Replagal

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

Agalsidase alfa

Tersedia dari:

Shire Australia Pty Ltd

Kelas:

Medicine Registered

Selebaran informasi

_Consumer Medicine Information _
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_REPLAGAL_
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REPLAGAL
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(AGALSIDASE ALFA GHU) 
1 MG/ML CONCENTRATED INJECTION VIAL 

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about REPLAGAL.  It does 
not contain all of the available 
information.  Reading this leaflet does 
not take the place of talking to your 
doctor or pharmacist.   

Please read this leaflet before you start 
taking REPLAGAL. 

All medicines have risks and benefits.  
Your doctor has weighed the possible 
risks of taking REPLAGAL against the 
expected benefits. 

If you have any concerns about taking 
REPLAGAL, ask your doctor or 
pharmacist. 

Keep this leaflet.  You may want to read 
it again. 

WHAT IS REPLAGAL USED FOR 

REPLAGAL is used to treat Fabry 
Disease.  REPLAGAL is given as 
enzyme replacement therapy when the 
level of enzyme in the body is lower 
than normal as in Fabry Disease. 

Agalsidase alfa is a form of the human 
enzyme 
α-galactosidase A.  It is 
produced by switching on the gene for 
α-galactosidase A in cells.  The enzyme 
is then removed from the cells and 
made into a sterile concentrate for 
solution for infusion.  

Before REPLAGAL is given to you, it is 
mixed with 0.9% sodium chloride 
intravenous solution (saline).  The 
prepared solution will be infused into a 
vein in your arm over a 40 minute 
period. 

Your doctor may have prescribed 
REPLAGAL for another use.  Ask your 
doctor if you have any questions about 
why REPLAGAL has been prescribed 
for you. 

REPLAGAL is not addictive. 

REPLAGAL is not expected to affect 
your ability to drive a car or operate 
machinery. 

REPLAGAL is only available on a 
doctor’s prescription. 

BEFORE YOU TAKE REPLAGAL 

_WHEN YOU MUST NOT USE IT _

Do not use REPLAGAL if: 

•  You are allergic (hypersensitive) 
to agalsidase alfa or a