TETANUS AND DIPHTHERIA TOXOIDS ADSORBED injection

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

CLOSTRIDIUM TETANI (UNII: 751E8J54VM) (CLOSTRIDIUM TETANI - UNII:751E8J54VM), CORYNEBACTERIUM DIPHTHERIAE (UNII: 3U7E3O07S8) (CORYNEBACTERIUM DIPHTHERIAE - UNII:3U7E3O07S8)

MAH:

Rebel Distributors

INN:

CLOSTRIDIUM TETANI

composition:

CLOSTRIDIUM TETANI 2.0 in 0.5 mL

administration_route:

INTRAMUSCULAR

therapeutic_indication:

MassBiologics' Td 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' Td 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.

leaflet_short:

The stopper of the vial is latex free. MassBiologics' Td is supplied in single-dose (0.5 ml) vials. NDC No. 14362-0111-3 - Package of 10 single dose vials.

authorization_status:

Biologic Licensing Application

SPC

TETANUS AND DIPHTHERIA TOXOIDS ADSORBED - TETANUS AND DIPHTHERIA
TOXOIDS
ADSORBED INJECTION
REBEL DISTRIBUTORS
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TETANUS AND DIPHTHERIA TOXOIDS ADSORBED
DESCRIPTION
Tetanus and Diphtheria Toxoids Adsorbed (Td) manufactured by
MassBiologics is a sterile vaccine for
intramuscular injection. After shaking, the vaccine appears as a
homogenous milky white suspension.
Each 0.5 ml dose of MassBiologics' Td 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. MassBiologics' Td does not contain a
preservative.
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