Ovitrelle
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
04-10-2023
Charakterystyka produktu
(SPC)
04-10-2023
Sprawozdanie z oceny publicznego
(PAR)
18-01-2021
Składnik aktywny:
choriogonadotropin alfa
Dostępny od:
Merck Europe B.V.
Kod ATC:
G03GA08
INN (International Nazwa):
choriogonadotropin alfa
Grupa terapeutyczna:
Sex hormones and modulators of the genital system,
Dziedzina terapeutyczna:
Anovulation; Reproductive Techniques, Assisted; Infertility, Female
Wskazania:
Ovitrelle is indicated in the treatment of:women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth;anovulatory or oligo-ovulatory women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.
Podsumowanie produktu:
Revision: 22
Status autoryzacji:
Authorised
Data autoryzacji:
2001-02-02
Ulotka dla pacjenta
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
OVITRELLE
250 MICROGRAMS/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
choriogonadotropin alfa
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ovitrelle is and what it is used for
2.
What do you need to know before you use Ovitrelle
3.
How to use Ovitrelle
4.
Possible side effects
5.
How to store Ovitrelle
6.
Contents of the pack and other information
1.
WHAT OVITRELLE IS AND WHAT IT IS USED FOR
WHAT OVITRELLE IS
Ovitrelle contains a medicine called ‘choriogonadotropin alfa’,
made in a laboratory by a special
recombinant DNA technique. Choriogonadotropin alfa is similar to a
hormone found naturally in your
body called ‘chorionic gonadotropin’, which is involved in
reproduction and fertility.
WHAT OVITRELLE IS USED FOR
Ovitrelle is used together with other medicines:
•
To help develop and ripen several follicles (each containing an egg)
in women undergoing
assisted reproductive technologies (procedure that may help you to
become pregnant) such as
‘
_in vitro_
fertilisation’. Other medicines will be given first to bring about
the growth of several
follicles.
•
To help release an egg from the ovary (ovulation induction) in women
who cannot produce eggs
(‘anovulation’), or women who produce too few eggs
(‘oligo-ovulation’). Other medicines will
be given first to develop and ripen the follicles.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU USE OVITRELLE
DO NOT USE OVITRELLE
•
if you are allergic to choriogonad
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled
syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 250 micrograms choriogonadotropin
alfa* (equivalent to
approximately 6,500 IU) in 0.5 mL solution.
* recombinant human chorionic gonadotropin, r-hCG produced in Chinese
hamster ovary (CHO) cells
by recombinant DNA technology
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, colourless to slightly yellow solution.
The pH of the solution is 7.0 ± 0.3, its osmolality 250-400 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ovitrelle is indicated in the treatment of
•
Adult women undergoing superovulation prior to assisted reproductive
technologies (ART) such
as in
_ vitro_
fertilisation (IVF): Ovitrelle is administered to trigger final
follicular maturation and
luteinisation after stimulation of follicular growth,
•
Anovulatory or oligo-ovulatory adult women: Ovitrelle is administered
to trigger ovulation and
luteinisation in anovulatory or oligo-ovulatory women after
stimulation of follicular growth.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Ovitrelle should be performed under the supervision of
a physician experienced in the
treatment of fertility problems.
Posology
The maximum dose is 250 micrograms. The following dose regimen should
be used:
•
Women undergoing superovulation prior to assisted reproductive
technologies (ART) such as
_in vitro_
fertilisation (IVF):
One pre-filled syringe of Ovitrelle (250 micrograms) is administered
24 to 48 hours after the
last administration of a follicle stimulating hormone (FSH) or human
menopausal gonadotropin
(hMG) preparation, i.e. when optimal stimulation of follicular growth
is achieved.
3
•
Anovulatory or oligo-ovulatory women:
One pre-filled syringe of Ovitrelle (250 micrograms) is administered
24 to 48 hours after
optimal stimula
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