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Adacel (Tetanus Diphtheria Pertussis Vaccine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

Adacel vaccine should be administered as a single injection of one dose (0.5 mL) by the intramuscular route. Adacel vaccine should not be combined through reconstitution or mixed with any other vaccine.

Just before use, shake the vial 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. (See DESCRIPTION.) If these conditions exist, the vaccine should not be administered.

When administering a dose from a rubber-stoppered vial, do not remove either the stopper or the metal seal holding it in place.

The preferred site is into the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there is a major nerve trunk.

Do NOT administer this product intravenously or subcutaneously.

Five years should have elapsed since the recipient's last dose of tetanus toxoid, diphtheria toxoid and/or pertussis containing vaccine.

There are no data to support repeat administration of Adacel vaccine.

The use of Adacel vaccine as a primary series or to complete the primary series for tetanus, diphtheria, or pertussis has not been studied.

Diphtheria Prophylaxis for Case Contacts

The ACIP has published recommendations on vaccination for diphtheria prophylaxis in individuals who have had contact with a person with confirmed or suspected diphtheria. (4)

Tetanus Prophylaxis in Wound Management

Clinicians should refer to guidelines for tetanus prophylaxis in routine wound management. (4) (13)

A thorough attempt must be made to determine whether a patient has completed primary immunization. Individuals who have completed primary immunization against tetanus and who sustain wounds that are minor and uncontaminated, should receive a booster dose of a tetanus toxoid containing preparation if they have not received tetanus toxoid within the preceding 10 years. For tetanus prone wounds (e.g., wounds contaminated with dirt, feces, soil and saliva, puncture wounds, avulsions and wounds resulting from missiles, crushing, burns or frostbite), a booster is appropriate if the patient has not received a tetanus toxoid containing preparation within the preceding 5 years. (4)

Adacel vaccine can be used as a one-time alternative to Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Td) vaccine in patients for whom the pertussis component is also indicated. (See INDICATIONS AND USAGE.)

If passive protection against tetanus is required, Tetanus Immune Globulin (Human) (TIG) may be administered at a separate site with a separate needle and syringe.

Concomitant Vaccine Administration

Safety and immunogenicity data are available on concomitant administration of Adacel vaccine with Hepatitis B (10 g, two dose regimen) and trivalent inactivated influenza vaccines (TIV). (See CLINICAL PHARMACOLOGY and ADVERSE REACTIONS sections.)

Concomitant immunization of Adacel vaccine with Hepatitis B vaccine did not result in reduced antibody responses to any of the antigens from either vaccine. (9)

No interference in tetanus and diphtheria seroprotection rates and responses to influenza vaccine, detoxified PT, FIM or FHA were observed when Adacel vaccine was administered concomitantly with TIV compared to separate administration. A lower PRN GMC was observed when Adacel vaccine was administered concomitantly with TIV compared to separate administration. (9)

The safety and effectiveness of concomitant administration of Adacel vaccine with other vaccines has not been evaluated.

Separate injection sites and separate syringes must be used in case of concomitant administration.

STORAGE

Adacel vaccine should be stored at 2 to 8C (35 to 46F). DO NOT FREEZE. Product which has been exposed to freezing should not be used.

Do not use after expiration date shown on the label.

HOW SUPPLIED

Syringe, without needle, 1 dose (5 per package) – Product No. 49281-400-15

Vial, 1 dose (5 per package) – Product No. 49281-400-05

Vial, 1 dose (10 per package) – Product No. 49281-400-10

Neither the vial nor the syringe for this product contain latex.

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