Sanofi Pasteur's AdacelĀ® Vaccine Syringe Made Without Natural Rubber Latex (August 2018)
Sanofi Pasteur is pleased to announce that Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) in a syringe made without natural rubber latex will be available in early August 2018!
This new presentation will have new National Drug Code (NDC) numbers for the prefilled syringe presentation made without natural rubber latex. A dose of Adacel vaccine has two (2) separate NDC numbers associated with it: the carton NDC number and an NDC number for the prefilled syringe.
Below are the two (2) different NDC numbers for Adacel vaccine in the prefilled syringe presentation:
Product
|
Location
|
NDC Number
|
Adacel Vaccine Latex-Containing Prefilled Syringe (Current) |
Syringe |
49281-400-88 |
|
Carton |
49281-400-15 |
Adacel Vaccine Prefilled Syringe Made Without Natural Rubber Latex (New!) |
Syringe |
49281-400-89 |
|
Carton |
49281-400-20 |
Please note: The CPT®* code for Adacel vaccine (90715) does not change; Adacel vaccine will continue to be offered in a carton of 5 prefilled syringes.
*CPT (Current Procedural Terminology) is a registered trademark of the American Medical Association.
IMPORTANT SAFETY INFORMATION FOR ADACEL VACCINE:
Adacel vaccine is contraindicated in persons who have had a severe allergic reaction (eg, anaphylaxis) to any other tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine, or to any component of Adacel vaccine; or encephalopathy within 7 days after a previous dose of a pertussis antigen-containing vaccine with no other identifiable cause.
For one presentation of Adacel vaccine, the tip caps of the prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals. The vial stopper is not made with natural rubber latex.
If Guillain-Barré syndrome or brachial neuritis has occurred within 6 weeks following previous vaccination with a tetanus toxoid-containing vaccine, if progressive or unstable neurologic disorders exist, or if adverse events have occurred in temporal relation to receipt of pertussis antigen-containing vaccine, the decision to give Adacel vaccine should be based on careful consideration of the potential benefits and risks.
Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of tetanus toxoid-containing vaccine should not receive Adacel vaccine unless at least 10 years have elapsed since the last dose of tetanus toxoid-containing vaccine.
Syncope (fainting) can occur in association with administration of injectable vaccines, including Adacel vaccine. Procedures should be in place to prevent falling injury and manage syncopal reactions.
The most common local and systemic adverse reactions to Adacel vaccine include pain, erythema, and swelling at the injection site; headache, body ache or muscle weakness, and tiredness. Other adverse reactions may occur. Vaccination with Adacel vaccine may not protect all individuals.
INDICATION FOR ADACEL VACCINE:
Adacel vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria, and pertussis. Adacel vaccine is approved for use as a single dose in individuals 10 through 64 years of age.
Before administration, please see the full Prescribing Information for
Adacel vaccine.
QUESTIONS:
For questions or for information regarding CCPAPP's agreement with Sanofi Pasteur including pricing, please visit CCPAPP's website. For questions regarding your practice's participation or eligibility in this agreement or in CCPAPP, please contact Priya Stemler, Director of Operations for CCPAPP, at 312.227.7437 or pstemler@ccpapp.org. For any further questions or if you are in need of your practice's username and/or password to log on to CCPAPP's website, please email info@ccpapp.org.
For questions regarding Sanofi Pasteur and/or its Adacel product, please contact your Sanofi Vaccine Specialist or call Sanofi at 1.800.VACCINE (1.800.822.2463).
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