Data from FDA - Curated by Toby Galbraith - Last updated 17 April 2017
FDA (Food and Drug Administration, USA)
CONTRAINDICATIONS Hypersensitivity to any component of the vaccine or the enteric-coated capsule.
The vaccine should not be administered to persons during an
The vaccine should not be administered to these persons regardless of
PRECAUTIONS General The health
Patients should be questioned about previous reactions to this or similar products.
The previous immunization history of the patient and current antibiotic usage should be obtained by the health
Information for Patients It is essential that all 4 doses of vaccine be taken at the prescribed alternate day interval to obtain a maximal
Vaccine potency is dependent upon storage under refrigeration [between 2 °C and 8 °C (35.6 °F- 46.4 °F)].
The vaccine should be stored under refrigeration at all times.
It is essential to replace unused vaccine in the refrigerator between doses.
The vaccine capsule should be swallowed approximately 1 hour before
The vaccine capsule should be swallowed as soon after placing in the mouth as possible.
Not all recipients of Vivotif (Typhoid Vaccine Live Oral Ty21a) will be fully
Travelers should take all necessary precautions to
Several anti-malaria drugs, such as mefloquine, chloroquine and proguanil (not
Clinical results (see Warnings - Drug-Interactions) indicate that mefloquine and chloroquine can be administered together with Vivotif.
Proguanil should be administered only if 10 days or more have elapsed since the final dose of Vivotif was ingested.
You may also report an
Pregnancy Category C Animal reproduction studies have not been conducted with Vivotif.
It is not known whether Vivotif® can cause fetalharm when administered to pregnant women or can affect reproduction capacity.
Vivotif® should be given to a pregnant woman only if clearly needed.
Nursing Mothers There is
It is not known if Vivotif is excreted in human milk.
Pediatric Use The
This product is not indicated for use in children under 6 years of age.
The overall symptom rates from both studies when vaccinated with capsules were combined and shown to be: abdominal
Only the incidence of
Administration of vaccine doses more than 5-fold
Post-marketing surveillance has revealed that
DOSAGE AND ADMINISTRATION One capsule is to be swallowed approximately 1 hour before
Immunization (ingestion of all 4 doses of Vivotif (Typhoid Vaccine Live Oral Ty21a) should be completed at least 1 week prior to potential exposure to S. typhi.
The blister containing the vaccine capsules should be inspected to ensure that
The vaccine capsule should not be chewed and should be swallowed as soon after placing in the mouth as possible.
Efficacy has been shown to persist for at least 5 years.
Further, there is
|Date Last Revised||18-03-2011|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Rebel Distributors Corp|