Myozyme Powder for Solution for Injection

Land: Malaysia

Språk: engelska

Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiva substanser:

rhGAA (ALGLUCOSIDASE ALFA)

Tillgänglig från:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International namn):

rhGAA (ALGLUCOSIDASE ALFA)

Enheter i paketet:

1Units Units

Tillverkad av:

Genzyme Ireland Limited

Bipacksedel

Not Applicable

Produktens egenskaper

1
MY/MYO/0320/CCDSV9
MYOZYME
alglucosidase alfa
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.
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 of 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 _
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 _
2
MY/MYO/0320/CCDSV9
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 increased by 2 mg/kg/h
every 30 minutes if there are no
signs of infusion associated reactions