Synagis

Palivizumab
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 Synagis. It does not contain all the information that is known about Synagis. 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. Bookmark or print this page, you may need to read it again.

What SYNAGIS is used for

SYNAGIS is used to help prevent a serious illness caused by a virus called respiratory syncytial virus (RSV). RSV illness usually occurs during the months of winter and early spring. It can cause a serious infection in the lungs of your child resulting in him/her being hospitalised. Your child is at high risk of getting this illness.
SYNAGIS belongs to a group of medicines called antibodies (or disease fighting substances). The active substance in SYNAGIS is called palivizumab and is made from humanized genetic material. It works only against RSV.
Your doctor may have prescribed SYNAGIS for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for your child.

Before your child is given SYNAGIS

When your child must not be given it

SYNAGIS must not be used if your child is allergic to it or to any of the ingredients
listed at the end of this leaflet.
SYNAGIS must not be used if your child is allergic to similar medicines.

Before your child begins to use it

If your child is unwell, tell your doctor as the use of SYNAGIS may need to be delayed.
Tell your doctor if your child has any bleeding disorders
Tell your doctor if your child has allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes

Taking other medicines

Tell your doctor if your child is taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
If you have not told your doctor about any of the above, tell them before SYNAGIS is given.

How SYNAGIS is given

SYNAGIS should be given to your child once a month for as long as the risk of RSV infection remains. The dose given will depend on your child's weight and is usually 15 mg/kg. To best protect your child, it is necessary to follow the instructions from your doctor about return visits for additional doses.
SYNAGIS is provided as a powder that is dissolved in water before injection. About twenty minutes after the water has been added to the vial, the injection is given into the muscle, most commonly in the outer part of the thigh.

If you use too much (overdose)

As SYNAGIS will be given by a health professional, it is very unlikely that your child will receive too much. The health professional will know how to deal with any overdose that your child accidentally receives.

While your child is using SYNAGIS

Contact your doctor immediately if your child becomes ill while using SYNAGIS.
If your child misses an injection, you should contact your doctor as soon as possible. Each injection of SYNAGIS can only help protect your child for about one month before another injection is needed.

Side Effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. Ask your doctor or pharmacist to answer any questions you may have.
You should contact your doctor if your child shows any side effects after receiving SYNAGIS.
Tell your doctor if your child has any of the following:
fever
nervousness
redness or swelling at the injection site
rash
diarrhoea
cold or ear infection
wheezing
These are the most common side effects that your child may have while on SYNAGIS.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if your child has any of the following:
swelling to the face, lips, mouth, throat or neck
difficulty in swallowing or breathing
These are very serious side effects. If your child has them, he/she may have had a serious allergic reaction to SYNAGIS. Your child may need urgent medical attention or hospitalisation.
These side effects are rare.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making your child unwell.
Do not be alarmed by this list of possible side effects. Your child may not experience any of them.

Overdose

In the case of a suspected overdose immediately telephone your doctor or the Poisons Information Centre (Australia: Telephone 13 11 26; New Zealand: Telephone 0800 764 766), or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

After using it

Storage

As SYNAGIS is given to you by a health professional, 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.

Disposal

The hospital staff will dispose of any unused medicine.

Product description

What it looks like

SYNAGIS is a powder supplied in a vial. It is available with an ampoule of Water for Injections. There are two strengths; 50 mg and 100 mg.

Ingredients

Each vial of SYNAGIS contains 50 mg or 100 mg of palivizumab.
Each vial also contains the following inactive ingredients:
histidine
glycine
mannitol

Manufacturer/Supplier

SYNAGIS is made in Germany and supplied by:
AbbVie Pty Ltd
32-34 Lord Street
Botany NSW 2019
Australia
AbbVie Limited
6th Floor, 156-158 Victoria St
Wellington, 6011
New Zealand
AUST R 68289/ TT50-6267
50 mg vial with an ampoule of Water for Injections*
AUST R 68290/ TT50-6267a
100 mg vial with an ampoule of Water for Injections
* This presentation is not marketed in New Zealand
This leaflet was prepared in
August 2012
Version 09