TDVAX- tetanus and diphtheria toxoids adsorbed injection

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), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:IRH51QN26H)

Available from:

MassBiologics

INN (International Name):

CLOSTRIDIUM TETANI TOXOID ANTIGEN - UNII:K3W1N8YP13)

Composition:

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2.0 [Lf] in 0.5 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

MassBiologics' TDVAX is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. This vaccine is approved for use in persons 7 years of age and older. A severe allergic reaction (e.g., anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration of MassBiologics' TDVAX vaccine. (See DESCRIPTION ). Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

Product summary:

The stopper of the vial is not made with natural rubber latex. MassBiologics' TDVAX is supplied in a package of 10 single dose vials. NDC No. 14362-0111-3 – Individual single dose (0.5 mL) vials. NDC No. 14362-0111-4 – Package containing ten vials. Store at 2°C - 8°C (36°F - 46°F). DO NOT FREEZE. Discard product if exposed to freezing. Do not use vaccine after expiration date.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TDVAX- TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION
MASSBIOLOGICS
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NDC 14362-0111-3
NDC 14362-0111-4
TETANUS AND DIPHTHERIA TOXOIDS ADSORBED
TDVAX™
_RX ONLY_
DESCRIPTION
TDVAX
manufactured by MassBiologics is a sterile vaccine for intramuscular
injection.
After shaking, the vaccine appears as a homogeneous milky white
suspension.
Each 0.5 mL dose of MassBiologics' TDVAX is formulated to contain the
following active
ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid.
Each 0.5 mL dose also
contains aluminum adjuvant (not more than 0.53 mg aluminum by assay),
< 100 mcg
(0.02%) of residual formaldehyde, and a trace amount of thimerosal
[mercury derivative,
(≤ 0.3 mcg mercury/dose)] (not as a preservative) from the
manufacturing process.
The _Corynebacterium diphtheriae_and _Clostridium tetani_organisms are
grown on modified
Mueller's media
which contains bovine extracts. The bovine material used in these
extracts is sourced from countries which the United States Department
of Agriculture
has determined neither have nor present an undue risk for bovine
spongiform
encephalopathy. Tetanus and diphtheria toxins produced during growth
of the cultures
are detoxified with formaldehyde. The detoxified materials are then
separately purified by
ammonium sulfate fractionation. The diphtheria toxoid is further
purified by column
chromatography. The tetanus and diphtheria toxoids are individually
adsorbed onto
aluminum phosphate.
The tetanus and diphtheria toxoids induce at least 2 units and 1 unit
of antitoxin per mL
of serum, respectively, in the guinea pig potency test.
CLINICAL PHARMACOLOGY
TETANUS
Tetanus (also known as lockjaw) is a serious, often fatal disease
caused by an extremely
potent neurotoxin produced by _C. tetani_.
Protection against disease is due to the development of neutralizing
antibodies to
tetanus toxin. A serum tetanus antitoxin level of 0.01 IU/mL measured
via a
neutralization assay is considered the minimum protective level.
The efficacy against
tetanus of MassBiologics