Mononine 500

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

human blood coagulation factor IX

Mevcut itibaren:

CSL Behring GmbH

INN (International Adı):

human blood coagulation factor IX

Doz:

500IU

Farmasötik formu:

powder and solvent for solution for injection or infusion

Reçete türü:

Prescription

Bilgilendirme broşürü

MONONINE 500
Powder and solvent for solution for injection or infusion
Human coagulation factor IX
IN THIS LEAFLET:
1. What Mononine 500 is and what it is used for
2. Before you use Mononine 500
3. How to use Mononine 500
4. Possible side effects
5. How to store Mononine 500
6. Further information
1. WHAT MONONINE 500 IS AND WHAT IT IS USED FOR
WHAT IS MONONINE 500?
Mononine 500 is made from human plasma (this is the liquid part of the
blood) and it contains human coagulation Factor IX. It is used to
prevent or to
stop bleeding that is caused by the congenital lack of Factor IX
(haemophilia B)
in the blood.
WHAT MONONINE 500 IS USED FOR
Factor IX is very important for blood clotting (coagulation). Lack of
Factor IX
means that blood does not clot as quickly as it should and so there is
an
increased tendency to bleed. The replacement of Factor IX with
Mononine 500
will temporarily repair the blood clotting mechanisms.
The made up solution is to be given by injection or infusion into a
vein.
2. BEFORE YOU USE MONONINE 500
The following sections contain information that you and your doctor
should
consider before you use Mononine 500.
DO NOT USE MONONINE 500:
• If you are allergic to the human coagulation factor IX or to any
of the ingre
dients of Mononine 500 or to mouse protein. Please inform your doctor
if
you are allergic to any medicine or food.
• If you have a high risk of forming blood clots (thrombosis) or if
you are more
likely to form blood clots than normal (disseminated intravascular
coagula
tion).
TAKE SPECIAL CARE WITH MONONINE 500:
• As with any injection of a protein, allergic reactions are
possible. The early
signs include hives, generalised skin rash, tightness of the chest,
wheezing,
fall in blood pressure and anaphylaxis (a serious allergic reaction
that caus
es severe difficulty in breathing, or dizziness). IF THESE SYMPTOMS
OCCUR,
YOU SHOULD STOP USING THE PRODUCT IMMEDIATELY AND CONTACT YOUR
DOCTOR.
• Mononine 500 contains, as remains of a special purification step,
TRACES OF
MOUSE PR

Ürün özellikleri

CSL Behring
MODoniDe~ 500
EDSICorelEnglisb,
Rev.:
_17-0CT-20121_
cbange
to WFI
Marburg
1.
NAME OF THE MEDICINAL PRODUCT
Mononine
500.
100 IV/ml,
powder
and solvent
for
solution
for
injection
or infusion
2.
QUALITATIVE
AND QUANTITATIVE
COMPOSITION
One vial
contains
powder
with 500 IV human coagulation
factor
lX.
After
reconstitution
with 5 ml
of
water
for
injections
I ml
contains:
human
coagulation
factor
IX
100 IU/ml
CSL Behring
Monomne ,
CCDS 500_17.0CT·2012_blank_16e021
The potency
(IV)
is determined
using the European
Pharmacopoeia
one stage clotting test.
The mean specific
activity
of
Mononine
500 is not
less than
190 IV/mg protein.
Excipient
recognized
to have a known effect:
Sodium (as chloride):
up to 10.2 mg
For
a full
list
of excipients,
see 6.1.
3.
PHARMACEUTICAL
FORM
Powder
and solvent
for
solution
for
injection
or infusion.
4.
CLINICAL PARTICULARS
4.1
Therapeutic
indications
Treatment
and prophylaxis
of bleeding
in patients
with haemophilia
B (congenital
factor
IX
deficiency).
4.2
Posology and method of administration
Treatment
should be initiated
under
the supervision
of a physician
experienced
in the
treatment
of haemophilia.
_Posology_
The dosage
and duration
of the substitution
therapy depend
on the severity
of the factor
IX
deficiency,
on the location
and extent
of the bleeding
and on the patient's
clinical
condition.
CSL Behring
Mononine'"
500
EDS/Core/English,
Rev.:
17-0CT-20
_121_
change
to WFI
Marburg
The number
of
units
offactor
IX administered
is expressed
in International
Units
(fU),
which
are related to the current
WHO standard
for
factor
IX products.
Factor
IX actvity in
plasma
is expressed
either
as a percentage
(relative
to normal
human plasma)
or
in
International
Units
(relative
to an international
standard
for
factor
IX in plasma).
One International
Unit
(IV)
offactor
IX activity
is equivalent
to that
quantity
of
factor
IX in
one ml
of normal
human plasma.
The calculation
of the required
dosage
of factor
IX is
based on the empirical
finding
that
1 IU factor
IX per
kg body weight
rai