FEIBA (Factor VIII Inhibitor Bypassing Activity) 25Uml Powder and solvent for solution for infusion

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

FACTOR VIII BYPASSING FRACTION

Dostupné z:

Takeda Malaysia Sdn Bhd

INN (Medzinárodný Name):

FACTOR VIII BYPASSING FRACTION

Počet v balení:

1 Vials

Výrobca:

Takeda Manufacturing Austria AG

Príbalový leták

Not Applicable

Súhrn charakteristických

Black
Black
Dieline
Technical Info
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Technical Specification:
0752864
1
0402140_1_PIL_Drwg
480 x 328 mm
104761028 / 402166595 / SGK München
11Dec2020
0402140
752864
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
FEIBA (FACTOR VIII INHIBITOR
BYPASSING ACTIVITY) 25 U/ML
POWDER AND SOLVENT FOR SOLUTION
FOR INFUSION
2.
QUALITATIVE AND
QUANTITATIVE COMPOSITION
Active
substance:
Factor
VIII
Inhibitor Bypassing Activity
1
ml
contains
25
U*
factor
VIII
inhibitor bypassing activity.
1
vial
FEIBA
25
U/ml
contains
500 U factor VIII inhibitor bypassing
activity in 200 – 600 mg human
plasma protein.
FEIBA also contains the factors II, IX
and X, mainly in non-activated form,
as well as activated factor VII. Factor
VIII coagulation antigen (F VIII C:Ag)
is present at a concentration of up
to 0.1 U./1 U. FEIBA. The factors of the
kallikrein-kinin system are present in
trace amounts only, if at all.
* 1 unit of FEIBA shortens the activated
partial thromboplastin time (aPTT) of
a factor VIII inhibitor plasma by 50% of
the buffer value (blank value).
Excipients
with
known
effect:
3.6 mmol sodium (80 mg) per vial.
For
a
full
list
of
excipients,
see
section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for
infusion.
White,
off-white
or
pale
green
powder.
The
pH
value
of
the
ready-to-use
solution
is
between
6.8 and 7.6.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FEIBA
is
used
for
the
treatment
and prophylaxis of hemorrhages in
hemophilia A and B patients with
inhibitors.
Furthermore,
FEIBA
can
be
used
for the treatment and prophylaxis
of hemorrhages in non-hemophilic
patients
who
have
developed
inhibitors to Factors VIII, IX and XI.
Individual
reports
exist
about
the
use
of
FEIBA
in
the
treatment
of
patients with acquired i