Myozyme® (Alglucosidase alfa) 50mg Powder for Solution for Infusion

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Alglucosidase alfa

Dostępny od:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Kod ATC:

A16AB07

Dawkowanie:

52.5 mg

Forma farmaceutyczna:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Skład:

Alglucosidase alfa 50 mg/vial

Droga podania:

INTRAVENOUS

Typ recepty:

Prescription Only

Wyprodukowano przez:

Genzyme Ireland Limited

Status autoryzacji:

ACTIVE

Data autoryzacji:

2008-08-28

Ulotka dla pacjenta

1 

MYOZYME (ALGLUCOSIDASE ALFA) 

FOR INTRAVENOUS INFUSION ONLY 

NAME OF THE MEDICINAL PRODUCT  
Myozyme 50 mg powder for concentrate for solution
for infusion. 

QUALITATIVE AND QUANTITATIVE COMPOSITION  
One vial contains 50 mg of alglucosidase alfa. 

After reconsititution, the solution contains 5
mg of alglucosidase alfa* per ml and after dilution, 
the concentration varies from 0.5 mg to 4 mg/ml. 

* Human acid 
α-glucosidase is produced in
Chinese hamster ovary cells (CHO) by recombinant 
DNA technology. 

For the full list of excipients, see section List
of Excipients. 

PHARMACEUTICAL FORM 
Powder for concentrate for solution for infusion. 
White to off-white powder. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Myozyme is indicated for long-term enzyme replacement
therapy (ERT) in patients with a 
confirmed diagnosis of Pompe disease (acid α-glucosidase
deficiency). 

Myozyme is indicated in adults and paediatric patients of all
ages. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Myozyme treatment should be supervised by a
physician experienced in the management of 
patients with Pompe disease or other inherited
metabolic or neuromuscular diseases. 

Posology 
The recommended  dose  regimen of alglucosidase alfa  is  20
mg/kg body weight administered 
once every 2 weeks.  
Patient response to treatment should be routinely evaluated based
on a comprehensive evaluation 
of all clinical manifestations of the disease. 

_Paediatric and older people _
2 

There is no evidence for special considerations when
Myozyme is administered to paediatric 
patients of all ages or older people. 

_Patients with renal and hepatic impairment _
The safety and efficacy of Myozyme in patients with
renal or hepatic impairment have not been 
evaluated and no specific dose regimen can be 

Charakterystyka produktu

1
SG/MYO/0520/CCDSV9
MYOZYME
Alglucosidase alfa
FOR INTRAVENOUS INFUSION ONLY
NAME OF THE MEDICINAL PRODUCT
Myozyme 50 mg powder for concentrate for solution for infusion.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 50 mg of alglucosidase alfa.
After reconstitution, the solution contains 5 mg of alglucosidase
alfa* per ml and after dilution,
the concentration varies from 0.5 mg to 4 mg/ml.
* Human acid α-glucosidase is produced in Chinese hamster ovary cells
(CHO) by recombinant
DNA technology.
For the full list of excipients, see section
_List of excipients_
.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white powder.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Myozyme is indicated for long-term enzyme replacement therapy (ERT) in
patients with a
confirmed diagnosis of Pompe disease (acid α-glucosidase deficiency).
Myozyme is indicated in adults and paediatric patients of all ages.
POSOLOGY AND METHOD OF ADMINISTRATION
Myozyme treatment should be supervised by a physician experienced in
the management of
patients with Pompe disease or other inherited metabolic or
neuromuscular diseases.
Posology
The recommended dose regimen of alglucosidase alfa is 20 mg/kg body
weight administered
once every 2 weeks.
Patient response to treatment should be routinely evaluated based on a
comprehensive evaluation
of all clinical manifestations of the disease.
2
SG/MYO/0520/CCDSV9
_Paediatric and older people _
There is no evidence for special considerations when Myozyme is
administered to paediatric
patients of all ages or older people.
_Patients with renal and hepatic impairment _
The safety and efficacy of Myozyme in patients with renal or hepatic
impairment have not been
evaluated and no specific dose regimen can be recommended for these
patients.
Method of administration
Myozyme should be administered as an intravenous infusion.
Infusions should be administered incrementally. It is recommended that
the infusion begin at an
initial rate of 1 mg/kg/h and be gradually incre