VAXIGRIP®; VAXIGRIP®

Junior
Inactivated Influenza Vaccine (split virion)
Consumer Medicine Information

These vaccines help to protect you or

What is in this leaflet Before you or your
your child against influenza (flu),
particularly if you or your child runs
child is given
Read all of this leaflet carefully VAXIGRIP/VAXIGRIP
before you or your child is a high risk of associated
complications. VAXIGRIP/ Junior
vaccinated.
VAXIGRIP Junior should be used
• Keep this leaflet. You may need When You or Your Child
according to official
to read it again. Must Not Be Given It
recommendations.
• If you have any further questions, When a person is given VAXIGRIP/ Do not have VAXIGRIP/
ask your doctor or pharmacist. VAXIGRIP Junior, the immune VAXIGRIP Junior:
• This vaccine has been prescribed system (the body's natural defence
• If you or your child is allergic
for you or your child. Do not pass system) will produce its own
(hypersensitive) to:
it on to others. protection (antibodies) against the
disease. None of the ingredients in • The active substances or
• If any of the side effects gets
serious, or if you notice any side the vaccine can cause flu. • Any of the other ingredients
effects not listed in this leaflet, Flu is a disease that can spread of VAXIGRIP/VAXIGRIP
please tell your doctor or rapidly and is caused by different Junior, see "Further
pharmacist. types of virus strains that can change information" or

In this leaflet: every year. This is why you or your • Any component that may be
child may need to be vaccinated present in very small amounts
• What VAXIGRIP/VAXIGRIP
every year. The greatest risk of such as eggs (egg proteins or
Junior are and what they are used
catching flu is during the cold chicken proteins), neomycin,
for
months. If you or your child was not formaldehyde or octoxinol-9.
• Before you or your child is given vaccinated in the autumn, it is still • If you or your child has an illness
VAXIGRIP/VAXIGRIP Junior possible to do it until spring since with a high temperature or acute
• How VAXIGRIP/VAXIGRIP you or your child runs the risk of infection, the vaccination should
Junior is given catching flu until then. Your doctor be postponed until after you or
will be able to recommend the best your child has recovered.
• Possible side effects
time to be vaccinated.
• Storing VAXIGRIP/VAXIGRIP
VAXIGRIP/VAXIGRIP Junior will Take special care with
Junior
protect you or your child against the VAXIGRIP/VAXIGRIP Junior
• Further Information three strains of virus contained in the
• You should tell your doctor
vaccine after about 2 to 3 weeks
before vaccination if you or your
following the injection.
child has or has had Guillain-
The incubation period for flu is a few Barré Syndrome (severe muscle
What VAXIGRIP/ days, so if you or your child is weakness) after getting a flu
VAXIGRIP Junior are exposed to flu immediately before or vaccine.
and what they are after your vaccination, you or your
used for • You should tell your doctor
child could still develop the illness.
before vaccination if you or your
The vaccine will not protect you or child has a poor immune response
VAXIGRIP and VAXIGRIP Junior
your child against the common cold, (immunodeficiency or taking
are vaccines.
even though some of the symptoms
are similar to flu.

VAXIGRIP®, VAXIGRIP® JUNIOR 1

 medicines affecting the immune immunosuppressant treatment, such • headache,
system). as corticosteroids, cytotoxic drugs or • sweating,
• Your doctor will decide if you or radiotherapy.
• muscular pain (myalgia), joint
your child should receive the pain (arthralgia),
vaccine. Having Other Vaccines
• fever, generally feeling unwell
• If, for any reason, you or your VAXIGRIP/VAXIGRIP Junior may
(malaise), shivering, fatigue,
child has to have a blood test be given at the same time as
pneumococcal vaccine and all of the • local reactions: redness, swelling,
within the days following the flu
vaccines scheduled for use in pain, bruising, hardness around
vaccination, please tell your
children. the area where the vaccine is
doctor. This is because false
injected.
positive blood test results have
been observed in a few patients These reactions usually disappear
who had recently been within 1-2 days without treatment.
vaccinated. How VAXIGRIP/ In addition to the common side
As with all vaccines, VAXIGRIP/ VAXIGRIP Junior is effects listed above, the following
VAXIGRIP Junior may not fully given side effects occurred after the
protect all persons who are vaccine came on the market:
vaccinated. VAXIGRIP/VAXIGRIP Junior is
• allergic reactions:
given as an injection, usually into
muscle or tissue below the skin of • leading to medical emergency
Pregnancy and breast-
upper arm (adults and children) or with a failure of the
feeding
leg (infants and young children). circulatory system to maintain
Tell your doctor or pharmacist if you adequate blood flow to the
VAXIGRIP/VAXIGRIP Junior
are pregnant or think you may be different organs (shock) in
should not be injected directly into
pregnant. rare cases,
the veins.
Flu vaccines can be used in all stages • swelling most apparent in the
of pregnancy. Larger datasets on How Much Is Given head and neck, including the
safety are available for the second face, lips, tongue, throat or
and third trimester, compared with • Adults and children over 35 any other part of the body
the first trimester; however, data months: A single injection (0.5 (angioedema) in very rare
from worldwide use of inactivated mL) cases,
influenza vaccines do not indicate • Children 6 to 35 months: A single • skin reactions that may spread
any adverse fetal and maternal injection (0.25 mL) throughout the body including
outcomes attributable to the vaccine. Some children require a second itchiness of the skin (pruritus,
VAXIGRIP may be used during injection a month later. urticaria), rash,
breast-feeding. Please ask your doctor if this • blood vessel inflammation which
Your doctor or pharmacist will be includes your child. may result in skin rashes
able to decide if you should receive (vasculitis) and in very rare cases
VAXIGRIP. When It Is Given temporary kidney problems,
VAXIGRIP/VAXIGRIP Junior • pain situated on the nerve route
Taking Other Medicines (neuralgia), anomalies in the
should be given annually.
Please tell your doctor or pharmacist perception of touch, pain, heat
if you or your child is taking or has and cold (paraesthesia), fits
recently taken any other vaccines or (convulsions) associated with
any other medicines, including Possible Side effects fever, neurological disorders that
medicines obtained without a may result in stiff neck,
prescription. Like all medicines, VAXIGRIP/ confusion, numbness, pain and
VAXIGRIP Junior can cause side weakness of the limbs, loss of
VAXIGRIP/VAXIGRIP Junior can
effects, although not everybody gets balance, loss of reflexes, paralysis
be given at the same time as other
them. of part or all the body
vaccines by using separate limbs. In
(encephalomyelitis, neuritis,
this case, the side effects may be During clinical trials, the following
Guillain-Barré Syndrome),
intensified. side effects have been observed.
Their frequencies have been • temporary reduction in the
The immunological response may
estimated as Common: affects 1 to 10 number of certain types of
decrease in case of
users in 100: particles in the blood called

VAXIGRIP®, VAXIGRIP® JUNIOR 2

 platelets; a low number of these • A/South Australia/55/2014
can result in excessive bruising or IVR-175 (A/Switzerland/
bleeding (transient 9715293/2013 [H3N2]-like),
thrombocytopenia), temporary • B/Phuket/3073/2013
swelling of the glands in the neck,
armpit or groin (transient Other ingredients:
lymphadenopathy). Buffered saline solution composed
of:
If any of the side effects gets serious,
or if you notice any side effects not • Sodium chloride
listed in this leaflet, please tell your • Potassium chloride
doctor or pharmacist.
• Sodium phosphate (dibasic
dihydrate)
• Potassium phosphate (monobasic)
Storing VAXIGRIP/ • Water for injection
VAXIGRIP Junior VAXIGRIP/VAXIGRIP Junior may
also contain traces of egg proteins,
VAXIGRIP/VAXIGRIP Junior is formaldehyde, octoxinol 9 and
usually stored in the doctor's surgery neomycin.
or clinic, or at the pharmacy.
VAXIGRIP/VAXIGRIP Junior does
However, if you need to store
not contain lactose, gluten, tartrazine
VAXIGRIP/VAXIGRIP Junior:
or any other azo dyes.
• Keep it where children cannot
reach. Name and Address of
• Keep it in the original pack until Australian Sponsor
it is time for it to be given.
Australia:
• Keep it in the refrigerator,
sanofi-aventis australia pty ltd
between 2°C and 8°C. Do not
freeze. Protect from light. Talavera Corporate Centre - Building
D
Freezing destroys the vaccine.
12 - 24 Talavera Road
Macquarie Park
NSW 2113
Further Information
Australia

What it looks like Tel: 1800 829 468

VAXIGRIP is 0.5 mL of liquid Aust R Number

vaccine in a single dose syringe.
Aust R 80198
VAXIGRIP Junior is 0.25 mL of
liquid vaccine in a single dose (VAXIGRIP)
syringe. Aust R 97971
(VAXIGRIP Junior)
Ingredients
Active ingredients: Date of Preparation
VAXIGRIP/VAXIGRIP Junior has 8 December 2014
been prepared on eggs and is made vax-vax-jr-ccdsv6-cmiv2-8dec14
from inactivated parts of the
following influenza virus strains:
• A/California/7/2009 NYMC
X-179A (A/California/7/2009
[H1N1]pdm09 - like),

VAXIGRIP®, VAXIGRIP® JUNIOR 3