KOATE DVI(5ML VIAL-250IU)

Land: Maleisië

Taal: Engels

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

Werkstoffen:

FACTOR VIII/ANTIHAEMOPHILIC FACTOR/AHF

Beschikbaar vanaf:

GRIFOLS MALAYSIA SDN. BHD.

INN (Algemene Internationale Benaming):

FACTOR VIII/ANTIHAEMOPHILIC FACTOR/AHF

Eenheden in pakket:

5ml mL

Geproduceerd door:

Grifols Therapeutics, Inc.

Bijsluiter

KOĀTE-DVI
_Consumer Medication Information Leaflet (RiMUP) _
Active Ingredient: antihemophilic factor VIII (human) 250 IU / 5 mL
Page 1
WHAT IS IN THIS LEAFLET
1. What KOĀTE-DVI is used for
2. How it works
3. Before you use KOĀTE-DVI
4. How to use KOĀTE-DVI
5. While you are using it
6. Side effects
7. Storage and Disposal of
KOĀTE-DVI
8. Further Information
WHAT KOĀTE-DVI IS USED FOR
KOĀTE-DVI is used for the
treatment and prevention of
bleeding, or in order to perform
emergency and elective surgery, for
patients with haemophilia A
(congenital factor VIII deficiency).
Limitation of use
KOĀTE-DVI is not indicated for
the treatment of von Willebrand
disease.
HOW KOĀTE-DVI WORKS
KOĀTE-DVI is one of the group of
medicines called clotting factors.
KOĀTE-DVI contains human
coagulation factor VIII obtained
from human plasma.
KOATE-DVI temporarily replaces
the missing clotting factor in order
to control or prevent bleeding
episodes.
BEFORE YOU USE KOĀTE-DVI
-When you must not use it
Do not use KOĀTE-DVI if you are
allergic to human coagulation factor
VIII or to any of the other
ingredients of this medicine (see
FURTHER INFORMATION
).
If you want more detailed
information then ask your doctor.
- Before you start to use it
Talk to your doctor, pharmacist or
nurse before using KOĀTE-DVI.
• Rarely you may have an
anaphylactic reaction (a sudden
severe allergic reaction) such as
rash, tightness of the chest,
dizziness, nausea, vomiting, or
difficulty breathing. If these
symptoms occur, you must stop
using the product immediately
and contact your doctor.
•
Your doctor should perform
some tests to make sure that the
dosage of KOĀTE-DVI you are
receiving is enough to achieve
and maintain appropriate
coagulation factor VIII levels and
thus stop any bleeding.
•
If your bleeding is not controlled
with KOĀTE-DVI, consult your
doctor immediately. You may
have developed factor VIII
inhibitors. These are antibodies
which block the clotting effect of
factor VIII. Your doctor will
perform some tests to confirm
wheth