GARDASIL HPV 6 L1 Protein / HPV 11 L1 Protein / HPV 16 L1 Protein / HPV 18 L1 Protein 20,40,40,20 micrograms/0.5mL sterile liquid syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

HPV Type 6 L1 Protein, Quantity: 20 microgram; HPV Type 11 L1 Protein, Quantity: 40 microgram; HPV Type 16 L1 Protein, Quantity: 40 microgram; HPV Type 18 L1 Protein, Quantity: 20 microgram

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

HPV Type 11 L1 Protein,HPV Type 16 L1 Protein,HPV Type 18 L1 Protein,HPV Type 6 L1 Protein

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: aluminium; histidine; polysorbate 80; borax; water for injections; sodium chloride

Administration route:

Intramuscular

Units in package:

10 x 0.5mL syringes, 1 x 0.5mL syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GARDASIL is indicated in females aged 9 through 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18 (which are included in the vaccine). GARDASIL is indicated in males 9 through 26 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by HPV types 6, 11, 16, and 18 (which are included in the vaccine). *Immunogenicity studies have been conducted to link efficacy in females and males aged 16 to 26 years to the younger populations.

Product summary:

Visual Identification: Cloudy white liquid; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-06-22

Patient Information leaflet

GARDASIL
®
_[Quadrivalent HPV (Types 6, 11, 16, 18) Recombinant Vaccine]_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GARDASIL. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the risks of your child or
you being given GARDASIL against
the benefits they expect it will have
for your child or you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS VACCINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT GARDASIL IS
USED FOR
GARDASIL is a vaccine that helps
prevent the following diseases in
girls and women 9 through 45 years
of age caused by Human
Papillomavirus (HPV) Types 6, 11,
16 or 18.
•
cervical (the lower end of the
uterus or womb), vulvar (the
outside of the female genitals),
vaginal, and anal cancer
•
abnormal and precancerous
(changes in cells which have a
risk of turning into cancer)
cervical, vaginal, vulvar and anal
lesions
•
genital warts
•
HPV infection
GARDASIL helps protect against
anal cancer, precancerous anal
lesions, external genital lesions
(including genital warts) and
infection caused by HPV types 6, 11,
16 and 18 in boys and men 9 through
26 years of age
GARDASIL, helps prevent, but does
not treat these diseases. You cannot
get HPV or any of the above diseases
from GARDASIL.
GARDASIL can be given to females
aged 9 to 45 years and males aged 9
to 26 years.
HPV is a common virus. Of the many
different types of HPV, some are
harmless and others can cause
diseases of the genital areas. While
most people clear the virus, those
who do not can develop cervical
cancer, precancerous lesions, or
genital warts.
In the absence of vaccination, it is
estimated that the majority of people
who have ever had sex will become
infected with HPV during their
lifetime. A male or female of any age
who has taken part in any kind of
sexual activity that involved genital

Summary of Product characteristics

PRODUCT INFORMATION
GARDASIL®
[Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
vaccine]
DESCRIPTION
GARDASIL
®
is a recombinant, quadrivalent vaccine.
The quadrivalent Human Papillomavirus Virus-Like Particle vaccine (HPV
VLP vaccine) is a
sterile liquid suspension prepared from the highly purified virus-like
particles (VLPs) of the
recombinant major capsid (L1) protein of HPV Types 6, 11, 16, and 18.
The L1 proteins are
produced
by
separate
fermentations
in
recombinant
yeast
_Saccharomyces _
_cerevisiae_
CANADE 3C-5 (Strain 1895) and self-assembled into VLPs. The VLPs for
each type are
purified
and
adsorbed
on
aluminium-containing
adjuvant
(amorphous
aluminium
hydroxyphosphate sulfate, or AAHS). The quadrivalent HPV VLP vaccine
is prepared by
combining
the
adsorbed
VLPs
of
each
HPV
type,
the
aluminium-containing
adjuvant
formulation, and a buffer.
GARDASIL is a sterile preparation for intramuscular administration.
Each 0.5-mL dose
contains approximately 20 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1
protein, 40 mcg
of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein.
Each 0.5-mL dose of the vaccine contains approximately 225 mcg of
aluminium (as
amorphous aluminium hydroxyphosphate sulfate adjuvant), 9.56 mg of
sodium chloride,
0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of borax,
residual traces
(<7mcg/dose) of yeast protein and water for injection. The product
does not contain a
preservative or antibiotics.
PHARMACOLOGY
MECHANISM OF ACTION
GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed
of a unique
recombinant L1 major capsid protein for the respective HPV type.
Because the virus-like
particles contain no viral DNA, they cannot infect cells or reproduce.
Pre-clinical
data
suggests
that
the
efficacy
of
L1
VLP
vaccines
is
mediated
by
the
development of humoral immune responses. Induction of
anti-papillomavirus antibodies with
L1 VLP vaccines resulted in protection against infection.
Administration of serum from
vaccinated to unvaccinated animals resulted