaccharide antigen)

Dosage Form

Tifivak

Lyophilizate for the preparation of solution for subcutaneous administration: 5 billion microbial cells amp. 5 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of a solution for subcutaneous administration in the form of a white amorphous powder; solvent – a transparent colorless liquid.

Preservative phenol – not more than 0.05%
Solvent isotonic sodium chloride solution for injections 0.9%.

1 ml – ampoules (5) in a set with a solvent (5 ml amp.) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of typhoid fever

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Double administration of the drug provides protection for 65% of vaccinated individuals against typhoid fever for 2 years.

Indications

Prevention of typhoid fever from the age of 18 years. The following groups are subject to priority vaccination

• Population living in territories with a high incidence of typhoid fever;
• Population living in territories during chronic water epidemics of typhoid fever;
• Persons employed in the field of public utilities (workers servicing sewer networks, structures and equipment, as well as enterprises for the sanitary cleaning of populated areas – collection, transportation and disposal of household waste);
• Persons working with live cultures of typhoid pathogens;
• Persons traveling to regions and countries hyperendemic for typhoid fever, as well as contacts in outbreaks for epidemiological indications.

For epidemiological indications, vaccinations are carried out in case of a threat of an epidemic or outbreak (natural disasters, major accidents in the water supply and sewer network), as well as during an epidemic, while mass immunization of the population is carried out in the threatened area.

ICD codes

Dosage Regimen

Vaccination is carried out twice with an interval of 25-35 days at a dose of

1st vaccination – 0.5 ml;

2nd vaccination – 1.0 ml;

Revaccination is carried out after 2 years at a dose of 1.0 ml.

The drug is administered with a syringe subcutaneously into the subscapular region.

Immediately before vaccination, 5 ml of solvent – isotonic 0.9% sodium chloride solution for injections – is added to the ampoule with the typhoid vaccine. The contents of the ampoule are mixed by gentle shaking. The dissolution time should not exceed 1 minute; The dissolved drug should be a uniform light gray suspension without flakes and foreign inclusions.

The resuspended vaccine, stored in compliance with aseptic rules, can be used within 2 hours.

Opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis.

Adverse Reactions

None.

Reactions to administration

After vaccine administration, general and local reactions may develop. The general reaction appears after 5-6 hours and is expressed by fever, malaise, and headache. Its duration, as a rule, does not exceed 48 hours.

The local reaction is characterized by the appearance of skin hyperemia, soreness, and the formation of an infiltrate, which disappear after 3-4 days.

Before mass vaccinations, the vaccine should be administered to a limited group (40-50) of people subject to vaccination, equivalent in age and health status to the main contingent of those being vaccinated.

Recording of the reaction is carried out 24 hours after vaccination.

A temperature increase up to and including 37.5°C (99.5°F) is considered a weak reaction, from 37.6 to 38.5°C (101.3°F) as a moderate reaction, and from 38.6°C (101.5°F) and above as a strong reaction.

Redness without infiltrate and an infiltrate with a diameter of up to and including 25 mm are considered a weak reaction, an infiltrate with a diameter from 26 to 50 mm inclusive as a moderate 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.

Provided that this instruction is strictly followed, the vaccine series can be used for subsequent vaccinations if strong and moderate temperature reactions and strong local reactions were detected after 24 hours in no more than 7% of cases, or if moderate temperature and local reactions were detected in no more than 12% of the vaccinated. In the latter case, cases of strong temperature and local reactions are also taken into account when calculating the percentage.

Considering the possibility of shock (in extremely rare cases in particularly sensitive individuals), it is necessary to provide medical observation of the vaccinated for 30 minutes. Vaccination sites must be equipped with anti-shock therapy means.

Contraindications

• Acute infectious and non-infectious diseases, exacerbation of chronic diseases – vaccination is carried out no earlier than one month after recovery (remission);
• Chronic diseases of the liver and biliary tract;
• Chronic kidney diseases;
• Diseases of the endocrine system;
• Diseases of the cardiovascular system: rheumatism, heart defects, myocarditis, hypertension;
• Bronchial asthma and other severe allergic diseases;
• Systemic connective tissue diseases;
• Infectious and non-infectious diseases of the central nervous system: a history of diseases accompanied by convulsions;
• Blood diseases, malignant neoplasms;
• Pregnancy.

To identify contraindications, the doctor conducts a survey and examination of the person to be vaccinated on the day of vaccination with mandatory thermometry. If necessary, an appropriate laboratory examination is carried out.

After the administration of the typhoid vaccine, scheduled vaccinations with other drugs are carried out no earlier than 1 month later.

Vaccinations performed are recorded in the established accounting forms indicating the date of vaccination, dose, manufacturer institute, series number, and reaction to the vaccination upon application.

Use in Pregnancy and Lactation

Contraindicated during pregnancy.

Use in Hepatic Impairment

Contraindicated in chronic kidney diseases.

Use in Renal Impairment

Contraindicated in chronic diseases of the liver and biliary tract.

Storage Conditions

The drug is stored in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F) in a place inaccessible to children. Transported in accordance with SP 3.3.2.1 at a temperature of 2 to 8°C (46.4°F).

Shelf Life

The shelf life of the vaccine is 3 years, the solvent is 5 years.

Dispensing Status

For medical and preventive institutions.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.