Name: Adacel TDAP
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
Adacel TDAP - Clinical Pharmacology
Tetanus is an acute and often fatal disease caused by an extremely potent neurotoxin produced by C tetani. The toxin causes neuromuscular dysfunction, with rigidity and spasms of skeletal muscles. The muscle spasms usually involve the jaw (lockjaw) and neck and then become generalized.
Spores of C tetani are ubiquitous. Serological tests indicate that naturally acquired immunity to tetanus toxin does not occur in the US. Thus, universal primary immunization, with subsequent maintenance of adequate antitoxin levels by means of appropriately timed boosters, is necessary to protect all age groups. Following immunization, protection generally persists for at least 10 years. (4)Diphtheria
C diphtheriae may cause both localized and generalized disease. The systemic intoxication is caused by diphtheria exotoxin, an extracellular protein metabolite of toxigenic strains of C diphtheriae. Both toxigenic and nontoxigenic strains of C diphtheriae can cause disease, but only strains that produce toxin can cause severe manifestations such as myocarditis and neuritis. Toxigenic strains are more often associated with severe or fatal respiratory infections than with cutaneous infections.
Complete immunization significantly reduces the risk of developing diphtheria and immunized persons who develop disease have milder illness.
Immunization with diphtheria toxoid does not, however, eliminate carriage of C diphtheriae in the pharynx, nose, or on the skin. Following immunization, protection lasts at least 10 years. (4)Pertussis
Pertussis (whooping cough) is a disease of the respiratory tract, most often caused by B pertussis. This gram-negative coccobacillus produces a variety of biologically active components, though their role in pathogenesis is not clearly defined.
Mechanism of Action
Protection against disease attributable to C tetani is due to the development of neutralizing antiboides to tetanus toxin. A serum antitoxin level of ≥0.1 IU/mL is considered protective, although a level of at least 0.01 IU/mL, measured by neutralization assay is considered the minimum protective level. (5) Protection against disease attributable to C diphtheriae is due to the development of neutralizing antibodies to diphtheria toxin. A serum antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection. Antitoxin levels of at least 0.1 IU/mL are generally regarded as protective. (6) Levels of 1.0 IU/mL have been associated with long-term protection. (7)
The mechanism of protection from B pertussis disease is not well understood. However, the pertussis components in Adacel vaccine (i.e., detoxified PT, FHA, PRN and FIM) have been shown to prevent pertussis in infants in a clinical trial with DAPTACEL vaccine. (See Clinical Studies.)
Indications and Usage for Adacel TDAP
Adacel vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age.
The use of Adacel vaccine as a primary series, or to complete the primary series, has not been studied.
Vaccination with Adacel vaccine may not protect all of vaccinated individuals.
Adacel vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product which has been exposed to freezing should not be used.
Do not use after expiration date shown on the label.
Product Information as of January 2009.
Printed in USA.
Sanofi Pasteur Limited
Toronto Ontario Canada
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
PRINCIPAL DISPLAY PANEL - Syringe Container
Tetanus Toxoid, Reduced
0.5 mL each
and adult use.
|ADACEL TDAP |
clostridium tetani toxoid antigen (formaldehyde inactivated), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen injection, suspension
|Labeler - Sanofi Pasteur Limited (086723285)|
|Sanofi Pasteur Limited||208206623||MANUFACTURE|