Gardasil

Country: Европска Унија

Језик: Енглески

Извор: EMA (European Medicines Agency)

Активни састојак:

human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein

Доступно од:

Merck Sharp & Dohme B.V. 

АТЦ код:

J07BM01

INN (Међународно име):

human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)

Терапеутска група:

Vaccines

Терапеутска област:

Papillomavirus Infections; Uterine Cervical Dysplasia; Condylomata Acuminata; Immunization

Терапеутске индикације:

Gardasil is a vaccine for use from the age of 9 years for the prevention of:premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types;genital warts (condyloma acuminata) causally related to specific HPV types.See sections 4.4 and 5.1 for important information on the data that support this indication.The use of Gardasil should be in accordance with official recommendations.

Резиме производа:

Revision: 48

Статус ауторизације:

Authorised

Датум одобрења:

2006-09-20

Информативни летак

37
B. PACKAGE LEAFLET
(VIAL)
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
GARDASIL SUSPENSION FOR INJECTION
Huma
n Papillomavirus Vaccine [Types
6, 11, 16, 18] (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 or
pharmacist.
-
If
you or your child get any side effects,
talk to your doctor,
pharmacist
or
nurse. This includes
any possible side
effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Gardasil is and what it is used for
2.
What you need to know b
efore you
or your child
receive Gardasil
3.
How Gardasil is given
4.
Possible side effects
5.
How to st
ore Gardasil
6.
Contents of the pack and other information
1.
WHAT GARDASIL IS AND WHAT IT IS USED FOR
Gardasil is a vaccine. Vaccination with Gardasil is intended to
protect against diseases caused by
Human
Papillomavirus (HPV) types
6, 11, 16, and 18.
These diseases include pre
-
cancerous lesions of the female genitals (cervix, vulva, and
vagina); pre
-
cancerous lesions
of the anus and
genital warts in males and females; cervical and anal cancers.
HPV
types 16 and 18 are responsible for
approximately 70
%
of cervical cancer
cases, 75-80 % of anal
cancer cases; 70
% of HPV-related pre-cancero
us lesions of the vulva and vagina;
80 % of HPV
related pre-
cancerous lesions of the anus.
HPV types
6 and 11 are responsible for
approximately 90
%
of
genital wart
cases.
Gardasil is intended to prevent these diseases. The vaccine is not
used to treat HP
V related diseases.
Gardasil 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 can still protect against disease
s
associated with
the other HPV types in the vaccine.
Garda

Карактеристике производа

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Gardasil suspension for injection.
Gardasil suspension for injection in a pre
-
filled syringe.
Huma
n Papillomavirus Vaccine
[Types
6, 11, 16, 18] (Recombinant, adsorbed).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5
ml) contains approximately:
Human Papillomavirus
1
Type 6 L1 protein
2,3
20 micrograms
Human Papillomavirus
1
Type 11 L1 protein
2,3
40 micrograms
Human Papillomavirus
1
Type 16 L1 protein
2,3
40 micrograms
Human Papillomavirus
1
Type 18 L1 protein
2,3
20
micrograms.
1
Human 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
adsorbed on amorphous alumin
i
um hydroxyphosphate sul
f
ate adjuvant (
0.225 milligrams Al).
For a full list
of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Gardasil s
uspension for injection.
Gardasil suspension for injection in a pre
-
filled syringe.
Prior to agitation, Gardasil may appear as a clear liquid with a white
precipitate. After thorough
agitation, it is a white,
cloudy liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gardasil is a va
ccine for use from the age of 9
years for the prevention of:
–
premalignant genital lesions (cervical, vulvar and vaginal),
premalignant anal lesions, cervical
cancers and
anal cancers
causally related to certain oncogenic Human Papillomavirus (HPV)
types
–
genital warts (condyloma acuminata) causally related to specific HPV
types.
See sections
4.4 and 5.1 for important information
o
n the data that support this
indication.
The use of Gardasil should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In
dividuals 9 to and including 13
years of age
Gardasil can be administered acco
rding to a 2-
dose schedule (0.5
ml at 0, 6
months) (see section
5.1).
If the second vaccine dose is administered earlier
than 6
months after the first dose, a third dose