IMMUNATE 50 IUML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

Von Willebrand Factor; HUMAN BLOOD COAGULATION FACTOR VIII

Tilgængelig fra:

Takeda Malaysia Sdn Bhd

INN (International Name):

Von Willebrand Factor; HUMAN BLOOD COAGULATION FACTOR VIII

Enheder i pakken:

1Units Units; 5 ml 1 Units mL

Fremstillet af:

Takeda Manufacturing Austria AG

Indlægsseddel

_IMMUNATE _
50 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

Produktets egenskaber

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Technical Info
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Technical Specification:
0750095
2
0402115_1_PIL_Drwg
435 x 270 mm
103988904 / 401937462 / SGK München
16Jun2020
0402115
750095
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
50
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
vial
contains
nominally
250
IU
human
coagulation
factor
VIII1
and
190 IU human von Willebrand factor
2
(VWF:RCo).
Immunate
250
IU
FVIII/190
IU
VWF
contains
approximately
50
IU/ml
of
human
coagulation
factor
VIII
and
38 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 vial contains approx. 9.8 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
deficiency.
4.2 POSOLOGY
AND
METHOD
OF
ADMINISTRATION
Treatment
should
be
under
the
supervision of a physician experienced in
the treatment of haemostatic disorders.
Posology
DOSAGE IN HAEMOP