NAGLAZYME galsulfase-rch 5mg/5mL concentrated solution for injection vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Galsulfase, Quantity: 5 mg

Saadav alates:

BioMarin Pharmaceutical Australia Pty Ltd

INN (Rahvusvaheline Nimetus):

Galsulfase

Ravimvorm:

Injection, concentrated

Koostis:

Excipient Ingredients: monobasic sodium phosphate monohydrate; water for injections; dibasic sodium phosphate heptahydrate; polysorbate 80; sodium chloride

Manustamisviis:

Intravenous Infusion

Ühikuid pakis:

1 x 5mL vial

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

For the long-term enzyme replacement therapy in patients with Mucopolysaccharidosis VI (MPS VI - N acetylgalactosamine 4-sulfatase deficiency)

Toote kokkuvõte:

Visual Identification: clear to slightly opalescent andcolourless to pale yellow; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

2007-03-20

Infovoldik

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 AN

Toote omadused

Naglazyme_PI_v7
Supersedes: Naglazyme PI 150925
Page 1 of 15
AUSTRALIAN PI – GALSULFASE (RCH) (NAGLAZYME
®
) 5 MG/5 ML CONCENTRATED SOLUTION
FOR INJECTION
1. NAME OF THE MEDICINE
galsulfase (rch)
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.
For the full list of excipients, see 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Concentrated solution for injection.
A sterile, nonpyrogenic, colourless to pale yellow, clear to slightly
opalescent solution at a
pH of approximately 5.8 that must be diluted in 0.9% Sodium Chloride
Injection prior to
administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NAGLAZYME (galsulfase-rch) is indicated as long term enzyme
replacement therapy in
patients with Mucopolysaccharidosis VI (MPS VI, N-acetylgalactosamine
4-sulfatase
deficiency, Maroteaux-Lamy syndrome).
4.2 DOSE AND METHOD OF ADMINISTRATION
NAGLAZYME treatment should be supervised by a physician experienced in
the
management of patients with MPS VI or other inherited metabolic
diseases. Administration
of NAGLAZYME should be carried out in an appropriate clinical setting
where resuscitation
equipment to manage clinical emergencies would be readily available.
DOSAGE
The recommended dosage regimen of NAGLAZYME is 1 mg/kg of body weight
administered
once weekly as an intravenous infusion.
Naglazyme_PI_v7
Supersedes: Naglazyme PI 150925
Page 2 of 15
_Paediatric Population _
For patients 2