Usual Adult Dose for Vaccination

One dose, orally, a minimum of 10 days before potential exposure to cholera

Comments:

• Effectiveness has not been established in persons living in cholera-affected areas.
• Effectiveness has not been established in persons with pre-existing immunity from exposure to V. cholerae or receipt of a cholera vaccine.
• This vaccine has not been shown to protect against V. cholerae serogroup O139 or other non-O1 serogroups.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS) at: https://vaers.hhs.gov

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Avoid food or drink for 60 minutes before and after vaccination.
• Avoid systemic antibiotic administration within 14 days prior to vaccination; they may prevent sufficient multiplication needed for a protective immune response.
• Final product must be consumed within 15 minutes of reconstitution.
• Drink the full contents of the cup at once.
• Some residue may remain in the cup and should be discarded with the cup.

• Keep frozen at -13F to 5F
• Protect from light and moisture

• Prepare and administer in a healthcare setting equipped to dispose of medical waste.
• Reconstitute within 15 minutes of removing from freezer; packets do not require thawing before reconstitution.
• When out of freezer, do not expose packets to temperatures above 80F.
• Use cold or room temperature purified water; do not use tap water, non-purified bottled water, or other liquids.
• Add buffer component, stir until completely dissolved; effervescence will occur.
• Add active component and stir for at least 30 seconds, until it disperses to a slightly cloudy suspension, possibly with white particles. Active component may not dissolve completely.
• Final product must be consumed within 15 minutes of reconstitution.
• If reconstituted in an improper order, discard vaccine.
• Dispose of cup, packets, and stirrer according to standard procedures for medical waste.
• Inactivate any spilled vaccine and clean any non-disposable equipment used in vaccine preparation with 70% isopropyl alcohol or 10% bleach solution.

• Advise vaccinees to exercise caution regarding food and water consumed in cholera affected areas.
• Most common adverse reactions occur within 7 days of vaccination.
• This is a live, attenuated virus, and can be transmitted to close contacts.
• For at least 14 days after vaccination, vaccinees should wash their hands thoroughly after using the bathroom and before preparing or handling food.