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Read this information with care before getting GARDASIL.
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You (the person getting GARDASIL) will need 3 doses of the
vaccine. It is important to read this leaflet when you get each dose.
This leaflet does not take the place of talking with your health care
provider about GARDASIL.
What is GARDASIL?
GARDASIL is a vaccine (injection/shot) that is used for girls and
women 9 through 26 years of age to help protect against the
following diseases caused by Human Papillomavirus (HPV):
Cervical cancer
Vulvar and vaginal cancers
Anal cancer
Genital warts
Precancerous cervical, vaginal, vulvar, and anal lesions
GARDASIL is used for boys and men 9 through 26 years of age to
help protect against the following diseases caused by HPV:
Anal cancer
Genital warts
Precancerous anal lesions
The diseases listed above have many causes, and GARDASIL
only protects against diseases caused by certain kinds of
HPV (called Type 6, Type 11, Type 16, and Type 18). Most of the
time, these 4 types of HPV are responsible for the diseases
listed above.
GARDASIL cannot protect you from a disease that is caused
by other types of HPV, other viruses, or bacteria.
GARDASIL does not treat HPV infection.
You cannot get HPV or any of the above diseases from
GARDASIL.
What important information about GARDASIL should I know?
You should continue to get routine cervical cancer screening.
GARDASIL may not fully protect everyone who gets the
vaccine.
GARDASIL will not protect against HPV types that you
already have.
Who should not get GARDASIL?
You should not get GARDASIL if you have, or have had:
an allergic reaction after getting a dose of GARDASIL.
a severe allergic reaction to yeast, amorphous aluminum
hydroxyphosphate sulfate, polysorbate 80.
What should I tell my health care provider before getting
GARDASIL?
Tell your health care provider if you:
are pregnant or planning to get pregnant. GARDASIL is not
recommended for use in pregnant women.
have immune problems, like HIV infection, cancer, or you take
medicines that affect your immune system.
have a fever over 100°F (37.8°C).
had an allergic reaction to another dose of GARDASIL.
take any medicines, even those you can buy over the counter.
Your health care provider will help decide if you should get the
vaccine.
How is GARDASIL given?
GARDASIL is a shot that is usually given in the arm muscle.
You will need 3 shots given on the following schedule:
Dose 1: at a date you and your health care provider choose.
Dose 2: 2 months after Dose 1.
Dose 3: 6 months after Dose 1.
Fainting can happen after getting GARDASIL. Sometimes people
who faint can fall and hurt themselves. For this reason, your
health care provider may ask you to sit or lie down for 15 minutes
after you get GARDASIL. Some people who faint might shake or
become stiff. This may require evaluation or treatment by your
health care provider.
Make sure that you get all 3 doses on time so that you get the best
protection. If you miss a dose, talk to your health care provider.
Can other vaccines and medications be given at the same
time as GARDASIL?
GARDASIL can be given at the same time as RECOMBIVAX HB
®
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[hepatitis B vaccine (recombinant)] or Menactra [Meningococcal
(Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid
Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced
Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
(Tdap)].
What are the possible side effects of GARDASIL?
The most common side effects with GARDASIL are:
pain, swelling, itching, bruising, and redness at the
injection site
headache
fever
nausea
dizziness
vomiting
fainting
There was no increase in side effects when GARDASIL was
given at the same time as RECOMBIVAX HB [hepatitis B
vaccine (recombinant)].
There was more injection-site swelling at the injection site
for GARDASIL when GARDASIL was given at the same time
as Menactra [Meningococcal (Groups A, C, Y and W-135)
Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel
[Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular
Pertussis Vaccine Adsorbed (Tdap)].
Tell your health care provider if you have any of the following
problems because these may be signs of an allergic reaction:
difficulty breathing
wheezing (bronchospasm)
hives
rash
Tell your health care provider if you have:
swollen glands (neck, armpit, or groin)
joint pain
unusual tiredness, weakness, or confusion
chills
generally feeling unwell
leg pain
shortness of breath
chest pain
aching muscles
muscle weakness
seizure
bad stomach ache
bleeding or bruising more easily than normal
skin infection
Contact your health care provider right away if you get any
symptoms that concern you, even several months after getting
the vaccine.
For a more complete list of side effects, ask your health
care provider.
What are the ingredients in GARDASIL?
The ingredients are proteins of HPV Types 6, 11, 16, and 18,
amorphous aluminum hydroxyphosphate sulfate, yeast protein,
sodium chloride, L-histidine, polysorbate 80, sodium borate, and
water for injection.
This leaflet is a summary of information about GARDASIL.
If you would like more information, please talk to your health care
provider or visit www.gardasil.com.
Manufactured and Distributed by: Merck Sharp & Dohme Corp.,
a subsidiary of Merck & Co., Inc.
Whitehouse Station, NJ 08889, USA
Issued April 2011
9883616
USPPI
Patient Information about
GARDASIL
®
(pronounced “gard-Ah-sill”)
Generic name: [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]
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Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc.
Copyright © 2006, 2009 Merck Sharp & Dohme Corp.,
a subsidiary of
Merck & Co., Inc.
All rights reserved
VACC-1067822-0010 04/13
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