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.
This medicine is new or being used in a different way. Please report side effects.
See the full CMI for further details.
1. Why am I being given PREVENAR 20?
PREVENAR 20 contains the active ingredient Pneumococcal polysaccharide conjugate vaccine
(20-valent, adsorbed). PREVENAR 20 is a vaccine, which is a type of medicine. PREVENAR
20 helps to protect (immunise) from certain infectious diseases.
2. What should I know before I am given PREVENAR 20?
Do not use if you have ever had an allergic reaction to pneumococcal or diphtheria
vaccines, or any of the ingredients listed at the end of this CMI; Tell your doctor
if you have a a fever or infection requiring a visit to the doctor; Tell your doctor
or clinic nurse if you are having anti-cancer therapy or have an HIV infection or
any other condition that affects the immune response; Tell your doctor or clinic nurse
if your child being vaccinated was born prematurely. Tell your doctor if you have
any other disease or 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?
Tell your doctor or nurse if you are taking any other medicines, including medicines
you buy without a prescription from a pharmacy, supermarket or health food shop, or
if you have recently been given any other vaccine.
4. How is PREVENAR 20 given?
A doctor or a nurse will give the PREVENAR 20 injection. The dose is injected into
a muscle in the upper arm or thigh. Other vaccines might be given at the same time,
but not at the same injection site.
Adults (18 years and older) are given one single dose. Dosing in children is based
on their age.
5. What should I know after being given PREVENAR 20?
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Things you should do
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Check with your doctor before you receive any other vaccines or medicines.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how PREVENAR
20 affects you.
PREVENAR 20 has no or negligible effect on your ability to drive and use machine.
However, other side effects may influence your ability to drive, such as fatigue or
headache.
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Looking after your medicine
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It is unlikely that you will be asked to store PREVENAR 20.
Keep PREVENAR 20 in a refrigerator (2°C to 8°C). Do not freeze.
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6. Are there any side effects?
Like all vaccines, PREVENAR 20 may cause unwanted side effects.
Common side effects of PREVENAR 20 are local reaction around the injection site such
as tenderness or pain, redness, swelling or the formation of hard lumps or scars,
headache, fatigue, fever, joint or muscle pain. Serious side effects include allergic
reactions.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at .
Active ingredient(s):
Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PREVENAR 20. It does not contain
all the available information. It does not take the place of talking to your doctor
or pharmacist.
All vaccinations have risks and benefits. Your doctor has weighed the risks of you
or your child receiving this vaccine against the benefits they expect it will have
for you.
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 PREVENAR 20.
Read this leaflet carefully before you use PREVENAR 20 and keep. You may need to read it again.
Where to find information in this leaflet:
1. Why am I being given PREVENAR 20?
PREVENAR 20 is a vaccine, which is a type of medicine that helps to protect (immunise)
people from certain infectious diseases. It does this by preparing the body's defences to fight the infection, before you
catch the bacteria or virus.
PREVENAR 20 is a mixture of the outer sugar coating (polysaccharide) from 20 different
strains or serotypes of bacteria called
Streptococcus pneumoniae
. Each serotype is joined to a non-toxic protein to make it work more effectively.
Streptococcus pneumoniae bacteria are one of the causes of:
meningitis (a serious brain infection that could cause death or brain damage)
bacteraemia (infection of the blood)
pneumonia (infection of the lung)
otitis media (an ear infection that can cause pain and temporary hearing loss and
may require you or your child to have an ear operation).
PREVENAR 20 can protect against 20 of the strains of Streptococcus pneumoniae that can cause these diseases. PREVENAR 20 does not replace the need for vaccination
with Haemophilus influenzae type b (Hib) or meningococcal vaccines that protect against other important causes
of meningitis. You cannot catch any of the above diseases from the vaccine itself,
because it is not made with live or whole bacteria. As with all vaccines, 100% protection
against the above diseases cannot be guaranteed.
Ask your doctor if you have any questions about this vaccine.
2. What should I know before I am given PREVENAR 20?
Warnings
Do not use if:
you or your child are allergic to any of the ingredients listed at the end of this
leaflet.
Check with your doctor or nurse if:
you or your child are sick with a high fever
your baby was born prematurely.
There is a higher risk of apnoea (temporarily stopping breathing) when vaccines are
given to babies born prematurely.
you suspect or know that you or your child may be allergic to anything, including
foods, any medicines or other vaccines
you or your child have had a reaction to an earlier dose of PREVENAR 20 vaccine or
any other pneumococcal vaccine.
In rare cases, the doctor or nurse may decide that the risk of a further reaction
may outweigh the benefits of immunisation.
Medical conditions and treatments
Tell your doctor or clinic nurse if the following medical conditions or treatments
apply to you or your child being vaccinated. PREVENAR 20 may not be suitable for individuals
with certain diseases.
you have any bleeding problems
you are having anti-cancer therapy or have an HIV infection or any other condition
that affects the immune response. PREVENAR 20 may not be as effective in individuals
with reduced immune responsiveness due to various causes such as these.
Tell your doctor or clinic nurse if you or your child have any other disease.
During 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
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or nurse if you or your child are taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from a
pharmacy, supermarket or health food shop.
Tell your doctor or nurse if you or your child have recently been given any other
vaccine.
4. How is PREVENAR 20 given?
A doctor or a nurse will give the PREVENAR 20 injection. The dose is 0.5 mL injected
into a muscle in the upper arm or thigh muscle. Other vaccines (including other routine
adult and childhood vaccines) might be given at the same time, but not at the same
injection site.
How many injections will be given
Babies and young children up to 5 years: The total number of injections required depends
on how old your child is when they receive the first dose of PREVENAR 20. Normally,
your child will receive either three or four doses of the vaccine, at least 4 weeks
apart, starting at 6 weeks to 2 months of age. Four is the maximum number of doses
required. Each dose will be given on a separate occasion. Your doctor or clinic nurse
will tell you the correct vaccination schedule for your child. It is important to
follow the instructions from the doctor or clinic nurse so that your child completes
the course of injections.
Premature infants: Your child will receive an initial course of three injections.
The first injection may be given as early as six weeks of age with at least one month
between doses. A fourth (booster) injection is recommended at approximately 12 months
of age.
Children 6 - 17 years and adults: One single dose.
Special populations: Individuals considered to be at a higher risk of pneumococcal
infection may receive at least one dose of Prevenar 20. Your doctor will advise the
appropriate vaccination schedule.
Adults (18 years and older): One single dose
If you use too much PREVENAR 20
A trained doctor or nurse gives this vaccination, so an overdose is unlikely to occur.
5. What should I know after being given PREVENAR 20?
Things you should do
Check with your doctor before you or your child receive any other vaccines or medicines.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PREVENAR
20 affects you.
PREVENAR 20 has no or negligible effect on your ability to drive and use machine.
However, other side effects may influence your ability to drive, such as muscle pain,
fatigue or headache.
Looking after your medicine
It is unlikely that you will be asked to store PREVENAR 20. If you are:
Keep this vaccine in the refrigerator at a temperature between 2°C and 8°C where young
children cannot reach it. Do not freeze it. If the vaccine has been frozen it should
not be used.
Keep PREVENAR 20 in the original pack until it is time to be given.
6. Are there any side effects?
All medicines can have side effects. If you or your child 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.
Side effects
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Side effect
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What to do
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General effects:
fatigue
fever or chills
irritability
crying
Nervous System reactions:
restless sleep or decreased sleep
drowsiness or increased sleep
headache
Nutritional effects:
decreased appetite
Gastrointestinal effects:
nausea
vomiting
diarrhoea
Skin reactions:
rash
Joints and muscle:
joint or muscle pain
Injection site effects:
local reaction around the injection site such as tenderness or pain, redness, rash,
itchiness or swelling or formation of hard lumps or scars
Glandular effects:
swelling of the glands in the neck, armpit or groin
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Speak to your doctor if you have any of these side effects and they worry you.
They are usually mild and short- lived.
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Immune reactions:
allergic reaction such as rash, itching or hives on the skin, swelling of the face,
lips, tongue or other parts of the body, shortness of breath or trouble breathing
rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse, dizziness, weakness
and fainting
Other reactions:
temperature higher than 39°C in babies or young children
a seizure or convulsion, which may be accompanied by a very high temperature. Symptoms
may include rapid uncontrollable shaking of the body, loss of muscle control, drooling,
sudden changes in mood or behaviour.
your child is pale, limp and does not respond to you.
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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 side effects.
You may need urgent medical attention or hospitalisation.
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Tell your doctor or pharmacist if you notice anything else that may be making you
or your child 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 or your child 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.
7. Product details
This medicine is only available with a doctor's prescription.
What PREVENAR 20 contains
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Active ingredient
(main ingredient)
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Pneumococcal purified capsular polysaccharides
diptheria CRM197 protein
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Other ingredients
(inactive ingredients)
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Aluminium phosphate
Sodium chloride
Succinic acid
Polysorbate 80
Water for injections
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You should not be given this vaccine if you are allergic to any of these ingredients.
What PREVENAR 20 looks like
PREVENAR 20 Pre-filled Syringe (Solution for injection)
PREVENAR 20 is a clear liquid with sediment which, after shaking, will look like a
white coloured liquid (called a suspension). PREVENAR 20 is supplied as a suspension
in 0.5 mL pre-filled syringes in packs of 1 and 10.
(AUST R 376353)
Who distributes PREVENAR 20
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in January 2024.
®= Registered Trademark