MYOZYME

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv bestanddel:

ALGLUCOSIDASE ALFA

Tilgængelig fra:

AVENTIS PHARMA - Indonesia

INN (International Name):

ALGLUCOSIDASE ALFA

Dosering:

50 Mg

Lægemiddelform:

SERBUK INFUS

Enheder i pakken:

DUS, 1 VIAL @ 50 MG

Fremstillet af:

GENZYME IRELAND LIMITED - Ireland

Autorisation dato:

2020-10-29

Produktets egenskaber

Pharmacode
1. NAME OF THE MEDICINAL PRODUCT
Myozyme 50 mg powder for concentrate for solution for infusion
2. 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 6.1.
3. PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white powder.
4. CLINICAL PARTICULARS
4.1 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.
4.2 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
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 (