CERVARIX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HPV-16 L1; HPV-18 L1

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J07CA

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

HPV-18 L1 20 MCG / 0.5 ML; HPV-16 L1 20 MCG / 0.5 ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

GLAXO SMITH KLINE BIOLOGICALS S.A

Therapeutic group:

BACTERIAL AND VIRAL VACCINES, COMBINED

Therapeutic indications:

Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types.

Authorization date:

2013-02-28

Summary of Product characteristics

1
_The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved In August 2014_
CERVARIX™
1.
NAME OF THE MEDICINAL PRODUCT
CERVARIX™
suspension for injection
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 genital
(cervical, vulvar and vaginal) lesions and cervical cancer 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.
2
AGE AT THE TIME OF THE FIRST
INJECTION
IMMUNIZATION AND
SCHEDULE
FLEXIBILITY FOR
IMMUNIZATION IF REQUIRED
9 to and including 14 years
Two doses each of 0.5 ml
at 0, 6 months
Second dose between 5 and
7 months after the 1
st
dose
From 15 years and above
Three doses each of 0.5
ml at 0, 1, 6 months
Second dose between 1 and
2.5 months after 1
st
dose
Third dose between 5 and
12 months after the 1
st
dose
If at any age the second vaccine dose is admini