Dukoral

 
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Dukoral
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About This Vaccine

What the vaccine is used for

DUKORAL is an oral vaccine that is used to help prevent travellers’ diarrhea caused by enterotoxigenic E. coli (or ETEC) and/or cholera. The ETEC bacterium is the most common cause of travellers’ diarrhea. DUKORAL is used to help protect people who are travelling to an area where there is a risk of travellers’ diarrhea caused by ETEC and/or cholera. This vaccine may be given to adults and children 2 years of age and older.

What the vaccine does

DUKORAL causes your body to produce its own protection against ETEC and cholera. After getting the vaccine, your body will make substances called antibodies, which fight the ETEC and cholera bacteria and toxins that cause diarrhea. If a vaccinated person comes into contact with ETEC or cholera 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 ETEC or cholera. Most people who take the vaccine will produce enough antibodies to protect them against diarrhea caused by ETEC or cholera. However, as with all vaccines, 100% protection is not guaranteed.

When Dukoral should not be used

Do not use this vaccine in the following cases:

  • Do not take DUKORAL if you have an allergy to the vaccine or any ingredient in it.

  • Do not give DUKORAL to a child who has an allergy to the vaccine or any ingredient in it.

  • Do not give DUKORAL to a person who has a fever or serious illness. Wait until the person is better to give the vaccine. Consult your doctor, nurse or pharmacist for guidance.

Talk to your doctor, nurse or pharmacist if you are not sure whether you or your child should take DUKORAL.

What the medicinal ingredients for Dukoral are

Each 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).

Each Sodium Hydrogen Carbonate sachet package contains

Sodium hydrogen carbonate.

What the important nonmedicinal ingredients for Dukoral are

Each Sodium Hydrogen Carbonate sachet contains

Citric acid, sodium carbonate, sodium citrate, raspberry flavour, saccharin sodium.

For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

What dosage forms Dukoral comes in

DUKORAL is a liquid vaccine that must be swallowed (taken orally). DUKORAL comes in a carton containing one or two doses.

The vaccine is a small amount of whitish suspension in a single-dose glass vial.

Each dose of vaccine comes with one sachet package that contains white granules of sodium hydrogen carbonate. The granules should be dissolved in a glass of water—do not use any other liquid. The vaccine is mixed with this liquid. The vaccine mixture has a raspberry taste.


Warnings and Precautions

If you have any of the following conditions, talk to your doctor, nurse or pharmacist BEFORE you take DUKORAL:

  • Persons who have diseases of the immune system or who 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.

  • Persons who have an allergy to any component of the vaccine or the container.

  • Persons who have an infection 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.

  • Pregnant women. DUKORAL is not recommended for use in pregnancy. Your doctor will discuss the possible risks and benefits of having DUKORAL during pregnancy.

DUKORAL prevents diarrhea caused by ETEC and cholera. It will not prevent diarrhea caused by other organisms. Travellers should always be careful when choosing food and should wash, peel or cook it themselves 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.


Interactions with This Vaccine

Do not eat, drink or take other medicine 1 hour before and 1 hour after taking the vaccine. Food and drink taken during this time may prevent the vaccine from working.


Proper Use of This Vaccine

To Protect Against Travellers Diarrhea Caused by ETEC

Primary Immunization for adults and children 2 years and older: 2 doses orally (by mouth) at least 1 week apart. Take the 1st dose 2 weeks before you leave for your trip. Take the 2nd dose 1 week after the first dose and at least 1 week before your trip. It takes 1 week after the last dose for protection to begin.

Protection against diarrhea caused by ETEC starts one week after the 2nd dose and lasts for 3 months. If you wait more than 6 weeks between the 1st and 2nd dose, you will have to start again.

Booster: If you had your last dose of the vaccine between 3 months and 5 years before, one booster dose will renew your protection. If more than 5 years has passed since your last dose, you should have the complete primary immunization again.

To Protect Against Cholera

Primary Immunization for adults and children 6 years and older: Take 2 doses orally (by mouth) at least 1 week apart. Take the 2nd dose 1 week after the first dose and at least 1 week before your trip. It takes 1 week after the last dose for protection to begin. Protection against cholera lasts for 2 years. If you wait more than 6 weeks between the 1st and 2nd dose, you will have to start again.

Booster for adults and children over 6 years: If you had your last dose of the vaccine between 2 and 5 years before, one booster dose will renew your protection. If more than 5 years has passed since your last dose, you should have the complete primary immunization again.

Primary Immunization for children 2 to 6 years: Give 3 doses orally (by mouth) at least 1 week apart and finishing at least 1 week before the trip.

Give the 1st dose at least 3 weeks before the trip, the 2nd dose 1 week later and the 3rd dose 1 week after that. It takes 1 week after the last dose for protection to begin. Protection against cholera will last for 6 months. If more than 6 weeks elapse between the first two doses, the child will have to start again.

Booster for children 2 to 6 years: If the child had the last dose of the vaccine between 6 months and 5 years before, one booster dose will renew protection. If more than 5 years has passed since the last dose, complete primary immunization (3 doses) is recommended.

Important Information about Taking DUKORAL

Do not eat or drink for 1 hour before and 1 hour after taking the vaccine.

Do not take any other medicine for 1 hour before and 1 hour after taking the vaccine.

Use only cool water to mix the vaccine. Do not use any other liquid.

Follow the directions for proper mixing. It is important to follow these instructions to make sure the vaccine works.

How to take DUKORAL: (see package insert for illustrations):

Step 1: Dissolve the powder from the sachet package in 5 oz (150 mL) of cool water. Use only water.

For children 2 to 6 years: dissolve the powder in 5 oz (150 mL) of cool water and pour away half of the mixture before proceeding to Step 2.

Step 2: Shake the glass vial that contains the vaccine to mix it well.

Step 3: Open one vial and add the vaccine to the water and granule mixture in the glass. Stir well and drink immediately.

If you don’t drink the mixture immediately, you should take it within 2 hours of mixing. Keep it at room temperature.

Your doctor or pharmacist will tell you how to take this vaccine. Follow their directions carefully. If you do not understand the instructions, ask your doctor, nurse or pharmacist for help.

When to take DUKORAL

It is important to take DUKORAL at the right time to make sure you will be protected against travellers’ diarrhea and cholera.

Make sure that you take the 2 doses at least one week apart (3 doses for children 2 to 6 years).

Make sure that you take the last dose of vaccine at least 1 week before leaving on your trip.

Overdose

If you take more than the recommended dose, you may have some of the side effects listed below.

If you are not sure what to do ask your doctor, nurse or pharmacist.

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).

If the second dose is missed, it can be taken at any time within 6 weeks. Food and drink must be avoided for 1 hour before and 1 hour after. Contact your doctor, nurse or pharmacist.


Technical Information