FluQuadri Junior Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 30mcg, 0.25mL suspens

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Influenza virus haemagglutinin

Dostępny od:

Sanofi-Aventis Australia Pty Ltd

INN (International Nazwa):

Influenza virus haemagglutinin

Status autoryzacji:

Registered

Ulotka dla pacjenta

FLUQUADRI™
_Inactivated Quadrivalent Influenza Vaccine (Split Virion)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU ARE VACCINATED.
•
Keep this leaflet. You may need
to read it again.
•
If you have any further questions,
ask your doctor or pharmacist.
•
This vaccine has been prescribed
for you. Do not pass it on to
others.
•
If any of the side effects get
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
IN THIS LEAFLET:
•
What FluQuadri is and what is it
used for
•
Before you are given FluQuadri
•
How FluQuadri is given
•
Possible side effects
•
Storing FluQuadri
•
Further information
WHAT FLUQUADRI IS AND
WHAT IT IS USED FOR
FluQuadri is a vaccine. Vaccines are
used to protect you against infectious
diseases.
FluQuadri is recommended to help
protect you against influenza.
FluQuadri may be administered to
persons aged 6 months and older,
especially those who run an
increased risk of influenza-associated
complications.
Influenza (flu) is a disease caused by
different types of virus. Influenza
viruses can spread rapidly, especially
in homes or institutions, where it can
be very easy for someone to catch flu
and spread the disease. The greatest
risk of catching flu is during the cold
months between May and October.
Your doctor will be able to
recommend the best time for you to
be vaccinated. Flu is present every
year, even when epidemics or
outbreaks are not reported.
The vaccine will only help to prevent
flu if it is caused by one of the four
strains of virus contained in the
vaccine, or other strains closely
related to them. FluQuadri will not
prevent flu if you are incubating the
disease before vaccination or if it is
caused by another virus.
You should also note that many
germs can cause influenza-like
illness and the vaccine will not
protect you against these.
Previous injections of flu vaccine are
unlikely to give you protection
against the current strains of flu virus
which

Charakterystyka produktu

fluq-ccdsv2-piv6-11dec19
1
AUSTRALIAN PRODUCT INFORMATION - FLUQUADRI INFLUENZA
VIRUS HAEMAGGLUTININ
1
NAME OF THE MEDICINE
Inactivated Quadrivalent Influenza Vaccine, Split Virion (Influenza
virus haemagglutinin)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FluQuadri for intramuscular injection is an inactivated influenza
virus vaccine, prepared from
influenza viruses propagated in embryonated chicken eggs. The
virus-containing allantoic fluid
is harvested and inactivated with formaldehyde. Influenza virus is
concentrated and purified in
a linear sucrose density gradient solution using a continuous flow
centrifuge. The virus is then
chemically disrupted using a non-ionic surfactant, octoxinol-9 (Triton
®
X-100), producing a
“split virus”. The split virus is further purified and then
suspended in sodium phosphate-
buffered isotonic sodium chloride solution. Antigens from the four
strains included in the
vaccine are produced separately and then combined to make the
quadrivalent formulation.
It is formulated to contain the following four influenza strains*
recommended for the 2020
influenza season:
ACTIVE SUBSTANCE
QUANTITY
(PER 0.5 ML DOSE)
A/Brisbane/02/2018(H1N1) pdm09-like virus (A/ Brisbane/02/2018
IVR-190)
15 micrograms
HA**
A/South Australia/34/2019 (H3N2)-like virus(A/South Australia/34/2019
IVR-
197)
15 micrograms
HA**
B/Washington/02/2019-like virus (B/Washington/02/2019)
15 micrograms
HA**
B/Phuket/3073/2013-like virus (B/Phuket/3073/2013)
15 micrograms
HA**
*
propagated in fertilised hens’ eggs from healthy chicken flocks
**
haemagglutinin
FluQuadri contains 60 micrograms (µg) haemagglutinin (HA) per 0.5 mL
dose in the
recommended ratio of 15 µg HA of each of the four strains.
The type and amount of viral antigens contained in FluQuadri conform
to the annual
requirements of the Australian Influenza Vaccine Committee (AIVC) and
the World Health
Organization (WHO) recommendations for the season.
Neither antibiotics nor preservative are used during manufacture.
FluQuadri is presented in prefilled sy