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Important Safety Information

Vivotif (Typhoid Vaccine Live Oral Ty21a) should not be administered to persons with a hypersensitivity to any component of the vaccine or the enteric-coated capsule. The vaccine should not be administered to persons during an acute febrile illness. Safety of the vaccine has not been demonstrated in persons deficient in their ability to mount a humoral or cell-mediated immune response, due to either a congenital or acquired immunodeficient state including treatment with immunosuppressive or antimitotic drugs. The vaccine should not be administered to these persons regardless of benefits. Vivotif is not to be taken during an acute gastrointestinal illness. The vaccine should not be administered to individuals receiving sulfonamides and antibiotics since these agents may be active against the vaccine strain and prevent a sufficient degree of multiplication to occur in order to induce a protective immune response. Postpone taking the vaccine if persistent diarrhea or vomiting is occurring. Unless a complete immunization schedule is followed, an optimum immune response may not be achieved. Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms, ie, travelers should take all necessary precautions to avoid contact or ingestion of potentially contaminated food or water. The health care professional should take all necessary precautions to ensure safe and effective use of the vaccine. 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 care professional.

PAX-US-0213

Vivotif Safety Information

Vivotif Prescribing Information

Vivotif Safety Information

Vivotif Prescribing Information

Vivotif Safety Information

Vivotif Prescribing Information

Important Safety Information

Vaxchora is contraindicated in people with a history of severe allergic reaction (e.g., anaphylaxis) to any
ingredient of Vaxchora or to a previous dose of any cholera vaccine.

The safety and effectiveness of Vaxchora have not been established in immunocompromised persons.

Vaxchora may be shed in the stool of recipients for at least 7 days. There is a potential for transmission
of the vaccine strain to non-vaccinated close contacts(e.g., household contacts). Use caution when
considering whether to administer Vaxchora to individuals with immunocompromised close contacts.

The most common adverse reactions (incidence >3%) were tiredness (31%), headache (29%),
abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%), and diarrhea (4%).

Indications and Usage

Vaxchora is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup 01 in adults 18 through 64 years of age traveling to cholera - affected areas.

Limitations of use: The effectiveness of Vaxchora has not been established in persons living in cholera - affected areas. The effective of Vaxchora has not been established in persons who have pre - existing immunity due to previous exposure to V.cholerae or receipt of a cholera vaccine. Vaxchora has not been shown to protect against disease caused by V.cholerae serogroup 0139 or other non - 01 serogroups.

For more information about Vaxchora, please see full Prescribing Information.

Important Safety Information

Vivotif (Typhoid Vaccine Live Oral Ty21a) should not be administered to persons with a hypersensitivity to any component of the
vaccine or the enteric-coated capsule. The vaccine should not be administered to persons during an acute febrile illness. Safety of
the vaccine has not been demonstrated in persons deficient in their ability to mount a
humoral or cell-mediated immune response, due to either a congenital or acquired immunodeficient state including treatment
with immunosuppressive or antimitotic drugs. The vaccine should not be administered to these persons regardless of benefits.

Vivotif is not to be taken during an acute gastrointestinal illness. The vaccine should not be administered to individuals receiving
sulfonamides and antibiotics since these agents may be active against the vaccine strain and prevent a sufficient degree of
multiplication to occur in order to induce a protective immune response. Postpone taking the vaccine if persistent diarrhea or
vomiting is occurring. Unless a complete immunization schedule is followed, an optimum immune response may not be achieved.
Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal
precautions against exposure to typhoid organisms, ie, travelers should take all necessary precautions to avoid contact or
ingestion of potentially contaminated food or water.

The health care professional should take all necessary precautions to ensure safe and effective use of the vaccine. 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 care professional.

Indications and Usage

Vivotif(Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella Typhi. Routine typhoid vaccination is not recommended in the United States of America. Selective immunization against typhoid fever is recommended for the following groups:

1) travelers to areas in which there is a recognized risk of exposure to S.Typhi;
2) persons with intimate exposure(eg, household contact) to an S.Typhi carrier; and
3) microbiology laboratorians who work frequently with S.Typhi. There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters, or in persons attending rural summer camps.

Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. The vaccine will not afford protection against species of Salmonella other than Salmonella Typhi or other bacteria that cause enteric disease. The vaccine is not suitable for treatment of acute infections with S.Typhi.