Synagis

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

palivizumab

Available from:

AstraZeneca AB

ATC code:

J06BD01

INN (International Name):

palivizumab

Therapeutic group:

Immune sera and immunoglobulins,

Therapeutic area:

Respiratory Syncytial Virus Infections

Therapeutic indications:

Synagis is indicated for the prevention of serious lower-respiratory-tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease:children born at 35 weeks of gestation or less and less than six months of age at the onset of the RSV season;children less than two years of age and requiring treatment for bronchopulmonary dysplasia within the last six months;children less than two years of age and with haemodynamically significant congenital heart disease.

Product summary:

Revision: 46

Authorization status:

Authorised

Authorization date:

1999-08-13

Patient Information leaflet

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYNAGIS 50 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.

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 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:

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

unresponsiven

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Synagis 50 mg/0.5 ml solution for injection
Synagis 100 mg/1 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Synagis solution contains 100 mg of palivizumab*.
Each 0.5 ml vial contains 50 mg of palivizumab.
Each 1 ml vial contains 100 mg of palivizumab.
*Palivizumab is a recombinant humanised monoclonal antibody produced
by DNA technology in
mouse myeloma host cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear or slightly opalescent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Synagis is indicated for the prevention of serious lower respiratory
tract disease requiring
hospitalisation caused by respiratory syncytial virus (RSV) in
children at high risk for RSV disease:

Children born at 35 weeks of gestation or less and less than 6 months
of age at the onset of the
RSV season.

Children less than 2 years of age and requiring treatment for
bronchopulmonary dysplasia
within the last 6 months.

Children less than 2 years of age and with haemodynamically
significant congenital heart
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of palivizumab is 15 mg/kg of body weight, given
once a month during
anticipated periods of RSV risk in the community.
The volume (expressed in ml) of // Palivizumab // to be administered
at one-monthly intervals =
[patient weight in kg] multiplied by 0.15.
Where possible, the first dose should be administered prior to
commencement of the RSV season.
Subsequent doses should be administered monthly throughout the RSV
season. The efficacy of
palivizumab at doses other than 15 mg per kg or of dosing differently
from monthly throughout the
RSV season, has not been established.
The majority of experience including the pivotal phase III clinical
trials with palivizumab has been
gained with 5 injections during one season (see section 5.1). Data,
although limited, are a