Generic Name and Formulations:
Cholera vaccine, live attenuated (V. cholerae strain CVD 103-HgR); 100mL per single dose; susp for oral administration after reconstitution.
Indications for VAXCHORA:
Immunization against disease caused by Vibrio cholerae serogroup 01 in adults 18–64 years of age traveling to cholera-affected areas.
Limitations Of use:
Efficacy not established in persons living in cholera-affected areas or persons with pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. Not shown to protect against disease caused by V. cholerae serogroup 0139 or other non-01 serogroups.
For oral administration only. Avoid food or drink for 60mins before and after administration. ≥18yrs: Give single oral dose a minimum of 10 days before potential cholera exposure.
<18yrs: not established.
Severe allergic reaction to any previous cholera vaccine.
Immunocompromised. Considering whether to administer to individuals with immunocompromised close contacts. Elderly. Pregnancy.
Avoid use within 14 days of systemic antibiotics. Give vaccine ≥10 days prior to antimalarial prophylaxis with chloroquine. Concomitant immunosuppressive therapy (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, high-dose corticosteroids): may get suboptimal response.
Tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, diarrhea.
To enroll patients in the pregnancy exposure registry call (800) 533-5899.
Single-dose carton—2 packets (buffer component + active component)
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