Androgel 25mg, gel of testosterone 1%

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

TESTOSTERONE

Διαθέσιμο από:

BREGO LIFE SCIENCES SDN. BHD

INN (Διεθνής Όνομα):

TESTOSTERONE

Μονάδες σε πακέτο:

030Units Units

Κατασκευάζεται από:

BESINS MANUFACTURING BELGIUM

Φύλλο οδηγιών χρήσης

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
ANDROGEL 50MG, GEL OF TESTOSTERONE 1%
ANDROGEL 25MG, GEL OF TESTOSTERONE 1%
TESTOSTERONE GEL 1%
WHAT IS IN THIS LEAFLET?
1.
What is Androgel used for
2.
How Androgel works
3.
Before you use Androgel
4.
How to use Androgel
5.
While you are using Androgel
6.
Side effects
7.
Storage and Disposal of Androgel
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT IS ANDROGEL IS USED FOR
Androgel
is
a
colourless
gel
containing
Testosterone
1%
in
a
5
g
sachet.
Testosterone is a male hormone produced
naturally in the body. (Pharmacotherapeutic
group: urogenital system and sex hormones).
Androgel is prescribed for problems relating
to testosterone deficiency in men over 18
years as hormone replacement therapy.
HOW ANDROGEL WORKS
Androgel
is
a
topical
daily
testosterone
replacement therapy (TRT) that can help
bring your testosterone levels back to normal
with daily morning use. This clear, odorless,
and concentrated quick-drying gel is used to
treat
adult
males
who
have
low
or
no
testosterone
due
to
certain
medical
conditions. The testosterone in AndroGel is
the
same
as
the
testosterone
your
body
makes naturally.
BEFORE YOU USE ANDROGEL
_When you must not use it _
-
Androgel is a transdermal product which is
applied topically and should not be taken
orally.
-
If you are suffering from prostate cancer or
breast cancer.
-
If you are allergic to testosterone or to any
of the ingredients of the gel
_Pregnancy and lactation _
Pregnant women must avoid any contact
with the Androgel application sites. This
medicine may
cause
the
development
of
unwanted
male
characteristics
in
the
developing baby. In the event of contact,
wash the area of contact as soon as possible
with soap and water. If your partner becomes
pregnant,
you
must
follow
the
advice
regarding
avoiding
transfer
of
the
testosterone gel.
_Before you start to use it _
Consult
with
your
doctor
or
pharmacist
before using Androgel.
-Androgel is not used for the treatment of
ma

Αρχείο Π.Χ.Π.

PACKAGE INSERT
ANDROGEL, GEL IN SACHET
1.
NAME OF THE MEDICINAL PRODUCT
ANDROGEL
25
mg,
gel
in
sachet
ANDROGEL 50 mg, gel in sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Testosterone ……………………………………….0.025 g for
one 2.5 g sachet
Testosterone ……………………………………….0.050 g for
one 5 g sachet
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Gel in sachet.
ANDROGEL is a transparent or slightly opalescent, colourless gel.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Testosterone replacement therapy for male hypogonadism when
testosterone deficiency has
been confirmed by clinical signs 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 (and up to one week). 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 _
ANDROGEL 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.
Method of Administration
Transdermal use
The application should be administered by the patient himself, onto
clean, dry, healthy skin
over both shoulders, or both arm