Patient Leaflet Updated 21-Feb-2023 | Valneva UK Limited
Dukoral suspension and effervescent powder for oral suspension Cholera vaccine (inactivated, oral))
DUKORAL® Suspension and effervescent powder for oral suspension
Cholera vaccine (inactivated, oral)
1. What Dukoral is and what it is used for
2. What you need to know before you use Dukoral
3. How to use Dukoral
4. Possible side effects
5. How to store Dukoral
6. Contents of the pack and other information
Dukoral is an oral vaccine against cholera that stimulates the immunological defence in the gut. The vaccine protects adults and children from 2 years of age against cholera.
Dukoral causes your body to produce its own protection against cholera.
After getting the vaccine, your body will make substances called anti- bodies, which fight the cholera bacteria and toxin that cause diarrhoea.
Talk to your doctor before taking Dukoral
The vaccine may provide you with a lower level of protection than it does for people with healthy immune systems.
The vaccine does not provide complete protection and it is important to adhere to dietary and hygiene advice to avoid diarrhoeal diseases.
Do not give this vaccine to children younger than 2 years since the protection has not been studied in this group.
Please tell your doctor if you are taking or have recently taken any other medicines.
Do not take other medicine starting 1 hour before until 1 hour after taking the vaccine.
Avoid food and drink starting 1 hour before until 1 hour after the vaccination.
If you are pregnant, think you may be pregnant or are planning to have a baby or are breast-feeding, ask your doctor before taking the vaccine.
There are no reasons to suspect that Dukoral will affect your ability to drive or handle machines.
Dukoral contains approximately 1.1 g sodium per dose. Please take this into consideration if you are on a controlled sodium diet.
Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor if you are not sure.
Adults and children from 6 years of age: The primary vaccination is 2 doses taken orally (by mouth) at least 1 week (up to 6 weeks) apart.
It takes about 1 week after the last dose for protection to begin.
For continuous protection, re-vaccination is recommended within 2 years.
If you had your last dose of vaccine less than 2 years ago a single dose will renew your protection. If more than 2 years have passed since you had the last vaccine dose, the primary vaccination (2 doses) should be repeated.
Children of 2 to below 6 years of age: The primary vaccination is 3 doses taken orally (by mouth) at least 1 week (up to 6 weeks) apart. Only half of the amount of the buffer solution should be mixed with the vaccine.
It takes about 1 week after the last dose for protection to begin.
For continuous protection, re-vaccination is recommended within 6 months.
If less than 6 months have passed since the last vaccination a single dose will renew the protection. If more than 6 months have passed since the last vaccination, the primary vaccination (3 doses) should be repeated.
The suspension supplied in a single-dose glass vial is a whitish suspension.
Each vial comes with one sachet package that contains a white effervescent powder of sodium hydrogen carbonate. The effervescent powder should be dissolved in a glass of cool water, and the resulting buffer solution should be mixed with the suspension. It is important to use the buffer solution, as it protects the vaccine from the gastric acid.
Drink the entire mixture within 2 hours after mixing with the buffer preparation.
1. To prepare the buffer solution, dissolve the effervescent powder in a glass of cool water (approx. 150 ml) by gently stirring.
Do not use any other liquid.
For children of 2 to below 6 years: pour away half of the buffer solution.
2. Shake the Dukoral® suspension vial (1 vial = 1 dose).
3. Pour the content of Dukoral® suspension vial into the glass of buffer solution (see 1).
Mix by gently stirring.
4. Drink the entire mixture within 2 hours.
Avoid food and drink starting 1 hour before until 1 hour after drinking the mixture.
If you take the doses less than 1 week apart, contact your doctor, pharmacist or nurse.
Because each vial of Dukoral contains only one dose, overdosage is unlikely.
If you have taken more than one dose at one time, please contact your doctor, pharmacist or nurse.
You can take the 2nd dose of Dukoral up to 6 weeks after the 1st dose (children of 2 to below 6 years have to take 3 doses). If more than 6 weeks have passed, contact your doctor, pharmacist or nurse.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Like all medicines, Dukoral can cause side effects, although not everybody gets them.
Contact a doctor immediately if you experience the following serious side effects:
Other side effects:
Uncommon side effects (may affect up to 1 in a 100 people)
Rare side effects (may affect up to 1 in a 1,000 people)
Very rare side effects (may affect up to 1 in a 10,000 people)
Other side effects (frequency cannot be estimated from the available data)
If you get any side effects, talk to your your doctor, nurse or pharmacist.
This includes any possible side effects not listed in this leaflet. You can also report side effects directly to:
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Keep this medicine out of the sight and reach of children.
Do not use Dukoral after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Dukoral is presented as a suspension and effervescent powder for oral suspension. The suspension is a whitish suspension supplied in a vial. The effervescent powder is white with a raspberry flavour and is supplied in a sachet.
Dukoral is available in packs of 1, 2 and 20 doses. Not all pack sizes may be marketed.
This leaflet was last revised in 01/2021
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