Basic Information
Dukoral
Regulatory Information
EMEA/H/C/000476
April 28, 2004
14
April 6, 2022
Company Information
Active Substances Detail
recombinant cholera toxin B subunitvibrio cholerae 01
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Dukoral is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas. The use of Dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions. Dukoral should not replace standard protective measures. In the event of diarrhoea measures of rehydration should be instituted.
Overview Summary
Dukoral is a vaccine that is given by mouth to protect people against cholera, a serious disease that causes severe diarrhoea. It is used in people aged from 2 years who will be visiting areas with high risk of cholera. Cholera is caused by the bacterium Vibrio cholerae (V. cholerae), which is caught from contaminated food or water. Dukoral should be used according to official recommendations, taking into account where cholera occurs and the risk of catching the disease. The vaccine contains 4 different inactivated strains (types) of V. cholerae serotype O1, and part of a toxin from one of these strains as active substances.