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Adacel

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Adacel

Adacel

INDICATIONS

Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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 (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine as a primary series, or to complete the primary series, has not been studied.

Vaccination with Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine may not protect all of vaccinated individuals.

DOSAGE AND ADMINISTRATION

Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine should be administered as a single injection of one dose (0.5 mL) by the intramuscular route. Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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 (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine.

The use of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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 (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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 (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine with Hepatitis B (10 μg, two dose regimen) and trivalent inactivated influenza vaccines (TIV). (See CLINICAL PHARMACOLOGY and ADVERSE REACTIONS sections.)

Concomitant immunization of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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 (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine was administered concomitantly with TIV compared to separate administration. A lower PRN GMC was observed when Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine was administered concomitantly with TIV compared to separate administration. (9)

The safety and effectiveness of concomitant administration of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine with other vaccines has not been evaluated.

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

Storage

Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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.

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 natural latex rubber.

REFERENCES

4 CDC. Diphtheria, tetanus and pertussis: recommendations for vaccine use and other preventive measures. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-10):1-28.

9 Data on file at Sanofi Pasteur Limited.

13 CDC. Update on adult immunization. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-12):1-52.

Product Information as of July 2008. Manufactured by:, Sanofi Pasteur Limited, Toronto, Ontario, Canada. Distributed by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA. FDA revision date: n/a

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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