FLUVAX inactivated influenza vaccine (split virion) thiomersal free 0.5 mL injection syringe 2019

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Influenza virus haemagglutinin

Available from:

Seqirus Pty Ltd

INN (International Name):

Influenza virus haemagglutinin

Authorization status:

Registered

Patient Information leaflet

Consumer Medicine Information (AUST R 91583, AUST R 117397 and AUST R
145707)
Page 1 of
4
FLUVAX

Inactivated Influenza Vaccine (Split Virion)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FLUVAX
® vaccine.
It does not contain all the available
information.
It does not take the place of talking
to your doctor, nurse or pharmacist.
All medicines, including vaccines,
have risks and benefits. Your
doctor considers the risks of you or
your child having FLUVAX
®
vaccine
and the benefits they expect it will
have.
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 FLUVAX
® VACCINE
IS USED FOR
FLUVAX
® vaccine helps prevent
influenza, often called “the flu”.
Influenza is caused by infection
with specific influenza viruses. New
types of influenza viruses can
appear each year. FLUVAX
® vaccine
contains fragments of three
different types of influenza virus.
Each year the Australian Influenza
Vaccine Committee and the New
Zealand Ministry of Health decide
which three types of viruses are
most suitable to include in the
vaccine.
The virus in the vaccine has been
killed. Therefore the vaccine cannot
give you or your child “the flu”.
NOTE: the vaccine will not protect
you or your child from the other
influenza viruses that FLUVAX
®
vaccine does not contain.
FLUVAX
®
vaccine is available only
with a doctor’s prescription. This
year (2018) the viruses are
A/Michigan/45/2015 (H1N1) pdm09
– like virus, A/Singapore /INFIMH-
16-0019/2016 (H3N2) – like virus
and B/Phuket/3073/2013– like
virus.
Vaccination against influenza is
recommended every year, for
anyone wanting to lower their
chance of catching influenza.
_HOW FLUVAX_
_®_ _VACCINE WORKS _
FLUVAX
® vaccine works by causing
your body to protect itself against
infection by the influenza viruses,
types A and B, that are in the
vaccine. The vaccine stimulates the
body to make substances, called
antibodies. Antibod

Summary of Product characteristics

Fluvax
®
vaccine 2018 (AUST R 91583, AUST R 117397 and AUST R 145707)
Product Information
0.5 mL and 10 x 0.5 mL presentations
Page 1 of 10
FLUVAX

WARNING: THIS SEASON’S VACCINE IS INDICATED FOR USE ONLY IN PERSONS
AGED 5 YEARS AND OVER.
IT MUST NOT BE USED IN CHILDREN UNDER 5 YEARS (SEE CONTRAINDICATIONS).
IT SHOULD ONLY BE USED IN
CHILDREN AGED 5 TO UNDER 9 YEARS BASED ON A CAREFUL CONSIDERATION OF
POTENTIAL RISKS AND BENEFITS IN
THE INDIVIDUAL (SEE PRECAUTIONS).
FOR SEASON 2018
NAME OF THE MEDICINE
Fluvax
®
vaccine
Inactivated influenza vaccine (split virion)
Suspension for injection
DESCRIPTION
This is a purified, inactivated, split virion (split virus) vaccine
each 0.5 mL of which contains antigens
representative of the following types:
A/Michigan/45/2015 (H1N1) pdm09 – like virus
(A/Singapore/GP1908/2015(IVR-180A))
15 μg haemagglutinin per dose
A/Singapore/INFIMH-16-0019/2016 (H3N2) – like virus
(A/Singapore/INFIMH-16-0019/2016 (IVR-186))
15 μg haemagglutinin per dose
B/Phuket/3073/2013 - like virus (B/Phuket/3073/2013(BVR-1B))
15 μg haemagglutinin per dose
Each 0.5 mL dose also contains, nominally: sodium chloride 4.1 mg,
dibasic sodium phosphate anhydrous
0.3 mg, monobasic sodium phosphate 0.08 mg, potassium chloride 0.02
mg, monobasic potassium
phosphate 0.02 mg and calcium chloride 1.5 μg.
Trace amounts of the following may also be present in each 0.5 mL
dose: sodium taurodeoxycholate,
ovalbumin (< 1 μg), sucrose, neomycin, polymyxin B sulfate and
propiolactone.
The type and amount of viral antigens in Fluvax

vaccine conform to the requirements of the Australian
Influenza Vaccine Committee and the New Zealand Ministry of Health for
the winter of 2018. The strains
chosen for vaccine manufacture are endorsed by the Australian
Influenza Vaccine Committee as being
antigenically equivalent to the reference virus.
The vaccine is prepared from virus grown in the allantoic cavity of
embryonated eggs, purified by zonal
centrifugation, inactivated by propiolactone and disrupted by sodium
taur