Naglazyme

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

Galsulfase

Disponibbli minn:

BioMarin Pharmaceutical Australia Pty Ltd

Klassi:

Medicine Registered

Fuljett ta 'informazzjoni

NAGLAZYME
®
NAGLAZYME
®
 (GALSULFASE-RCH), CONCENTRATE FOR SOLUTION FOR INFUSION.
BEFORE NAGLAZYME 
ADMINISTRATION
Naglazyme should not be given if  
you have experienced severe or  
life-threatening allergic (hypersensitive) 
reactions to galsulfase-rch or any of 
the other ingredients of Naglazyme 
listed at the end of this CMI and  
re-administration of the medicine was 
not successful. 
If you are treated with Naglazyme, 
you may develop infusion reactions. 
An infusion reaction is any side effect 
occurring during the infusion or shortly 
after (refer to Side Effects section). 
When you experience such a reaction, 
YOU SHOULD IMMEDIATELY CONTACT 
YOUR HEALTH CARE PROFESSIONAL.
MPS VI disease can cause pressure on 
the upper spinal cord, which can occur 
while you are receiving Naglazyme. 
Please talk to your health care 
professional if you experience muscle 
pain, numbness in your arms or legs, 
or any bowel or bladder problems.
BEFORE Naglazyme administration, 
talk to your health care professional if:
•  you have a fever, or if you are 
having difficulty breathing before 
this medicine is given. 
•  you have kidney or liver 
insufficiency. This medicine has 
not been tested in patients with 
kidney or liver problems. 
•  you are pregnant or intend 
to become pregnant or are 
breastfeeding.
Naglazyme should not be given during 
pregnancy unless clearly necessary. 
Ask your doctor or health care 
professional for advice before taking 
any medicine. It is not known whether 
galsulfase-rch is excreted in milk, 
therefore breast-feeding should be 
stopped during Naglazyme treatment.
_TAKING OTHER MEDICINES_
Tell your doctor or health care 
professional if you are taking any other 
medicines, including any that you 
buy without prescription from your 
pharmacy, supermarket or health food 
shop. 
Interaction studies with Naglazyme 
have not been conducted.
HOW NAGLAZYME IS 
ADMINISTERED
Naglazyme is administered once 
a week directly into the vein