Fluvax vaccine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Influenza virus A/Hong Kong/4801/2014 (H3N2) - like strain 15ug (A/Hong Kong/4801/2014 (X-263B)); Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15ug (A/Singapore/GP1908/2015 (IVR-180)); Influenza virus B/Brisbane/60/2008 - like strain 15ug (B/Brisbane/46/2015)

Available from:

Seqirus (NZ) Ltd

INN (International Name):

Influenza virus A/Hong Kong/4801/2014 (H3N2) - like strain 15 µg (A/Hong Kong/4801/2014 (X-263B))

Dosage:

0.5 mL

Pharmaceutical form:

Suspension for injection

Composition:

Active: Influenza virus A/Hong Kong/4801/2014 (H3N2) - like strain 15ug (A/Hong Kong/4801/2014 (X-263B)) Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15ug (A/Singapore/GP1908/2015 (IVR-180)) Influenza virus B/Brisbane/60/2008 - like strain 15ug (B/Brisbane/46/2015) Excipient: Calcium chloride dihydrate Dibasic sodium phosphate Monobasic potassium phosphate Monobasic sodium phosphate dihydrate Potassium chloride Sodium chloride Water for injection

Units in package:

Syringe, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Seqirus Pty Ltd

Therapeutic indications:

Fluvax is indicated for the prevention of influenza caused by Infuenza Virus, Types A and B. For the Southern Hemisphere 2017 season, the vaccine is indicated for use only in persons aged 5 years and over

Product summary:

Package - Contents - Shelf Life: Syringe, no needle - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, + needle - 1 dose units - 15 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, no needle - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, + needle - 10 dose units - 15 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

1969-12-31

Patient Information leaflet

Consumer Medicine Information (TT50-3839)
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 (2017) the viruses are
A/Michigan/45/2015 (H1N1) – like
strain, A/Hong Kong/4801/2014
(H3N2) – like strain and
B/Brisbane/60/2008– like strain.
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. Antibodies fight the
influenza virus. If you have been
vac

Summary of Product characteristics

Fluvax
®
vaccine 2017 (TT50-3839)
New Zealand Data Sheet
0.5 mL and 10 x 0.5 mL presentations
Page 1 of 9
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 2017
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/Singapore/GP1908/2015 (IVR-180) (A/Michigan/45/2015 (H1N1) –
like):
15 μg haemagglutinin per dose
A/Hong Kong/4801/2014 (NYMC X-263B) (A/Hong Kong/4801/2014 (H3N2) –
like):
15 μg haemagglutinin per dose
B/Brisbane/46/2015 (B/Brisbane/60/2008 - like):
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 2017. 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
taurodeoxycholate. Fluvax

vaccine conforms in safety and sterility to the requir