Ganirelix Gedeon Richter

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ganirelix acetate

Available from:

Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)

ATC code:

H01CC01

INN (International Name):

ganirelix

Therapeutic group:

Pituitary and hypothalamic hormones and analogues

Therapeutic area:

Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female

Therapeutic indications:

Prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).

Authorization status:

Authorised

Authorization date:

2022-07-15

Patient Information leaflet

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET: INFORMATION FOR THE USER
GANIRELIX GEDEON RICHTER 0.25 MG/0.5 ML SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
ganirelix
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ganirelix Gedeon Richter is and what it is used for
2.
What you need to know before you use Ganirelix Gedeon Richter
3.
How to use Ganirelix Gedeon Richter
4.
Possible side effects
5.
How to store Ganirelix Gedeon Richter
6.
Contents of the pack and other information
1.
WHAT GANIRELIX GEDEON RICHTER IS AND WHAT IT IS USED FOR
Ganirelix Gedeon Richter contains the active substance ganirelix and
belongs to a group of medicines
called “antigonadotropin-releasing hormones” which act against the
actions of the natural
gonadotropin-releasing hormone (GnRH). GnRH regulates the release of
gonadotropins (luteinising
hormone (LH) and follicle stimulating hormone (FSH)). Gonadotropins
play an important role in
human fertility and reproduction. In women, FSH is needed for the
growth and development of
follicles in the ovaries. Follicles are small round sacs that contain
the egg cells. LH is needed to
release the mature egg cells from the follicles and ovaries (i.e.
ovulation). Ganirelix Gedeon Richter
inhibits the action of GnRH, resulting in suppression of the release
of especially LH.
_Ganirelix Gedeon Richter is used for _
In women undergoing assisted reproduction techniques, including
_in vitro _
fertilisation (IVF) and other
methods, occasionally ovulation may occur too early cau

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ganirelix Gedeon Richter 0.25 mg/0.5 mL solution for injection in
pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 mL
aqueous solution.
The active substance ganirelix (INN) is a synthetic decapeptide with
high antagonistic activity to the
naturally occurring gonadotropin releasing hormone (GnRH). The amino
acids at positions 1, 2, 3, 6, 8
and 10 of the natural GnRH decapeptide have been substituted resulting
in [N-Ac-D-Nal(2)
1
, D-
pClPhe
2
, D-Pal(3)
3
, D-hArg(Et2)
6
, L-hArg(Et2)
8
, D-Ala
10
]-GnRH with a molecular weight of 1570.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless solution, with a pH of 4.8–5.2 and an
osmolality of 260-300 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ganirelix Gedeon Richter is indicated for the prevention of premature
luteinising hormone (LH)
surges in women undergoing controlled ovarian hyperstimulation (COH)
for assisted reproduction
techniques (ART).
In clinical studies ganirelix was used with recombinant human follicle
stimulating hormone (FSH) or
corifollitropin alfa, the sustained follicle stimulant.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ganirelix Gedeon Richter should only be prescribed by a specialist
experienced in the treatment of
infertility.
Posology
Ganirelix is used to prevent premature LH surges in women undergoing
COH. Controlled ovarian
hyperstimulation with FSH or corifollitropin alfa may start at day 2
or 3 of menses. Ganirelix Gedeon
Richter (0.25 mg) should be injected subcutaneously once daily,
starting on day 5 or day 6 of FSH
administration or on day 5 or day 6 following the administration of
corifollitropin alfa. The starting
day of ganirelix is depending on the ovarian response, i.e. the number
and size of growing follicles
and/or the amount of circulating oestradiol. The start of ganirelix
may