Naglazyme

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Galsulfase 1 mg/mL

Mevcut itibaren:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Adı):

Galsulfase 1 mg/mL

Doz:

1 mg/mL

Farmasötik formu:

Concentrate for infusion

Kompozisyon:

Active: Galsulfase 1 mg/mL Excipient: Polysorbate 80 Sodium chloride Sodium phosphate Water for injection

Reçete türü:

Prescription

Tarafından üretildi:

BioMarin Pharmaceutical Inc

Terapötik endikasyonlar:

Naglazyme is indicated as long term enzyme replacement therapy in patients with Mucopolysaccharidosis VI (MPS VI, N-acetylgalactosamine 4-sulfatase deficiency, Maroteaux-Lamy syndrome).

Ürün özeti:

Package - Contents - Shelf Life: Vial, glass, 5 cc, Type I borosilicate tubing glass - 5 mL - 3 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Do not shake. 48 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)

Yetkilendirme tarihi:

2015-04-24

Bilgilendirme broşürü

NAGLAZYME
®
version 7
1
NAGLAZYME®
_galsulfase (rch) concentrated solution for injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Naglazyme.
It does not contain all the available
information. It does not take the
place of talking to your doctor or a
trained health care professional.
All medicines have risks and
benefits. Your doctor has weighed
the risks of having Naglazyme
against the benefits they expect it
will have.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
HEALTH CARE PROFESSIONAL.
KEEP THIS LEAFLET WHILE YOU ARE
BEING TREATED WITH NAGLAZYME.
You may need to read it again.
WHAT NAGLAZYME IS
USED FOR
Naglazyme is used as an enzyme
replacement therapy in patients with
Mucopolysaccharidosis VI (MPS
VI) storage disorder, a disease in
which the enzyme level of
_N_
-
acetylgalactosamine 4-sulfatase is
absent or lower than normal.
_HOW IT WORKS _
Patients with MPS VI disease do not
produce enough of their own
enzyme,
_ N_
-acetylgalactosamine 4-
sulfatase. The reduced or absent
_N_
-
acetylgalactosamine 4-sulfatase
activity in patients results in the
accumulation of substances called
glycosaminoglycans (GAGs) in
many tissues in the body.
This medicine contains a
recombinant enzyme called
galsulfase-rch. This can replace the
natural enzyme which is lacking in
MPS VI patients. Treatment has
been shown to improve walking and
stair-climbing ability, and to reduce
the levels of GAG in the body. This
medicine may improve the
symptoms of MPS VI.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NAGLAZYME
HAS BEEN PRESCRIBED FOR YOU.
Naglazyme is available only with a
doctor's prescription.
_USE IN CHILDREN _
Naglazyme is recommended for use
in children and adults.
BEFORE YOU ARE GIVEN
NAGLAZYME
_WHEN YOU MUST NOT HAVE IT _
NAGLAZYME SHOULD NOT BE GIVEN IF
YOU HAVE EXPERIENCED SEVERE OR
LIFE-THREATENING ALLERGIC
(HYPERSENSITIVE) REACTIONS TO
GALSULFASE-RCH OR ANY OF THE OTHER
INGREDIENTS OF NAGLAZYME LISTED AT
THE END OF THIS CMI AND

Ürün özellikleri

Data Sheet – New Zealand
Naglazyme_DS_v2
Supersedes: Naglazyme DS 160324
Page 1 of 13
NEW ZEALAND DATA SHEET
1.
NAGLAZYME 5 MG/5 ML CONCENTRATED SOLUTION FOR INJECTION
NAGLAZYME
®
galsulfase (rch) 5 mg/mL concentrated solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 1 mg galsulfase (rch). Each vial of 5 mL
extractable solution contains
5 mg galsulfase (expressed as protein content).
NAGLAZYME (galsulfase-rch) is a normal variant form of the polymorphic
human enzyme,
N-acetylgalactosamine 4-sulfatase that is produced by recombinant DNA
technology in a Chinese
hamster ovary cell line. Galsulfase-rch (glycosaminoglycan
N–acetylgalactosamine 4-sulfatase, EC
3.1.6.12) is a lysosomal enzyme that catalyzes the cleavage of the
sulfate ester from terminal
N-acetylgalactosamine 4-sulfate residues of glycosaminoglycans (GAG),
chondroitin 4-sulfate and
dermatan sulfate.
Galsulfase-rch is a glycoprotein with a molecular weight of
approximately 56 kDa. The recombinant
protein is comprised of 495 amino acids and contains six
asparagine-linked glycosylation sites, four of
which carry a bis mannose–6–phosphate mannose7 oligosaccharide for
specific cellular recognition.
Post-translational modification of Cys53 produces the catalytic amino
acid residue, Cα-formylglycine,
which is required for enzyme activity and is conserved in all members
of the sulfatase enzyme family.
NAGLAZYME has a specific activity of approximately 70 units per mg of
protein content. One
activity unit is defined as the amount of enzyme required to convert 1
micromole of
4-methylumbelliferyl sulfate to 4-methylumbelliferone and free sulfate
per minute at 37°C.
Excipient(s) with known effect
Each 5 mL vial contains 0.8 mmol (18.5 mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrated solution for injection is supplied as a sterile,
nonpyrogenic, colourless to pale yellow,
clear to slightly opalescent solution at a pH of approximately 5.8
that must be diluted