AGRIPPAL inactivated influenza (surface antigen) vaccine injection pre-filled syringe (with needle) 2015

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

AGRIPPAL
® 2015
_Inactivated Influenza Vaccine (surface antigen)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Agrippal vaccine.
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 VACCINE. 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
considers the risks of you or your
child having Agrippal vaccine and
the benefits he/she 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 AGRIPPAL VACCINE
IS USED FOR
Agrippal vaccine helps prevent
influenza, often called the flu.
Influenza is caused by infection with
specific influenza viruses. New types
of influenza virus can appear each
year. Agrippal vaccine contains
strains 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 virus are most suitable.
Vaccination against influenza helps
prevent infection with influenza and
to control the spread of the disease.
The virus in the vaccine is
inactivated. Therefore the vaccine
will not give you or your child the
flu.
Note: the vaccine will not protect you
or your child from the other influenza
viruses that Agrippal vaccine does
not contain. It will not protect you
from other types of influenza virus or
from infections with other agents
causing flu-like symptoms (such as
the common cold).
Agrippal vaccine is available only
with a doct

Summary of Product characteristics

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AGRIPPAL
® 2015
NAME OF MEDICINE
Inactivated Influenza Vaccine (surface antigen)
DESCRIPTION
Agrippal is a clear colourless suspension for injection. It is an
egg-grown, inactivated
influenza virus vaccine based on isolated surface antigens of A and B
strains of influenza
virus. The antigen composition and strains for the 2015 influenza
season corresponds to the
following types:
A/California/7/2009 (H1N1)– like strain;
A/Switzerland/9715293/2013 (H3N2)-like strain ; and
B/Phuket/3073/2013-like strain
The type and amount of viral antigens in Agrippal conform to the
requirements of the
Australian Influenza Vaccine Committee (AIVC) and the New Zealand
Ministry of Health for
the winter of 2015. The strains chosen for vaccine manufacture are
endorsed by the AIVC as
being antigenically equivalent to the reference virus.
Each 0.5 mL vaccine dose contains 15µg haemagglutinin of each of the
recommended strains.
The vaccine preparation also contains Sodium chloride 4.0 mg,
Potassium chloride 0.1 mg,
Potassium dihydrogen phosphate 0.1 mg, Sodium phosphate-dibasic 0.66
mg, Magnesium
chloride 0.05 mg, Calcium chloride 0.06 mg and Water for Injections to
0.5 mL. The vaccine
may contain residues of the following substances: eggs, chicken
proteins, kanamycin sulfate,
neomycin sulfate, sodium citrate, barium sulfate, formaldehyde,
sucrose, cetrimonium
bromide (CTAB), polysorbate 80 and less than 0.2 µg of ovalbumin per
0.5 mL dose.
PHARMACOLOGY
Agrippal induces humoral antibodies against haemagglutinins, the
surface antigens of the
virus. These antibodies neutralize influenza viruses and are important
in the prevention of
natural infections.
Seroprotection is generally obtained within 2 to 3 weeks. The duration
of postvaccinal
immunity to homologous strains or to strains closely related to the
vaccine strains varies but is
usually 6-12 months.
Influenza viral strains undergo antigenic changes from year to year.
Therefore the antigen
component of Agrippal is revised for every flu season and annual
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