Active ingredient
- palivizumab
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/99/117/003, EU/1/99/117/004, EU/1/99/117/001, EU/1/99/117/002.
Synagis 100 mg/ml solution for injection
Package leaflet: Information for the user
Synagis50 mg/0.5 ml solution for injection
Synagis 100 mg/1 ml solution for injection
Active substance: palivizumab
Read all of this leaflet carefully before your child is given this medicine because it contains important information for you and your child.
What is in this leaflet
1. What Synagis is and what it is used for
2. What you need to know before Synagis is given to your child
3. How will my child receive Synagis
4. Possible side effects
5. How to store Synagis
6. Contents of the pack and other information
1. What Synagis is and what it is used for
Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV.
Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).
Children who are more likely to get severe RSV disease (high-risk children) include babies born prematurely (35 weeks or less) or babies born with certain heart or lung problems.
Synagis is a medicine to help protect your child from getting severe RSV illness.
2. What you need to know before Synagis is given to your child
Your child should not be given Synagis
If he/she is allergic to palivizumab or any of the other ingredients of this medicine (listed in section 6).
Signs and symptoms of a severe allergic reaction include:
Warnings and precautions
Take special care with Synagis
Other medicines and Synagis
Synagis is not known to interact with other medicines. However, you should inform your doctor of all medicines your child is currently taking before starting Synagis.
3. How will my child receive Synagis
How often will Synagis be given to my child?
Synagis should be given to your child at a dose of 15 mg/kg body weight once a month for as long as the risk of RSV infection remains. For your child’s best protection, it is necessary to take the doctor’s advice about when to return for additional doses of Synagis.
If your child is to have a heart operation (cardiac bypass surgery), he or she may be given an extra dose of Synagis after the operation. Your child can then go back to the original planned injections.
How will my child receive Synagis?
Synagis will be given by injection to your child into a muscle, usually in the outer part of the thigh.
What should you do if your child misses an injection of 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.
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure about how this product will be given to your child, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Synagis may cause serious side effects including:
Call your doctor or get medical help right away if your child has any of the serious side effects listed above after receiving any dose of Synagis.
Additional side effects
Very common (affects at least 1 user in 10):
Common (affects 1 to 10 users in 100):
Uncommon (affects less than 1 user in 100):
Reporting of side effects
If your child gets any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Synagis
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after ‘EXP’. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Keep the vial in the carton in order to protect from light.
6. Contents of the pack and other information
What Synagis contains
What Synagis looks like and contents of the pack
Synagis solution for injection is a clear or slightly opalescent solution and is available in vials of either 0.5 ml or 1 ml.
Pack size of 1.
Marketing Authorisation holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in June 2020
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
To listen to or request a copy of this leaflet in Braille, large print or audio, please contact the local representative of the Marketing Authorisation Holder.
AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, UK
+44 (0)1628 561 092
+44 (0)1628 561 092