Synagis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Palivizumab

Available from:

Abbvie Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

SYNAGIS

_Palivizumab_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SYNAGIS.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of your child using
SYNAGIS against the benefits they
expect it will have for him/her.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD USING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
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 Y

Summary of Product characteristics

_Synagis PI _
_Version 14 _
_12 August 2013 _
_Page _
_1 of 14 _

PRODUCT INFORMATION 
SYNAGIS
®

NAME OF MEDICINE 

Palivizumab 50mg and 100mg 
CAS Number: 188039-54-5  

DESCRIPTION 
Palivizumab  is  a  humanized  IgG1  monoclonal  antibody  directed  to  an  epitope  in  the  A 
antigenic site of the fusion protein
of respiratory syncytial virus (RSV). 

This humanized monoclonal antibody is composed of 95% human and 5% murine amino acid 
sequences.    Palivizumab  is  composed  of  two  heavy  chains  and  two  light  chains  having  a 
molecular weight of approximately 148,000 Daltons. 

Palivizumab is supplied as a sterile lyophilised product for reconstitution with sterile water for 
intramuscular  injection.    Upon  reconstitution,  palivizumab  contains  the  following  excipients:  
47 mM histidine, 3.0 mM glycine and 5.6% mannitol and the active ingredient, palivizumab, at 
a concentration of 100 milligrams per mL.  The reconstituted solution should appear clear or 
slightly opalescent. 

PHARMACOLOGY_ _
_ _
_MECHANISM OF ACTION _
Palivizumab  exhibits  neutralising  and  fusion-inhibitory  activity  against  RSV.    These  activities 
inhibit  RSV  replication  in  laboratory  experiments.    Although  resistant  RSV  strains  may  be 
isolated  in  laboratory  studies,  a  panel  of  clinical  RSV  isolates  were  all  neutralised  by 
palivizumab.  Palivizumab serum concentrations of approximately 30 

g/mLhave been shown 
to produce a mean 99% reduction in pulmonary RSV replication
in the cotton rat model. 

The  _in  vivo  _neutralising  activity  of  the  active  ingredient  in  palivizumab  was  assessed  in  a 
randomised, placebo-controlled study of 35 paediatric patien