TETANUS TOXOID ADSORBED clostridium tetani antigen (formaldehyde inactivated) injection suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K3W1N8YP13)

Available from:

Sanofi Pasteur Inc.

INN (International Name):

CLOSTRIDIUM TETANI TOXOID ANTIGEN - UNII:K3W1N8YP13)

Composition:

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf] in 0.5 mL

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TETANUS TOXOID ADSORBED- CLOSTRIDIUM TETANI TOXOID ANTIGEN
(FORMALDEHYDE
INACTIVATED) INJECTION, SUSPENSION
SANOFI PASTEUR INC.
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TETANUS TOXOID
ADS ORBED
AHFS Category 80:08
TTOX
_RX ONLY_
DESCRIPTION
Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc., for
intramuscular injection, is a sterile
suspension of alum-precipitated (aluminum potassium sulfate) toxoid in
an isotonic sodium chloride
solution. The vaccine, after shaking, is a turbid liquid, whitish-gray
in color.
_Clostridium tetani_ culture is grown in a peptone-based medium
containing an extract of bovine muscle
tissue and detoxified with formaldehyde. The bovine muscle tissue used
in this medium is US sourced.
The detoxified material is then purified by serial ammonium sulfate
fractionation and diafiltration,
followed by sterile filtration. The toxoid is adsorbed to aluminum
potassium sulfate (alum). The
adsorbed toxoid is diluted with physiological saline solution (0.85%).
Tetanus Toxoid Adsorbed
manufactured by Sanofi Pasteur Inc. is supplied in a unit dose 0.5 mL
vial, which contains a trace amount
of thimerosal [(mercury derivative), (≤0.3 μg mercury/dose)] from
the manufacturing process. Tetanus
Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. is also supplied
in a 5 mL vial, which contains
the preservative thimerosal [(mercury derivative), (25 μg
mercury/dose)].
Each 0.5 mL dose is formulated to contain 5 Lf (flocculation units) of
tetanus toxoid and not more than
0.25 mg of aluminum. The residual formaldehyde content, by assay, is
less than 0.02%. The tetanus
toxoid induces at least 2 units of antitoxin per mL in the guinea pig
potency test.
CLINICAL PHARMACOLOGY
Tetanus is an intoxication manifested primarily by neuromuscular
dysfunction caused by a potent
exotoxin elaborated by _Clostridium tetani_.
Neonatal tetanus occurs among infants born under unhygienic conditions
to inadequately vaccinated
mothers. Vaccinated mothers confer protection to their infants through
transplacental transfer of
maternal antibody.
Spores o