Country: United States
Language: English
Source: NLM (National Library of Medicine)
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)
Grifols USA, LLC
CLOSTRIDIUM TETANI TOXOID ANTIGEN - UNII:K3W1N8YP13)
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2.0 [Lf] in 0.5 mL
INTRAMUSCULAR
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.
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. 13533-131-00-Individual single dose (0.5mL) vials. NDC No. 13533-131-01-Package containing ten vials.
Biologic Licensing Application
TDVAX- TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION, SOLUTION GRIFOLS USA, LLC ---------- NDC 13533-131-00 NDC 13533-131-01 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 Read the complete document