CERVARIX human papillomavirus vaccine types 16 and 18 [recombinant, AS04 adjuvanted] suspension for injection pre-filled syringe

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

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

Prieinama:

GlaxoSmithKline Australia Pty Ltd

INN (Tarptautinis Pavadinimas):

HPV Type 16 L1 Protein,HPV Type 18 L1 Protein

Vaisto forma:

Injection, suspension

Sudėtis:

Excipient Ingredients: monobasic sodium phosphate; aluminium hydroxide hydrate; water for injections; 3-O-desacyl-4'-monophosphoryl lipid A; sodium chloride

Vartojimo būdas:

Intramuscular

Vienetai pakuotėje:

1 x 10 dose PFS with no needles, 1 single dose pre-filled syringe (PFS) with 1 needle, 1 single dose PFS with 2 needles, 1 x 20 dose PFS with 20 needles, 1 x 10 dose PFS with 10 needles, 1 single dose PFS with no needles

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

CERVARIX is indicated in females from 10 to 45 years of age for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by human papillomavirus types 16 and 18. lmmunogenicity studies have been conducted in females aged 10 to 14 years and 26 to 45 years to link efficacy in females aged 15 to 25 years to other populations (See Precautions and Clinical Trials).

Produkto santrauka:

Visual Identification: Turbid liquid after shaking. White deposit and colourless supernatant after sedimentation; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizacija statusas:

Licence status A

Leidimo data:

2007-05-18

Pakuotės lapelis

CERVARIX
1
CERVARIX
_Human Papillomavirus Vaccine Types 16 and 18 (Recombinant, AS04
adjuvanted) _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use CERVARIX.
This leaflet answers some common
questions about CERVARIX. It does
not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Sometimes new risks are
found even when a medicine has
been used for many years. Your
doctor has weighed the expected
benefits of you taking CERVARIX
against the risks this medicine could
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS CERVARIX
USED FOR?
CERVARIX is a vaccine used in
females from 10 to 45 years of age to
prevent early stage cervical cancers
(pre-cancerous lesions), pap smear
abnormalities and cervical cancer
caused by human papillomaviruses
(HPV) types 16 and 18.
HPV is a very common virus which
affects humans. More than 100 types
of HPV have been identified, most of
which are harmless. About 30 types
are spread through sexual contact, of
which some types can cause visible
genital warts, while others can cause
cervical cancer and other genital
cancers. HPV 16 and 18 belong to
the group of HPVs that cause
cervical cancer and other genital
cancers.
When a person is given the vaccine,
the immune system (the body's
natural defence system) will make
antibodies against HPV. These
antibodies are expected to protect
against disease caused by HPV.
As with all vaccines, CERVARIX
may not completely protect all
people who are vaccinated against
the human papillomavirus infections
it is intended to prevent.
If you are already infected with HPV
at initiation of the vaccination course,
CERVARIX is not expected to
induce regression of the lesions and
may not be able to protect you
against the disease progression.
AS CERVICAL CANCER CAN BE CAUSED
BY HPV TYPES

Prekės savybės

1
AUSTRALIAN PRODUCT INFORMATION
CERVARIX HUMAN PAPILLOMAVIRUS VACCINE TYPES 16 AND 18
(RECOMBINANT, AS04 ADJUVANTED) SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Human Papillomavirus Vaccine Types 16 and 18 (Recombinant, AS04
adjuvanted)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CERVARIX contains recombinant C-terminally truncated L1 proteins from
human
papillomavirus (HPV) type-16 and type-18 each assembled as virus-like
particles (VLPs).
The HPV-16 and HPV-18 L1 antigens are prepared by recombinant DNA
technology using a
Baculovirus expression system in Trichoplusia ni cells.
HPV-16 and HPV-18 L1 antigens in CERVARIX are adjuvanted with AS04.
This AS04
adjuvant system comprises aluminium hydroxide hydrate (Al(OH)3) and
3-O-desacyl-4’-
monophosphoryl lipid A (MPL). The MPL within AS04 enhances the
initiation of the immune
response through the activation of innate immunity, leading to an
improved cellular and
humoral adaptive immune response.
Each 0.5 mL dose of CERVARIX contains 20 micrograms each of HPV-16 L1
and HPV-18
L1 proteins, 0.5 milligrams of Al(OH)3 and 50 micrograms of MPL.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Suspension for injection.
CERVARIX is presented as a turbid white suspension. Upon storage, a
fine white deposit
with a clear colourless supernatant can be observed. This does not
constitute a sign of
deterioration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CERVARIX is indicated in females from 10 to 45 years of age for the
prevention of persistent
infection, premalignant cervical lesions and cervical cancer caused by
human papillomavirus
types 16 and 18. Immunogenicity studies have been conducted in females
aged 10 to 14
years and 26 to 45 years to link efficacy in females aged 15 to 25
years to other populations.
(see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and section
5.1
PHARMACODYNAMIC PROPERTIES, Clinical trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage
The vaccination schedule depends on the age of the