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National Drug Formulary

DUKORAL VACCINE AGAINST CHOLERA AND ETEC-DIARRHOEA [SIN12186P]

Active ingredients: DUKORAL VACCINE AGAINST CHOLERA AND ETEC-DIARRHOEA

View product's general information
Last updated 24 April 2026

Product Info

DUKORAL VACCINE AGAINST CHOLERA AND ETEC-DIARRHOEA

[SIN12186P]

Product information

Active Ingredient and Strength

RECOMBINANT CHOLERA TOXIN B SUBUNIT (RCTB) - 1 MG/DOSE
VIBRIO CHOLERAE O1 INABA CLASSIC STRAIN (HEAT INACTIVATED) - 31.25 X 109 BACTERIA
VIBRIO CHOLERAE O1 INABA EL TOR STRAIN (FORMALIN INACTIVATED) - 31.25 X 109 BACTERIA
VIBRIO CHOLERAE O1 OGAWA CLASSIC STRAIN (FORMALIN INACTIVATED) - 31.25 X 109 BACTERIA
VIBRIO CHOLERAE O1 OGAWA CLASSIC STRAIN (HEAT INACTIVATED) - 31.25 X 109 BACTERIA

Dosage Form

SUSPENSION

Manufacturer and Country

VALNEVA SWEDEN AB - SWEDEN
RECIPHARM STOCKHOLM AB (EFFERVESCENT GRANULES) - SWEDEN

Registration Number

SIN12186P

Licence Holder

AENON PHARMACEUTICALS SEA PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

J07AE01

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

INDICATIONS
Cholera: Active immunisation of adults and children from 2 years of age who will be visiting areas with an ongoing or anticipated epidemic or who will be spending an extended period of time in areas in which cholera infection is a risk.
ETEC: Active immunisation of adults and children from 2 years of age who will be visiting areas posing a great risk of diarrheal illness caused by enterotoxigenic Escherichia coli (ETEC), one of the most common causes of “travellers’ diarrhea”.
DUKORAL® should not replace standard protective measures. In the event of diarrhea measures of rehydration should be instituted.

Dosing

DOSAGE AND ADMINISTRATION
Cholera: Primary immunisation: consists of 2 doses of vaccine for adults and children over the age of 6 years. Children from 2 to below 6 years of age should receive 3 doses. Doses are to be administered at intervals of at least 1 week. If more than 6 weeks elapse between doses, the primary immunisation course should be re-started. Immunisation should be completed at least 1 week prior to potential exposure.
Booster dose: For continuous long-term protection, a single booster dose is recommended for adults after 2 years.
Children from 2–6 years of age should receive a booster dose after 6 months.
ETEC: Primary immunisation: For adults and children consists of 2 doses of vaccine at an interval of at least 1 week. If more than 6 weeks elapse between doses, basic immunisation should be restarted.
Satisfactory protection against cholera and ETEC diarrhoea can be expected about 1 week after basic immunisation is concluded.

Children below 2 years
DUKORAL® has been given to children between 1 and 2 years of age in safety and immunogenicity studies, but the protective efficacy has not been studied in this age group. Therefore, DUKORAL® is not recommended to be used in children below 2 years of age.

Elderly
There are only very limited data on protective efficacy of the vaccine in subjects aged 65 years and more.

Method of Administration
The vaccine is intended for oral use. Before ingestion, the vaccine suspension should be mixed with a buffer (sodium hydrogen carbonate) solution.

The sodium hydrogen carbonate (buffer) is supplied as effervescent granules which should be dissolved in a glass of cool water (ca. 1.5 dl). Chlorinated water can be used.
The vaccine suspension should then be mixed with the buffer solution and drunk within 2 hours. Food and drink should be avoided 1 hour before and 1 hour after vaccination. Oral administration of other medicinal products should be avoided within 1 hour before and 1 hour after administration of DUKORAL®.
Children 2–6 years of age: half the amount of the buffer solution is poured away and the remaining part (approx. 75ml) is mixed with the entire contents of the vaccine bottle.

Contraindications

CONTRAINDICATIONS
Hypersensitivity to the active substances, to any of the excipients or to formaldehyde.
Administration of DUKORAL® should be postponed for subjects suffering from acute gastrointestinal illness or acute febrile illness.