CEREZYME 400 UNIT

Pajjiż: Malasja

Lingwa: Ingliż

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

Ingredjent attiv:

Imiglucerase

Disponibbli minn:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Isem Internazzjonali):

Imiglucerase

Unitajiet fil-pakkett:

1Units Units; 1 Units Units

Manifatturat minn:

GENZYME CORPORATION

Karatteristiċi tal-prodott

CEREZYME
Imiglucerase for injection
200 Units
400 Units
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 β-D-glucopyranoside
(pNP-Glc) per minute at 37°C.
** Imiglucerase is a modified form of human acid β-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 _List of Excipients_.
This medicinal product contains sodium and is administered in 0.9%
sodium chloride intravenous solution
(see section_ Dosage and Administration_). 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.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Cerezyme is a white to off-white powder.
DESCRIPTION
Cerezyme® (imiglucerase for injection) is an analogue of the human
enzyme ß-gluco cere -brosidase,
produced by recombinant DNA technology. ß-Gluco cere brosidase
(ß-D-glucosyl-N-acylsphingosine
glucohydrolase, E.C. 3.2.1.45) is a lysosomal glycoprotein enzyme
which catalyzes the hydrolysis of the
glycolipid glucocerebroside to glucose and ceramide.
Cerezyme® is produced by recombinant DNA technology using mammalian
cell culture (Chinese hamster
ovary). Purified imiglucerase is a monomeric glycoprotein of 497 amino
acids, containing 4 N-linked
glycosylation sites (Mr = 60,430). Imiglucerase differs from placental
glucocerebrosidase by one amino
acid at position 495, where histidine is substituted for arginine.
The oligosaccharide chains at the glycosylation sites have been
modified to terminate in mannose
sugars. The modified carbohydrate structures on im