Flexvac Vaccine ad prophylaxim disentery lipopolysaccharide (Solution) Instructions for Use

Marketing Authorization Holder

Gritvak, LLC (Russia)

Manufactured By

Fncirip Named After M.P. Chumakov Ran, Fsbsi (Russia)

Packaging and Quality Control Release

Gritvak, LLC (Russia)

ATC Code

J07AX (Other bacterial vaccines)

Dosage Form

Flexvac (Dysentery vaccine against Shigella flexneri lipopolysaccharide)

Solution for intramuscular and subcutaneous administration 0.5 ml/1 dose: amp. 0.5 ml 5 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular and subcutaneous administration in the form of a colorless, transparent or slightly opalescent liquid with a phenol odor.

Excipients: phenol – not more than 0.75 mg, sodium chloride – 4.2 mg, disodium hydrogen phosphate heptahydrate – 0.052 mg, sodium dihydrogen phosphate dihydrate – 0.017 mg, water for injection – up to 0.5 ml.

0.5 ml – ampoules made of colorless glass (5) – cardboard packs.

Clinical-Pharmacological Group

Dysentery vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

An aqueous solution of modified lipopolysaccharides extracted from a culture of Shigella flexneri, purified by enzymatic and physicochemical methods.

Administration of the vaccine leads to the rapid appearance and intensive increase in the blood of vaccinated individuals of specific antibodies, which provide immunity to infection for 1 year within 2-3 weeks.

Indications

Prophylaxis of Flexner’s dysentery in adults.

ICD codes

Dosage Regimen

The vaccine is administered to adults subcutaneously (deeply) or intramuscularly into the outer surface of the upper third of the shoulder in a dose corresponding to 125 mcg of modified lipopolysaccharide once for all ages.

Re-vaccination is carried out if necessary annually once with the same dose of the vaccine.

The performed vaccination is registered 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

Local reactions frequently – redness (hyperemia) and induration at the injection site.

Contraindications

Hypersensitivity (including to previous administration of dysentery vaccine); acute infectious and non-infectious diseases, exacerbation of chronic diseases; the period of convalescence or remission for 1 month after the acute period of the disease; pregnancy; breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Special Precautions

Routine vaccination is recommended for: employees of infectious disease hospitals and bacteriological laboratories; persons employed in the catering sector, food production enterprises and public utilities.

Vaccinations are carried out for epidemic indications: in case of a complicated epidemic situation (natural disasters, major accidents on utility networks, etc.); persons in epidemic foci of Flexner’s dysentery; persons traveling to regions with a high incidence of Flexner’s dysentery.

In order to identify contraindications on the day of vaccination, a complete history of diseases should be collected and thermometry should be performed; if necessary, the necessary laboratory tests should be carried out.

Drug Interactions

It is forbidden to mix the vaccine in the same syringe with any preparations for parenteral administration.

Vaccination can be carried out on the same day with other prophylactic vaccinations with inactivated vaccines.

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.