Cholera Vaccine Live Oral

Administration

Oral Administration

Administer orally as a single dose.1

Avoid eating or drinking for 60 minutes before and after ingestion of the vaccine.1

Provided by the manufacturer in single-dose carton that contains foil packet of lyophilized live, attenuated V. cholerae CVD 103-HgR (active component) and foil packet of dry powder buffer (buffer component).1 Reconstitute and mix these 2 components according to manufacturer's instructions to provide an oral suspension containing cholera vaccine live oral.1 (See Reconstitution under Dosage and Administration.)

Oral suspension must be administered within 15 minutes after preparation.1 Swallow entire contents of the cup (100 mL) at one time.1

After the vaccine is administered, the cup (including any residue remaining in the cup), stirrer, and empty component packets are considered biohazardous materials;1 handle and dispose of according to standard procedures for medical waste.1 Use 70% isopropyl alcohol or 10% bleach to clean nondisposable equipment used to prepare the oral suspension and to inactivate any spilled vaccine.1

Remove single-dose carton containing foil packet of lyophilized live, attenuated V. cholerae CVD 103-HgR (active component) and foil packet of dry powder buffer (buffer component) from freezer.1 Thawing unnecessary.1 Use within 15 minutes after removal from frozen storage;1 do not expose packets to temperatures >27°C.1 (See Storage under Stability.)

The buffer component must be reconstituted first.1 Open foil packet of buffer component with scissors and pour contents into a clean disposable cup containing 100 mL of cold or room temperature (5–22°C) purified bottled water;1 do not use tap water, nonpurified bottled water, or any other beverage or liquid.1 Effervescence will occur;1 stir with a disposable stirrer until powder buffer dissolves completely.1

After buffer component is dissolved, open foil packet containing lyophilized cholera vaccine (active component) with scissors and pour contents into the cup containing reconstituted buffer.1 Stir the mixture for at least 30 seconds to form a slightly cloudy suspension that may contain some white particles;1 lyophilized vaccine may not dissolve completely.1

If buffer component and active component are not reconstituted and mixed in proper sequence, discard the vaccine.1

Dosage

Adults

Administer a single dose of 100 mL of reconstituted oral suspension (see Reconstitution under Dosage and Administration).1 Give dose ≥10 days before potential exposure to cholera.1

Duration of immunity and protection against cholera after a single dose not fully determined (see Duration of Immunity under Cautions).1 3 Safety and efficacy of revaccination or booster doses not established;1 3 ACIP does not currently recommend use of booster doses.3

Special Populations

Hepatic Impairment

No specific dosage recommendations.1

Renal Impairment

No specific dosage recommendations.1

Geriatric Patients

Not indicated in geriatric adults ≥65 years of age.1

Before you take this vaccine, tell the health care professional if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your health care professional for more details.

Before taking this vaccine, tell your health care professional your medical history, especially of: immune system problems (such as due to cancer treatments).

A weakened form of the bacteria may pass in your stools for at least 7 days after taking this vaccine. Rarely, an infection may occur in people who are in close contact with you. To prevent the spread of infection, always wash your hands well after using the bathroom and before preparing/handling any food. Discuss the risks and benefits of this vaccine with your health care professional if you have family/household members with weakened immune systems (such as due to cancer).

During pregnancy, this vaccine should be taken only when clearly needed. Discuss the risks and benefits with your health care professional.

It is unknown if this vaccine passes into breast milk. Consult your health care professional before breast-feeding.