Orgalutran
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
04-04-2023
Valmisteyhteenveto
(SPC)
04-04-2023
Julkisesta arviointikertomuksesta
(PAR)
21-07-2013
Aktiivinen ainesosa:
ganirelix
Saatavilla:
N.V. Organon
ATC-koodi:
H01CC01
INN (Kansainvälinen yleisnimi):
ganirelix
Terapeuttinen ryhmä:
Pituitary and hypothalamic hormones and analogues
Terapeuttinen alue:
Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
Käyttöaiheet:
The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques.In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.
Tuoteyhteenveto:
Revision: 24
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2000-05-16
Pakkausseloste
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ORGALUTRAN 0.25 MG/0.5 ML SOLUTION FOR INJECTION
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 Orgalutran is and what it is used for
2.
What you need to know before you use Orgalutran
3.
How to use Orgalutran
4.
Possible side effects
5.
How to store Orgalutran
6.
Contents of the pack and other information
1.
WHAT ORGALUTRAN IS AND WHAT IT IS USED FOR
Orgalutran contains the active substance ganirelix and belongs to a
group of medicines called “anti-
gonadotrophin-releasing hormones” which act against the actions of
the natural gonadotrophin
releasing hormone (GnRH). GnRH regulates the release of gonadotrophins
(luteinising hormone (LH)
and follicle stimulating hormone (FSH)). Gonadotrophins 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). Orgalutran inhibits
the action of GnRH, resulting in
suppression of the release of especially LH.
Orgalutran is used for
_ _
In women undergoing assisted reproduction techniques, including
_in vitro_
fertilisation (IVF) and other
methods, occasionally ovulation may occur too early causing a
significant reduction in the chance of
getting pregnant. Orgalutran is used to prevent the premature LH surge
that might cause such
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Orgalutran 0.25 mg/0.5 mL solution for injection
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
gonadotrophin 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.
Excipient with known effect
This medicinal product contains less than 1 mmol sodium (23 mg) per
injection, that is to say
essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Orgalutran 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 Orgalutran was used with recombinant human
follicle stimulating hormone (FSH)
or corifollitropin alfa, the sustained follicle stimulant.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Orgalutran should only be prescribed by a specialist experienced in
the treatment of infertility.
_ _
_ _
Posology
Orgalutran 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. Orgalutran
(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 Orgalutran is depending on the ovarian response, i.e. the
number and size of growing follicles
and/or the amount of circulating oestradiol. The
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