Vaxchora Dosage

Dose and Schedule

Administer a single oral dose of VAXCHORA a minimum of 10 days before potential exposure to cholera.

The safety and effectiveness of revaccination with VAXCHORA have not been established.

Restrictions on Eating and Drinking

Instruct recipients to avoid eating or drinking for 60 minutes before and after oral ingestion of VAXCHORA.

Preparation, Reconstitution and Administration

Prepare and administer VAXCHORA in a healthcare setting equipped to dispose of medical waste [see Disposal Instructions (2.4)].

1.

Remove the carton from the refrigerator [see Storage and Handling (16.2)]. Locate the 2 packets: the buffer component (Packet 1) and the active component (Packet 2).

2.

Pour 100 milliliters (mL) of cold or room temperature (41°F-72°F; 5°C-22°C) bottled water (purified, spring, or sparkling [carbonated]) into a clean, disposable cup. Do not use tap/faucet water, or any non-purified bottled water, other beverages, or liquids.

3.

Use scissors to cut the top off the buffer component packet.

4.

Empty buffer component packet contents into cup. Effervescence will occur.

5.

Using a disposable stirrer, stir until the buffer component completely dissolves. For children 2 through 5 years of age, discard half of the buffer solution after mixing.

6.

Use scissors to cut the top off the active component packet.

7.

Empty the active component packet contents (lyophilized V. cholerae CVD 103-HgR) into the cup containing the buffer solution.

8.

Stir for at least 30 seconds and until active component disperses to form a slightly cloudy suspension that may contain some white particulates.
If desired, no more than 4 g (1 teaspoon) of sucrose (table sugar) or no more than 1 g (1/4 teaspoon) of non-flavored stevia sweeteners may be added and stirred into the suspension. Do not add any other sweeteners or medicinal flavorings as this can reduce the effectiveness of the vaccine.

9.

Consume VAXCHORA within 30 minutes, if sucrose or non-flavored stevia are added. Consume VAXCHORA within 4 hours of reconstitution, if sucrose and non-flavored stevia have not been added, at room temperature around 70 °F (21°C).
The recipient should drink the full contents of the cup. Some residue may remain in the cup and should be discarded with the cup.

NOTE: If the packets are reconstituted in the improper order, the vaccine must be discarded [see Disposal Instructions (2.4)].

Disposal Instructions

Dispose of the cup, packets, and stirrer according to standard procedures for medical waste.

Inactivate any spilled vaccine and clean any non-disposable equipment used in the preparation of VAXCHORA with 70% isopropyl alcohol or 10% bleach solution.