VIVOTIF- salmonella typhi ty21a capsule, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SALMONELLA TYPHI TY21A LIVE ANTIGEN (UNII: 0MZI008M96) (SALMONELLA TYPHI TY21A LIVE ANTIGEN - UNII:0MZI008M96)

Available from:

Emergent Travel Health Inc.

INN (International Name):

SALMONELLA TYPHI TY21A LIVE ANTIGEN

Composition:

SALMONELLA TYPHI TY21A LIVE ANTIGEN 6000000000 [CFU]

Administration route:

ORAL

Therapeutic indications:

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 (e.g. household contact) to a S. typhi carrier, and 3) microbiology laboratorians who work frequently with S. typhi (7). 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 Salm

Product summary:

A single foil blister contains 4 doses of vaccine in a single package. NDC 69401-000-01 and NDC 69401-000-02

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

VIVOTIF- SALMONELLA TYPHI TY21A CAPSULE, COATED
EMERGENT TRAVEL HEALTH INC.
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TYPHOID VACCINE LIVE ORAL TY21A
VIVOTIF
DESCRIPTION
Vivotif (Typhoid Vaccine Live Oral Ty21a) is a live attenuated vaccine
for oral
administration only. The vaccine contains the attenuated strain
_Salmonella typhi_ Ty21a
(1, 2).
Vivotif is manufactured by Emergent Travel Health Inc., USA. The
vaccine strain is grown
in fermenters under controlled conditions in medium containing a
digest of yeast
extract, an acid digest of casein, dextrose and galactose. The
bacteria are collected by
centrifugation, mixed with a stabilizer containing sucrose, ascorbic
acid and amino acids,
and lyophilized. The lyophilized bacteria are mixed with lactose and
magnesium stearate
and filled into gelatin capsules which are coated with an organic
solution to render them
resistant to dissolution in stomach acid. The enteric-coated,
salmon/white capsules are
then packaged in 4-capsule blisters for distribution. The contents of
each enteric-coated
capsule are shown in Table 1.
_Table 1: Contents of one enteric-coated capsule of Vivotif _(Typhoid
Vaccine Live Oral
Ty21a)
Viable _S. typhi_ Ty21a
2.0–10.0x10 colony-forming units*
Non-viable _S. typhi_ Ty21a
5‑50x10 bacterial cells
Sucrose
3.3 – 34.2 mg
Ascorbic acid
0.2 – 2.4 mg
Amino acid mixture
0.3 – 3.0 mg
Lactose
up to 180 - 200 mg
Magnesium stearate
3.6–4.0 mg
*Vaccine potency (viable cell counts per capsule) is determined by
inoculation of agar
plates with appropriate dilutions of the vaccine suspended in
physiological saline.
CLINICAL PHARMACOLOGY
_Salmonella typhi_ is the etiological agent of typhoid fever, an
acute, febrile enteric disease.
Typhoid fever continues to be an important disease in many parts of
the world.
Travelers entering infected areas are at risk of contracting typhoid
fever following the
ingestion of contaminated food or water. Typhoid fever is considered
to be endemic in
most areas of Central and South America, the African continent, the
Near East and the
Middle East