Firmagon 120 mg

Χώρα: Ιορδανία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

Degarelix 120 mg

Διαθέσιμο από:

مستودع البتراء للمواد الطبية - Petra Drug Store

Φαρμακολογική κατηγορία (ATC):

L02BX02

INN (Διεθνής Όνομα):

Degarelix 120 mg

Δοσολογία:

120 mg

Μονάδες σε πακέτο:

2 Vials Powder & 2 pre-filled syringes with 3ml solvent

Κατασκευάζεται από:

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

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PHARMAC£lJTICAl.$
-
-
FIRMAGON®120
mg
-
Powder
&
solvent for solution
-
-
-
for Injection
ltUALITADVE
AND
QUANmADVE
COMPOSITION;
Each
vial
contains 120
mg
degarelix (as acetate). After reconstitution,each
ml
of
solution contains
40
mg
of
degarelix.
PHARMACEUTICAL
FORM
Powder
and
solvent
lor
solution for injection
(powder
for
injection
and
solvent)
Powder
:
White
to
off-white
powder
Solvent: Clear, colour\ess solulion
ld.INICAL
PARDcw.A
.BS:
Therapeutic
indications
FIRMAGON
is a gonadotrophin releasing
hormone
(GnRH)
antagonist indicated for
treatment
of
adull
male
patients with
advanced
hormone-dependent
prostate cancer.
Posology
and
methOd
0'
administration
~
Starting
dose
Maintenance
dose
- monthly
dministration
240
mg
administered
as
two
80
mg
adminislered
as one
subcutaneous
subcutaneous injections
of
120
mg
each
injection
The first maintenance
dose
should be given
one
month
after the starting dose.
The
therapeutic effect
of
degarelix should be monitored by clinical
parameters
and prostate specific antigen (PSA) serum
levels. ClinIcal
stud
ies
have
shown
that testosterone (T)
suppression
occurs
immediately
after administration
of
the
starting
dose
with
96%
of
the patients having
plasma
testosterone
levels
corresponding
to
med~1
castration
_[T _
~0.5
nglml)
after
Ihree
days
and
100%
after
one
month. Long term treatment
wHh
the maintenance
dose
up
to
1
year
shows
that
97%
of
the
patients
have
sustained suppressed testosterone levels
_[T _
:S
0.5 ng/ml},
In
case
the patient's clinical response
appears
to
be
sub-optimal, it should
be
confirmed that
serum
testosterone levels
are remaining sufficiently suppressed.
Since
degarelix
does
not
induce a testosterone
surge
it is
not
necessary
to
add
an anti-androgen as surge protecHon
at
initia