GARDASIL 9 Human Papillomavirus 9-valent Vaccine, Recombinant, 30, 40, 60, 40, 20, 20, 20, 20, 20 micrograms / 0.5mL, suspension for injection, vial

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

HPV Type 6 L1 Protein, Quantity: 30 microgram; HPV Type 11 L1 Protein, Quantity: 40 microgram; HPV Type 16 L1 Protein, Quantity: 60 microgram; HPV Type 18 L1 Protein, Quantity: 40 microgram; HPV Type 31 L1 Protein, Quantity: 20 microgram; HPV Type 33 L1 Protein, Quantity: 20 microgram; HPV Type 45 L1 Protein, Quantity: 20 microgram; HPV Type 52 L1 Protein, Quantity: 20 microgram; HPV Type 58 L1 Protein, Quantity: 20 microgram

Tillgänglig från:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International namn):

HPV Type 11 L1 Protein,HPV Type 16 L1 Protein,HPV Type 18 L1 Protein,HPV Type 31 L1 Protein,HPV Type 33 L1 Protein,HPV Type 45 L

Läkemedelsform:

Injection, suspension

Sammansättning:

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

Administreringssätt:

Intramuscular

Enheter i paketet:

1, 10

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

GARDASIL 9 is indicated in females aged 9 to 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, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,GARDASIL 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,* Evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. Immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). Immunogenicity studies of GARDASIL 9 have been conducted relating to females over 26 years of age (see section 5.1 CLINICAL TRIALS for GARDASIL 9).

Produktsammanfattning:

Visual Identification: White cloudy liquid. (Prior to agitation, may appear as a clear liquid with a white precipitate.); Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Bemyndigande status:

Licence status A

Tillstånd datum:

2015-06-29

Bipacksedel

GARDASIL
® 9
_[Human Papillomavirus 9-valent Vaccine, Recombinant]_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GARDASIL 9. 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 9
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 9 IS
USED FOR
GARDASIL 9 is a vaccine that helps
protect against disease caused by the
following types of Human
Papillomavirus (HPV):
6,11,16,18,31,33,45,52 and 58.
In girls and women 9 to 45 years of
age, it helps prevent:
•
cervical (the lower end of the
uterus or womb), vulvar (the
outside of the female genitals),
vaginal, and anal cancers
•
abnormal and precancerous
(changes in cells which have a
risk of turning into cancer)
cervical, vaginal, vulvar and anal
lesions
•
genital warts and
•
HPV infection
In boys and men 9 to 26 years of age,
GARDASIL 9 helps prevent
•
Anal cancer and precancerous
anal lesions
•
External genital lesions, including
genital warts and
•
HPV infection
GARDASIL 9, helps prevent, but
does not treat these diseases. You
cannot get HPV or any of these
diseases from GARDASIL 9.
WHAT IS HUMAN PAPILLOMAVIRUS?
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 disease,
including cervical cancer, some
vaginal, vulval and anal cancers and
genital warts.
WHO IS AT RISK FOR HPV AND WHY IS
VACCINATION WITH GARDASIL 9
IMPORTANT?
Without 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
t

Produktens egenskaper

Copyright © 2019 Merck Sharp & Dohme Corp., a subsidiary of Merck &
Co., Inc., Whitehouse Station, NJ, USA. All
Rights Reserved
AUSTRALIAN PRODUCT INFORMATION – GARDASIL® 9 (HUMAN PAPILLOMAVIRUS
9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) VACCINE,
RECOMBINANT) SUSPENSION
FOR INTRAMUSCULAR ADMINISTRATION
1
NAME OF THE MEDICINE
Human Papillomavirus 9-valent Vaccine, Recombinant
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
GARDASIL
9,
Human
Papillomavirus
9-valent
Vaccine,
Recombinant,
is
a
non-infectious
recombinant 9-valent vaccine prepared from the purified virus-like
particles (VLPs) of the major
capsid (L1) protein of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and
58.
The
L1
proteins
are
produced
by
separate
fermentations
using
recombinant
yeast
_Saccharomyces cerevisiae_ and self-assembled into VLPs. The
fermentation process involves
growth of _S. cerevisiae_ on chemically-defined fermentation media
which include vitamins, amino
acids, mineral salts, and carbohydrates. The VLPs are released from
the yeast cells by cell
disruption and purified by a series of chemical and physical methods.
The purified VLPs are
adsorbed
on
pre-formed
aluminum-containing
adjuvant
(Amorphous
Aluminum
Hydroxyphosphate Sulfate or AAHS). The 9-valent HPV VLP vaccine is a
sterile liquid suspension
that is prepared by combining the adsorbed VLPs of each HPV type and
additional amounts of
the aluminum-containing adjuvant formulation and the final
purification buffer.
Each 0.5-mL dose contains approximately 30 micrograms of HPV 6 L1
protein, 40 micrograms of
HPV 11 L1 protein, 60 micrograms of HPV 16 L1 protein, 40 micrograms
of HPV 18 L1 protein,
20 micrograms of HPV 31 L1 protein, 20 micrograms of HPV 33 L1
protein, 20 micrograms of
HPV 45 L1 protein, 20 micrograms of HPV 52 L1 protein, and 20
micrograms of HPV 58 L1
protein.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
GARDASIL
9 is a suspension for intramuscular administration available in 0.5-mL
single-dose
vials and prefi