OVIDREL

Land: Indonesia

Språk: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv ingrediens:

CHORIONIC GONADOTROPHIN

Tilgjengelig fra:

MERCK TBK - Indonesia

INN (International Name):

CHORIONIC GONADOTROPHIN

Dosering :

250 MCG/0,5 ML

Legemiddelform:

CAIRAN INJEKSI

Enheter i pakken:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML

Produsert av:

MERCK SERONO SPA - Italy

Autorisasjon dato:

2018-12-31

Preparatomtale

Page 1 of 6
_DW/ia-jt/19Apr2022 _
OVIDREL

CHORIOGONADOTROPIN ALFA
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 250 micrograms choriogonadotropin alfa*
(equivalent to approximately
6,500 IU).
*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 5.1 List of excipients.
2.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen.
Clear, colourless to slightly yellow solution.
The pH of the solution is 7.0 ± 0.3, its osmolality 250-400 mOsm/kg.
3.
CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS
Ovidrel is indicated in the treatment of:
•
Adult women undergoing superovulation prior to assisted reproductive
technologies (ART) such as _in_
_vitro_ fertilisation (IVF): Ovidrel is administered to trigger final
follicular maturation and luteinisation
after stimulation of follicular growth,
•
Anovulatory or
oligo-ovulatory adult women: Ovidrel is administered to trigger
ovulation and
luteinisation in anovulatory or oligo-ovulatory women after
stimulation of follicular growth.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Ovidrel should be performed under the supervision of a
physician experienced in the
treatment of fertility problems.
Posology
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 pen of Ovidrel (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.
•
Anovulatory or oligo-ovulatory women:
One pre-filled pen of Ovidrel (250 micrograms) is administered 24 to
48 hours after optimal stimulation
of follicular growth is achieved. The patient is recommended to have
coitus on the day of, and the day
after, Ovidrel injection.
Special populations