Cholera bivalent chemical vaccine (Tablets) Instructions for Use

Marketing Authorization Holder

Microb Russian Research Anti-Plague Institute of Rospotrebnadzor FSUH (Russia)

ATC Code

J07AE (Cholera vaccines)

Dosage Form

Cholera bivalent chemical vaccine

Enteric-coated tablets: 210 tabs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets with a shiny coating; the tablet content is a grayish-yellow mass, tasteless and odorless.

Excipients: sucrose, starch, talc, calcium stearate.

Enteric coating composition: cellacephate.

210 pcs. – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of cholera

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine induces the development of anti-cholera immunity in vaccinated individuals lasting up to 6 months.

Indications

Prevention of cholera in adults, adolescents, and children from 2 years of age.

The following individuals are subject to vaccination

• Persons traveling to countries with unfavorable cholera situations (in agreement with the Federal Service for Surveillance on Consumer Rights Protection and Human Well-being);
• The population of border areas of Russia in case of an unfavorable cholera situation in adjacent territories (by decision of the Federal Service for Surveillance on Consumer Rights Protection and Human Well-being).

ICD codes

Dosage Regimen

One vaccination dose of the drug is for adults – 3 tablets, for adolescents 11-17 years old – 2 tablets, for children 2-10 years old – 1 tablet.

Cholera vaccine tablets are taken orally 1 hour before a meal, swallowed whole without chewing, with 1/8 – 1/4 glass of boiled water.

Revaccination is carried out 6-7 months after vaccination; the dose for adults and adolescents is 2 tablets, for children 2-10 years old – 1 tablet.

The vaccine must not be used if the integrity of its packaging is damaged, if information on the labels is missing, if the appearance of the tablets has changed (integrity violation, color change), or if the expiration date has passed.

The drug can be taken simultaneously (on the same day) with the administration of inactivated vaccines from the National Calendar of Preventive Vaccinations and the Calendar of Preventive Vaccinations for Epidemic Indications (except for anti-rabies vaccines and BCG vaccine).

Precautions for use

It is not recommended to combine the intake of cholera vaccine tablets with the administration of anti-rabies vaccines and BCG vaccine.

Adverse Reactions

1-2 hours after taking the vaccine, some vaccinated individuals may experience mild discomfort in the epigastric region, rumbling in the abdomen, and pasty stools.

Contraindications

• Acute infectious and non-infectious diseases, including intestinal dysfunction, chronic diseases in the acute phase; vaccinations are carried out no earlier than 1 month after recovery (remission);
• Malignant neoplasms and malignant blood diseases;
• Immunodeficiency states;
• Pregnancy.

To identify contraindications, the doctor (paramedic) conducts a survey and examination of the persons to be vaccinated on the day of vaccination with mandatory temperature measurement.

Use in Pregnancy and Lactation

Contraindicated during pregnancy.

Pediatric Use

Children who have reached 2 years of age are subject to vaccination.

Drug Interactions

Interaction with other medicinal products has not been established.

Storage Conditions

Store in accordance with SP 3.3.2.1248-03 at a temperature from 0 to 8°C (46.4°F) in a place inaccessible to children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

For therapeutic-prophylactic and sanitary-prophylactic 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.