PANVAX H1N1 VACCINE JUNIOR H1N1 pandemic influenza vaccine (split-virion, inactivated) 0.25mL suspension for injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Influenza virus haemagglutinin, Quantity: 7.5 microgram

Available from:

Seqirus Pty Ltd

INN (International Name):

Influenza virus haemagglutinin

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: sodium chloride; dibasic sodium phosphate; monobasic sodium phosphate; potassium chloride; monobasic potassium phosphate; calcium chloride dihydrate

Administration route:

Intramuscular, Subcutaneous

Units in package:

10 x 0.25mL pre-filled syringe, 1 x 0.25mL pre-filled syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For active immunisation to prevent influenza disease caused by the influenza A (H1N1) virus, in persons from 6 months of age.

Product summary:

Visual Identification: Clear to slightly opaque liquid; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 1 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-12-03

Patient Information leaflet

PANVAX(R)
1
PANVAX(R) H1N1
VACCINE / PANVAX(R)
H1N1 VACCINE JUNIOR
_H1N1 Pandemic influenza vaccine (split virion, inactivated)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
The information provided in this
leaflet applies to Panvax(R) H1N1
Vaccine and Panvax(R) H1N1
Vaccine Junior, except where
differences are indicated.
This leaflet answers some common
questions about Panvax(R) H1N1
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
has weighed the risks of you, or your
child, having Panvax(R) H1N1
Vaccine 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 PANVAX(R) H1N1
VACCINE IS USED FOR
Panvax(R) H1N1 Vaccine is used in
adults, adolescents and children from
6 months of age. It helps prevent
influenza caused by the pandemic
(H1N1) 2009 influenza virus, often
called "the swine flu". Influenza is
caused by infection with specific
influenza viruses. New types of
influenza virus can appear each year.
In 2009, a new H1N1 influenza virus
appeared that is the cause of the
current pandemic. Panvax(R) H1N1
Vaccine contains purified fragments
of the pandemic (H1N1) 2009
influenza virus.
The virus in the vaccine is killed.
Therefore the vaccine will not give
you "the flu".
Note: the vaccine will not protect
you, or your child, from the other
influenza viruses that Panvax(R)
H1N1 Vaccine does not contain.
_HOW IT WORKS_
Panvax(R) H1N1 Vaccine works by
causing your body to produce its
own protection (antibodies) against
the fragments of killed virus in the
vaccine. These antibodies may help
your immune system to destroy the
virus if you later come into contact
with it. This prevents you from
getting pandemic influenza.
Your body takes a few weeks after
vaccination to develop antibodies
against the influenza virus.
As wi

Summary of Product characteristics

Panvax
®
H1N1 Vaccine / Panvax
®
H1N1 Vaccine Junior
(AUST R 165345, 163897, 163900 and 166312)
5mL and 10mL multi-dose vial; 0.5mL and 0.25mL pre-filled
single dose syringe presentations
Product Information
December 2009
Page 1 of 9
NAME OF THE MEDICINE
Panvax
®
H1N1 Vaccine / Panvax
®
H1N1 Vaccine Junior
H1N1 Pandemic influenza vaccine (split virion, inactivated).
DESCRIPTION
Panvax
®
H1N1 Vaccine / Panvax
®
H1N1 Vaccine Junior is a purified, inactivated,
monovalent, split virion (split virus) vaccine containing antigen of
the following type:
A/California/7/2009 (H1N1) (A/California/7/2009 (H1N1)v-like)
7.5 µg haemagglutinin (HA) per 0.25 mL dose
15 µg HA per 0.5 mL dose
Each 0.5 mL dose contains, nominally: sodium chloride 4.1 mg, sodium
phosphate –
dibasic
anhydrous
0.3 mg,
sodium
phosphate – monobasic
0.08 mg,
potassium
chloride
0.02 mg,
potassium
phosphate – monobasic
0.02 mg,
calcium
chloride
1.5 μg and thiomersal 50 μg (for multi-dose vial presentation only).
Each 0.25 mL
dose contains half of these quantities.
The following are also present in each 0.5 mL dose: sodium
taurodeoxycholate
≤
5 μg, ovalbumin ≤ 1.0 μg, sucrose < 10 μg, neomycin
≤
0.7 ng, polymyxin B sulfate
≤
0.11 ng and beta-propiolactone
≤
1.4 ng.
The virus strain in this vaccine complies with the Australian
Influenza Vaccine
Committee (AIVC) decision, endorsing the World Health Organisation
recommended
virus for the influenza A(H1N1) vaccine.
Panvax
®
H1N1 Vaccine / Panvax
®
H1N1 Vaccine Junior is prepared from influenza
virus propagated in the allantoic fluid of embryonated chicken eggs.
The virus is
harvested from the eggs, purified by zonal centrifugation, inactivated
with beta-
propiolactone and disrupted with sodium taurodeoxycholate to produce
split virion
particles.
Note: The vaccine is referred to as Panvax
®
H1N1 Vaccine throughout this document, unless
the information presented is specific to the Panvax
®
H1N1 Vaccine Junior presentation.
PHARMACOLOGY
Immunisation
with
inactivated
influenza
vaccine