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DOSAGE AND ADMINISTRATION
Preparation For Administration
Just 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.
Administration, Dose And Schedule
Adacel 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.
Additional Dosing Information
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.
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.
Dosage Forms And Strengths
Adacel vaccine is a suspension for injection (0.5 mL dose) available in 0.5 mL single-dose vials and prefilled syringes. [See DOSAGE AND ADMINISTRATION and Storage And Handling]
Storage And Handling
Syringe, without needle, 1 dose - NDC No. 49281-400-88; in package of 5 syringes, NDC No. 49281-400-15. The tip caps of the prefilled syringes may contain natural rubber latex. No other components are made with natural rubber latex.
Vial, 1 dose - NDC No. 49281-400-58; in package of 5 vials; NDC No. 49281-400-05. The vial stopper is not made with natural rubber latex.
Vial, 1 dose - NDC No. 49281-400-58; in package of 10 vials; NDC No. 49281-400-10. The vial stopper is not made with natural rubber latex.
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.
Manufactured by: Sanofi Pasteur Limited, Toronto Ontario Canada. Distributed by: Sanofi Pasteur Inc., Swiftwater PA 18370 USAThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/6/2014
Additional Adacel Information
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