Patient Medication Information: uses, side effects, how to take - Dukoral
What is DUKORAL® used for?
DUKORAL® is an oral vaccine that is used to help prevent diarrhea caused by cholera and a particular strain of bacteria producing a heat-sensitive toxin (called heat-labile toxin producing enterotoxigenic Escherichia coli [or LT-producing ETEC]).
DUKORAL® is used to help protect people who are travelling to an area where there is a risk of diarrhea caused by cholera and/or LT-producing ETEC. This vaccine may be given to adults and children 2 years of age and older.
How does DUKORAL® work?
DUKORAL® causes your body to produce its own protection against cholera and LT-producing ETEC diarrhea. After getting the vaccine, your body will make substances called antibodies, which fight the cholera and LT-producing ETEC bacteria and toxins that cause diarrhea. If a vaccinated person comes into contact with cholera or LT-producing ETEC bacteria the body is usually ready to destroy it.
It usually takes one week after you have completed all doses of the vaccine to be protected against diarrhea due to cholera or LT-producing ETEC. Most people who take the vaccine will produce enough antibodies to protect them against diarrhea caused by LT-producing ETEC or cholera. However, as with all vaccines, 100% protection is not guaranteed.
What are the ingredients in DUKORAL®?
Medicinal ingredients:
Each DUKORAL® single-dose vaccine vial contains: V. cholera O1 Inaba classic strain, heat inactivated V. cholera O1 Inaba El Tor strain, formalin inactivated V. cholerae O1 Ogawa classic strain, heat inactivated V. cholerae O1 Ogawa classic strain, formalin inactivated Recombinant cholera toxin B subunit (rCTB)
Non-medicinal ingredients:
Each DUKORAL® single-dose vaccine vial contains:
Sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, water for injection.
Each Sodium Hydrogen Carbonate effervescent powder sachet contains:
Citric acid, saccharin sodium, sodium carbonate, sodium citrate, sodium hydrogen carbonate, raspberry flavour.
One dose of DUKORAL® contains approximately 1200 mg sodium.
DUKORAL® comes in the following dosage forms:
DUKORAL® is a liquid vaccine that must be taken orally (by mouth) after adding the content of the Dukoral® vaccine vial to the buffer solution (effervescent powder+water mixture). DUKORAL® comes in a carton containing one or two doses.
The vaccine (DUKORAL® vaccine vial) is a small amount of whitish suspension in a single-dose glass vial.
Each dose of DUKORAL® vaccine vial comes with one white sachet package that contains a white effervescent powder of sodium hydrogen carbonate, which looks like a white powder. To prepare the buffer solution, the effervescent powder should be dissolved in a glass of water (150 mL or approx. 5 oz) – do not use any other liquid. The content of the DUKORAL® vaccine vial is then added and mixed with the buffer solution. The resulting vaccine mixture has a raspberry taste.
Do not use DUKORAL® in the following cases:
- Do not take DUKORAL® if you are allergic to any ingredient of the vaccine or to formaldehyde.
- Do not give DUKORAL® to a child who is allergic to any ingredient of the vaccine or to formaldehyde.
- Do not give DUKORAL® to a person who has a fever or acute gastrointestinal illness (e.g. diarrhea). Wait until the person is better to give the vaccine. Consult your doctor, nurse or pharmacist for guidance.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DUKORAL®. Talk about any health conditions or problems you may have, including if you:
- Have diseases of the immune system or take a medical treatment that affects the immune system. The vaccine may provide you with a lower level of protection than it does for people with healthy immune systems.
- Have an allergy to any component of the vaccine or the container or to formaldehyde.
- Have acute gastrointestinal illness (e.g. diarrhea) or high temperature. You may need to postpone taking DUKORAL® until the illness has passed. You may take the vaccine if you have a mild illness, such as a cold.
Are a pregnant woman. DUKORAL® is not recommended for use in pregnancy. Your doctor will discuss the possible risks and benefits of having DUKORAL® during pregnancy.
Other warnings you should know about:
DUKORAL® prevents diarrhea caused by cholera and LT-producing ETEC. It will not prevent diarrhea caused by other organisms. While travelling, be careful when choosing food and wash, peel or cook it yourself if possible. Drink bottled or boiled water. If possible, wash hands before eating and after using toilet facilities.
As with any vaccine, immunization with DUKORAL® may not protect 100% of susceptible persons.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with DUKORAL®:
Do not eat, drink or take other medicine for 1 hour before and for 1 hour after taking the vaccine mixture (DUKORAL® vaccine vial+buffer solution). Food and drink taken during this time may prevent the vaccine from working.
How to take DUKORAL®:
Important Information about taking DUKORAL®:
The vaccine (the content of the DUKORAL® vaccine vial) has to be taken mixed with a buffer solution (effervescent powder+water mixture) to protect it from the stomach acid. Use only cool water to prepare the buffer solution. Do not use any other liquid.
Do not eat or drink for 1 hour before and for 1 hour after taking the vaccine mixture (DUKORAL® vaccine vial+buffer solution).
Do not take any other medicine orally (by mouth) for 1 hour before and 1 hour after taking the vaccine mixture (DUKORAL® vaccine vial+buffer solution). The vaccination effect is not achieved by drinking the content of the DUKORAL® vaccine vial alone, but by drinking the vaccine mixture (DUKORAL® vaccine vial+ buffer solution). Follow the directions for proper mixing as shown below. It is important to follow these instructions to make sure the vaccine mixture works.
How to prepare DUKORAL®:
Locate the two components: the effervescent powder (sodium hydrogen carbonate) in a white sachet and the DUKORAL® vaccine vial.
Step 1. Prepare the buffer solution. To prepare the buffer solution, open the white sachet containing the effervescent powder (sodium hydrogen carbonate) and pour its content into 150 mL (approx. 5 oz) of cool water. Stir gently with a spoon to dissolve. Do not use any other liquid. For children 2 to 6 years - pour away half of the prepared buffer solution before proceeding to Step 2 (keep 75 mL, approx. 2.5 oz). | |
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Step 2. Shake the DUKORAL® vaccine vial. Shake the DUKORAL® vaccine vial (1 vial = 1 dose) to mix it well. | |
Step 3. Prepare the vaccine mixture. To prepare the vaccine mixture, pour the content of the DUKORAL® vaccine vial (see Step 2) into the glass of prepared buffer solution (see Step 1). Stir gently with a spoon to mix all the ingredients. | |
Step 4. Drink the entire vaccine mixture immediately. Drink the entire vaccine mixture (see Step 3) immediately, as it should be consumed within 2 hours after its preparation. Keep the mixture at room temperature if not drunk immediately. IMPORTANT: Do not eat or drink any other liquids (including water), or take any other medication for 1 hour before and 1 hour after taking the vaccine mixture. |
Your doctor or pharmacist will tell you how to prepare and take this vaccine. Follow their directions carefully. If you do not understand the instructions, ask your doctor, nurse or pharmacist for help.
Usual dose:
- TO PROTECT AGAINST CHOLERA:
Primary vaccination course for adults and children 6 years and older: Take 2 doses orally (by mouth) at least 1 week (up to 6 weeks) apart. Take the 2nd dose at least 1 week after the first dose and at least 1 week before your trip. It takes about 1 week after the last dose for protection to begin. Protection
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against cholera lasts for about 2 years. If you wait more than 6 weeks between the 1st and 2nd dose, you will have to start again with the 1st dose.
Booster for adults and children over 6 years: If you had your last dose of the vaccine between 2 and 5 years before, a single dose will renew your protection. If more than 5 years have passed since your last dose, you should have the complete primary vaccination course (2 doses) again.
Primary vaccination course for children 2 to 6 years: Give 3 doses orally (by mouth) at least 1 week (up to 6 weeks) apart and finishing at least 1 week before the trip.
Give the 1st dose at least 3 weeks before the trip, the 2nd dose at least 1 week after the 1st dose, and the 3rd dose at least 1 week after the 2nd dose. It takes about 1 week after the last dose for protection to begin. Protection against cholera will last for about 6 months. If more than 6 weeks elapse between any of the doses, the child will have to start again with the 1st dose.
Booster for children 2 to 6 years: If the child had the last dose of the vaccine between 6 months and 5 years before, a single dose will renew protection. If more than 5 years have passed since the last dose, complete primary vaccination course (3 doses) is recommended.
- TO PROTECT AGAINST DIARRHEA CAUSED BY LT-producing ETEC:
Primary vaccination course for adults and children 2 years and older: 2 doses orally (by mouth) at least 1 week (up to 6 weeks) apart. Take the 1st dose no later than 2 weeks before you leave for your trip. Take the 2nd dose at least 1 week after the 1st dose and at least 1 week before your trip. It takes about 1 week after the last dose for protection to begin.
Protection against diarrhea caused by LT-producing ETEC starts about 1 week after the 2nd dose and lasts for about 3 months. If you wait more than 6 weeks between the 1st and 2nd dose, you will have to start again with the 1st dose.
Booster: If you had your last dose of the vaccine between 3 months and 5 years before, a single dose will renew your protection. If more than 5 years have passed since your last dose, you should have the complete primary vaccination course (2 doses) again.
Overdose:
If you take more than the recommended dose, you may have some of the side effects listed below.
| If you think you, or a person you are caring for, have taken too much DUKORAL®, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
You can take the 2nd dose of DUKORAL® up to 6 weeks after the 1st dose (children 2 to 6 years have to take 3 doses to protect against cholera).
If the 2nd (or 3rd) dose is missed, it can be taken at any time within 6 weeks of the previous dose. Food and drink must be avoided for 1 hour before and for 1 hour after taking the vaccine.
What are possible side effects from using DUKORAL®?
These are not all the possible side effects you may have when taking DUKORAL®. If you experience any side effects not listed here, tell your healthcare professional.
A vaccine, like any medicine, may cause serious problems, such as severe allergic reactions. The risk of DUKORAL® causing serious harm is extremely small. The small risks associated with DUKORAL® are much less than the risks associated with getting the diseases.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well after receiving DUKORAL®.
The side effects of DUKORAL® are usually mild. The most common side effects are gastrointestinal upsets, such as abdominal pain, diarrhea, nausea or vomiting. Some people who receive DUKORAL® may feel feverish. Potentially serious side effects (e.g., dehydration, shortness of breath) are extremely rare.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Suspected Side Effects for Vaccines For the general public: Should you experience a side effect following immunization, please report it to your healthcare professional. Should you require information related to the management of the side effect, please contact your healthcare professional. The Public Health Agency of Canada, Health Canada and Valneva Canada cannot provide medical advice. For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to your local Health Unit. |
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Storage:
Store the DUKORAL® vaccine vial in a refrigerator at 2°C to 8°C (35°F to 46°F). DO NOT FREEZE DUKORAL®. Freezing destroys the vaccine.
The DUKORAL® vaccine vial may be used if stored at room temperature (up to 25°C) for up to 21 days in total. However, this is not a storage recommendation.
After mixing the content of the DUKORAL® vaccine vial with the buffer solution, the vaccine mixture should be taken within 2 hours.
Do not use after expiration date. Do not take DUKORAL® after the expiry date printed on the carton.
Keep out of reach and sight of children.
If you want more information about DUKORAL®:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.valneva.ca, or by calling Medical Information at Valneva Canada Inc. at 1-855-356-0831. Business hours: 9:00 a.m. to 5:00 p.m. Eastern Time, Monday to Friday.