KOATE DVI(5ML VIAL-250IU)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FACTOR VIII/ANTIHAEMOPHILIC FACTOR/AHF

Boleh didapati daripada:

GRIFOLS MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

FACTOR VIII/ANTIHAEMOPHILIC FACTOR/AHF

Unit dalam pakej:

5ml mL

Dikeluarkan oleh:

Grifols Therapeutics, Inc.

Risalah maklumat

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

Ciri produk

colors: BLACK
K/P Corporation
Job No. 41292 / 45648 / 47272
Client: Grifols Therapeutics LLC
Cat. No. 3054840
Fonts: Nimbus Sans Condensed
Edits: reb
Date: 11/18/2016, 10/21, 10/22, 1/20/2020 1/21, 1/22, 2/6
ID: 1,4,14
Size: 5-1/8" x 15" (Spec 9024812)
Proof 7
Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (% normal or
IU/dL) x 0.5
• Estimate the expected _in vivo_ peak increase in Factor VIII
level, expressed as IU/dL (or % normal), using the following formula:
Estimated Increment of Factor VIII
(% normal or IU/dL) = [Total Dose (IU)/Body Weight (kg)] x 2
• Patients may vary in their pharmacokinetic (e.g., half-life, in
vivo recovery) and clinical responses. Base the dose and frequency on
the individual
clinical response.
Control and Prevention of Bleeding Episodes
A guide for dosing KOĀTE-DVI for the control and prevention of
bleeding episodes (1,2) is provided in Table 1. Consideration should
be given to
maintaining a Factor VIII activity at or above the target range.
Table 1: Dosage Guidelines for Patients with Hemophilia A
Type of Bleeding
Factor VIII:C
Level Required
(% of normal)
Doses
(IU/kg)
Frequency
of Doses
(hours)
Duration of Therapy
(days)
Minor
Large bruises
Significant cuts or scrapes
Uncomplicated joint hemorrhage
30
15
12
(twice daily)
Until hemorrhage stops and healing
has been achieved (1–2 days).
Moderate
Nose, mouth and gum bleeds
Dental extractions
Hematuria
50
25
12
(twice daily)
Until healing has been achieved
(2–7 days, on average).
Major
Joint hemorrhage
Muscle hemorrhage
Major trauma
Hematuria
Intracranial and intraperitoneal bleeding
80-100
Initial: 40-50
Maintenance: 25
12
(twice daily)
For at least 3–5 days
Until healing has been achieved for
up to 10 days.
Intracranial hemorrhage may
require prophylaxis therapy for up
to 6 months.
Surgery
Prior to surgery: 80-100
After surgery: 60-100
40-50
30-50
Once
12
(twice daily)
Prior to surgery
For the next 7–10 days, or until
healing has been achieved.
It should be emphasized that the dosage of KOĀTE-DVI required for