Firmagon 80mg 80 mg

Land: Jordan

Sprog: engelsk

Kilde: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Aktiv bestanddel:

Degarelix 80 mg

Tilgængelig fra:

مستودع البتراء للمواد الطبية - Petra Drug Store

ATC-kode:

L02BX02

INN (International Name):

Degarelix 80 mg

Dosering:

80 mg

Enheder i pakken:

1 powder vial , 1 solvent pre-filled syrige , 1 vial adaptor and 1 injection needle

Fremstillet af:

RENTSCHLER BIOTECHNOLOGIC GMBH & CO.KG/GERMANY (المانيا)

Indlægsseddel

--
--
---
'~Ii
~"""'
~
':"
fli)
p r
1
11
r
=
FoL
.JlnQ
---
..
-
--
-!:.
f-l
f>
f
t
D I·
dt
10
1'1
---
--
['
II
!
11
ft
'
l !
-t-t
Ph..!
t·
!JI
.,
l
'lIjl
I'
IJ~
I
tJ"
j
II
(
t'
f
f
'.1
~)
_I, _
mil'
'r
')
ITI
t
"
,
'
-
-
FIRMAGON®
80
mg
t
-
­
-
Powder
&
solvent for solution
(),'
I
WI"
nl~
IE-~S
- .'.U3
for
Injection
:3
1
~~E.AlilLQUANTITAIIVE
CQ]ol~
Each vial contains
80
mg degarelix (as acetate). After reconslitution,each ml
of
solution contains 20 mg
01
degarelix,
'tOOjll,201l11'
I
o
'"
1J
CIJ
..0
PHARMACEUII~
Powder and solvent for solution for injection (powder for injection
and solvent)
Powder.
White
to off-white
powder
Solvent: Clear, colourless solution
!;:LlNICAL PARTI!;:ULARS:
Therapeutic
indications
FIRMAGON
is a gonadotrophin releasing hormone (GnRH) antagonist indicated for
treatment of adult male patients with
advanced hormone-dependent prostate cancer.
Posology
and
method
of
administration
~
Starting dose
Maintenance dose - monthly
administration
240
mg administered
as
two
80
mg
administered
as
one
subcutaneous
subcutaneous injections of 120 mg each
injection
The
first maintenance dose should be given
one
month aher the starting dose.
The
therapeutic eHect of degarelix should
be
monitored
by
clinical parameters and prostate specific antigen (PSA) serum
levels. Clinical studies have shown that testosterone
(T)
suppression occurs immediately after administration of the
(}a:~§
~~~J)~ge~~~~
~ae~~~~n~s03~Xi~~trl~~~~:~tt~
.
sL:~~~~~~~~~::~f~~~i~~et~~~~!~~n~~S~~~p
to
1
year
shows
that
97"10
of the patients have sustained suppressed testosterone levels
(T:s:
0.5 ng/ml).
~r~:~:~i~;~~~;i~~~~~~~~:~.~~:~~~a~:I~u~~':fst:~'i
'
n~~::~e~~o~~::~~ee~~~ga~
~~~u:tt~~~~~~~~~e:~~s
an anti-androgen as surge protection at initiation of therapy.
Special patient populations
_Elderly. _
hepatically
or
renalty impaired patients:
There
is
no
need to adjust the dose for the eldel1y
or
in patients with mild or moderate liver
or
kidney function impairment
Patients with severe liver
or
kidney impairment have not been studied a