Typhous combined E vaccine live ZHKSV-E (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07AR01 (Inactivated whole bacteria of typhus pathogens)

Dosage Form

Typhus E combined live vaccine (ZHKSV-E)

Lyophilizate for preparation of suspension for subcutaneous administration 0.25 ml/1 dose: amp. 20 doses 5 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intramuscular administration is a porous mass in the form of a tablet ranging from light yellow to dark brown in color. The reconstituted preparation is a homogeneous suspension of light yellow color.

* minimum infecting doses of rickettsiae for developing chick embryos
** 1 immunizing dose – 0.25 ml of vaccine reconstituted with solvent

Excipients: sterile skimmed drinking milk.

Solvent sodium chloride 0.9% solution***; 1 ml of solvent contains sodium chloride – 9 mg, water for injections – up to 1 ml.

20 doses – ampoules (5) in a set with solvent (5 ml amp. 5 pcs.) – cardboard packs.

*** sodium chloride solvent for preparation of dosage forms for injections 0.9% (LP-№(001316)-(RG-RU)).

Clinical-Pharmacological Group

Vaccine for the prevention of typhus

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

A single administration of the vaccine is accompanied by the development of specific immunity on days 15-30 after vaccination.

Indications

• Specific prevention of typhus in individuals aged 18 to 60 years.

The vaccine is used for epidemiological indications in situations representing a threat of typhus infection, as well as to protect laboratory personnel working with Rickettsia prowazekii.

ICD codes

Dosage Regimen

Administer the vaccine once subcutaneously in the subscapular region.

Use a single dose of 0.25 ml for both initial vaccination and revaccination.

Perform revaccination with a 0.25 ml dose no earlier than one year after the initial vaccination.

Reconstitute the lyophilizate immediately before use with 5 ml of the supplied 0.9% sodium chloride solvent.

Inspect the reconstituted vaccine; it must form a homogeneous light yellow suspension within two minutes.

Discard the vaccine if it contains undissolved flakes or if dissolution takes longer than two minutes.

Use the reconstituted vaccine within 30 minutes at room temperature or within 60 minutes when stored at 2-8°C (46.4°F).

Do not administer the vaccine to individuals with a body temperature above 37°C (98.6°F).

Maintain an interval of at least one month between this vaccine and other immunizations.

Record the vaccination details, including date, dose, manufacturer, and batch number, in the appropriate medical forms.

Adverse Reactions

A local reaction to the administration may be observed in the form of slight swelling or tissue infiltration without clear boundaries and pain in 10-20% of vaccinated individuals.

Early general reactions, occurring within the first 6-72 hours after vaccination in 7-12% of vaccinated individuals, may manifest as a one- to two-day increase in temperature to subfebrile levels and complaints of weakness and dizziness.

Late general reactions, which are a manifestation of the vaccine infection, appear after 9-18 (rarely later) days after vaccination in 2-3% of vaccinated individuals and are expressed by an increase in temperature for 1-4 days, headache, malaise, and often muscle pain.

During revaccination with ZHKSV-E, reactions to the vaccine administration are usually not observed.

Contraindications

• Acute infectious and non-infectious diseases; chronic diseases in the acute phase. Vaccinations are carried out no earlier than one month after recovery or remission;
• Allergic diseases (according to medical history): bronchial asthma, atopic dermatitis, pollinosis, etc.; allergy to chicken protein;
• Degenerative and progressive diseases of the nervous system;
• Diseases of the kidneys and adrenal glands;
• Systemic connective tissue diseases;
• Immunodeficiency states (primary and secondary);
• Pregnancy and lactation period.

The possibility of vaccinating individuals suffering from diseases not listed in this list of contraindications is determined by the doctor, based on the health status of the person to be vaccinated.

Immediately before vaccination, the doctor conducts a thorough medical examination with thermometry and interviews the vaccinees to identify contraindications. Vaccination is not performed at a temperature above 37°C (98.6°F).

Vaccinations are carried out no earlier than 1 month after the previous immunization with other prophylactic drugs.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Renal Impairment

Contraindicated in kidney diseases.

Pediatric Use

The vaccine is used in patients aged 18 to 60 years.

Geriatric Use

The vaccine is used in patients aged 18 to 60 years.

Special Precautions

Precautions for use

Before use, each ampoule with the vaccine is carefully inspected. If the ampoule has cracks, foreign inclusions, color uncharacteristic of the vaccine, or other defects, as well as damaged labeling and expired shelf life, this ampoule is rejected and inactivated by boiling for 30 minutes or by immersing the broken ampoule in a 3% chloramine solution for 1 day.

Immediately before vaccination, 5 ml of sodium chloride 0.9% solution for injections is added to the ampoule with the vaccine. The vaccine should dissolve within 2 minutes to form a homogeneous light yellow suspension. If dissolution takes longer, or if there are undissolved flakes in the dissolved preparation, the contents of the ampoule are not suitable for use and must be destroyed as indicated above.

The opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis. The dissolved vaccine is suitable for use within 30 minutes when stored under a sterile napkin at room temperature and within 60 minutes when stored at a temperature of 2 to 8°C (46.4°F). Dissolved and unused vaccine within this period is destroyed by the methods indicated above.

The performed vaccination is registered in the appropriate accounting forms indicating the date, dose, manufacturer, batch number, and reaction to the vaccination.

Effect on ability to drive vehicles and mechanisms

The effect on the ability to drive vehicles and mechanisms has not been established.

Drug Interactions

Not identified.

Storage Conditions

The vaccine should be stored in accordance with SP 3.3.2.1.1248-03 at a temperature of 2 to 8°C (46.4°F) in a place inaccessible to children. Freezing is not allowed.

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.