Shigelat (Solution) Instructions for Use

ATC Code

J07AX (Other bacterial vaccines)

Clinical-Pharmacological Group

Dysentery vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

A solution of lipopolysaccharide extracted from a culture of Shigella sonnei, purified by enzymatic and physicochemical methods.

It induces specific resistance to Shigella sonnei, stimulates the appearance of specific antibodies, providing immunity to the infection within 2-3 weeks for a duration of 1 year.

Indications

Shigellosis sonnei (prophylaxis).

ICD codes

Dosage Regimen

Solution

Adults and children aged 3 years and older are administered the drug subcutaneously (deeply) or intramuscularly into the outer surface of the upper third of the shoulder – 50 mcg (0.5 ml) once. If necessary, revaccination is carried out annually in the same dose.

The opening of ampoules and the administration procedure are carried out in strict compliance with the rules of asepsis and antisepsis. The drug from an opened ampoule must be used immediately.

The performed vaccination is recorded in the established registration forms indicating the name of the drug and the date of vaccination, dose, manufacturer, batch number, and reaction to the vaccination.

Adverse Reactions

Rarely (within the first 24 hours after immunization) – hyperthermia (in 3-5% of cases – low-grade fever for 24-48 hours), headache, local reactions (hyperemia, pain at the injection site).

Contraindications

Hypersensitivity (including to previous administration of dysentery vaccine); acute period of infectious and non-infectious diseases; exacerbations of chronic diseases; convalescence period or remission for 1 month after the acute period of the disease; pregnancy; children’s age (under 3 years).

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy.

Pediatric Use

Contraindicated in children under 3 years of age.

Special Precautions

Prophylactic vaccination is recommended for workers of infectious disease hospitals and bacteriological laboratories; persons employed in the catering sector and public utilities; children attending childcare facilities and departing for health camps; persons traveling to regions with a high incidence of Shigellosis sonnei; before the seasonal rise in the incidence of this infection.

For epidemiological indications, vaccinations are carried out during an epidemic or threat of its occurrence (natural disasters, major accidents in water supply and sewerage networks).

To identify contraindications on the day of vaccination, a complete medical history should be collected and thermometry performed; if necessary, the necessary laboratory tests should be conducted.

Before vaccination, the integrity of the ampoule and packaging, the condition of the physical properties of the drug are assessed, and its expiration date is checked.

Drug Interactions

Vaccination can be carried out on the same day with other prophylactic vaccinations with inactivated drugs or with an interval after the last vaccination of at least 1 month.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.