CEREZYME

Land: Indonesië

Taal: Indonesisch

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

Werkstoffen:

IMIGLUCERASE

Beschikbaar vanaf:

AVENTIS PHARMA - Indonesia

INN (Algemene Internationale Benaming):

IMIGLUCERASE

Dosering:

400 UNIT/VIAL

farmaceutische vorm:

SERBUK INFUS

Eenheden in pakket:

DUS, 1 VIAL @ 400 UNIT

Geproduceerd door:

GENZYME CORPORATION - USA

Autorisatie datum:

2018-03-06

Productkenmerken

Pharmacode
1. NAME OF THE MEDICINAL PRODUCT
Cerezyme 400 U Powder for concentrate for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 400 units* of imiglucerase**.
After reconstitution, the solution contains 40 units (approximately
1.0
mg) of imiglucerase per ml (400 U/10 ml).
* An enzyme unit (U) is defined as the amount of enzyme that
catalyses the hydrolysis of one micromole of the synthetic substrate
para-nitrophenyl ß-D-glucopyranoside (pNP-Glc) per minute at 37°C.
** Imiglucerase is a modified form of human acid ß-glucosidase and is
produced
by
recombinant
DNA
technology
using
a
mammalian
Chinese Hamster Ovary (CHO) cell culture, with mannose modification
for targeting macrophages.
Excipients:
For a full list of excipients, see section 6.1.
This medicinal product contains sodium and is administered in 0.9%
sodium
chloride
intravenous
solution
(see
section
6.6).
After
reconstitution, the solution contains 1.24 mmol sodium (400 U/10 mL).
To be taken into consideration by patients on a controlled sodium
diet.
3. PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Cerezyme is a white to off-white powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cerezyme®
(imiglucerase
for
injection)
is
indicated
for
long-term
enzyme replacement therapy for pediatric and adult patients with a
confirmed diagnosis of type 1 Gaucher disease that result in one or
more of the following conditions:
a. Anaemia after exclusion of other causes, such as iron deficiency
b. Thrombocytopenia
c.
Bone disease after exclusion of other causes such as Vitamin D
deficiency
d.
Hepatomegaly or splenomegaly
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Disease management should be directed by physicians knowledgeable
in the treatment of Gaucher disease.
Posology
Due to the heterogeneity and the multi-systemic nature of Gaucher
disease, dosage should be individualised for each patient based on a
comprehensive evaluation of all clinical manifestations of the
disease.
Once
individual
pati