Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Valneva Sweden AB, S-105 21 Stockholm, Sweden +46 (0)8 735 1000 infodukoral@valneva.com
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.
The standard primary course of vaccination with Dukoral against cholera consists of 2 doses for adults and children from 6 years of age. Children 2 to below 6 years of age should receive 3 doses. Doses are to be administered at intervals of at least one week. If more than 6 weeks have elapsed between doses, the primary immunisation course should be re-started.
Immunisation should be completed at least 1 week prior to potential exposure to V. cholerae O1.
For continuous protection against cholera a single booster dose is recommended within 2 years for adults and children from 6 years of age, and within 6 months for children aged 2 to below 6 years. No clinical efficacy data has been generated on repeat booster dosing. However, immunological and duration of protection data suggest that if up to 2 years have elapsed since the last vaccination for adults and up to 6 months for children aged 2 to below 6 years a single booster dose should be given. If more than 2 years have elapsed since the last vaccination (more than 6 months for children aged 2 to below 6 years) the primary course should be repeated.
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 less than 2 years of age.
There are only very limited data on protective efficacy of the vaccine in subjects aged 65 years and more.
The vaccine is intended for oral use. Before ingestion, the suspension should be mixed with the buffer (sodium hydrogen carbonate) solution. The sodium hydrogen carbonate is supplied as effervescent granules, which should be dissolved in a glass of cool water (approx. 150 ml). Chlorinated water can be used. The 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 to below 6 years of age: half of the buffer solution is poured away and the remaining part (approx. 75 ml) is mixed with the entire contents of the vial.
Data on overdose are limited. Adverse reactions reported are consistent with those seen after the recommended dosing.
3 years.
After the effervescent granules have been dissolved in water and the vaccine suspension has been added, the mixture should be drunk within 2 hours.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Product in the unopened vial and sachet, stored in the outer carton, is stable at temperatures up to 25°C for a period of 14 days. At the end of this period the product should be used or discarded.
For storage conditions after first opening of the medicinal product, see section 6.3.
The vaccine suspension is filled in a volume of 3 ml in vials (type I glass) with a rubber stopper (bromobutyl rubber) and a screw cap.
The effervescent granules are filled in an amount of 5.6 g in sachets with an inner layer of polyester/LD-polyethylene and an outer layer of aluminium/LD-polyethylene.
Each dose of vaccine is supplied as one vial of suspension together with one sachet of effervescent granules.
Pack sizes: 1x1 dose, 2x1 dose, 20x1 dose
Not all pack sizes may be marketed.
The effervescent granules should be dissolved in approximately 150 ml of cool water to get the buffer solution. The vaccine vial should be shaken gently and the vaccine suspension should then be added to the buffer solution and mixed well to get the colourless slightly opalescent oral suspension.
Children 2 to below 6 years of age: half of the buffer solution is poured away and the remaining part (approx. 75 ml) is mixed with the entire contents of the vaccine vial.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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