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(tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
- Patient Information:
Details with Side Effects
Adacel® , Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration. After shaking, the vaccine is a white, homogenous, cloudy suspension. Neither the vial nor the syringe for this product contain natural latex rubber.
Each dose of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine (0.5 mL) contains the following active ingredients:
|Detoxified Pertussis Toxin (PT)||2.5 μg|
|Filamentous Hemagglutinin (FHA)||5 μg|
|Pertactin (PRN)||3 μg|
|Fimbriae Types 2 and 3 (FIM)||5 μg|
|Tetanus Toxoid (T)||5 Lf|
|Diphtheria Toxoid (d)||2 Lf|
Other ingredients per dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤ 5 μg residual formaldehyde, < 50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The antigens are the same as those in DAPTACEL® , Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP); however, Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine is formulated with reduced quantities of d and detoxified PT.
The acellular pertussis vaccine components are obtained from Bordetella pertussis cultures grown in Stainer-Scholte medium (1) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and co-purified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde, FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed onto aluminum phosphate.
Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (2) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (3) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.
The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection.
Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The tetanus component induces at least 2 neutralizing units/mL of serum and the diphtheria component induces at least 0.5 neutralizing units/mL of serum. The potency of the acellular pertussis vaccine components is evaluated by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA).
1 Stainer DW, et al. A simple chemically defined medium for the production of phase I Bordetella pertussis. J Gen Microbiol 1970;63:211-20.
2 Stainer DW. Production of diphtheria toxin. In: Manclark CR, editor. Proceedings of an informal consultation on the World Health Organization requirements for diphtheria, tetanus, pertussis and combined vaccines. United States Public Health Service, Bethesda, MD. DHHS 91-1174. 1991. p. 7-11.
3 Mueller JH, et al. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271-7.
What are the possible side effects of this vaccine (Adacel (Tdap), Boostrix (Tdap))?
You should not receive a booster vaccine if you had a life threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell your doctor if the previous shot caused any side effects.
Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely...
What are the precautions when taking tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Adacel)?
Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before receiving this medication, tell your doctor or pharmacist your medical history, especially of: nervous system disorders (e.g., seizures, encephalopathy, Guillain-Barre syndrome), current illness/infection, bleeding disorders, immune system disorders (e.g., autoimmune disorders, radiation treatment), vaccination history including previous reactions to any vaccines.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and...
Last reviewed on RxList: 1/6/2009
This monograph has been modified to include the generic and brand name in many instances.
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