REPLAGAL agalsidase alfa ghu 3.5mg/3.5mL concentrated injection vial

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

Agalsidase alfa, Quantity: 1 mg/mL

Inapatikana kutoka:

Takeda Pharmaceuticals Australia Pty Ltd

Dawa fomu:

Injection, concentrated

Tungo:

Excipient Ingredients: polysorbate 20; water for injections; sodium hydroxide; sodium chloride; monobasic sodium phosphate monohydrate

Njia ya uendeshaji:

Intravenous Infusion

Vitengo katika mfuko:

1 vial

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Replagal (agalsidase alpha ghu) is indicated for long-term enzyme replacement therapy of patients with Fabry Disease (alpha-galactosidase A deficiency).

Bidhaa muhtasari:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2002-05-17

Taarifa za kipeperushi

REPLAGAL
®
_agalsidase alfa ghu 3.5 mg / 3.5 mL concentrated injection vial_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about REPLAGAL. It does
not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
Please read this leaflet before you
start using REPLAGAL.
All medicines have risks and
benefits. Your doctor has weighed
the possible risks of using
REPLAGAL against the expected
benefits.
If you have any concerns about using
REPLAGAL, ask your doctor or
pharmacist.
Keep this leaflet. You may want to
read it again.
WHAT IS REPLAGAL
USED FOR
REPLAGAL is used to treat Fabry
Disease. REPLAGAL is given as
enzyme replacement therapy when
the level of enzyme in the body is
lower than normal as in Fabry
Disease.
Agalsidase alfa is a form of the
human enzyme
α
-galactosidase A. It
is produced by switching on the gene
for
α
-galactosidase A in cells. The
enzyme is then removed from the
cells and made into a sterile
concentrate for solution for infusion.
Before REPLAGAL is given to you,
it is mixed with 0.9% sodium
chloride intravenous solution
(saline). The prepared solution will
be infused into a vein in your arm
over a 40 minute period.
Your doctor may have prescribed
REPLAGAL for another use. Ask
your doctor if you have any questions
about why REPLAGAL has been
prescribed for you.
REPLAGAL is not addictive.
REPLAGAL is not expected to affect
your ability to drive a car or operate
machinery.
REPLAGAL is only available on a
doctor's prescription.
BEFORE YOU USE
REPLAGAL
_WHEN YOU MUST NOT USE IT_
Do not use REPLAGAL if:
•
You are allergic (hypersensitive)
to agalsidase alfa or any of the
other ingredients of REPLAGAL
•
The package is torn or shows
signs of tampering
•
The expiry date (EXP) printed on
the pack has passed. If you use
this medication after the expiry
date has passed, it may not work
as well
_BEFORE YOU START TO USE IT_
TELL YOUR DOCTOR IF:
1.
YOU THINK YOU ARE ALLERGIC TO
ANY OF THE INGREDIEN

Tabia za bidhaa

____________________________________________________________________________________
REPLAGAL PI V3 (CCDS V20) 1
AUSTRALIAN PRODUCT INFORMATION
REPLAGAL
 (AGALSIDASE ALFA GHU)
1
NAME OF THE MEDICINE
Agalsidase alfa ghu
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3.5 mL vial of REPLAGAL contains 3.5 mg of agalsidase alfa ghu.
Agalsidase alfa ghu is a human

-galactosidase A produced by genetic engineering technology.
Agalsidase alfa ghu is a homodimer comprised of 2 approximately 50,000
dalton subunits, with
each subunit containing 398 amino acid residues. The product is
synthesised by a human cell line
and has the identical amino acid sequence as that of

-galactosidase A produced in human tissues.
REPLAGAL is now manufactured using a serum-free bioreactor process.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
REPLAGAL is provided as a sterile, clear and colourless solution
intended for intravenous (IV)
administration. A minute amount of fine particulate matter, causing
the solution to appear slightly
hazy, may be present.
REPLAGAL contains no antimicrobial agent. It is supplied in a
single-dose vial.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REPLAGAL (agalsidase alfa ghu) is indicated for long-term enzyme
replacement therapy of
patients with Fabry Disease (

-galactosidase A deficiency).
4.2
DOSE AND METHOD OF ADMINISTRATION
In adults and children 6.5 years of age and older, REPLAGAL is
administered at a dose of 0.2
mg/kg body weight every 2 weeks by intravenous infusion over a period
of 40 minutes. Therapy
with REPLAGAL should only be initiated or continued by a physician
with expertise in the
treatment of Fabry Disease (see Section 4.4 Special warnings and
precautions for use). Infusion
of REPLAGAL at home may be considered for patients who have been
stabilised in a controlled
hospital setting and are tolerating their infusions well. REPLAGAL is
not recommended in
children below 6.5 years of age.
INSTRUCTION FOR USE/HANDLING
REPLAGAL for pat