GONAL-F® SOLUTION FOR INJECTION IN PRE-FILLED PEN

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

FOLLITROPIN ALFA

Tilgjengelig fra:

MERCK SDN. BHD.

INN (International Name):

FOLLITROPIN ALFA

Enheter i pakken:

150 International Unit per Milliliter; 1Units Units

Produsert av:

Merck Serono S.p.A.

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
GONAL-F
® SOLUTION FOR INJECTION IN
PRE-FILLED PEN
Follitropin alfa (22mcg/0.5ml)
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 fertilisation (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
•
have ovary failure
•
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 starting in

Preparatomtale

1. NAME OF THE MEDICINAL PRODUCT
GONAL-f 150 IU/0.25mL (11 micrograms/0.25mL) solution for injection in
pre-filled
pen.
GONAL-f 300 IU/0.75 mL (22 micrograms/0.5 ml) solution for injection
in pre-filled pen.
GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 ml) solution for injection
in pre-filled
pen.
GONAL-f 900 IU/0.75 mL (66 micrograms/1.5 ml) solution for injection
in pre-filled pen.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the solution contains 600 IU of follitropin alfa*,
(equivalent to 44 micrograms).
Each 150IU pre-filled multidose pen delivers 150 IU (equivalent to 11
micrograms) in 0.25mL
Each 300IU pre-filled multidose pen delivers 300 IU (equivalent to 22
micrograms) in 0.5 mL.
Each 450IU pre-filled multidose pen delivers 450 IU (equivalent to 33
micrograms) in 0.75
mL.
Each 900IU pre-filled multidose pen delivers 900 IU (equivalent to 66
micrograms) in 1.5 mL.
* recombinant human follicle stimulating hormone (r-hFSH) produced in
Chinese Hamster
Ovary (CHO) cells by recombinant DNA technology.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection in pre-filled pen.
Clear colourless solution.
The pH of the solution is 6.7-7.3.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adult women
•
Anovulation (including polycystic ovarian syndrome) in women who have
been
unresponsive to treatment with clomiphene citrate.
•
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.
Patients must be provided with the correct number of pens for their
treatment course and
educated to use the proper injection techniques.
Posology
The dose recommendations given for GONAL-f are those in use for
urinary FSH. Clinical
asses