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Prescribing Information

Before administering Pentacel vaccine, please see full Prescribing Information.

Reimbursement Information

Pentacel®

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
For children 6 weeks through 4 years of age [prior to fifth birthday]

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About Pentacel Vaccine

IMPORTANT SAFETY INFORMATION FOR PENTACEL VACCINE

Contraindications to vaccination with Pentacel vaccine include: severe allergic reaction (eg, anaphylaxis) after a previous dose of Pentacel vaccine, any ingredient of Pentacel vaccine, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, or Haemophilus influenzae type b vaccine; encephalopathy within 7 days after a previous dose of a pertussis-containing vaccine with no other identifiable cause; or a progressive neurologic disorder.

Carefully consider benefits and risks before administering Pentacel vaccine to persons with a history of: fever ?105°F, hypotonic-hyporesponsive episode (HHE), or persistent, inconsolable crying lasting ?3 hours within 48 hours after a previous pertussis-containing vaccine; seizures within 3 days after a previous pertussis-containing vaccine; or adverse events after a previous dose of Pentacel vaccine or receipt of any other tetanus toxoid, diphtheria toxoid, or pertussis antigen-containing vaccine.

If Guillain-Barré syndrome has occurred within 6 weeks following receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following Pentacel vaccine.

For infants and children with a history of previous seizures, an antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with Pentacel vaccine and for the next 24 hours.

Apnea following intramuscular vaccination has been observed in some infants born prematurely.

The most common local and systemic adverse reactions to Pentacel vaccine include redness, swelling, and tenderness at the injection site; fever, fussiness, and abnormal crying. Other adverse reactions may occur. Vaccination with Pentacel vaccine may not protect all individuals.

INDICATION FOR PENTACEL VACCINE

Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to H influenzae type b. Pentacel vaccine is approved for use as a 4-dose series in children 6 weeks through 4 years of age (prior to fifth birthday).

Before administering Pentacel vaccine, please see accompanying full Prescribing Information.

 

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