Gardasil 9

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed)

Available from:

Merck Sharp & Dohme B.V.

ATC code:

J07BM03

INN (International Name):

human papillomavirus 9-valent vaccine (recombinant, adsorbed)

Therapeutic group:

Papillomavirus vaccines

Therapeutic area:

Condylomata Acuminata; Papillomavirus Infections; Immunization; Uterine Cervical Dysplasia

Therapeutic indications:

Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV typesGenital warts (Condyloma acuminata) caused by specific HPV types.See sections 4.4 and 5.1 for important information on the data that support these indications.The use of Gardasil 9 should be in accordance with official recommendations.

Product summary:

Revision: 22

Authorization status:

Authorised

Authorization date:

2015-06-10

Patient Information leaflet

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
GARDASIL
9 SUSPENSION FOR INJECTION
Human
Papillomavirus 9
-
valent Vaccine
(
Recombinant, adsorbed
)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
OR YOUR CHILD
.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor, pharmacist
or nurse.
-
If you or your child get any side effects, talk to your doctor,
pharmacist or nurse.
T
his includes
any possible side effects not listed in this leaflet. See section
4.
WHAT IS
IN THIS LEAFLET
1.
What Gardasil
9 is and what it is used for
2.
What you need to know before you or your child receive Gardasil
9
3.
How Gardasil
9 is given
4.
Possible side effects
5.
How to store Gardasil
9
6.
Contents of the pack and other info
rmation
1.
WHAT GARDASIL
9 IS AND WHAT IT IS USED FOR
Gardasil
9 is a vaccine
for
children and
adolescents
from 9
years of age
and adults. It is given to
protect against diseases caused by Human Papillomavirus (
HPV) types
6, 11, 16, 18, 31, 33, 45, 52
and 58.
These diseases include
pre-cancerous lesions and cancers
of the female genitals (cervix, vulva, and
vagina), pre-cancerous lesions and cancers
of the anus
and
genital warts in males and females
.
Gardasil 9 has been studied in males
9 to 26
years of age
and females 9 to
45
years of age.
Gardasil
9 protects against the HPV types that cause
most cases of these diseases.
Gardasil 9
is intended to prevent these diseases. The vaccine is not used to
treat HPV related diseases.
Gardasil 9 does
not have any effect in individuals who already have a persistent
infection or disease
associated with any of the HPV types in the vaccine. However, in
individuals who are already infected
with one or more of the vaccine HPV types,
Gardasil 9
can still prot
ect against diseases associated
with the other HPV types in the vaccine.
Gardasil
9 cannot cause
HPV-related diseases.
When an individual is vaccinated with Gardasil

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Gardasil 9
suspension for injection
.
Gardasil
9 suspension for injection in a pre
-filled syringe.
Human Papillomavirus 9
-
valent Vaccine
(
Recombinant
, adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5
ml) contains approximately:
Human Papillomavirus
1
Type 6 L1 protein
2,3
30 micrograms
Human
Papillomavirus
1
Type 11 L1 protein
2,3
40 micrograms
Human Papillomavirus
1
Type 16 L1 protein
2,3
60 micrograms
Human Papillomavirus
1
Type 18 L1 protein
2,3
40 micrograms
Human Papillomavirus
1
Type 31 L1 protein
2,3
20 micrograms
Human
Papillomavirus
1
Type 33 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 45 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 52 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 58 L1 protein
2,3
20 micrograms
1
Huma
n Papillomavirus = HPV.
2
L1 protein in the form of virus
-
like particles produced in yeast cells (
Saccharomyces cerevisiae
CANADE 3C-5 (Strain
1895)) by recombinant DNA technology.
3
A
dsorbed on amorphous alumin
i
um hydroxyphosphate sul
f
ate adjuvant (
0.5 milligrams Al).
For the full list
of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Suspension for injection.
Clear liquid with white precipitate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gardasil 9
is indicated for active immuni
sation
of individuals
from the age of 9
years
against the
following HPV diseases
:
•
Premalignant lesions
and cancers affecting the cervix, vulva, vagina and anus
caused by vaccine
HPV types.
•
Genital warts (Condyloma acuminata) caused by
specific HPV types.
See sections
4.4 and 5.1 for important information on the data that support
these indications.
The use of Gardasil 9
should be in accordance with official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATI
ON
Posology
Individuals 9 to
and including
14
years of age at time of first injection
Gardasil
9 can be administered according to a 2
-dose (0, 6
–
12
months) schedule (see section
5.1)