Cervarix vaccine suspension for injection 0.5ml pre-filled syringes

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Human papillomavirus type 18 L1 protein; Human papillomavirus type 16 L1 protein

Διαθέσιμο από:

GlaxoSmithKline UK Ltd

INN (Διεθνής Όνομα):

Human papillomavirus type 18 L1 protein; Human papillomavirus type 16 L1 protein

Φαρμακοτεχνική μορφή:

Suspension for injection

Οδός χορήγησης:

Intramuscular

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 14040000; GTIN: 5000123112432 5000123112531

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CERVARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
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 and anal lesions (changes in cells of the
cervix, vulva, vagina and anus 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 is vaccinated with Cervarix, the immune system (the
body’s natural defence system)
will make antibodies against HPV types 16 and 18. In clinical trials
Cervarix has been shown to
prevent HPV related diseases in women aged 15 years and older.
Cervarix also stimulates production
of antibodies in female

Αρχείο Π.Χ.Π.

OBJECT 1
CERVARIX
Summary of Product Characteristics Updated 25-May-2018 |
GlaxoSmithKline UK
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.
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