FABRAZYME agalsidase beta-rch 35mg powder for injection vial

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

Agalsidase beta, Quantity: 35 mg

Tersedia dari:

Sanofi-Aventis Australia Pty Ltd

Bentuk farmasi:

Injection, powder for

Komposisi:

Excipient Ingredients: monobasic sodium phosphate; nitrogen; dibasic sodium phosphate heptahydrate; mannitol

Rute administrasi :

Intravenous Infusion

Unit dalam paket:

1 x 20mL vial

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha-galactosidase deficiency).

Ringkasan produk:

Visual Identification: 20mL glass vial with grey butyl stopper and aluminium seal containing white to off-white cake or powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2002-05-30

Selebaran informasi

FABRAZYME
®
[FAB-RA-ZIME]
_Agalsidase beta-rch [ag-al-SI-daze bee-ta R.C.H] 5.5 & 35 mg/mL,
Powder for Concentrate for Solution_
_for Infusion_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FABRAZYME.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your treating physician has
weighed the risks of you or your
child taking FABRAZYME against
the benefits they expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
TREATING PHYSICIAN OR NURSE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT FABRAZYME IS
USED FOR
FABRAZYME is used as enzyme
replacement therapy in Fabry's
Disease, a disease in which the level
of an enzyme called
α
-galactosidase
is lower than normal.
_HOW IT WORKS_
Patients with Fabry's Disease do not
produce enough of their own
enzyme,
α
-galactosidase. The
reduced
α
-galactosidase activity in
patients results in the accumulation
of substances called
glycosphingolipids, predominantly
globotriaosylceramide (GL-3) in a
number of cell types and tissues.
FABRAZYME is an enzyme
replacement therapy that is intended
to restore a level of enzyme activity
sufficient to remove the accumulated
substances and to prevent further
accumulation.
BEFORE YOU ARE GIVEN
FABRAZYME
_WHEN YOU OR YOUR CHILD_
_MUST NOT BE GIVEN IT_
DO NOT TAKE FABRAZYME IF YOU
HAVE A KNOWN, SEVERE, LIFE-
THREATENING ALLERGIC REACTION TO:
•
FABRAZYME
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
skin rash, itching or hives.
IF YOU ARE NOT SURE WHETHER YOU OR
YOUR CHILD SHOULD HAVE
FABRAZYME, TALK TO YOUR
TREATING PHYSICIAN OR NURSE.
_BEFORE YOU OR YOUR CHILD ARE_
_GIVEN IT_
TELL YOUR TREATING PHYSICIAN IF YOUR
CHILD IS UNDER 8 YEARS OF AGE AND
HAS BEEN P

Karakteristik produk

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AUSTRALIAN PRODUCT INFORMATION – FABRAZYME
(AGALSIDASE BETA - RCH)
1
NAME OF THE MEDICINE
Fabrazyme, agalsidase beta-rch mg powder for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fabrazyme 5 mg – each vial contains a nominal value of 5 mg of
agalsidase beta.
Fabrazyme 35 mg – each vial contains a nominal value of 35 mg of
agalsidase beta.
After reconstitution with Sterile Water for Injection (see Section 4.2
DOSE AND METHOD
OF ADMINISTRATION, Instructions for Use) the resulting solution has an
agalsidase beta
concentration of 5 mg/mL and a pH of approximately 7. The
reconstituted solution must be
diluted further. The diluted solution may be filtered through an
in-line low protein-binding
0.2 μm filter during administration.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Fabrazyme is supplied as a sterile, non-pyrogenic, white to off-white
lyophilised powder in a
clear glass vial. Fabrazyme is a powder for injection.
Fabrazyme is intended for intravenous infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FABRAZYME is indicated for long-term enzyme replacement therapy in
patients with a
confirmed diagnosis of Fabry disease (

-galactosidase deficiency).
4.2
DOSE AND METHOD OF ADMINISTRATION
Therapy with FABRAZYME should only be initiated or continued by a
physician with
expertise in the treatment of Fabry disease (see Section 4.4 SPECIAL
WARNING AND
PRECAUTIONS FOR USE).
If an infusion-associated reaction occurs during a FABRAZYME infusion,
decreasing the
infusion rate, temporarily stopping the infusion and/or administration
of antipyretics,
antihistamines and/or steroids may ameliorate the symptoms. Patients
who experience an
infusion -associated reaction during a FABRAZYME infusion should be
treated with caution
when FABRAZYME is re-administered. If severe allergic or anaphylactoid
reactions occur,
.
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immediate discontinuation of the administration of FABRAZYME and
current m