Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about your child using this
medicine, speak to your doctor or pharmacist.
1. Why is my child being given Synagis?
Synagis contains the active ingredient palivizumab. Synagis is used to prevent a serious
lung condition caused by a virus known as respiratory syncytial virus (RSV).
2. What should I know before my child is given Synagis?
Check the list of ingredients at the end of the CMI. Synagis should not be given if
your child has ever had an allergic reaction to any of them, or to other medicines
like Synagis.
Talk to your doctor before your child is given this medicine if he/she is not aware
that your child has any other medical conditions or takes any other medicines.
3. What if my child is taking other medicines?
4. How is Synagis given?
The Synagis dose is calculated by your doctor according to your child's weight.
It is given by injection into the muscle by your doctor or other healthcare professional.
5. What should I know while my child is receiving Synagis?
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Things you should do
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Tell your doctor if your child is unwell when treatment is about to start.
Keep all your child's appointments to ensure he/she receives all the required injections.
Remind any doctor, dentist or pharmacist you visit that your child is receiving Synagis.
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Things you should not do
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Once treatment has started, do not allow your child to miss any of the monthly injections
of Synagis without checking with your doctor.
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Driving or using machines
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As Synagis is for use in children, there is no information on the effect of Synagis
on the ability to drive or use machines.
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Drinking alcohol
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As Synagis is for use in children, there is no information on the effect of using
Synagis with alcohol.
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Looking after your medicine
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Store Synagis in the refrigerator (2°C to 8°C).
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6. Are there any side effects?
The most common side effects include fever, infection in the upper airways, middle
ear infection, runny nose, wheezing, redness or pain at the injection site, rash,
diarrhoea.
Active ingredient(s):
[palivizumab] (pal-e-viz-you-mab)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Synagis. 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 Synagis.
Where to find information in this leaflet:
1. Why is my child being given Synagis?
Synagis contains the active ingredient palivizumab.
Synagis is used to prevent a serious lung condition caused by a virus known as respiratory
syncytial virus (RSV) in children at high risk.
2. What should I know before my child is given Synagis?
Warnings
Serious allergic reactions, including anaphylaxis, can occur in some children receiving
Synagis. These can be fatal. Your doctor will have medicines on stand-by if your child
shows symptoms of anaphylaxis straight away.
Do not use Synagis if:
your child is allergic to palivizumab, or any of the ingredients listed at the end
of this leaflet.
your child is allergic to similar medicines.
Check with your doctor if your child:
is not well or has a temperature when treatment is about to start
has thrombocytopenia, not having enough platelets in the blood (cells that form clots
when injured)
has any bleeding disorder
takes any medicines for any other condition
During treatment, 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
As Synagis is for use in children, there is no information in use in pregnancy or
breastfeeding.
3. What if my child is taking other medicines?
Tell your doctor or pharmacist if your child is taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
It is not expected that Synagis will be affected by other medicines or will affect
how other medicines work, but tell your doctor about all the medicines your child
is taking, regardless.
4. How is Synagis given?
How much is given
Your doctor will calculate the dose of Synagis based on your child's weight.
When to receive Synagis
Synagis is given every month while the risk of RSV infection remains.
It is given as an injection into the muscle, usually into the outer part of the thigh.
Please look for the QR code on the medicine pack. Scan this code with your smart phone
for more information on
Synagis.
If you forget an injection of Synagis
To best protect your child, it is necessary to follow the instructions from your doctor
about return visits for additional doses.
If you miss an injection, contact your doctor straight away.
If too much Synagis is given
As Synagis is given by a doctor or other healthcare professional, it is not likely
that your child will receive too much. If necessary, your doctor can manage the situation.
If you do think your child has received too much Synagis, you should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while my child is receiving Synagis?
Things you should do
Call your doctor straight away if your child:
Shows signs of an allergic reaction, including rash, swelling of the face, lips, mouth,
throat or neck
Becomes ill while being treated with Synagis
Tell your doctor if your child is unwell or has a temperature when treatment is about
to start.
Keep all your child's appointments to ensure he/she receives all the required injections.
If your child has any blood tests, tell the technician that he/she is receiving Synagis.
Remind any doctor, dentist or pharmacist you visit that your child is receiving Synagis.
Things you should not do
Once treatment has started, do not allow your child to miss any of the monthly injections
of Synagis without checking with your doctor.
Driving or using machines
As Synagis is for use in children, there is no information on the effect of Synagis
on the ability to drive or use machines.
Looking after your medicine
As Synagis is given to your child in hospital, you will not need to store the medicine
yourself. The hospital staff will keep the medicine in a refrigerator until it is
time to use it.
Getting rid of any unwanted medicine
The hospital staff will dispose of any unused medicine.
6. Are there any side effects?
All medicines can have side effects. If your child does 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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Signs of an infection in the upper airways:
fever
sore throat
pain in the middle ear
runny nose
wheezing
Skin:
redness or pain at the injection site
rash
Other:
diarrhoea
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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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Symptoms of a serious allergic reaction (anaphylaxis):
sudden appearance of skin rash
swelling of lips, tongue or face
difficulty swallowing
shortness of breath
difficulty breathing
passing out
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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 your
child feel unwell.
Other side effects not listed here may occur in some children.
Reporting side effects
After you have received medical advice for any side effects 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.
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.
Synagis is for injection by a doctor or other healthcare professional.
What Synagis contains
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Active ingredient
(main ingredient)
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palivizumab
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Other ingredients
(inactive ingredients)
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histidine
glycine
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What Synagis looks like
Synagis is supplied as:
Clear colourless solution in a glass vial ready for injection, containing 50 mg/0.5
mL solution (AUST R 231133)
Clear colourless solution in a glass vial ready for injection, containing 100 mg/1
mL solution (AUST R 231139)
Who distributes Synagis?
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone: - 1800 805 342
This leaflet was prepared in December 2021.
Synagis name is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca 2021
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