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.
Why am I using Adacel Polio?
Adacel Polio contains the active ingredients diphtheria toxoid, tetanus toxoid, pertussis
toxoid, pertussis filamentous haemagglutinin, pertussis fimbriae 2+3, pertactin and
poliovirus types 1,2 and 3 (Vero). Adacel Polio is used to help to protect you or
your child against whooping cough (pertussis), tetanus, diphtheria and polio. For
more information, see Section
1. Why am I using Adacel Polio? in the full CMI.
What should I know before I use Adacel Polio?
Do not use if you or your child has ever had an allergic reaction to Adacel Polio
or any of the ingredients listed at the end of the CMI, or if you or your child ever
had a disease of brain without an apparent cause within 7 days of a previous pertussis,
tetanus or diphtheria vaccination. 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. For more information, see Section
2. What should I know before I use Adacel Polio? in the full CMI.
What if I am taking other medicines?
How do I use Adacel Polio?
Adacel Polio is given by your doctor, nurse or pharmacist. More instructions can be
found in Section
4. How do I use Adacel Polio? in the full CMI.
What should I know while using Adacel Polio?
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Things you should do
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Tell your doctor, nurse or pharmacist before you receive the vaccine if you or your
child
is allergic to the active ingredients or any of the other ingredients in this vaccine.
is suffering from an illness
has a bleeding problem or bruise easily.
ever fainted from an injection
has not previously received the complete course of tetanus and diphtheria vaccination
had a disease of brain without an apparent cause within 7 days of a previous pertussis,
tetanus or diphtheria vaccination.
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Driving or using machines
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Adacel Polio should not normally interfere with your ability to drive or operate machinery.
However, it may cause light-headedness, tiredness, drowsiness in some people.
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Looking after your medicine
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Adacel Polio is usually stored in the surgery or clinic, or at the pharmacy. However,
if you need to store Adacel Polio, keep in the fridge between 2-8°C. Do not freeze.
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Are there any side effects?
Common side effects include a local reaction around the injection site such as bruising,
redness, itchiness, tenderness, pain or discomfort, warmth, burning or stinging, swelling
or the formation of hard lumps or scars, rash, headaches, tiredness, weakness or fatigue,
fever, rigors, soreness, aching muscles, muscle tenderness or weakness (not caused
by exercise), joint pain or swelling, irritability, nausea and vomiting, diarrhoea.
Serious side effects can include red, itchy rash or hives, swelling of the face, lips,
tongue or other parts of the body, shortness of breath, wheezing or trouble breathing,
a temporary inflammation of the nerves, causing pain, weakness, and paralysis in the
extremities and often progressing to the chest and face, severe pain and decreased
mobility of arm and shoulder, fits or convulsion, fainting, tingling or numbness of
the hands or decreased feeling or sensitivity of the vaccinated arm, a paralysed nerve
in the face, dizziness, generally feeling unwell, pale skin, stomach pain . See your
doctor immediately if you notice this.For more information, including what to do if
you or your child have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
Pertussis Vaccine - Acellular and Diphtheria and Tetanus Toxoids (Adsorbed) Combined
with Inactivated Poliovirus Type 1, 2 and 3 (Vero cell)
Consumer Medicine Information (CMI)
This leaflet provides important information about using Adacel Polio. 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 Adacel Polio.
Where to find information in this leaflet:
Why am I using Adacel Polio?
Adacel Polio contains the active ingredients diphtheria toxoid, tetanus toxoid, pertussis
toxoid, pertussis filamentous haemagglutinin, pertussis fimbriae 2+3, pertactin and
poliovirus types 1,2 and 3 (Vero).
Adacel Polio is a vaccine used to help to protect you or your child against whooping
cough (pertussis), tetanus, diphtheria and polio.
Adacel Polio works by causing the body to produce its own protection against whooping
cough, tetanus, diphtheria, and polio. It does this by making substances called antibodies
in the blood, which fight the bacteria and toxins that cause these diseases. If a
vaccinated person comes into contact with these bacteria and toxins, the body is usually
ready to destroy them.
It usually takes several weeks after vaccination to develop protection against these
diseases.
Use of Adacel Polio during pregnancy allows antibodies to be passed to the baby in
the womb from the pregnant woman to protect the baby from whooping cough during the
first few months of life.
Most people will produce enough antibodies against these diseases. However, as with
all vaccines, 100% protection cannot be guaranteed.
The vaccine will not give you or your child any of these diseases.
The chance of a severe reaction from Adacel Polio is very small, but the risks from
not being vaccinated against these diseases may be very serious. Polio, whooping cough,
tetanus and diphtheria cause significant sickness and sometimes death in unvaccinated
infants, children, and adults.
This vaccine is for use as a booster in adults, adolescents and children aged four
years and older who have previously received childhood immunisation. Children from
four to six years of age should have already received four doses of whooping cough,
tetanus, diphtheria and polio vaccine. Adacel Polio is not intended for primary immunisation.
What should I know before I use Adacel Polio?
Warnings
Do not use Adacel Polio if your or your child:
had an allergic reaction to Adacel Polio or any of the ingredients listed at the end
of this leaflet.
had an allergic reaction to another vaccine designed to protect against pertussis,
tetanus, diphtheria or polio.
had serious encephalopathy (disease of brain) without an apparent cause within 7 days
of a previous pertussis, tetanus or diphtheria vaccination.
Always check the ingredients to make sure you or your child can receive this vaccine.
Adacel Polio is not recommended for use in children under 4 years.
Check with your doctor if you or your child:
Has or ever had any other medical conditions, such as:
a poor or reduced immune system due to medication (e.g. steroid or medicines used
to treat cancer (including radiation therapy) diseases such as some blood disorders,
malaria, kidney disease requiring dialysis, HIV/AIDS or cancer
a progressive illness affecting the brain/nerves or uncontrolled fits
takes any medicines for any other condition
has reacted to previous vaccination with any of the following: life-threatening allergic
reaction, fainting or collapse, shock-like state or being unresponsive for a long
period of time, fits or convulsions, high temperature (greater than 40°C), crying
or screaming lasting for more than 3 hours, severe skin reaction at the injection
site, including severe bruising.
had a Guillain-Barré syndrome (temporary loss of movement and feeling in all or part
of the body) within 6 weeks of a previous dose of a tetanus containing vaccine.
has not previously received the complete course of tetanus and diphtheria vaccination.
has an infection or high temperature. Your doctor may decide to delay vaccination
until the illness has passed. A mild illness, such as a cold, is not usually a reason
to delay vaccination.
Has any allergies to any vaccines, any other medicines or any other substance such
as foods, preservatives or dyes.
After vaccination, you or your child 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?
Pregnancy and breastfeeding
Tell your doctor or nurse if you are pregnant or breast-feeding, think you might be
pregnant or are planning to have a baby. Your doctor will help you decide if you should
receive Adacel Polio during pregnancy.
Adacel Polio may be administered during pregnancy for prevention of pertussis in young
infants.
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.
Having other vaccines
Tell your doctor if you or your child has had any vaccines in the last 4 weeks.
Your doctor will advise you if Adacel Polio is to be given with another vaccine.
Your doctor and pharmacist may have more information on medicines and vaccines to
be careful with or avoid during vaccination with Adacel Polio.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Adacel Polio.
How do I use Adacel Polio?
Adacel Polio is given as an injection, usually into your
upper arm muscle by a doctor or nurse.
How much is given
The dose of Adacel Polio is a single dose of 0.5mL.
When to receive Adacel Polio
Adacel Polio is generally given whenever a booster dose of tetanus and diphtheria
is required and where a booster dose of whooping cough and polio is considered necessary.
What should I know while using Adacel Polio?
Things you should do
Keep an updated record of your vaccinations.
Call your doctor straight away if you or your child:
does not feel well after having Adacel Polio
has any signs of allergic reaction which may include difficulty breathing, shortness
of breath, swelling of the face, lips, throat or tongue, cold, clammy skin, palpitations,
dizziness, weakness, fainting, rash or itching.
Driving or using machines
Adacel Polio should not normally interfere with your ability to drive or operate machinery.
However, it may cause light-headedness, tiredness, drowsiness in some people.
Looking after your medicine
Adacel Polio is usually stored in the doctor's surgery or clinic, or at the pharmacy.
However, if you need to store Adacel Polio:
keep Adacel Polio in the original pack until it is time for it to be given.
keep it in the refrigerator, store at 2°C to 8°C. Do not freeze Adacel Polio.
Do not use Adacel Polio after the expiry date which is stated on the carton after
EXP.
Do not use Adacel Polio if the packaging is torn or shows signs of tampering.
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.
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
Serious side effects
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 . By reporting side effects, you can help provide more information on the safety of
this medicine.
Product details
This medicine is only available with a doctor's prescription.
What Adacel Polio contains
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Active ingredients
(main ingredient)
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not less than 2 IU (2 LF) diptheria toxoid
not less than 20 IU (5 LF) tetanus toxoid
2.5 micrograms pertussis toxoid
5 micrograms pertussis filamentous haemagglutinin
3 micrograms pertussis pertactin
5 micrograms pertussis fimbriae 2 + 3
40 DAgU Poliovirus inactivated type 1
8 DAgU Poliovirus inactivated type 2
32 DAgU Poliovirus inactivated type 3
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Other ingredients
(inactive ingredients)
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aluminium phosphate
phenoxyethanol
polymyxin B sulfate
neomycin
streptomycin sulfate
formaldehyde
glutaral
polysorbate 80
water for injections
Medium Hanks 199 without phenol red (including phenylalanine)
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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
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Do not take this medicine if you are allergic to any of these ingredients.
What Adacel Polio looks like
Adacel Polio is a sterile, uniform cloudy, white suspension for injection.
Aust R 106576 - Syringe
Who distributes Adacel Polio
Australia:
sanofi-aventis australia pty ltd
12 - 24 Talavera Road
Macquarie Park
NSW 2113, Australia
Tel: 1800 816 806
New Zealand:
sanofi-aventis new zealand limited
Level 8,
56 Cawley St
Ellerslie
Auckland
New Zealand
Tel: 0800 727 838
This leaflet was prepared in June 2021.
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