Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Typhim Vi?
Typhim Vi contains the active ingredient Salmonella typhi Vi Polysaccharide (Ty2 strain).
Typhim Vi is used to help prevent typhoid fever, which is caused by a bacterium called
Salmonella typhi. Typhim Vi may be given to people aged 2 years and older.
2. What should I know before I use Typhim Vi?
Do not use if you have ever had an allergic reaction to Typhim Vi or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Typhim Vi and affect how it works.
4. How do I use Typhim Vi?
Typhim Vi is given as an injection, usually into the muscle of your upper arm or thigh,
by a doctor or nurse.
Typhim Vi should be given at least 14 days before any risk of coming into contact
with typhoid bacteria.
5. What should I know while using Typhim Vi?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Typhim Vi.
Do not feel well after having Typhim Vi.
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Looking after your medicine
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Typhim Vi is usually stored in the doctor’s surgery or clinic. However, if you need
to store Typhim Vi keep it in the refrigerator, between 2°C and 8°C. Do not freeze
Typhim Vi. Freezing destroys the vaccine.
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6. Are there any side effects?
Serious side effects can include sudden signs of allergy such as rash, itching or
hives on the skin, swelling of the face, lips, tongue or other parts of the body,
shortness of breath, wheezing or difficulty breathing. It can also include allergic
reactions, symptoms for which include fever, swelling, skin rash, enlargement of the
lymph nodes. If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital.
The most common side effects of Typhim Vi are local reaction around the injection
site, headaches, tiredness, weakness or fatigue, feeling unwell, decreased activity,
raised temperature, aching muscles, muscle tenderness or weakness, not caused by exercise,
nausea, vomiting, diarrhoea, stomach pains, joint pain, asthma, fainting, and skin
reactions such as rash, itching and itchy rash.
Active ingredient(s): Salmonella typhi Vi Polysaccharide (Ty2 strain)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Typhim Vi. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Typhim Vi.
Where to find information in this leaflet:
1. Why am I using Typhim Vi?
Typhim Vi contains the active ingredient Salmonella typhi Vi Polysaccharide (Ty2 strain).
Typhim Vi is vaccine used to help prevent typhoid fever, which is caused by a bacterium
called Salmonella typhi.
The organism which causes typhoid fever can be passed on through contaminated food
or water. If you are in an area where there is a risk of getting typhoid fever, in
addition to having Typhim Vi, it is also very important to be careful with your personal,
food and water hygiene. Hygiene will also help avoid illness caused by other bacteria
in the water.
Typhim Vi may be given to people aged 2 years and older.
Typhim Vi works by causing your body to produce its own protection against typhoid
fever. It does this by making substances, called antibodies, which destroy the Salmonella
typhi organism. If you have been vaccinated against Salmonella typhi, your body is
able to attack that organism if you come in contact with it.
Your body usually takes several weeks after vaccination to fully develop this protection
against typhoid fever.
You must have one dose at least 2 weeks before you may be exposed to typhoid fever.
If you are continually or repeatedly exposed to the Salmonella typhi organism, it
is recommended that you have an injection of Typhim Vi every 3 years.
Most people will make enough antibodies against Salmonella typhi. However, as with
all vaccines, 100% protection cannot be guaranteed.
The vaccine cannot give you or your child typhoid fever.
The chance of a severe reaction from Typhim Vi is very small, but the risks from not
being vaccinated against typhoid fever may be very serious.
2. What should I know before I use Typhim Vi?
Warnings
Do not use Typhim Vi if:
you are allergic to Salmonella typhi Vi Polysaccharide (Ty2 strain), or any of the
ingredients listed at the end of this leaflet.
if you have, or recently have had, an illness, with fever.
Check with your doctor if you:
have reacted to any previous vaccination with an allergic reaction.
have lowered immunity due to illness, such as some blood disorders, HIV/AIDS or cancer.
have lowered immunity due to treatment with medicines such as corticosteroids, cyclosporin
or other medicines used to treat cancer.
have a low platelet count or are prone to easy bruising or bleeding.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Children under 2 years of age
Typhim Vi is not recommended for use in children under 2 years of age. Typhim Vi vaccine
is a polysaccharide vaccine: just as with other polysaccharide vaccines, children
under 2 years are too young to make sufficient antibodies to this type of vaccine.
If you are not sure whether you or your child should have Typhim Vi, talk to your
doctor or pharmacist.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Your doctor will discuss the possible risks and benefits of having Typhim Vi during
pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known if Typhim Vi passes into breast milk. Your doctor will discuss the
possible risks and benefits of having Typhim Vi during breast-feeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Typhim Vi and affect how it works.
Your doctor or pharmacist will advise you and decide whether or not to give the vaccine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Typhim Vi.
Having other vaccines
Your doctor will advise you if Typhim Vi is to be given at the same time as another
vaccine.
Your doctor and pharmacist may have more information on medicines and vaccines to
be careful with, or avoid, during vaccination with Typhim Vi.
4. How do I use Typhim Vi?
How much to use
The dose is the same for adults and children, 0.5 mL of vaccine.
Typhim Vi is given as an injection, usually into your upper arm muscle, by a doctor
or nurse. For children, the muscle of the upper thigh may be preferred.
Typhim Vi should not be injected directly into a vein, or any blood vessel.
When to use Typhim Vi
Typhim Vi should be given at least 14 days before any risk of coming into contact
with typhoid bacteria.
If you live in an area where you are at risk of getting typhoid fever, it is recommended
that you have an injection of Typhim Vi every 3 years
If you use too much Typhim Vi
Overdose is unlikely as your doctor is giving you the injection.
If you have any concerns, ask your doctor.
5. What should I know while using Typhim Vi?
Things you should do
If you want more information on personal care in areas where there is a risk of getting
typhoid fever, talk to your doctor, nurse or pharmacist.
Call your doctor straight away if you:
Do not feel well after having Typhim Vi.
Remind any doctor, dentist or pharmacist you visit that you are using Typhim Vi.
Looking after your medicine
Typhim Vi is usually stored in the doctor's surgery or clinic, or at the pharmacy.
However, if you need to store Typhim Vi:
Keep Typhim Vi in the original pack until it is time for it to be given.
Keep it in the refrigerator, between +2°C and +8°C
Do not freeze Typhim Vi. Freezing destroys the vaccine.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
Do not have Typhim Vi if the packaging is torn or show signs of tampering.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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At the injection site:
pain or discomfort
tenderness
redness
hard lump
Systemic side effects:
headache
tiredness, weakness or fatigue
generally feeling unwell
decreased activity
raised temperature
aching muscles, muscle tenderness or weakness, not caused by exercise
nausea
vomiting
diarrhoea
stomach pains
joint pain
asthma
fainting
skin reactions such as rash, itching or itchy rash
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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sudden signs of allergy such as rash, itching or hives on the skin, swelling of the
face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty
breathing
allergic reactions, symptoms for which include fever, swelling, skin rash, enlargement
of the lymph nodes
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems in Australia or in New Zealand at
https://nzphvc.otago.ac.nz/reporting/ . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Typhim Vi contains
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Active ingredient
(main ingredient)
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Salmonella typhi Vi Polysaccharide (Ty2 strain)
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Other ingredients
(inactive ingredients)
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Phenol, sodium chloride, dibasic sodium phosphate dihydrate, monobasic sodium phosphate
dihydrate, water for injection, traces of formaldehyde and casein.
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Potential allergens
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None
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Do not take this medicine if you are allergic to any of these ingredients.
Typhim Vi does not contain lactose, sucrose, gluten, tartrazine or other azo or non-azo
type of dyes.
The manufacture of this product includes exposure to bovine materials. No evidence
exists that any case of vCJD (considered to be the human form of bovine spongiform
encephalopathy) has resulted from the administration of any vaccine product.
What Typhim Vi looks like
Each dose of Typhim Vi consists of one syringe pre-filled with 0.5 mL of clear colourless
liquid (Aust R 45073).
Who distributes Typhim Vi
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
This leaflet was prepared in October 2023.
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