Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about DUKORAL®.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you or your child taking DUKORAL® against the benefits they expect it will have.
If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist.
Keep this leaflet. You may need to read it again.
What DUKORAL® is used for
DUKORAL® is a vaccine used to help prevent cholera.
DUKORAL® is used to protect people who are travelling to an area where there is a risk of cholera.
How it works
DUKORAL® works by causing your body to produce its own protection against cholera. It does this by making substances called antibodies in the intestine wall, which fight the cholera bacteria (Vibrio cholerae) and the cholera toxin. Cholera toxin causes diarrhoea and is produced by the cholera bacteria. If a vaccinated person comes into contact with cholera bacteria or cholera toxin, the body is usually ready to destroy it.
Your body usually takes two weeks after vaccination to develop protection against diarrhoea due to Cholera.
Most people will produce enough antibodies to protect against diarrhoea due to cholera. However, as with all vaccines, 100% protection cannot be guaranteed. About 85% of people can expect to be protected against cholera in the 6 months following initial vaccination. This decreases to 52% at the end of the second year, when a booster should be given.
The vaccine will not give you or your child cholera.
The chance of a severe reaction from DUKORAL® is very small, but the risks from not being vaccinated against cholera may be very serious.
Before you take DUKORAL®
When you or your child must not take it
Do not take DUKORAL® if you have an allergy to DUKORAL® or any of the ingredients listed at the end of this leaflet
Do not take DUKORAL® if you have a high temperature.
Do not give DUKORAL® to a child under 2 years. There is not enough experience with the use of DUKORAL® in children under 2 years.
Do not take DUKORAL® after the expiry date printed on the pack.
Do not take DUKORAL® if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
Talk to your doctor or pharmacist if you are not sure whether you or your child should take DUKORAL®.
Before you or your child start to take it
Tell your doctor if you have an infection or high temperature. Your doctor may decide to delay vaccination until the illness has passed. A mild illness, such as a cold, is not usually a reason to delay vaccination.
Tell your doctor if you have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
Tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the possible risks and benefits of having DUKORAL® during pregnancy.
DUKORAL® is not expected to cause any problems for breast-fed babies.
How to take DUKORAL®
Follow all directions given to you by your doctor or pharmacist carefully. Your doctor or pharmacist will tell you how to take this vaccine.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
Cholera: the course of primary vaccination is 2 doses for adults and children over the age of 6. Children from 2 to 6 years of age should receive three doses. Doses are to be administered with an interval of 1 to 6 weeks between them. Adults and children over 6 years should receive a booster dose after 2 years and children 2-6 years should receive a booster dose after 6 months.
How to take it
Please see the diagram on the carton.
1.Dissolve the sodium bicarbonate (sodium hydrogen carbonate) buffer from the buffer sachet in a glass of cool water. (Approx. 150 mL) Children 2-6 years: pour away half of the solution.
2.Shake the vaccine vial (1 vial - 1 dose)
3.Add the vaccine to the sodium bicarbonate solution. Mix well and drink mixture.
The vaccine must not be injected.
It is important to follow these instructions otherwise the vaccine will not work.
When to take it
For best protection against cholera the last dose of vaccine should be taken 2 weeks before arrival at your destination.
DUKORAL® should be taken at least 1 hour before or at least 1 hour after food and drink.
If you forget to take it
For optimum protection you should take two doses 1-6 weeks apart. If more than 6 weeks have elapsed between doses you should consult your doctor or pharmacist about the need to repeat the primary course.
If you are not sure what to do, ask your doctor or pharmacist.
After taking DUKORAL®
Things you or your child must do
Keep an updated record of your vaccinations.
Keep follow-up appointments with your doctor or clinic. It is important to take your follow-up doses of Dukoral® at the appropriate times to make sure the vaccine has the best chance of providing protection against cholera.
Things to be careful of
Avoid food and drink 1 hour before and 1 hour after vaccination. Food and drink taken during this time may inactivate the vaccine.
The side effects of Dukoral® are usually mild and limited to gastrointestinal upsets due to the bicarbonate buffer used with this vaccine. Rarely severe abdominal cramping occurs.
Tell your doctor or pharmacist as soon as possible if you or your child do not feel well after having DUKORAL®.
Store DUKORAL® in a refrigerator, between 2°C and 8°C. Do not freeze DUKORAL®. Freezing destroys the vaccine.
What it looks like
DUKORAL® is supplied as a glass vial, containing one dose of the vaccine, together with a sachet, containing the buffer, in a carton. The buffer is a dry granular powder. The vaccine is a small amount of whitish liquid.
The vaccine vial contains -
Vibrio cholerae O1 Inaba classic strain, heat inactivated.
Vibrio cholerae O1 Inaba El Tor strain, formalin inactivated.
Vibrio cholerae O1 Ogawa classic strain, formalin inactivated.
Vibrio cholerae O1 Ogawa classic strain, heat inactivated.
Recombinant cholera toxin B subunit
Sodium phosphate, monobasic
Sodium phosphate, dibasic dihydrate
Water for injection
The buffer sachet contains:
Sodium Bicarbonate (Sodium hydrogen carbonate)
Citric acid, anhydrous
Sodium Carbonate - anhydrous
DUKORAL® does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
SANOFI PASTEUR PTY.LTD.,
ABN 79 085 258 797
Talavera Corporate Centre - Building D
12 -24 Talavera Road
AUST R Number
Aust R 94483
Date of preparation: