Aflunov(r) Prepandemic Influenza Vaccine, H5N1 (surface antigen, inactivated, adjuvanted) 0.5mL pre-filled syringe

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

Influenza virus haemagglutinin

Доступно од:

Seqirus Pty Ltd

INN (Међународно име):

Influenza virus haemagglutinin

Класа:

Medicine Registered

Статус ауторизације:

Registered

Информативни летак

AFLUNOV CMI
Page 1 of 3
AFLUNOV
_Prepandemic Influenza _
_Vaccine H5N1 _
_CONSUMER MEDICINE _
_INFORMATION _
_WHAT IS IN THIS LEAFLET _
This leaflet answers some
common questions about
AFLUNOV.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
The information in this leaflet
was last updated on the date
listed on the final page. More
recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU
SPEAK TO YOUR PHARMACIST
OR DOCTOR TO OBTAIN THE MOST
UP-TO-DATE INFORMATION ON
THE MEDICINE. YOU CAN ALSO
DOWNLOAD THE MOST UP-TO-
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain
important information about
the medicine and its use of
which you should be aware.
All medicines, including
vaccines, have risks and
benefits. Your doctor has
weighed the risks of you or
your child having
AFLUNOV against the
benefits they expect it will
have for you.
_ _
IF YOU HAVE ANY CONCERNS
ABOUT THIS VACCINE, ASK YOUR
DOCTOR, NURSE OR
PHARMACIST.
_ _
KEEP THIS LEAFLET.
You may need to read it
again.
_ _
_ _
_WHAT AFLUNOV IS USED _
_FOR _
AFLUNOV is a vaccine for
use in adults from 18 years
old. It is intended to be given
before or during the next
influenza (flu) pandemic to
prevent flu caused by the
H5N1 type of the virus.
Pandemic flu is a type of
influenza that occurs every
few decades and which
spreads rapidly around the
world. The symptoms of
pandemic flu are similar to
those of an ordinary flu but
may be more severe.
When a person is given the
vaccine, the immune system
(the body’s natural defense
system) will produce its own
protection (antibodies)
against the disease. None of
the ingredients in the vaccine
can cause flu.
As with all vaccines,
AFLUNOV may not fully
protect all persons who are
vaccinated.
_HOW IT WORKS _
AFLUNOV works by
causing your body to produce
its own protection (or
antibodies), against the H5N1
subtype of Influenza A virus.
Your body usually takes a
couple of weeks after
vaccination to develop
protection aga

Карактеристике производа

Page 1
AFLUNOV
®
Prepandemic influenza vaccine, H5N1
NAME OF THE MEDICINE
Aflunov
®
suspension for injection in pre-filled syringe.
Prepandemic influenza vaccine, H5N1 (surface antigen, inactivated,
adjuvanted).
Pharmacotherapeutic group: Influenza vaccines, ATC code: JO7BB02.
DESCRIPTION
Aflunov
®
is
a
prepandemic
influenza
vaccine,
monovalent
H5N1,
surface
antigen,
inactivated, adjuvanted with MF59C.1. Aflunov
®
contains 7.5 micrograms (expressed
in microgram haemagglutinin) per 0.5 ml dose of A/turkey/Turkey/1/05
(H5N1) - like
strain used (NIBRG-23).
The vaccine is propagated in eggs
Each 0.5 ml of the adjuvant MF59C.1 contains:
squalene
9.75 milligrams
polysorbate 80
1.175 milligrams
sorbitan trioleate
1.175 milligrams
A complete list of excipients is provided in Presentation and Storage
Conditions.The
pharmaceutical form is a suspension (milky-white liquid) for injection
in pre-filled
syringe.
CLINICAL TRIALS
The clinical experience with Aflunov
®
following a two-dose administration is described
below.
A clinical trial was conducted with a H5N1 vaccine combined with
MF59C.1 adjuvant in
486
healthy
adult
volunteers.
Two
doses
of
vaccine
containing
H5N1
(A/Vietnam/1194/2004) (7.5 µg haemagglutinin [HA]/dose) with MF59C.1
adjuvant were
administered three weeks apart.
The
seroprotection
rate*,
seroconversion
rate*
and
the
seroconversion
factor**
for
anti-HA antibody to H5N1 A/Vietnam/1194/2004 in the adults measured by
SRH were as
follows:
ANTI-HA ANTIBODY
21 DAYS AFTER 1
ST DOSE
21 DAYS AFTER 2
ND DOSE
Seroprotection rate
41% (95% CI: 33-49)
86% (95% CI: 79-91)
Seroconversion rate
39% (95% CI: 31-47)
85% (95% CI: 79-91)
AFLUNOV
® PRODUCT INFORMATION
Page 2
Seroconversion factor
2.42 (2.02-2.89)
7.85 (6.7-9.2)
* measured by SRH assay ≥ 25 mm
2
** geometric mean ratios of SRH
The
seroprotection
rate*,
seroconversion
rate*
and
the
seroconversion
factor**
for
anti-HA antibody to H5N1 A/Vietnam/1194/2004 in subjects aged over 60
measured by
SRH were as follows:
ANTI-HA ANTIBODY
21 DAYS AFTER 1
ST DOSE
21 DA