IMMUNATE 100 IUML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Von Willebrand Factor; HUMAN BLOOD COAGULATION FACTOR VIII

Boleh didapati daripada:

Takeda Malaysia Sdn Bhd

INN (Nama Antarabangsa):

Von Willebrand Factor; HUMAN BLOOD COAGULATION FACTOR VIII

Unit dalam pakej:

1Units Units; 1Units Units; 10 ml 1 Units mL; 5 ml 1 Units mL

Dikeluarkan oleh:

Takeda Manufacturing Austria AG

Risalah maklumat

_IMMUNATE _
100 IU/ML
HUMAN COAGULATION FACTOR VIII (HUMAN VON WILLEBRAND FACTOR)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What
_IMMUNATE _
is used for
2.
How
_IMMUNATE _
works
_3._
_ _
Before you use
_IMMUNATE _
_4._
_ _
How to use
_IMMUNATE _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_IMMUNATE _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _IMMUNATE IS _USED FOR
_IMMUNATE _
is used for the treatment
and prevention of bleeding in patients
with haemophilia A (congenital factor
VIII deficiency, haemophilia A with
factor VIII inhibitor, acquired factor VIII
deficiency due to spontaneous
development of factor VIII inhibitor).
_IMMUNATE _
is also used for the
treatment of bleeding in patients with
von Willebrand’s disease with factor
VIII deficiency.
HOW _IMMUNATE WORKS _
_ _
_IMMUNATE _
is a coagulation factor VIII
/ von Willebrand factor complex made
from human plasma. The coagulation
factor VIII in
_IMMUNATE _
replaces the
factor VIII which is lacking or is not
functioning properly in haemophilia A.
Haemophilia A is a sex-linked,
hereditary blood coagulation defect due
to reduced factor VIII levels. This results
in severe bleeding in joints, muscles and
inner organs, either spontaneously or as a
consequence of accidental or surgical
traumata. The administration of
_IMMUNATE _
temporarily corrects the
factor VIII deficiency and reduces the
bleeding tendency.
In addition to its role as a Factor VIII
protecting protein, von Willebrand
Factor (VWF) mediates platelet adhesion
to sites of vascular injury and plays a
role in platelet aggregation.
BEFORE YOU USE _IMMUNATE _
_ _
_When you must not use it _
Do not take
_IMMUNATE _
if you are
allergic to human coagulation factor VIII
or any of the other ingredients of this
medicine. See the end of this leaflet for a
complete list of ingredients in
_IMMUNATE. _
If you are unsure about this, ask your
doctor.
_Before you start use it _
_ _
_When allergic

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Technical Info
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Technical Specification:
0750096
2
0402115_1_PIL_Drwg
435 x 270 mm
103988959 / 401937516 / SGK München
16Jun2020
0402115
750096
CODE ITF 2/5
DATAMATRIX CODE
NA
RSS / GS1-128 CODE
NA
PHARMACODE
NA
CODE 3 OF 9
NA
GTIN / EAN-13 CODE
NA
BODY TEXT SIZE
9 pt
FRONT
BACK
1. NAME OF THE MEDICINAL PRODUCT
IMMUNATE
100
IU/ML
POWDER
AND
SOLVENT FOR SOLUTION FOR INJECTION
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Active Substances: Human coagulation
Factor
VIII/
Human
von
Willebrand
Factor
Each
5
ml
vial
contains
nominally
500 IU human coagulation factor VIII
1
and
375
IU
human
von
Willebrand
factor
2
(VWF:RCo).
Each
10
ml
vial
contains
nominally
1000
IU
human
coagulation
factor
VIII1 and 750 IU human von Willebrand
factor
2
(VWF:RCo).
IMMUNATE
100
IU/ML
POWDER
FOR
INJECTION
contains
approximately
100 IU/ml of human coagulation factor
VIII and 75 IU/ml human von Willebrand
factor after reconstitution.
The
potency
of
factor
VIII
(IU)
is
determined
using
the
European
Pharmacopoeia
chromogenic
assay.
The
specific
activity
of
Immunate
is 70 ± 30 IU FVIII/mg protein
3
. The
potency of VWF (IU) is determined using
the European Pharmacopoeia ristocetin
co-factor assay (VWF:RCo).
Produced from the plasma of human
donors. Excipients with known effect:
1 5 ml vial contains approx. 9.8 mg
sodium.
1 10 ml vial contains approx. 19.6 mg
sodium.
For the full list of excipients, see section
6.1.
3. PHARMACEUTICAL FORM
Powder
and
solvent
for
solution
for
injection. White or pale yellow powder
or friable solid.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding
in
patients
with
haemophilia
A
(congenital
factor
VIII
deficiency,
haemophilia A with factor VIII inhibitor,
acquired factor VIII deficiency due to
spontaneous development of factor VIII
inhibitor).
Von Willebrand’s disease with factor VIII