ADYNOVATE 2000IU Powder and Solvent for Solution for Injection

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Rurioctocog alfa pegol

Boleh didapati daripada:

Takeda Malaysia Sdn Bhd

INN (Nama Antarabangsa):

Rurioctocog alfa pegol

Unit dalam pakej:

5 ml

Dikeluarkan oleh:

Baxalta US Inc

Risalah maklumat

_ADYNOVATE_
250, 500, 750, 1000, 1500, 2000, 3000IU
ANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_ADYNOVATE_
is used for
2.
How
_ADYNOVATE _
works
3.
Before you use
_ADYNOVATE_
4.
How to use
_ADYNOVATE _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_ADYNOVATE_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _ADYNOVATE IS_ USED FOR
_ADYNOVATE_
is an injectable medicine
that is used to help treat and control
bleeding in children and adults with
hemophilia A (congenital Factor VIII
deficiency). Your healthcare provider
may give you
_ADYNOVATE _
when you
have surgery.
_ADYNOVATE_
can reduce
the number of bleeding episodes when
used regularly (prophylaxis).
_ADYNOVATE_
is not used to treat von
Willebrand disease.
HOW _ADYNOVATE WORKS_
_ADYNOVATE, _
a PEGylated form of
recombinant antihemophilic factor
(
_ADVATE_
), temporarily replaces the
missing coagulation factor VIII needed
for effective hemostasis in congenital
hemophilia A patients.
_ADYNOVATE_
exhibits an extended terminal half-life
through pegylation of the parent
molecule,
_ADVATE_
, which
reduces binding to the physiological
factor VIII clearance receptor (LRP1).
BEFORE YOU USE _ADYNOVATE_
_When you must not use it _
_ _
You should not use
_ADYNOVATE _
if you:
•
are allergic to any ingredients in
_ADYNOVATE_
or
_ADVATE_
. See
the end of this leaflet for a
complete list of ingredients in
_ADYNOVATE._
•
are allergic to mice or hamster
protein.
If you are unsure about this, ask your
doctor.
_Before you start to use it _
You should tell your healthcare provider
if you:
•
Have or have had any medical
problems.
•
Have any allergies, including
allergies to mice or hamsters.
•
Are breastfeeding. It is not
known if
_ADYNOVATE_
passes
into your milk and if it can harm
your baby.
•
Are pregnant or planning to
become pregnant. It is not
known if
_ADYNOVATE_
may
harm your unborn baby.
•
Have been told

Ciri produk

FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
ADYNOVATE 250IU powder and solvent for solution for injection
ADYNOVATE 500IU powder and solvent for solution for injection
ADYNOVATE 750IU powder and solvent for solution for injection
ADYNOVATE 1000IU powder and solvent for solution for injection
ADYNOVATE 1500IU powder and solvent for solution for injection
ADYNOVATE 2000IU powder and solvent for solution for injection
ADYNOVATE 3000IU powder and solvent for solution for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADYNOVATE 250IU powder and solvent for solution for injection
Each vial contains nominally 250 IU human coagulation factor VIII
(rDNA), rurioctocog
alfa pegol
ADYNOVATE 500IU powder and solvent for solution for injection
Each vial contains nominally 500 IU human coagulation factor VIII
(rDNA), rurioctocog
alfa pegol.
ADYNOVATE 750IU powder and solvent for solution for injection
Each vial contains nominally 750 IU human coagulation factor VIII
(rDNA), rurioctocog
alfa pegol.
ADYNOVATE 1000IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU human coagulation factor VIII
(rDNA), rurioctocog
alfa pegol
ADYNOVATE 1500IU powder and solvent for solution for injection
Each vial contains nominally 1500 IU human coagulation factor VIII
(rDNA), rurioctocog
alfa pegol
ADYNOVATE 2000IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU human coagulation factor VIII
(rDNA), rurioctocog
alfa pegol
ADYNOVATE 3000IU powder and solvent for solution for injection
Each vial contains nominally 3000 IU human coagulation factor VIII
(rDNA), rurioctocog
alfa pegol
1 INDICATIONS AND USAGE
ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human
antihemophilic factor indicated in children and adults with hemophilia
A (congenital
factor VIII deficiency) for:
•
On-demand treatment and control of bleeding episodes
•
Perioperative management
•
Routine prophylaxis to reduce the frequency of bleeding episodes
Limitation of Use
ADYNOV