IMPORTANT FACTS
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^ABOUT PREVNAR 13™
• Prevnar 13'" is a vaccine which helps protect
against 13 strains of
Streptococcus pneumoniae
(1,3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,
and 23F) that can cause invasive disease.
• Prevnar 13™
may also be used for the prevention of
otitis media (ear infection) caused by
Streptococcus
pneumoniae
strains 4, 6B, 9V, 14, 18C, 19F, and
23F. No efficacy data for ear infections are
available for strains 1, 3,5, 6A, 7F, and 19A.
• Prevnar 13™
may not protect all individuals
receiving the vaccine. Protection against ear
infections is expected to be less than that for
invasive disease.
• Prevnar 13™
does not replace the use of 23-valent
pneumococcal polysaccharide vaccine (PPV23)
in children >24 months of age with sickle cell
disease, damaged spleen, HIV infection, chronic
illness or who have weakened immune systems.
^
BEFORE STARTING PREVNAR 13™
Tell your child’s health care provider about all
of your child’s medical conditions, including:
• Previous allergic or adverse reactions to other vaccines.
• Certain conditions that weaken your child’s immune
system such as a damaged spleen, HIV infection,
cancer, or kidney problems. Children with weakened
immune systems may have a reduced immune
response to Prevnar 13™
.
Tell your child’s health care provider about all the
medicines your child takes, including prescription
and over-the-counter medicines, vitamins and
herbal supplements.
Especially tell your child’s health care provider if
your child is taking medicines that can weaken his or
her immune system such as steroids (e.g., prednisone)
and cancer medicines or if your child is undergoing
radiation therapy.
WHO SHOULD RECEIVE PREVNAR 13™?
• Prevnar 13™
is recommended for children 6
weeks through 5 years of age.
• Prevnar 13™
is regularly given as a 4-dose series
at 2, 4, 6, and 12 to 15 months of age.
•
Transition schedule:
Children who have received
one or more doses of Prevnar® (Pneumococcal
7-valent Conjugate Vaccine [Diphtheria CRM|97
Protein 1) may complete the 4-dose immunization
series with Prevnar 13™
.
•
Catch-up Schedule:
Children 15 months through 5
years of age who have received 4 doses of Prevnar®
may receive one dose of Prevnar 13™
to elicit
immune responses to the six additional strains.
• The immune response from the transition or
catch-up schedules might be lower for the 6
additional strains (types 1, 3, 5, 6A, 7F, and 19A)
than if your child had received the full 4 doses
of Prevnar 13™
. It’s not known how medically
important this difference is.
WHO SHOULD NOT RECEIVE PREVNAR 13 “?
• Children under 6 weeks of age and over 6 years
of age.
• Children who have had a serious allergic reaction
to any component of Prevnar 13™
, Prevnar®, or any
diphtheria toxoid-containing vaccine.
POSSIBLE SIDE EFFECTS OF PREVNAR 13™
Prevnar 13™
may cause serious side effects including:
• Temporary pause of breathing in some infants born
prematurely
• Bronchiolitis (an infection of the lungs)
• Gastroenteritis (inflammation of the stomach and
small intestine)
• Pneumonia
The most common side effects of Prevnar 13™
are:
• Redness, swelling and tenderness at the injection site
• Fever • Decreased appetite • Irritability
• Increased sleep • Decreased sleep
Any side effects associated with the vaccination
should be reported to your child's health care provider.
These arc not all of the possible side effects of
Prevnar 13™. For a complete list, ask your child’s
health care provider.
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NEED MORE INFORMATION?
'
• This is only a summary of important information.
Ask your child's health care provider for complete
product information.
• Go to
www.prevnarl3.com
or call 1-800-666-7248.
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Wyeth
Manufactured by Wyeth Pharmaceuticals Inc.
Marketed by Pfizer Inc.
Rx only
266107-01
0 2010 Pfizer Inc.
All rights reserved.
Printed in USA/May 2010
