INFLUVAC inactivated influenza 0.5 mL vaccine long syringe with 16 mm needle 2017
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
Influenza virus haemagglutinin
Available from:
Mylan Health Pty Ltd
INN (International Name):
Influenza virus haemagglutinin
Authorization status:
Registered
Patient Information leaflet
INFLUVAC
®
_Inactivated influenza vaccine [surface antigen]_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions about Influvac
vaccine. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist. Please read it
carefully and keep it for future
reference.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the possible risks of you
having Influvac against the expected
benefits.
TALK TO YOUR DOCTOR, NURSE OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT RECEIVING INFLUVAC.
Your doctor and pharmacist have
more information.
WHAT INFLUVAC IS
USED FOR
Influvac is used to prevent certain
types of influenza (commonly called
flu). The vaccine works by causing
the body to produce its own
protection (antibodies) against three
different types of influenza virus.
Each year new types of influenza
virus can appear, so every year
Influvac is changed to contain
fragments of the new types of virus.
Therefore, influenza vaccination is
recommended every year.
PLEASE NOTE THAT INFLUVAC WILL ONLY
PROTECT YOU AGAINST THE THREE TYPES
OF INFLUENZA VIRUS USED TO MAKE THE
VACCINE. IT WILL NOT PROTECT YOU
FROM INFLUENZA CAUSED BY OTHER
TYPES OF INFLUENZA VIRUS OR FROM
INFECTIONS WITH OTHER AGENTS
CAUSING FLU-LIKE SYMPTOMS (SUCH AS
THE COMMON COLD).
Influenza is an infectious illness.
Influenza is spread by small droplets
from the nose, throat or mouth of an
infected person. Symptoms of
influenza begin 48 hours after
coming into contact with the virus.
These consist of chills, fever,
generalised aches and pains,
headache and respiratory symptoms
(sore throat, runny nose, cough). The
severity and type of symptoms can
vary. Most people recover
completely within a week. The risk
of serious complications (e.g.
pneumonia and death) is greater in
very young, very old and chronically
ill persons.
Influvac can be used in adults and in
children over the age of 6 months.
For full details regarding
recommendations for inf
Read the complete document
Summary of Product characteristics
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PRODUCT INFORMATION
INFLUVAC
_ _
NAME OF THE MEDICINE
Influvac inactivated influenza vaccine (surface antigen)
DESCRIPTION
Influvac 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
myxovirus influenza.
The type and amount of viral antigens in Influvac conform to the
requirements of the Australian
Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of
Health for the winter of 2017.
The strains chosen for vaccine manufacture are endorsed by the AIVC as
being antigenically equivalent
to the reference virus.
This is a purified, inactivated influenza vaccine (surface antigen),
each 0.5 mL of which contains
antigens representative of the following type:
A/Michigan/45/2015 (H1N1)pdm09-like strain (A/Singapore/GP1908/2015,
IVR-180) 15 µg
haemagglutinin/dose
A/Hong Kong/4801/2014 (H3N2)-like strain (A/Hong Kong/4801/2014,
X-263B)15 µg
haemagglutinin/dose
B/Brisbane/60/2008-like strain (B/Brisbane/60/2008, wild type)15 µg
haemagglutinin/dose
INACTIVE:
Potassium chloride, monobasic potassium phosphate, dibasic sodium
phosphate, sodium chloride,
calcium chloride dihydrate, magnesium chloride hexahydrate and water
for injections.
PHARMACOLOGY
The vaccine stimulates production of antibodies with a specific
capacity against influenza. Protection is
only against those strains of the virus from which the vaccine is
prepared or closely related strains.
Seroprotection is obtained within 2-3 weeks. The duration of
post-vaccination immunity varies between
6-12 months.
INDICATIONS
For the prevention of influenza caused by influenza virus, types A and
B.
For full details regarding recommendations for influenza vaccination,
please refer to the relevant
National Immunisation Guidelines.
CONTRAINDICATIONS
Hypersensitivity to the active substances, to any of the excipients
and to residues of eggs, chicken
protein, formaldehyde, cetrimonium bromide, polysorbate
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