Immunate 250IU+190IU powder and solvent for solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

human blood coagulation factor VIII, Von Willebrand Factor(VWF:RCo)

Available from:

Baxter AG

ATC code:

B02BD06

INN (International Name):

human blood coagulation factor VIII, Von Willebrand Factor(VWF:RCo)

Dosage:

250IU+190IU

Pharmaceutical form:

powder and solvent for solution for injection

Units in package:

(1) glass vial, glass vial 5ml with solvent, (1) transfer/filter set, (1) disposable syringe 5ml, (1) disposable needle, (1) win

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-07-16

Patient Information leaflet

Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
–
Keep this leaflet. You may need to read it
again.
–
If you have any further questions, please ask
your doctor or pharmacist.
–
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
–
If you get any side effects, talk to your doctor
or
pharmacist.
This
includes
any
possible
side
effects
not
listed
in
this
leaflet.
See
section 4.
What is in this leaflet
1. What Immunate is and what it is used for
2. What
you
need
to
know
before
you
use
Immunate
3. How to use Immunate
4. Possible side effects
5. How to store Immunate
6. Contents of the pack and other information
1. What Immunate is and what it is used for
What Immunate is
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.
What Immunate is used for
Immunate is used for the treatment and prevention
of
bleeding
in
congenital
(haemophilia
A)
or
acquired factor VIII deficiency.
Immunate
is
also
used
for
the
treatment
of
bleeding in patients with von Willebrand’s disease
with factor VIII deficiency, if no specific preparation
effective
against
von
Willebrand’s
disease
is
available,
and
when
desmopressin
(DDAVP)
treatment alone is ineffe

Summary of Product characteristics

SPC
IMMUNATE 250 IU
November 2017
1/11
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Immunate 250 IU FVIII/190 IU VWF 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 VIII
1
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 congenital
(haemophilia A) or
acquired factor VIII deficiency.
Treatment of bleeding in patients with von Willebrand's disease with
factor VIII
deficiency, if no specific preparation effective against von
Willebrand’s disease is
available, and when desmopressin (DDAVP) treatment alone is
ineffective or contra-
indicated.
1
The FVIII potency was determined against the WHO International
Standard for FVIII Concentrates.
2
The ristocetin cofactor activity of human von Willebrand factor was
determined against the WHO International Standard for von
Willebrand Factor, Concentrate.
3
without stabilizer (albumin); The maximum specific activity at a 1:1
ratio of factor VIII activity to von Willebrand factor-antigen is
100 IU factor VIII per mg protein.
SPC
IMMUNATE 250 IU
November 2017
2/11
4.2