This medication belongs to the class of medications called vaccines. It is used to help prevent travellers' diarrhea caused by enterotoxigenic E. coli (ETEC) and cholera for adults and children 2 years of age and older. It is recommended for people travelling to areas with a high risk of cholera or travellers' diarrhea.

This vaccine works by introducing very small amounts of dead cholera bacteria and nontoxic components of cholera toxin into the body. This allows the body to make antibodies against the bacteria and toxin so that if the bacteria does get into the body and produce the toxin, they are immediately attacked by the body's own defense system. The cholera toxin is very similar to the toxin produced by ETEC, the bacteria that causes most cases of traveller's diarrhea. Therefore, the body's defenses against cholera toxin will also work against the ETEC toxin. It generally takes one week after finishing the first course of immunization for the body's defenses to develop protection against the bacteria.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

To prevent cholera: Adults and children over 6 years of age should receive 2 doses of the vaccine at least 1 week apart and no more than 6 weeks apart. The first dose should be taken at least 2 weeks before departure. The second dose should be taken at least 1 week before departure and 1 week after the first dose. Protection lasts for 2 years. A single booster dose can be taken if the last dose was given between 2 years and 5 years earlier.

Children from 2 to 6 years of age should receive 3 doses, 1 to 6 weeks apart. The third dose should be given at least 1 week before departure. Protection against cholera lasts for 6 months. A single booster dose can be taken if the last dose was given between 6 months and 5 years earlier.

To prevent travellers' diarrhea caused by ETEC: Adults and children 2 years of age and over should receive 2 doses, 1 to 6 weeks apart. The first dose should be taken at least 2 weeks before departure, and the second dose should be taken at least 1 week before departure. Protection lasts for 3 months. A booster dose can be taken if the last dose was taken between 3 months and 5 years earlier.

For all people using this medication, if more than 5 years have passed since last completing the course of vaccination, the complete schedule needs to be repeated.

Many things can affect the dose of medication that a person needs, such as the severity of the condition, body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are receiving the medication without consulting your doctor. It is very important to take this medication exactly as prescribed by your doctor.

The vaccine must be taken by mouth. Avoid food and drink for 1 hour before and 1 hour after taking the vaccine, as food and drink may decrease the effectiveness of the vaccine. Do not take any other medication for 1 hour before and 1 hour after taking the vaccine.

To prepare the vaccine:

Step 1: Prepare the buffer solution: Dissolve the powder from the sachet in a glass of cool water (approximately 150 mL or 5 oz). Do not use any other liquid. For adults and children 6 years and older, proceed to Step 2. For children 2 years to 6 years old, discard half (about 75 mL) of the mixture and proceed to Step 2.

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

Step 3: Open the vial and add the vaccine to the liquid in the glass. Stir well and drink immediately. If the mixture is not taken immediately, it should be kept at room temperature and consumed within 2 hours of mixing.

It is important to take this medication exactly as recommend by your doctor or pharmacist. If you forget a dose, it may be taken any time within 6 weeks. If it has been more that 6 weeks since your last dose, contact your doctor or pharmacist for advice.

Before mixing, store the vaccine in the refrigerator. Do not allow it to freeze. The vaccine may be stored at room temperature for up to 28 days. The sodium hydrogen carbonate sachet may be stored separately at room temperature if desired.

After mixing, the vaccine should be consumed within 2 hours.

The vaccine is a whitish suspension in a single-dose glass vial. The sodium hydrogen carbonate is supplied as white effervescent granules with a raspberry flavour, which should be dissolved in a glass of water. Each dose of vaccine is supplied with one sachet of sodium hydrogen carbonate. One sachet (5.6 g) of sodium hydrogen carbonate contains sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate, and raspberry flavour. Vaccine: V. cholerae O1 Inaba classic strain (heat inactivated); V. cholerae 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). Nonmedicinal ingredients: sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, and water for injection to 3 mL.

Each dose of this vaccine contains 1.1 grams of sodium.

Cholera and travellers' diarrhea vaccine should not be used by anyone who:

• is allergic to any of the ingredients of the vaccine or sachet
• has an acute illness, including those accompanied by fever or vomiting and diarrhea

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• diarrhea
• nausea
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• fever
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a severe allergic reaction (difficulty breathing, hives, swelling of the mouth or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: Rarely, this vaccine may cause severe allergic reactions. If you notice the signs of a severe allergic reaction (e.g., hives; trouble breathing or swallowing; or swelling of the lips, face, throat, or tongue), get emergency medical attention immediately.

Immunocompromised people: This vaccine may not be as effective for people with a compromised immune system (e.g., people with AIDS, people taking anti-rejection medications after an organ transplant, people receiving chemotherapy, people taking any medication that suppresses the immune system). People who have reduced immune function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Protection against cholera and travellers' diarrhea caused by ETEC: Not all people who take the vaccine will be fully protected against cholera and travellers' diarrhea caused by ETEC. This vaccine will not protect against diarrhea caused by other organisms. Travellers should take all necessary precautions to avoid contact with, or ingestion of, potentially contaminated sources of food or water (e.g., drink bottled or boiled water, wash hands before eating and after using toilet facilities).

Pregnancy: This vaccine should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this vaccine, contact your doctor immediately.

Breast-feeding: This vaccine may be safely used while breast-feeding.

Children: The safety and effectiveness of using this vaccine have not been established for children 2 years of age and younger.

There may be an interaction between cholera and travellers' diarrhea vaccine and any of the following:

• abatacept
• acetaminophen
• acetylsalicylic acid (ASA)
• anakinra
• anticancer medications (e.g., azacitidine, busulfan, capecitabine, carboplatin, cytarabine, doxorubicin, etoposide, ifosfamide, treosulfan, vincristine)
• anti-rejection medications (e.g., cyclosporine, mycophenolate, tacrolimus, sirolimus)
• azathioprine
• corticosteroids (e.g., dexamethasone, prednisone)
• hydroxyurea
• leflunomide
• monoclonal antibodies (e.g., adalimumab, certolizumab, infliximab, rituximab, sarilumab)
• protein kinase inhibitors (e.g., bosutinib, dasatinib, idelalasib, imatinib, nilotinib, tofacitinib)
• multiple sclerosis (MS) medications (e.g., fingolimod, ozanimod, siponimod)
• methotrexate
• non-steroidal anti-inflammatory medications (SAIDs; diclofenac, ibuprofen, ketorolac, naproxen)
• typhoid vaccine (if taken by mouth)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.