Androgel 25mg

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Testosterone 1%

Dostępny od:

PHARMED IMPORT & EXPORT PTE LTD

Dawkowanie:

0.025g

Forma farmaceutyczna:

GEL

Skład:

Testosterone 1% 0.025g

Droga podania:

CUTANEOUS

Typ recepty:

Prescription Only

Wyprodukowano przez:

Laboratoires Besins International

Status autoryzacji:

ACTIVE

Data autoryzacji:

2005-12-22

Charakterystyka produktu

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
Testosterone .....................
.........................................0.050 g
For excipients, see 6.1.
For one 2.5 g sachet
For one 5 g sachet
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
Cutaneous use.
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 doctor 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.
The application should be administered by the patient himself, onto
clean, dry, healthy skin over
both shoulders, and both arms and abdomen.
After opening the sachets, the total contents must
be extracted
from the sachet and applied
immediately onto the skin. The gel has just to be simply spread on the
skin gently as a thin layer. It is
not necessary to rub it on the skin. Allow drying for at least 3-5
minutes before dressing. Wash hands
with soap and water after application.
Do not apply to the genital areas as the high alcohol content may
cause local irritation.
Steady state plasma testosterone concentrations are reached
approximately on the 2
nd
day of
treatment
by
ANDROGEL.
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
start