Product Specifications
| Specification | Details |
| Manufacturer / Brand | Sanofi Vaccines US Inc. / Adacel® |
| Manufacturer # / SKU | 49281040010 |
| NDC Number | 49281-0400-10 |
| Vaccine Type | Tdap (Tetanus, Diphtheria, Acellular Pertussis) |
| Dose Volume | 0.5 mL per Dose |
| Container Type | Single-Dose Vial (SDV) |
| Formulation | Preservative-Free, Sterile Suspension |
| Route of Admin | Intramuscular (IM) ONLY |
| Packaging | 10 Vials per Carton |
| Storage | Refrigerate at 2°C to 8°C (36°F to 46°F); Do Not Freeze |
Key Features
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Preservative-Free: Formulated without thimerosal or other preservatives, addressing patient preferences and reducing the risk of preservative-related sensitivities.
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Triple Protection: Provides comprehensive booster immunity in a single 0.5 mL injection, simplifying the immunization schedule for adolescents and adults.
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Highly Purified: Utilizes acellular pertussis components (PT, FHA, pertactin, and fimbriae types 2 and 3), which are associated with fewer local reactions compared to older whole-cell vaccines.
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Standard-of-Care: Widely recommended by the CDC/ACIP for adolescents (age 11-12) and adults who have not previously received a Tdap dose.
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Latex-Free Components: The vial stopper is not made with natural rubber latex, ensuring safety for patients with latex allergies.
Clinical Applications
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Adolescent Boosters: Standard 6th-grade/middle school entry requirement to boost immunity from childhood DTaP series.
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Adult Immunization: Used for adults requiring a tetanus booster if their last Tdap status is unknown or if they are in contact with infants.
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Pregnancy: Often administered during each pregnancy (ideally between 27 and 36 weeks) to provide passive immunity to the newborn.
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Wound Management: Used for tetanus prophylaxis in wound management for patients who have not received a tetanus-containing vaccine within the last 5 to 10 years.
⚠️ Usage Note: Shake the vial well before withdrawing the dose. The vaccine should appear as a uniform, white, cloudy suspension. Do not use if the product cannot be resuspended by shaking.
⚠️ Safety Alert: Syncope (fainting) can occur following vaccination. Patients should be seated or lying down during administration and observed for 15 minutes afterward.
⚠️ Contraindications: Do not administer to individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or a history of encephalopathy within 7 days of a previous pertussis-containing vaccine.
