Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
questions about . It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
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What Prevenar 13 is used for
Prevenar 13 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 13 is usually recommended for use in babies and young children from 6 weeks to 5 years of age. Prevenar 13 is a mixture
of the outer sugar coating (polysaccharide) from 13 different strains or serotypes of bacteria called Streptococcus pneumoniae.
Each serotype is joined to a non-toxic protein to make it work more effectively in babies and young children. Prevenar 13
is not recommended for use in adults or in children older than 5 years of age.
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
otitis media (an ear infection that can cause pain and temporary hearing loss and may require your child to have an ear operation).
Prevenar 13 can protect against 13 of the strains of Streptococcus pneumoniae that can cause these diseases. Prevenar 13 does
not replace the need for vaccination with Haemophilus influenzae type b (Hib) or meningococcal vaccines that protect against
other important causes of meningitis.
Your child 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.
Before your child is given Prevenar 13
When your child should not be given Prevenar 13
Your child should not have Prevenar 13 if he or she has ever had an allergic reaction to pneumococcal or diphtheria vaccines,
or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
The vaccination of your child should be delayed if he/she has a fever or infection requiring a visit to the doctor.
If you are not sure whether your child should be given Prevenar 13, talk to your doctor or clinic nurse. A mild illness without
a raised temperature (such as a cold) is not usually a reason to delay vaccination.
Before giving Prevenar 13 make sure that the expiry date (EXP) printed on the pack has not been passed. If it has, use a new
pack.
Prevenar 13 is not recommended for babies younger than 6 weeks or children older than 5 years.
Before each Prevenar 13 injection
You must tell the doctor or nurse
if you suspect or know that your child may be allergic to anything, including foods, any medicines or other vaccines
if your child has had a reaction to an earlier dose of Prevenar 13 vaccine
if your child has any bleeding problems
if your child is sick with a high fever
if your child has a previous history of interruption in breathing after any vaccination.
In rare cases, the doctor or nurse may decide that the risk of a further reaction may outweigh the benefits of immunisation.
Tell your doctor if your baby was born prematurely
There is a higher risk of apnoea (temporarily stopping breathing) when vaccines are given to premature babies.
Tell your doctor or clinic nurse if your child is having anti-cancer therapy or has an HIV infection or any other condition
that affects their immune response.
Prevenar 13 may not be as effective in children with reduced immune responsiveness due to various causes such as these.
Tell your doctor or clinic nurse if your child has any other disease.
Prevenar 13 may not be suitable for all children with certain diseases.
Taking other medicines
Tell your doctor or nurse if your child is taking any other medicines, including medicines you buy without a prescription
from a pharmacy, supermarket or health food shop, or if your child has recently been given any other vaccine.
How Prevenar 13 is given
A doctor or a nurse will give Prevenar 13 injection to your child. The dose is 0.5 mL injected into a muscle in the thigh
or upper arm. Other childhood vaccines might be given at the same time, but not at the same injection site.
How long will your child be having the injections
The total number of injections required depends on how old your child is when they receive the first dose of Prevenar 13.
Normally, your child will receive four doses of the vaccine, at least 4 weeks apart, starting at 6 weeks 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.
If your child misses one or more doses
If your child misses one or more doses, talk to your doctor or clinic nurse.
Overdose
A trained doctor or nurse gives this vaccination, so an overdose is unlikely to occur. An overdose would be unlikely to harm
your baby.
Side Effects
Do not be alarmed by this list of possible side effects.
Your child may not experience any of them.
Tell your doctor or clinic nurse as soon as possible if your child is not well after receiving Prevenar 13.
Like all vaccines, Prevenar 13 may cause unwanted side effects in some children. All medicines including vaccines, can have
side effects. Sometimes they are serious, most of the time they are not. Your child may need medical treatment for some side
effects.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
local reaction around the injection site such as redness, itchiness, tenderness, pain or discomfort, warmth, burning or stinging,
swelling or the formation of hard lumps or scars
flushing or redness of the skin
sleepiness
disturbed sleep
irritability
crying
loss of appetite
vomiting
diarrhoea
skin rash, itchy spots or red lumps on the skin, also called hives
swelling of the glands in the neck, armpit or groin
itchiness, hives or rash over the body
These side effects are usually mild.
If any of the following happen, tell your doctor or pharmacist immediately or go to Accident and Emergency at your nearest
hospital:
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
a seizure or convulsion, which may be accompanied by a very high temperature
rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse, dizziness, weakness and fainting
temperature higher than 39°C
temporary interruptions of breathing. In babies born very prematurely (at or before 28 weeks before gestation), longer gaps
than normal between breaths may occur for 2 - 3 days after vaccination.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that
is making your child feel unwell.
Ask your doctor or clinic nurse to answer any questions you may have.
After receiving Prevenar 13
Storage
It is unlikely that you will be asked to store Prevenar 13. If you are:
Keep this vaccine in the refrigerator at a temperature between 2° 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 13 in the original pack until it is time to be given.
Product description
What it looks like
Prevenar 13 is a clear liquid with sediment, which after shaking will look like a white coloured liquid (called a suspension).
Prevenar 13 is supplied as a suspension in 0.5 mL pre-filled syringes in packs of 1 and 10.
Ingredients
Each 0.5 mL dose of Prevenar 13 contains the following active ingredients:
30.8 micrograms of pneumococcal purified capsular polysaccharides
32 micrograms of CRM197 protein
plus the following inactive ingredients:
aluminium phosphate
sodium chloride
succinic acid
polysorbate 80
water for injections
The manufacture of this product includes exposure to bovine derived 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.
Supplier
Prevenar 13 is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
WEST RYDE NSW 2114
Toll Free Number: 1800 675 229
Prevenar 13 is supplied in New Zealand by:
Pfizer New Zealand Ltd
PO Box 3998
Auckland
Toll Free Number: 0800 736 363
Australian registration number
Prevenar 13 pre-filled syringes: AUST R 158450
Date of preparation
This leaflet was prepared in May 2011
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