TYPHIM VI- salmonella typhi ty2 vi polysaccharide antigen injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN (UNII: 7194H8W3KT) (SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN - UNII:7194H8W3KT)

Available from:

A-S Medication Solutions

INN (International Name):

SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN

Composition:

SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN 25 ug in 0.5 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older. Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi . Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14) Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi . (14) Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized r

Product summary:

Product: 50090-1493 NDC: 50090-1493-0 .5 mL in a SYRINGE / 1 in a POUCH

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TYPHIM VI- SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN INJECTION,
SOLUTION
A-S MEDICATION SOLUTIONS
----------
TYPHOID VI POLYSACCHARIDE VACCINE
TYPHIM VI
AHFS Category: 80:12
TYPH
_RX ONLY_
DESCRIPTION
Typhim Vi
, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Pasteur SA,
for
intramuscular use, is a sterile solution containing the cell surface
Vi polysaccharide
extracted from_ Salmonella enterica _serovar_ Typhi_,_ S typhi _Ty2
strain. The organism is
grown in a semi-synthetic medium. Casein derived raw materials are
used early in
manufacturing during the fermentation process. The capsular
polysaccharide is
precipitated from the concentrated culture supernatant by the addition
of
hexadecyltrimethylammonium bromide, and the product is purified by
differential
centrifugation and precipitation. Each 0.5 mL dose may contain
residual amounts of
formaldehyde (not more than 100 mcg) used for the inactivation of the
bacterial culture.
The potency of the purified polysaccharide is assessed by molecular
size and O-acetyl
content. Phenol, 0.25%, is added as a preservative. The vaccine
contains residual
polydimethylsiloxane or fatty-acid ester-based antifoam. The vaccine
is a clear, colorless
solution. Each dose of 0.5 mL is formulated to contain 25 mcg of
purified Vi
polysaccharide in a colorless isotonic phosphate buffered saline (pH 7
± 0.3), 4.150 mg
of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of
Monosodium
Phosphate, and 0.5 mL of Sterile Water for Injection. The vial stopper
and the plunger
stopper of the syringe are not made with natural rubber latex.
CLINICAL PHARMACOLOGY
Typhoid fever is an infectious disease caused by_ S typhi_. Humans are
the only natural
host and reservoir for _S typhi_; infections result from the
consumption of food or water
that has been contaminated by the excretions of an acute case or a
carrier._ S typhi_
organisms efficiently invade the human intestinal mucosae ultimately
leading to
bacteremia; following a typical 10- to 14-day incubation period, a
systemic illn