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 vial

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 vials, 1 x 0.5mL vial

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: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-06-22

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