EPARs - Dukoral//Oral Cholera vaccine

FICHA FARMACOLÓGICA de Oral Cholera vaccine. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. MAYO 04, 2009.-

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EPARs for authorised medicinal products for human use - Dukoral

Active Substance
Vibrio cholerae O1 Inaba, classical biotype (heat inactivated)
Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated)
Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated)
Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated)
Recombinant cholera toxin B subunit (rCTB) (produced in V. cholerae O1 Inaba, classical biotype strain 213.)
International Nonproprietary Name or Common Name
Oral Cholera vaccine
Pharmaco-therapeutic Group
Bacterial vaccines
ATC Code
J07A E01

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.

Date of issue of Marketing Authorisation valid throughout the European Union
28 April 2004