País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
CLOSTRIDIUM TETANI (UNII: 751E8J54VM) (CLOSTRIDIUM TETANI - UNII:751E8J54VM), CORYNEBACTERIUM DIPHTHERIAE (UNII: 3U7E3O07S8) (CORYNEBACTERIUM DIPHTHERIAE - UNII:3U7E3O07S8)
Rebel Distributors
CLOSTRIDIUM TETANI
CLOSTRIDIUM TETANI 2.0 in 0.5 mL
INTRAMUSCULAR
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.
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.
Biologic Licensing Application
TETANUS AND DIPHTHERIA TOXOIDS ADSORBED - TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION REBEL DISTRIBUTORS ---------- 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 Llegiu el document complet