Cervarix (prefilled syringe)

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

HPV-16 L1; HPV-18 L1

Beschikbaar vanaf:

GLAXOSMITHKLINE PTE LTD

ATC-code:

J07BM02

Dosering:

20 μg/0.5ml

farmaceutische vorm:

INJECTION, SUSPENSION

Samenstelling:

HPV-16 L1 20 μg/0.5ml; HPV-18 L1 20μg/0.5ml

Toedieningsweg:

INTRAMUSCULAR

Prescription-type:

Prescription Only

Geproduceerd door:

GlaxoSmithKline Biologicals s.a.

Autorisatie-status:

ACTIVE

Autorisatie datum:

2007-11-22

Bijsluiter

1 

_CERVARIX_
_™_
_ _

1. NAME OF THE MEDICINAL PRODUCT

_Cervarix_
_TM_
_ _
Human Papillomavirus vaccine Types 16 and 18 (Recombinant, AS04
adjuvanted). 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

1 dose (0.5 ml) contains: 
Human Papillomavirus type 16 L1 protein
1
 20 
micrograms 
Human Papillomavirus type 18 L1 protein
1
 20 
micrograms 
3-_O_-desacyl-4’- monophosphoryl lipid A (MPL)
2
 50 
micrograms 
Aluminium hydroxide, hydrated
2

0.5 milligrams Al
3+ 

1
L1 protein in the form of non-infectious virus-like
particles (VLPs) produced by recombinant DNA 
technology using a Baculovirus expression system 
2
The GlaxoSmithKline proprietary AS04 adjuvant system is composed of
aluminium hydroxide and 3-
_O_
-desacyl-4’- monophosphoryl lipid A (MPL) (see section 5.1) 

3. PHARMACEUTICAL FORM 

Suspension for injection. 

4. CLINICAL PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 

Cervarix is a vaccine indicated in females  from 9 to 25 years of
age for the prevention of persistent 
infection, premalignant cervical lesions and cervical cancer
caused by  Human Papillomavirus (HPV) 
Types 16 & 18. See sections 4.4 and 5.1 for important information on
the data regarding HPV-16 
and/or HPV-18, and other oncogenic HPV types that support this
indication.            

The indication is based on the demonstration of efficacy in women
aged 15-25 years following 
vaccination with Cervarix and on the immunogenicity of the
vaccine in girls and women aged 9-25 
years.  

The use of Cervarix should be in accordance with official
recommendations. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

The vaccination schedule depends on the age of the subject. 
From age 9 to and including 14 years of age at the time of the first
injection, Cervarix can be 
administered as either a 2 or 3 dose schedule.  
From age 15 years and above, only the 3-dose schedule is
recommended. 
 2-dose 
schedule: the vaccination sc

Productkenmerken

1
CERVARIX_ _
1. NAME OF THE MEDICINAL PRODUCT
Cervarix_ _
Human Papillomavirus vaccine Types 16 and 18 (Recombinant, AS04
adjuvanted) Suspension
for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Human Papillomavirus type 16 L1 protein
1
20 micrograms
Human Papillomavirus type 18 L1 protein
1
20 micrograms
3-_O_-desacyl-4’-monophosphoryl lipid A (MPL)
2
50 micrograms
Aluminium hydroxide, hydrated
2
0.5 milligrams Al
3+
1
L1 protein in the form of non-infectious virus-like particles (VLPs)
produced by recombinant DNA
technology using a Baculovirus expression system
2
The GlaxoSmithKline proprietary AS04 adjuvant system is composed of
aluminium hydroxide and 3-
_O_-desacyl-4’-monophosphoryl lipid A (MPL) _(see section 4.1)_
3. CLINICAL INFORMATION
3.1
THERAPEUTIC INDICATIONS
Cervarix is a vaccine indicated in females from 9 to 25 years of age
for the prevention of persistent
infection, premalignant cervical lesions and cervical cancer caused by
Human Papillomavirus (HPV)
Types 16 & 18. See sections 3.4 and 4.1 for important information on
the data regarding HPV-16
and/or HPV-18, and other oncogenic HPV types that support this
indication.
The indication is based on the demonstration of efficacy in women aged
15 to 25 years following
vaccination with Cervarix and on the immunogenicity of the vaccine in
girls and women aged 9 to 25
years.
The use of Cervarix should be in accordance with official
recommendations.
3.2
POSOLOGY AND METHOD OF ADMINISTRATION
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*
or
Three doses each of 0.5 ml at 0, 1, 6 months**
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 5th month after
the first dose, a third dose
should always be administered.
**If flexibility in the vaccination s