ALDURAZYME

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

LARONIDASE

Boleh didapati daripada:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Kod ATC:

A16AB05

Dos:

2.9mg

Borang farmaseutikal:

INJECTION, SOLUTION

Komposisi:

LARONIDASE 2.9mg

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

Vetter Pharma-Fertigung GmbH & Co. KG

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2007-08-28

Risalah maklumat

A
LDURAZYME


(laronidase)

P
ROPRIETARY AND CONFIDENTIAL

1 
ALDURAZYME

 (LARONIDASE) 
1 

2 
Solution for Intravenous Infusion Only 
3 

4 
DESCRIPTION 
5 

6 
ALDURAZYME

  (laronidase) i s a  pol ymorphic va riant o f t he hum an
e nzyme 
7 
α
-
L
-iduronidase t hat i s  produced
b y  recombinant D NA t echnology i n
a  C hinese ha mster 
8 
ovary cell line.  α-
L
-iduronidase (glycosaminoglycan α-
L
-iduronohydrolase, EC 3.2.1.76) is 
9 
a lysosomal hydrolase
that catalyses the hydrolysis of terminal α-
L
-iduronic acid residues of 
10 
dermatan sulfate and heparan sulfate. 
11 

12 
Laronidase i s a  g lycoprotein w ith
a  m olecular w eight of   approximately 83 kD .  T he 
13 
predicted amino acid sequence
of the recombinant form, as well as the nucleotide sequence 
14 
that e ncodes i t, a re i dentical t o
a  pol ymorphic f orm of  hum an  α-
L
-iduronidase.  T he 
15 
recombinant protein is comprised
of 628 amino acids after cleavage of the N-terminus and 
16 
contains 6 N -linked ol igosaccharide m odification s ites.
 T wo ol igosaccharide c hains 
17 
terminate in  mannose-6-phosphate s ugars.
 A LDURAZYME ha s a  s pecific a ctivity o f 
18 
approximately 172 U/mg.  
19 

20 
ALDURAZYME,
f or i ntravenous  (IV)  infusion, i s s upplied
a s a  s terile, nonp yrogenic, 
21 
colorless to  pale yellow, clear to  slightly opalescent solution that must
be diluted prior to 
22 
administration in 0.9% Sodium Chloride Injection, USP.
 The solution in each vial contains 
23 
a nom inal l aronidase  concentration
of  0.58  mg/mL a nd  a pH  of   approximately 5.5.
 T he 
24 
extractable volume of 5.0 mL from each vial provides 2.9
m g laronidase, 43.9 m g sodium 
25 
chloride, 63.5 m g sodium phos

Ciri produk

A
LDURAZYME
®
(laronidase)
SG/ALD/0621/USPI1219
PROPRIETARY & CONFIDENTIAL
ALDURAZYME
®
(LARONIDASE)
Solution for Intravenous Infusion Only
DESCRIPTION
ALDURAZYME
®
(laronidase) is a
polymorphic
variant
of
the
human
enzyme
α-L-
iduronidase that is produced by recombinant DNA technology in a
Chinese hamster ovary
cell line.
α-L-iduronidase (glycosaminoglycan α-L-iduronohydrolase, EC
3.2.1.76) is a
lysosomal hydrolase that catalyses the hydrolysis of terminal
α-L-iduronic acid residues of
dermatan sulfate and heparan sulfate.
Laronidase is a glycoprotein with a molecular weight of approximately
83 kD. The predicted
amino acid sequence of the recombinant form, as well as the nucleotide
sequence that encodes
it, are identical t o a polymorphic form of hum an α-L-iduronidase.
The recombinant protein
is comprised of 628 amino acids after cleavage of the N-terminus and
contains 6 N -linked
oligosaccharide modification sites. Two oligosaccharide chains
terminate in mannose-6-
phosphate sugars. ALDURAZYME has a specific activity of approximately
172 U/mg.
ALDURAZYME, for intravenous infusion, is supplied as a sterile,
nonpyrogenic,
colorless to pale yellow, clear to slightly opalescent solution that
must be diluted prior to
administration in 0.9% Sodium Chloride Injection, USP. The solution in
each vial contains a
nominal laronidase concentration of 0.58 mg/mL and a pH of
approximately 5.5.
The
extractable volume of 5mL from each vial provides 2.9 mg laronidase,
43.9 mg sodium
chloride, 63.5 mg sodium phosphate monobasic monohydrate, 10.7 mg
sodium phosphate
dibasic heptahydrate, and 0.05 mg polysorbate 80. ALDURAZYME does not
contain
preservatives; vials are for single use only.
CLINICAL PHARMACOLOGY
Mechanism of Action
Mucopolysaccharide storage disorders are caused by the deficiency of
specific lysosomal
enzymes required for the catabolism of glycosaminoglycans (GAG).
Mucopolysaccharidosis I (MPS I) is characterized by the deficiency of
α-L-iduronidase, a
lysosomal hydrolase which catalyzes the hydrolysis of t