ALDURAZYME
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
उत्पाद विशेषताएं
(SPC)
26-05-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
Laronidase
थमां उपलब्ध:
Genzyme Australasia Pty Ltd
वर्ग:
Medicine Registered
उत्पाद विशेषताएं
VERSION: ALD ANZ A1202-01
SUPERCEDES: ALD ANZ A1104-01
COMMERCIAL
Page 1 of 16
ALDURAZYME
®
(
laronidase-rch concentrate for solution for infusion
)
PRODUCT INFORMATION
NAME OF THE MEDICINE
ALDURAZYME
®
(laronidase), 500 U, concentrate for solution for infusion.
CAS No. 210589-09-6
DESCRIPTION
ALDURAZYME is produced by recombinant DNA technology and
is a replacement
therapy for the human enzyme,
-
L
-iduronidase. Purified 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 to human
-
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. Laronidase is produced by a
genetically engineered Chinese
hamster ovary cell line. The protein is purified
by a column chromatography process
that includes steps to inactivate and remove potential
viruses, resulting in a highly
purified, active protein.
ALDURAZYME is intended for intravenous infusion. It is
supplied as a sterile,
nonpyrogenic, colourless to pale yellow,
clear to slightly opalescent solution that must
be diluted prior to administration. The solution has a
nominal laronidase
concentration of 100 U/mL (0.58 mg/mL) and a pH of
approximately 5.5. The
extractable volume of 5.0 mL from each vial provides 2.9 mg
(500 U) laronidase, 43.9
mg sodium chloride, 63.5 mg monobasic sodium phosphate
monohydrate, 10.7 mg
dibasic sodium phosphate, and 0.05 mg polysorbate 80. ALDURAZYME
does not
contain preservatives; vials are for single
use only. It is recommended that the diluted
solution be filtered through an in - line low protein –
binding 0.2μm
filter during
administration.
VERSION: A
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