Androgel 25mg gel of testosterone 1%

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

TESTOSTERONE

Commercializzato da:

BREGO LIFE SCIENCES SDN. BHD

INN (Nome Internazionale):

TESTOSTERONE

Confezione:

030Units Units

Prodotto da:

Delpharm Drogenbos S.A

Foglio illustrativo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ANDROGEL 50MG, GEL OF TESTOSTERONE 1%
ANDROGEL 25MG, GEL OF TESTOSTERONE 1% TESTOSTERONE GEL 1%
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 problemsrelating
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
male st

Scheda tecnica

5005027
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 2nd 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 3rd 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 arms and abdomen.
Aft