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Important Safety Information for Prevnar 13®
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PREVNAR® and PREVNAR 13® are registered trademarks of Wyeth LLC.
Manufactured by Wyeth Pharmaceuticals Inc. Marketed by Pfizer Inc.
PSP509608-01 ©2012 Pfizer Inc.
All rights reserved. November 2012
This site is intended only for residents of the United States. All rights reserved. Please read our Privacy Policy and Terms and Conditions.
The product information provided in this site is intended for residents of the United States. The products discussed herein may have different product labeling in different countries.
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a health care provider. All decisions regarding patient care must be made with a health care provider, considering the unique characteristics of the patient.
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INDICATIONS FOR PREVNAR 13®
- Prevnar 13® is a vaccine approved for use in children 6 weeks through 5 years for prevention of invasive disease (caused by the 13 strains of Streptococcus pneumoniae included in the vaccine) and ear infections (caused by 7 of the 13 strains)
- Based upon immune responses to the vaccine, Prevnar 13® is also approved for adults 50 years and older for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 vaccine strains
- Prevnar 13® is not 100% effective and will only help protect against the 13 strains included in the vaccine
- Effectiveness when given less than 5 years after a pneumococcal polysaccharide vaccine is not known
IMPORTANT SAFETY INFORMATION FOR PREVNAR 13®
- Prevnar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine
- Children and adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response
- A temporary pause of breathing following vaccination has been observed in some infants born prematurely
- The most commonly reported serious adverse events in children were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
- In infants and toddlers, the most common side effects were tenderness, redness or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever
- In adults, immune responses to Prevnar 13® were reduced when given with injected seasonal flu vaccine
- In adults, the common side effects were pain, redness, or swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, chills, or rash
- Ask your health care provider about the risks and benefits of Prevnar 13®. Only a health care provider can decide if Prevnar 13® is right for your child
Please see the full Prescribing Information for Prevnar 13®
You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.
The above Prescribing Information is available in PDF (portable document format).
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