FEIBA (Factor VIII Inhibitor Bypassing Activity) 50Uml Powder and solvent for solution for infusion

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

FACTOR VIII BYPASSING FRACTION

Dostopno od:

Takeda Malaysia Sdn Bhd

INN (mednarodno ime):

FACTOR VIII BYPASSING FRACTION

Enote v paketu:

1 Vials; 1 Vials

Izdeluje:

Takeda Manufacturing Austria AG

Navodilo za uporabo

Not Applicable

Lastnosti izdelka

Technical Info
Dieline
NA
NA
NA
CODE 3 OF 9
DATAMATRIX CODE
RSS / GS1-128 CODE
BODY TEXT SIZE
9.0 pt
756232
CODE ITF 2/5
NA
PHARMACODE
NA
GTIN / EAN-13 CODE
BACK
Black
TECHNICAL SPECIFICATION:
ARTWORK DIMENSIONS/SIZE:
ITEM NUMBER:
FRONT
0756232
VERSION: 1
PROFILE: 0402140_1_PIL_Drwg
0402140
480 x 328 mm
GRAPHICS HOUSE:
SGK Redmond
DATE:
29DEC2021
OPTIONAL: Artwork Approver outside the Shire Management System:
ROLE:
NAME:
SIGNATURE:
DATE:
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1.
NAME OF THE MEDICINAL PRODUCT
FEIBA (FACTOR VIII INHIBITOR
BYPASSING ACTIVITY) 50 U/ML
POWDER AND SOLVENT FOR SOLUTION
FOR INFUSION
2.
QUALITATIVE AND
QUANTITATIVE COMPOSITION
Active
substance:
Factor
VIII
Inhibitor Bypassing Activity
1
ml
contains
50
U*
factor
VIII
inhibitor bypassing activity.
FEIBA
50U/ml
is
available
in
the
following presentation:
-
The
presentation
500
U
FEIBA
contains
500
U
factor
VIII
inhibitor
bypassing
activity
in
200
–
600
mg
human
plasma
protein,
-
The
presentation
1000
U
FEIBA
contains
1000
U
factor
VIII
inhibitor
bypassing
activity
in
400 – 1,200 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:
1.8 mmol sodium (40 mg) per vial
with 500 U FEIBA.
3.6 mmol sodium (80 mg) per vial
with 1000 U FEIBA.
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