IDELVION 1000 IU powder and solvent for solution for injection

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Albutrepenonacog Alfa

Boleh didapati daripada:

DKSH MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

Albutrepenonacog Alfa

Unit dalam pakej:

6 ml

Dikeluarkan oleh:

CSL Behring GmbH

Risalah maklumat

IDELVION
®
Albutrepenonacog alfa (250IU, 500IU, 1000IU, 2000IU)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What IDELVION is used for
2.
How IDELVION works
3.
Before you use IDELVION
4.
How to use IDELVION
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
IDELVION
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IDELVION IS USED FOR
IDELVION
is
used
in
children
and
adults with hemophilia B to control and
prevent
bleeding
episodes.
Your
healthcare
provider
may
give
you
IDELVION
when
you
have
surgery.
IDELVION can reduce the number of
bleeding episodes when used regularly
(prophylaxis).
HOW IDELVION WORKS
IDELVION is a haemophilia medicine
that replaces a natural blood clotting
(coagulation)
factor
IX.
The
active
substance
in
IDELVION
is
albutrepenonacog
alfa
(recombinant
fusion
protein
linking
coagulation
factor IX with albumin (rIX-FP)).
Factor IX is involved in blood clotting.
Patients with haemophilia B have a lack
of this factor which means that their
blood does not clot as quickly as it
should so there is an increased tendency
to
bleed.
IDELVION
works
by
replacing factor IX in haemophilia B
patients to enable their blood to clot.
BEFORE YOU USE IDELVION
-
_When you must not use it _
_ _
If
you
are
allergic
to
the
active
ingredient
(albutrepenonacog
alfa)
or
any
of
the
other
ingredients
listed
below.
_ _
-
_Before you start use it _
Talk
to
your
doctor,
pharmacist
or
nurse before using IDELVION.
•
Allergic
(hypersensitivity)
reactions
are
possible.
The
product
contains
traces
of
hamster
proteins
(see
also
“When
you
must
not
use
it”).
If
symptoms of allergic reactions occur,
you
should
stop
using
the
medicine
immediately and contact your doctor.
Your doctor should inform you of the
early
signs
of
hypersensitivity
reactions.
These
include
hives,
generalised skin rash, tightness of the
chest,
wheezing,
low
blood
pressure
(hypotension),
and
anaphylaxis
(a
serious
allergic
reaction
that
cau

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
IDELVION 250IU powder and solvent for solution for injection
IDELVION 500IU powder and solvent for solution for injection
IDELVION 1000IU powder and solvent for solution for injection
IDELVION 2000IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial IDELVION contains nominally 250/500/1000/2000 IU of the
active substance,
recombinant fusion protein linking coagulation factor IX with albumin
(rIX-FP),
(INN = albutrepenonacog alfa).
After reconstitution with 2.5 ml water for injections (250/500/1000
IU) the solution contains
100/200/400 IU/ml of albutrepenonacog alfa. When reconstituted with 5
ml water for
injections (2000 IU) the solution contains 400 IU/ml of
albutrepenonacog alfa.
The potency (International Units [IU]) is determined using an in-vitro
activated partial
thromboplastin time (aPTT)-based one-stage clotting assay calibrated
against the World
Health Organization (WHO) International Standard for factor IX
concentrate.
Albutrepenonacog alfa is a purified protein produced by recombinant
DNA technology,
generated by the genetic fusion of recombinant albumin to recombinant
coagulation factor
IX. The genetic fusion of the cDNA of human albumin to the cDNA of
human coagulation
factor IX enables the protein to be produced as a single recombinant
protein and assures
product homogeneity by avoiding chemical conjugation. The recombinant
factor IX portion
is identical to the Thr148 allelic form of plasma-derived factor IX.
The cleavable linker
between the recombinant factor IX and albumin molecules is derived
from the endogenous
“activation peptide” in native factor IX.
Excipient with known effect:
Sodium approximately 75 mmol/l (1.7243 g/l).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Pale yellow to white powder and clear, colourless solvent for solution
for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IDELVION is indicated in children