Synagis
palivizumab
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
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. See section 4.
What Synagis is and what it is used for
What you need to know before Synagis is given to your child
How will my child receive Synagis
Possible side effects
How to store Synagis
Contents of the pack and other information
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.
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:
severe rash, hives, or itching skin
swelling of the lips, tongue, or face
closing of the throat, difficulty swallowing
difficult, rapid, or irregular breathing
bluish colour of skin, lips, or under fingernails
muscle weakness or floppiness
a drop in blood pressure
unresponsiveness
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.
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 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Synagis may cause serious side effects including:
severe allergic reactions, such reactions may be life threatening or fatal (see "Your child should not be given Synagis" for a list of signs and symptoms).
unusual bruising or groups of tiny red spots on the skin.
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.
Very common (affects at least 1 user in 10):
rash
fever
Common (affects 1 to 10 users in 100):
pain, redness or swelling at the injection site
a pause in breathing or other breathing difficulties
Uncommon (affects less than 1 user in 100):
fits
hives
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 via thenationalreportingsystemlistedin Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 (2ºC to 8ºC). Do not freeze.
Keep the vial in the carton in order to protect from light.
The active substance is palivizumab. One ml of Synagis solution for injection contains 100 mg
of palivizumab.
Each 0.5 ml vial contains 50 mg of palivizumab.
Each 1 ml vial contains 100 mg of palivizumab.
The other ingredients are histidine, glycine and water for injections.
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.
AstraZeneca AB
SE-151 85 Södertälje Sweden
AbbVie S.r.l.
04011 Campoverde di Aprilia (LT) Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB AstraZeneca Lietuva
Tel: +370 5 2660550
АстраЗенека България ЕООД
Teл.: +359 2 44 55 000
AstraZeneca Czech Republic s.r.o Tel: +420 222 807 111
Associated Drug Co. Ltd Tel: +356 2277 8000
AstraZeneca BV
Tel: +31 79 363 2222
AstraZeneca
Tel: +372 6549 600
AstraZeneca AS
Tlf: +47 21 00 64 00
AstraZeneca A.E.
Τηλ: +30 2 106871500
AstraZeneca Österreich GmbH
Tel: +43 1 711 31 0
AstraZeneca Farmacéutica Spain, S.A.
Tel: +34 91 301 91 00
AstraZeneca
Tél: +33 1 41 29 40 00
AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
AstraZeneca Produtos Farmacêuticos, Lda.
Tel: +351 21 434 61 00
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41
AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100
AstraZeneca UK Limited
Tel: +386 1 51 35 600
Vistor hf.
Sími: +354 535 7000
AstraZeneca S.p.A. Tel: +39 02 00704500
AstraZeneca Oy
Puh/Tel: +358 10 23 010
Αλέκτωρ Φαρµακευτική Λτδ
Τηλ: +357 22490305
AstraZeneca AB
Tel: +46 8 553 26 000
SIA AstraZeneca Latvija Tel: +371 67377100
AstraZeneca UK Ltd Tel: +44 1582 836 836
The following information is intended for medical or healthcare professionals only:
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Palivizumab should not be mixed with any medicinal products or diluents.
Both the 0.5 ml and 1 ml vials contain an overfill to allow the withdrawal of 50 mg or 100 mg respectively.
To administer, remove the tab portion of the vial cap and clean the stopper with 70 % ethanol or equivalent. Insert the needle into the vial and withdraw into the syringe an appropriate volume of solution. Palivizumab solution for injection does not contain a preservative, is for single use and should be administered immediately after drawing the dose into the syringe.
Any unused product or waste material should be disposed of in accordance with local requirements.
Palivizumab is administered once a month intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The injection should be given using standard aseptic technique.
Injection volumes over 1 ml should be given as a divided dose.
When using Palivizumab 100 mg/1 ml, the volume (expressed in ml) of Palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15
For example, for a baby with a body weight of 3 kg, the calculation becomes: (3 x 0.15) ml = 0.45 ml palivizumab per month.