BeneFIX powder and solvent for solution for injection 250 IUVial.

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

NONACOG ALFA (RECOMBINANT COAGULATION FACTOR IX)

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

NONACOG ALFA (RECOMBINANT COAGULATION FACTOR IX)

Unit dalam pakej:

1 mcg/mL; 1 Units; 1 Units

Dikeluarkan oleh:

Wyeth Farma, S.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
BENEFIX POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
Nonacog alfa (250 IU, 500 IU, 1000 IU or 2000 IU)
1
WHAT IS IN THIS LEAFLET
1.
What BeneFIX is used for
2.
How BeneFIX works
3.
Before you use BeneFIX
4.
How to use BeneFIX
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of BeneFIX
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of Revision
WHAT BENEFIX IS USED FOR
BeneFIX is an injectable medicine that is
used to help control and prevent bleeding
episodes
including
those
people
with
haemophilia
B
(a
hereditary
bleeding
disorder caused by a lack of blood clotting
factor IX).
BeneFIX is also used to help control and
reduce bleeding in surgical settings.
HOW BENEFIX WORKS
BeneFIX
contains
active
ingredient
nonacog
alfa
(recombinant
coagulation
factor IX).
People who are born with haemophilia B
(also known as Christmas disease) lack
sufficient factor IX to control bleeding.
BeneFIX works by replacing factor IX to
enable their blood to clot.
BEFORE YOU USE BENEFIX
-
_When you must not use it_
Do not take BeneFIX
-
If you are hypersensitive (allergic) to
nonacog alfa or to any of the other
ingredients of the medicine (listed in
Product Description).
-
If you are allergic to hamster protein.
-
_Before you start to use it_
Tell your doctor, pharmacist or nurse:
-
If you have a symptoms or history of
allergic
reaction
like
difficulty
breathing,
shortness
of
breath,
swelling,
hives,
itching,
chills,
flushing,
tightness
of
the
chest,
wheezing,
faintness,
low
blood
pressure and blurred vision.
-
If you suffer from liver disease or if
you have recently had surgery or you
are
known
to
have
coagulation
disorder, there is an increased risk for
blood
clotting
(coagulation)
complications.
_Pregnancy and lactation_
If
you
are
pregnant,
planning
for
pregnancy or breast-feeding ask your
doctor or pharmacist for advice before
using this medicine.
During pregnancy and breast-feeding,
BeneFIX should only be given if it is
clearly indi

Ciri produk

Pfizer Confidential
1
1.
NAME OF THE MEDICINAL PRODUCT
BeneFIX 250 IU powder and solvent for solution for injection.
BeneFIX 500 IU powder and solvent for solution for injection.
BeneFIX 1000 IU powder and solvent for solution for injection.
BeneFIX 2000 IU powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BeneFIX 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 ml (0.234%) sodium chloride
solution for injection, each ml
of the solution contains approximately 50 IU nonacog alfa.
BeneFIX 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 ml (0.234%) sodium chloride
solution for injection, each ml
of the solution contains approximately 100 IU nonacog alfa.
BeneFIX 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 ml (0.234%) sodium chloride
solution for injection, each ml
of the solution contains approximately 200 IU nonacog alfa.
BeneFIX 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 ml (0.234%) sodium chloride
solution for injection, each ml
of the solution contains approximately 400 IU nonacog alfa.
Excipients:
For a full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
White/almost white powder and clear and colourless solvent for
solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
BeneFIX Coagulation Factor IX (Recombinant), is indicated for the
control and prevention of
hemorrhagic episodes and for routine prophylaxis in patients with
hemophilia B (congenital factor
IX deficiency or C