SYNAGIS 100 mg
powder and solvent for solution for injection
Palivizumab
Read all of this leaflet carefully because it contains important information for you and your child.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as those of your child.
- If any of the side effects get serious, or if you notice that your child has any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What SYNAGIS is and what it is used for
- 2. Before SYNAGIS is given to your child
- 3. How will my child receive SYNAGIS
- 4. Possible side effects
- 5. How to store SYNAGIS
- 6. Further information
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).
SYNAGIS is a medicine to help protect your child from getting severe RSV illness.
Before Synagis Is Given To Your Child
Your child should not be given SYNAGIS
- if he/she has ever had an allergic (hypersensitive) reaction to the active ingredient of SYNAGIS (palivizumab) or to any of the other ingredients of SYNAGIS (see a full list of ingredients in Section 6)
Take special care with SYNAGIS
- if your child is unwell. Please tell your doctor if your child is unwell, as the use of SYNAGIS may need to be delayed.
- if your child has any bleeding disorders as SYNAGIS is usually injected into the thigh.
Taking other medicines
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.
How Will My Child Receive Synagis
Instructions for proper use
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 you feel that your child has become ill while being treated with SYNAGIS?
If your child becomes ill, please contact your doctor immediately.
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.
If you have any further questions on how this product will be given to your child, ask your doctor or pharmacist.
Synagis 100mg Side Effects
Like all medicines, SYNAGIS can cause side effects, although not everybody gets them.
What side effects may occur while taking SYNAGIS?
Common (affects 1 to 10 users in 100):
- fever;
- nervousness;
- redness or swelling at the injection site;
- diarrhoea.
Uncommon (affects 1 to 10 users in 1000):
- colds;
- coughs;
- runny nose;
- wheeze;
- vomiting;
- rash;
- pain;
- viral infection;
- bleeding;
- weakness;
- constipation;
- drowsiness;
- hyperactivity;
- decrease in white blood cell counts;
- increase in liver function tests which will be seen in blood tests;
- upper respiratory infection.
Not known (occurence cannot be estimated):
- fits;
- reduced platelet count (cells that are needed for blood clotting);
- a pause in breathing or other breathing difficulties;
- severe allergic reactions.
What should you do if side effects occur?
If your child shows any side effects after receiving SYNAGIS you should contact your doctor. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, contact your doctor.
How To Store Synagis
Keep out of the reach and sight of children
Do not use SYNAGIS after the expiry date which is stated on the label.
After reconstitution use within 3 hours
Stored in a refrigerator (2°C-8°C)
Do not freeze.
Store in the original container
Further Information
What SYNAGIS contains
- The active substance is palivizumab. 100 mg per vial, providing 100 mg/ml of palivizumab when reconstituted as recommended.
- The other ingredients are,
- for the powder: histidine, glycine and mannitol.
- for the solvent: water for injections.
What SYNAGIS looks like and contents of the pack
SYNAGIS is presented as a powder and solvent for solution for injection (100 mg of powder in vial) + 1 ml of solvent in ampule - Pack size of 1. SYNAGIS is a white to off-white cake.
Marketing Authorisation holder
Berkshire
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last approved in December 2009
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
131-026-20
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