Adacel Tdap
Loading...Adacel Tdap Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Adacel is a vaccine indicated for active booster immunization against tetanus, diphtheria and pertussis. Adacel vaccine is approved for use as a single dose in individuals 10 through 64 years of age.
History
There is currently no drug history available for this drug.
Other Information
Adacel vaccine is a sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on aluminum phosphate, for intramuscular injection.
Each 0.5 mL dose contains 5 Lf tetanus toxoid (T), 2 Lf diphtheria toxoid (d), and acellular pertussis antigens [2.5 mcg detoxified pertussis toxin (PT), 5 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)].Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤5 mcg 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 vaccine; however, Adacel vaccine is formulated with reduced quantities of diphtheria and detoxified PT.
The acellular pertussis vaccine components are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (2) 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.
The tetanus toxin is produced from Clostridium tetani 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. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (4) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered.
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. Adacel vaccine does not contain a preservative.
In the guinea pig potency test, 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).
Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.
Sources
Adacel Tdap Manufacturers
-
Sanofi Pasteur Inc.
![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 [Sanofi Pasteur Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Adacel Tdap | Sanofi Pasteur Inc.
2.1 Preparation for AdministrationJust before use, shake the vial or syringe well until a uniform, white, cloudy suspension results.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the vaccine should not be administered.
When withdrawing a dose from a stoppered vial, do not remove either the stopper or the metal seal holding it in place. Use a separate sterile needle and syringe for each injection. Using a sterile needle and syringe, withdraw the 0.5 mL dose of vaccine from the single-dose vial and administer the vaccine to the individual. Changing needles between withdrawing the vaccine from the vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.
Adacel vaccine should not be combined through reconstitution or mixed with any other vaccine.
2.2 Administration, Dose and ScheduleAdacel vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm.
Do not administer this product intravenously, subcutaneously or intradermally.
There are no data to support repeat administration of Adacel vaccine.
Five years should have elapsed since the recipient's last dose of tetanus toxoid, diphtheria toxoid and/or pertussis containing vaccine and the administration of Adacel vaccine.
2.3 Additional Dosing InformationPrimary series: The safety and effectiveness of Adacel vaccine used as a primary series or to complete the primary series, for diphtheria, tetanus, or pertussis has not been demonstrated.
Wound management: If tetanus prophylaxis is needed for wound management, Adacel may be given if no previous dose of any Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) has been administered.
Login To Your Free Account