Aleviate Human Coagulation Factor VIIIVWF Complex Powder for Injection

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Von Willebrand Factor; HUMAN BLOOD COAGULATION FACTOR VIII

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

Von Willebrand Factor; HUMAN BLOOD COAGULATION FACTOR VIII

Unit dalam pakej:

1 Units Units; 1 Units Units

Dikeluarkan oleh:

CSL Behring Australia Pty Ltd

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
ALEVIATE
_® _
HUMAN COAGULATION FACTOR
VIII/VWF COMPLEX, POWDER FOR INJECTION
_ _
Human coagulation factor VIII (FVIII) / human von Willebrand factor
(VWF) complex (250 IU FVIII/600 IU VWF, 500 IU FVIII/1200
IU VWF)
_____________________________________________________________________________________________________
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1
of
4
WHAT IS IN THIS LEAFLET
1.
What Aleviate
®
is used for
2.
How Aleviate
®
works
3.
Before you use Aleviate
®
4.
How to use Aleviate
®
5.
While you are using Aleviate
®
6.
Side effects
7.
Storage and Disposal of Aleviate
®
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT ALEVIATE
®
IS USED FOR
Aleviate
®
is for individuals with reduced
levels
or
abnormality
of
either
von
Willebrand
factor
(VWF)
or
factor
VIII
(FVIII)
in
the
bloodstream
resulting
in
abnormal blood clotting, which may result
in excessive bleeding.
Aleviate
®
is
used
to
prevent
or
treat
bleeding, including during surgery, due to
lack
of
VWF
in
individuals
with
von
Willebrand disease, when treatment with
another
medicine,
desmopressin,
is
not
effective or cannot be given.
Aleviate
®
is also used to prevent or treat
bleeding, including during surgery, due to
lack
of
FVIII
in
individuals
with
Haemophilia A.
HOW ALEVIATE
®
WORKS
Aleviate
®
contains FVIII and VWF in a
purified and concentrated form. Both FVIII
and
VWF
are
blood
proteins
that
are
essential for normal blood clotting.
Ask your Haemophilia Treatment Centre if
you
have
any
questions
about
why
Aleviate
®
has been prescribed for you.
BEFORE YOU USE ALEVIATE
®
_- When you must not use it _
Tell your doctor if you:
•
have allergies to any medicines
•
have allergies to any of the ingredients
in
this
medicine
(listed
in
Product
Description)
_ _
_- Before you start to use it _
Tell your doctor if you:
•
have any other medical conditions
•
are pregnant or breast feeding
•
become pregnant during your
treatment
If
you
want further
information,
consult
your

Ciri produk

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ALEVIATE
®
MALAYSIA
1
NAME OF THE MEDICINE
Human coagulation factor VIII and human von Willebrand factor complex,
powder for
injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aleviate
®
is a high purity, sterile, powder for injection containing a human
coagulation factor
VIII (FVIII) and human von Willebrand factor (VWF) complex. Aleviate
®
is manufactured
from human plasma. The FVIII/VWF complex in Aleviate
®
is purified from cryoprecipitate
using selective precipitation and size exclusion chromatography steps.
VON WILLEBRAND FACTOR (VWF)
Following reconstitution, 1 mL of Aleviate
®
contains:
•
Aleviate
®
50 IU FVIII/mL: approximately 120 IU of human plasma derived VWF
•
Aleviate
®
100 IU FVIII/mL: approximately 240 IU of human plasma derived VWF.
The VWF activity of Aleviate
®
is determined using a VWF to platelet glycoprotein Ib binding
activity assay (VWF:Ac). The VWF activity is expressed as
international units (IU) and 1 IU
VWF:Ac is equivalent to 1 IU VWF ristocetin cofactor (VWF:RCo) in
accordance with the
WHO standard. The specific VWF activity of the product prior to the
addition of human
albumin as a stabiliser is approximately 100 IU of VWF/mg protein.
FACTOR VIII (FVIII)
Following reconstitution, 1 mL of Aleviate
®
contains:
•
Aleviate
®
50 IU FVIII/mL: approximately 50 IU of human plasma derived
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coagulation FVIII
•
Aleviate
®
100 IU FVIII/mL: approximately 100 IU of human plasma derived
coagulation FVIII.
The FVIII potency (IU) is determined using the European Pharmacopoeia
chromogenic assay.
The activity of FVIII is measured as FVIII coagulation activity
(FVIII:C). The specific FVIII
activity of Aleviate
®
prior to the addition of human albumin as a stabiliser is
approximately 70
IU of FVIII/mg protein.
Aleviate
®
contains other proteins such as fibrinogen, fibronectin,
immunoglobulins (IgA,
IgM, IgG) and transforming growth factor-β
(
TGF-β
),
all of which are present at significantly
lower levels than in normal plasma.
Aleviate
®
is registered