Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
CHORIONIC GONADOTROPHIN
MERCK TBK - Indonesia
CHORIONIC GONADOTROPHIN
250 MCG/0,5 ML
CAIRAN INJEKSI
DUS, 1 PREFILLED SYRINGE @ 0,5 ML
MERCK SERONO SPA - Italy
2018-12-31
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 Baca dokumen lengkapnya