GONAL-F® 75 IU (5.5MCG) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FOLLITROPIN ALFA

Boleh didapati daripada:

MERCK SDN. BHD.

INN (Nama Antarabangsa):

FOLLITROPIN ALFA

Unit dalam pakej:

1Units Units; 5Units Units; 10Units Units

Dikeluarkan oleh:

Merck Serono S.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
GONAL-F
® POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
Follitropin alfa (450 IU/0.75 ml, 75 IU/ml)
WHAT IS IN THIS LEAFLET
1.
What Gonal-F is used for
2.
How Gonal-F works
3.
Before you use Gonal-F
4.
How to use Gonal-F
5.
While you are using Gonal-F
6.
Side effects
7.
Storage and Disposal of Gonal-F
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT GONAL-F IS USED FOR
Gonal-F can be used to bring about the
development of follicles (each follicle
contains one egg) in women who are
not ovulating and who have not
responded to treatment with
clomiphene citrate.
Gonal-F is also used to stimulate the
development of several follicles in
women undergoing assisted
reproductive technologies (ART) such
as in vitro fertilization (IVF).
HOW GONAL-F WORKS
Gonal-F contains follitropin alfa,
which is similar to follicle stimulating
hormone (FSH) found naturally in
humans.
Gonal-F belongs to a class of
hormones called gonadotrophins. FSH
is necessary for the growth and
development of egg cells (follicles) in
women.
BEFORE YOU USE GONAL-F
_- When you must not use it _
Do not use Gonal-F if you have a
history of allergy to any of the
ingredients listed at the end of this
leaflet.
Do not use Gonal-F if you have
tumours of the hypothalamus or
pituitary gland (both are part of the
brain).
Do not use Gonal-F if you:
•
are pregnant
•
are breastfeeding
•
have enlarged ovaries
•
have an unexplained ovarian cyst
•
have unexplained vaginal or uterine
bleeding
•
have cancer of the ovaries, uterus or
breasts
•
ovaries have failed
•
have fibroids in your uterus or
malformations of sexual organs
which would make pregnancy
impossible
•
have testicular insufficiency
_ _
_- Before you start to use it _
Your doctor will assess you and your
partner's fertility. This may include
tests for other medical conditions,
which may interfere with your ability
to become pregnant. If necessary,
other medical conditions may be
treated before s

Ciri produk

page 1
Stimulation of multifollicular development in women
•
undergoing superovulation for assisted reproductive
technologies (ART) such as in vitro fertilisation (IVF),
gamete intra-fallopian transfer and zygote intra-
fallopian transfer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with GONAL-f should be initiated under the
supervision of a physician experienced in the treatment of
fertility disorders.
Posology
The dose recommendations given for GONAL-f are those
in use for urinary FSH. Clinical assessment of GONAL-f
indicates that its daily doses, regimens of administration, and
treatment monitoring procedures should not be different from
those currently used for urinary FSH-containing medicinal
products. It is advised to adhere to the recommended starting
doses indicated below. Comparative clinical studies have
shown that on average patients require a lower cumulative
dose and shorter treatment duration with GONAL-f compared
with urinary FSH. Therefore, it is considered appropriate
to give a lower total dose of GONAL-f than generally used
for urinary FSH, not only in order to optimise follicular
development but also to minimise the risk of unwanted
ovarian hyperstimulation. See section 5.1.
_Women with anovulation (including polycystic ovarian _
_syndrome)_
GONAL-f may be given as a course of daily injections. In
menstruating women treatment should commence within
the first 7 days of the menstrual cycle.
A commonly used regimen commences at 75-150 IU FSH
daily and is increased preferably by 37.5 or 75 IU at 7
or preferably 14 day intervals if necessary, to obtain an
adequate, but not excessive, response. Treatment should
be tailored to the individual patient’s response as assessed
by measuring follicle size by ultrasound and/or oestrogen
secretion. The maximal daily dose is usually not higher than
225 IU FSH. If a patient fails to respond adequately after 4
weeks of treatment, that cycle should be abandoned and the
patient should undergo further evaluation after which she
may recommence treatment a