Ad Copy with ISI scrolling:
Pentacel ® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and
Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine]
Professional Indication:
Pentacel is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to H influenzae type b. Pentacel is approved for use as a 4-dose series in children 6 weeks through 4 years of age (prior to fifth birthday).
Professional Fair Balance:
IMPORTANT SAFETY INFORMATION FOR PENTACEL
Contraindications to vaccination with Pentacel include: a severe allergic reaction (e.g., anaphylaxis) after a previous dose of Pentacel, any ingredient of Pentacel, or any other diphtheria toxoid-, tetanus toxoid-, pertussis antigen-containing vaccine, inactivated poliovirus vaccine, or Haemophilus influenzae type b vaccine; encephalopathy within 7 days after a previous dose of a pertussis antigen-containing vaccine with no other identifiable cause; or a progressive neurologic disorder.
Carefully consider benefits and risks before administering Pentacel to persons with a history of: fever ≥105°F, hypotonic-hyporesponsive episode, or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis antigen-containing vaccine; seizures within 3 days after a previous pertussis antigen- containing vaccine; or adverse events after a previous dose of Pentacel 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.
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 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 include redness, swelling, and tenderness at the injection site; fever, fussiness, and abnormal crying. Other adverse reactions may occur.
Vaccination with Pentacel may not protect all individuals.
Reference:
1. Data on File. Gross Sales VI Cube - Direct Doses public and private for Sanofi Pasteur U.S. 2020
2. Pentacel [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.
MAT-US-2106047-v1.0-07/2021
Professional Indication:
Pentacel is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to H influenzae type b. Pentacel is approved for use as a 4-dose series in children 6 weeks through 4 years of age (prior to fifth birthday).
Professional Fair Balance:
IMPORTANT SAFETY INFORMATION FOR PENTACEL
Contraindications to vaccination with Pentacel include: a severe allergic reaction (e.g., anaphylaxis) after a previous dose of Pentacel, any ingredient of Pentacel, or any other diphtheria toxoid-, tetanus toxoid-, pertussis antigen-containing vaccine, inactivated poliovirus vaccine, or Haemophilus influenzae type b vaccine; encephalopathy within 7 days after a previous dose of a pertussis antigen-containing vaccine with no other identifiable cause; or a progressive neurologic disorder.
Carefully consider benefits and risks before administering Pentacel to persons with a history of: fever ≥105°F, hypotonic-hyporesponsive episode, or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis antigen-containing vaccine; seizures within 3 days after a previous pertussis antigen- containing vaccine; or adverse events after a previous dose of Pentacel 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.
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 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 include redness, swelling, and tenderness at the injection site; fever, fussiness, and abnormal crying. Other adverse reactions may occur.
Vaccination with Pentacel may not protect all individuals.
Reference:
1. Data on File. Gross Sales VI Cube - Direct Doses public and private for Sanofi Pasteur U.S. 2020
2. Pentacel [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.
MAT-US-2106047-v1.0-07/2021
Please see full Prescribing information for Pentacel (49281-0510-05 and 49281-0511-05).
