ANDROGEL

Ország: Indonézia

Nyelv: indonéz

Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktív összetevők:

TESTOSTERONE

Beszerezhető a:

SYDNA FARMA - Indonesia

INN (nemzetközi neve):

TESTOSTERONE

Adagolás:

0.050 G

Gyógyszerészeti forma:

GEL

db csomag:

DUS, 30 SACHET @ 5 GRAM

Gyártó:

BESINS MANUFACTURING BELGIUM SA - Belgium

Engedély dátuma:

2020-04-06

Termékjellemzők

Androgel SmPC – ID – Sep-20
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ANDROGEL 50 mg, gel in sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet of 5 g contains 50 mg of testosterone.
Excipients with known effect: Ethanol.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel in sachet.
Transparent or slightly opalescent, colourless gel in sachet.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Testosterone replacement therapy for male hypogonadism when
testosterone deficiency has
been
confirmed by clinical features and biochemical tests (see 4.4 Special
warnings and
precautions
for use).
4.2
Posology and method of administration
Posology
_Adult and Elderly men_
The recommended dose is 5 g of gel (i.e. 50 mg of testosterone)
applied once daily at about
the
same time, preferably in the morning. The daily dose should be
adjusted by the physician
depending on the clinical or laboratory response in individual
patients, not exceeding 10 g of gel per
day. The adjustment of posology should be achieved by 2.5 g of gel
steps.
Steady
state
plasma
testosterone
concentrations
are
reached
approximately
on
the
2
nd
day
of
treatment
by
this
medicine.
In
order
to
adjust
the
testosterone
dose,
serum
testosterone
concentrations must be measured in the morning before application from
the 3
rd
day on after
starting
treatment
(one
week
seems
reasonable).
The
dose
may
be
reduced
if
the
plasma
testosterone
concentrations are raised above the desired level. If the
concentrations are low,
the dosage may be
increased, not exceeding 10 g of gel per day.
_Paediatric population_
This medicine is not indicated for use in children and has not been
evaluated clinically in males
under 18 years of age.
_Use in women _
This medicine is not indicated for use in women.
DISETUJUI OLEH BPOM: 22/09/2020
EREG10021912000055
Androgel SmPC – ID – Sep-20
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Method of administration
Transdermal use.
The application should be administered by the patient himself, onto
clean, dry, h