Cervarix

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

human papillomavirus1 type 16 L1 protein, human papillomavirus type 18 L1 protein

Saadav alates:

GlaxoSmithKline Biologicals S.A.

ATC kood:

J07BM02

INN (Rahvusvaheline Nimetus):

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

Terapeutiline rühm:

Vaccines

Terapeutiline ala:

Papillomavirus Infections; Uterine Cervical Dysplasia; Immunization

Näidustused:

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

Toote kokkuvõte:

Revision: 39

Volitamisolek:

Authorised

Loa andmise kuupäev:

2007-09-20

Infovoldik

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
CERVARIX SUSPENSION FOR INJECTION IN A VIAL
Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted,
adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
VACCINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Cervarix is and what it is used for
2.
What you need to know before you receive Cervarix
3.
How Cervarix is given
4.
Possible side effects
5.
How to store Cervarix
6.
Contents of the pack and other information
1.
WHAT CERVARIX IS AND WHAT IT IS USED FOR
Cervarix is a vaccine intended to protect from the age of 9 years
against the diseases caused by
infection with Human Papillomaviruses (HPV).
These diseases include:
-
cervical cancer (cancer of the cervix i.e. lower part of the uterus or
womb) and anal cancer,
-
precancerous cervical, vulvar, vaginal and anal lesions (changes in
genital or anal cells that have a
risk of turning into cancer).
The Human Papillomavirus (HPV) types contained in the vaccine (HPV
types 16 and 18) are
responsible for approximately 70% of cervical cancers, 90% of anal
cancers, 70% of HPV-related pre-
cancerous lesions of the vulva and vagina and 78% of HPV-related
pre-cancerous lesions of the anus.
Other HPV types can also cause ano-genital cancers. Cervarix does not
protect against all HPV types.
When a female or a male individual is vaccinated with Cervarix, the
immune system (the body’s
natural defence system) will make antibodies against HPV types 16 and
18.
Cervarix is not infectious and so, it cannot cause HPV related
diseases.
Cervarix is not used to treat HPV related diseases already present a

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cervarix suspension for injection in pre-filled syringe
Cervarix suspension for injection in a vial
Cervarix suspension for injection in multidose container
Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted,
adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Human Papillomavirus
1
type 16 L1 protein
2,3,4
20 micrograms
Human Papillomavirus
1
type 18 L1 protein
2,3,4
20 micrograms
1
Human Papillomavirus = HPV
2
adjuvanted by AS04 containing:
3-
_O_
-desacyl-4’- monophosphoryl lipid A (MPL)
3
50 micrograms
3
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
)
0.5 milligrams Al
3+
in total
4
L1 protein in the form of non-infectious virus-like particles (VLPs)
produced by recombinant DNA
technology using a Baculovirus expression system which uses Hi-5
Rix4446 cells derived from
_Trichoplusia ni_
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cervarix is a vaccine for use from the age of 9 years for the
prevention of premalignant ano-genital
lesions (cervical, vulvar, vaginal and anal) and cervical and anal
cancers causally related to certain
oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1
for important information on
the data that support this indication.
The use of Cervarix should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The vaccination schedule depends on the age of the subject.
3
AGE AT THE TIME OF THE FIRST
INJECTION
IMMUNIZATION AND SCHEDULE
9 to and including 14 years*
Two doses each of 0.5 ml. The second dose given
between 5 and 13 months after the first dose
From 15 years and above
Three doses each of 0.5 ml at 0, 1, 6 months**
*If the second vaccine dose is administered before the 5
th
month after the first dose, a third dose
should always be administered.
**If flexibility