IMPORTANT SAFETY INFORMATION FOR PENTACEL AND QUADRACELPRESCRIBING INFORMATION FOR PENTACEL (49281-0510-05AND 49281-0511-05) PRESCRIBING INFORMATION FOR QUADRACEL
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Contraindications to vaccination with Pentacel or Quadracel vaccine include: a severe allergic reaction (eg, anaphylaxis) to any ingredient of the vaccine, or following any other diphtheria toxoid-, tetanus toxoid-, pertussis antigen-containing vaccine, inactivated poliovirus vaccine, or Haemophilus influenzae type b vaccine (Pentacel vaccine only); 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 or Quadracel 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 antigen-containing vaccine; seizures within 3 days after a previous pertussis antigen-containing vaccine; Guillain-Barré syndrome occurring within 6 weeks following receipt of a prior vaccine containing tetanus toxoid; or adverse events after a previous dose of Pentacel or Quadracel vaccine or receipt of any other tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing 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 erythema, swelling, and tenderness at the injection site; fever, fussiness, and abnormal crying. The most common local and systemic adverse reactions to Quadracel vaccine include pain, erythema, and edema at the injection site; myalgia, malaise, and headache. Other adverse reactions may occur.

Vaccination with Pentacel or Quadracel vaccine may not protect all individuals.

INDICATION FOR PENTACEL AND QUADRACEL VACCINES

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).

Quadracel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis. A single dose of Quadracel vaccine is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received 4 doses of Pentacel vaccine and/or DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed).

Before administration, please see the full Prescribing Information for Pentacel or Quadracel vaccines.

For questions regarding the above referenced vaccine products, please contact your respective Sanofi Pasteur vaccine representative or please call Sanofi Pasteur at 1.800.VACCINE (1.800.822.2463).
IMPORTANT SAFETY INFORMATION FOR PENTACEL AND QUADRACEL
Please see the accompanying full Prescribing Information for Pentacel® (49281-0510-05 and 49281-0511-05) and Quadracel®
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Contraindications to vaccination with Pentacel or Quadracel include: a severe allergic reaction (e.g., anaphylaxis) to any ingredient of the vaccine, or following any other diphtheria toxoid-, tetanus toxoid-, pertussis antigen-containing vaccine, inactivated poliovirus vaccine, or Haemophilus influenzae type b vaccine (Pentacel only); 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 or Quadracel 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; Guillain-Barré syndrome occurring within 6 weeks following receipt of a prior vaccine containing tetanus toxoid; or adverse events after a previous dose of Pentacel or Quadracel or receipt of any other tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing 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 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 erythema, swelling, and tenderness at the injection site; fever, fussiness, and abnormal crying. The most common local and systemic adverse reactions to Quadracel include pain, erythema, and edema at the injection site; myalgia, malaise, and headache. Other adverse reactions may occur.

Vaccination with Pentacel or Quadracel may not protect all individuals.

Please see the accompanying full Prescribing Information for Pentacel® (49281-0510-05 and 49281-0511-05) and Quadracel®

PRESCRIBING INFORMATION FOR ADACELIMPORTANT SAFETY INFORMATION FOR ADACEL
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Adacel is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to any other tetanus toxoid‐, diphtheria toxoid‐, or pertussis antigen‐containing vaccine, or to any component of Adacel; 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, 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 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 unless at least 10 years have elapsed since the last dose of tetanus toxoid‐containing vaccine.

Syncope can occur in association with administration of injectable vaccines, including Adacel.

Procedures should be in place to prevent falling injury and manage syncopal reactions.

After the first and second dose of Adacel, the most frequently reported solicited reactions were pain, swelling, and erythema at the injection site; headache, body ache or muscle weakness, tiredness, myalgia, and malaise.

Other adverse reactions may occur. Vaccination with Adacel may not protect all individuals.

Before administration, please see the full Prescribing Information for Adacel.

IMPORTANT SAFETY INFORMATION FOR FLUBLOK QUADRIVALENT AND FLUZONE HIGH-DOSE QUADRIVALENT
PRESCRIBING INFORMATION FOR FLUBLOK QUADRIVALENT
PRESCRIBING INFORMATION FOR FLUZONE HIGH-DOSE QUADRIVALENT
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Flublok Quadrivalent and Fluzone High-Dose Quadrivalent should not be administered to anyone who has had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine (including egg protein for Fluzone High-Dose Quadrivalent) or after previous dose of the respective vaccine. In addition, Fluzone High-Dose Quadrivalent should not be administered to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine. 

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. 

If Guillain-Barré syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Flublok Quadrivalent and Fluzone High-Dose Quadrivalent should be based on careful consideration of the potential benefits and risks.  

If Flublok Quadrivalent and Fluzone High-Dose Quadrivalent are administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be lower than expected. 

Vaccination with Flublok Quadrivalent and Fluzone High-Dose Quadrivalent may not protect all recipients. 

For Flublok Quadrivalent, in adults 18 through 49 years of age, the most common injection-site reactions were tenderness and pain; the most common solicited systemic adverse reactions were headache, fatigue, myalgia, and arthralgia. In adults 50 years of age and older, the most common injection-site reactions were tenderness and pain; the most common solicited systemic adverse reactions were headache, and fatigue. 

For Fluzone High-Dose Quadrivalent, in adults 65 years of age and older, the most common injection-site reaction was pain; the most common solicited systemic adverse reactions were myalgia, headache, and malaise. 

For Flublok Quadrivalent and Fluzone High-Dose Quadrivalent, other adverse reactions may occur.

Before administration, please view the Full Prescribing Information for Flublok Quadrivalent and Fluzone High-Dose Quadrivalent.

PRESCRIBING INFORMATION FOR MENACTRAIMPORTANT SAFETY INFORMATION FOR MENACTRA
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Menactra is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid-, or CRM197-containing vaccine, or to any component of the vaccine.

Persons previously diagnosed with Guillain-Barré syndrome (GBS) may be at increased risk of GBS following receipt of Menactra. GBS has been reported in temporal relationship following administration of Menactra. The decision to give Menactra should be based on careful consideration of the potential benefits and risks.

Syncope (fainting) can occur in association with administration of injectable vaccines, including Menactra. Procedures should be in place to prevent falling injury and manage syncopal reactions.

The most common local and systemic adverse reactions to Menactra include pain, redness, and swelling at the injection site and appetite loss (all age groups); induration at the injection site and diarrhea (all age groups except infants); irritability and drowsiness (infants and children); abnormal crying, vomiting, and fever (infants); headache, fatigue, malaise, and arthralgia (adolescents and adults). Other adverse reactions may occur. Vaccination with Menactra may not protect all individuals.

Before administration, please see the full Prescribing Information for Menactra.

PRESCRIBING INFORMATION FOR MENQUADFI IMPORTANT SAFETY INFORMATION FOR MENQUADFI
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MenQuadfi should not be administered to anyone who has had a severe allergic reaction to any component of the vaccine, or after a previous dose of MenQuadfi or any other tetanus toxoid-containing vaccine.

Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine.

Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MenQuadfi. Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (eg, eculizumab) are at increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, W, and Y, even if they develop antibodies following vaccination with MenQuadfi.

Syncope can occur following, or even before, vaccination with MenQuadfi. Procedures should be in place to prevent falling and injury and to manage syncope.

Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to give MenQuadfi to persons with a history of GBS should take into account the expected benefits and potential risks.

Immunization with MenQuadfi does not substitute for routine tetanus immunization.

Vaccination with MenQuadfi may not protect all vaccine recipients.

The most common adverse reactions following a primary dose of MenQuadfi in individuals 2 years of age and older include pain at the injection site; myalgia, headache, and malaise. Other common adverse reactions in children 2 through 9 years of age include erythema and swelling at the injection site. In adolescents and adults, rates of solicited adverse reactions following a booster dose were comparable to those observed following primary vaccination. Other adverse reactions may occur.

Before administration, please see the full Prescribing Information for MenQuadfi.

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This information is intended for US-Licensed Health Care Providers. MAT-US-2101318-v1.0 02/2021