VIVAXIM®

Salmonella typhi Vi polysaccharide and inactivated hepatitis A virus antigen vaccine

Consumer Medicine Information

organisms, the body is usually ready • VIVAXIM or any of the

to destroy them. ingredients listed at the end of
Your body usually takes two weeks this leaflet.
What is in this leaflet after vaccination to develop Symptoms of an allergic reaction
protection against typhoid fever and may include:
This leaflet answers some common hepatitis A infection. • Shortness of breath, wheezing or
questions about VIVAXIM.
Initial protection is provided by one difficulty breathing
It does not contain all the available dose of VIVAXIM. For long-term • Swelling of the face, lips, tongue
information. protection against hepatitis A virus a or other parts of the body
It does not take the place of talking to booster vaccination with an
• Skin rash, itching or hives.
your doctor or pharmacist. inactivated hepatitis A vaccine will
be required 6 to 36 months after Do not have VIVAXIM if you have
All medicines, including vaccines,
vaccination with VIVAXIM. The a fever or acute illness. Minor
have risks and benefits. Your doctor
body does not develop long-term infections are not a reason to delay
has weighed the risks of you having
protection against typhoid fever and vaccination.
VIVAXIM against the benefits they
expect it will have for you. repeat vaccinations are required to Do not give VIVAXIM to persons
maintain protection. younger than 16 years. The safety
If you have any concerns about this
Most people will produce enough and effectiveness of VIVAXIM in
vaccine, ask your doctor, nurse or
antibodies against typhoid fever and persons under 16 years have not
pharmacist.
hepatitis A infection. However, as yet been established.
Keep this leaflet. You may need to with all vaccines, 100% protection Do not have VIVAXIM after the
read it again. cannot be guaranteed. expiry date printed on the pack.
The vaccine will not give you Do not have VIVAXIM if the
typhoid fever or hepatitis A infection. packaging is torn or shows signs of
tampering.
What VIVAXIM is used The chance of a severe reaction from
for VIVAXIM is very small, but the Talk to your doctor or pharmacist
risks from not being vaccinated if you are not sure whether you
VIVAXIM is a vaccine used to help against typhoid fever or hepatitis A should have VIVAXIM.
prevent typhoid fever and hepatitis A infection may be very serious.
disease in adults aged 16 years and Before you are given it
older who are at risk of these Tell your doctor if you have ever
diseases. had a serious allergic reaction to a
Before you are given vaccine.
How it works VIVAXIM Tell your doctor if you have an
VIVAXIM works by causing your infection or high temperature.
body to produce its own protection When you must not be given
Your doctor may decide to delay
against typhoid fever and hepatitis A it
vaccination until the illness has
infection. It does this by making You have had a severe reaction to a passed. A mild illness, such as a cold,
substances called antibodies in the previous injection of this vaccine. is not usually a reason to delay
blood, which fight the typhoid vaccination.
Do not have VIVAXIM if you have
bacteria and hepatitis A virus. If a
vaccinated person comes into contact an allergy to: Tell your doctor if you have, or
have had, any medical conditions,
with the typhoid or hepatitis A
especially the following:

VIVAXIM® 1
• Lowered immunity due to How VIVAXIM is given pharmacist to answer any questions
diseases such as some blood you may have.
disorders, malaria, kidney disease VIVAXIM is given as a slow Tell your doctor or pharmacist if
requiring dialysis, HIV/AIDS or injection into your upper arm muscle you notice any of the following and
cancer by a doctor or nurse. they worry you:
• Lowered immunity due to VIVAXIM should not be injected • Local reaction around the
treatment with medicines such as directly into the veins or into the injection site such as redness,
corticosteroids, cyclosporin, or buttocks. pain, swelling or hardness
other medicines used to treat
• Headaches
cancer (including radiation How much is given
therapy) • Generally feeling unwell
The dose is one millilitre of the
• Leukaemia or any other cancers • Soreness, aching muscles, muscle
mixed vaccine.
of the blood, bone marrow or tenderness or weakness (not
lymph system. caused by exercise)
When it is given
If you have lowered immunity then • Nausea or diarrhoea
VIVAXIM should be given 14 days
the vaccine may not work as well as • Fever
before you are exposed to risk of
it would in healthy individuals.
both typhoid fever and hepatitis A. • Fainting.
Tell your doctor if you have For long term protection against These are the more common side
allergies to: infection with hepatitis A virus you effects of VIVAXIM. Mostly these
• Any other medicines should obtain a booster dose of are mild and short-lived.
• Any other substances, such as AVAXIM® (hepatitis A vaccine) 6-
Less common side effects include
foods, preservatives or dyes 36 months after your dose of
itchiness of the skin, dizziness and a
VIVAXIM. You should be
• Neomycin. rash. Very rarely some patients
revaccinated against typhoid fever,
experience fainting, vomiting,
Tell your doctor if you are every 3 years.
abdominal pain and increased liver
pregnant or intend to become
pregnant. enzymes.
Tell your doctor immediately if
VIVAXIM is not recommended for
use during pregnancy. If there is a After having VIVAXIM you notice any of the following:
need to consider VIVAXIM during • Abscess at the injection site
your pregnancy, your doctor will Things you must do: • Unusual bleeding, bruising or
discuss with you the benefits and purple spots on the skin
• Keep an updated record of your
risks of having it.
vaccinations • Skin rash, itchy spots or red
Tell your doctor if you are breast- lumps on the skin
• Attend any other appointments
feeding.
made by your doctor or nurse • Painful, swollen joints
Your doctor will discuss the possible
• Report any side effects to your • Swelling of the glands in the
risks and benefits of having
doctor. neck, armpit or groin
VIVAXIM during breastfeeding.
• Itchiness, hives or rash over the
Having other medicines body.

As VIVAXIM does not contain any If any of the following happen, tell
Side effects your doctor immediately or go to
live bacteria or viruses, it can
generally be given at the same time Accident and Emergency at your
Tell your doctor or pharmacist as
as other inactivated vaccines, but at a nearest hospital:
soon as possible if you do not feel
different injection site. well after having VIVAXIM. • Sudden signs of allergy such as
VIVAXIM can be given at the same rash, itching or hives on the skin,
VIVAXIM may have unwanted side
time as yellow fever vaccine at swelling of the face, lips, tongue
effects in a few people. All
different injection sites. or other parts of the body
medicines, including vaccines, can
Other medicines should be taken as have side effects. Sometimes they • Pinkish, itchy swellings on the
usual after the vaccination. are serious, most of the time they are skin, also called hives or nettle
not. You may need medical rash, shortness of breath,
treatment if you get some of the side wheezing or trouble breathing.
effects. Ask your doctor or

VIVAXIM® 2
These are very serious side effects. • 160 antigen units hepatitis A Tel: 0800 283 684
You may need urgent medical virus.
attention or hospitalisation. Other ingredients: AUST R number
All of these side effects are very rare. • Sodium chloride AUST R 82745
Other side effects not listed above • Dibasic sodium phosphate
may occur in some patients. Tell dihydrate
your doctor or pharmacist if you Date of preparation
notice anything that is making you • Monobasic sodium phosphate
February 2019
dihydrate
feel unwell.
Do not be alarmed by this list of • Water for injections
• Aluminium hydroxide hydrate vivaxim-ccdsv9-cmiv4-27feb19
possible side effects. You may not
experience any of them. • Phenoxyethanol
• Formaldehyde
• Medium 199 (Hanks)
Storing VIVAXIM • Polysorbate 80
• Neomycin (trace)
VIVAXIM is usually stored in the
doctor's surgery or clinic, or at the • Bovine Serum Albumin (trace).
pharmacy. However, if you need to The hepatitis A virus that this
store VIVAXIM: vaccine contains was grown in a cell
• Keep it in the refrigerator, line derived from human embryonic
between 2°C and 8°C. Do not lung in the 1960s.
freeze VIVAXIM The manufacture of this product
• Keep it where children cannot includes exposure to bovine derived
reach it materials. No evidence exists that
any case of vCJD (considered to be
• Keep VIVAXIM in the original
the human form of bovine
pack until it is time for it to be spongiform encephalopathy) has
given.
resulted from the administration of
Freezing destroys the vaccine. any vaccine product.

Name and address of the

sponsor
Product description Australia:
sanofi-aventis australia pty ltd
What it looks like and
contents of the pack Talavera Corporate Centre -

VIVAXIM is a combination vaccine Building D

contained in a dual chamber syringe. 12 - 24 Talavera Road
One chamber contains the hepatitis A Macquarie Park NSW 2113
vaccine, which appears as a white
Australia
suspension, the other chamber
contains the typhoid vaccine, which Tel: 1800 818 806
appears as a clear liquid. The two
vaccine components become mixed
New Zealand:
together when the plunger is
depressed. sanofi-aventis new zealand limited
Level 8
Ingredients 56 Cawley St
Active ingredients: Ellerslie
• 25 micrograms Salmonella typhi Auckland
Vi polysaccharide (Ty-2 Strain)
New Zealand

VIVAXIM® 3