国家: 亚美尼亚
语言: 英文
来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ganirelix (ganirelix acetate)
N.V. Organon
H01CC01
ganirelix (ganirelix acetate)
0,25mg/0,5ml
solution for s/c injection
(5) pre-filled syringes 0,5ml
Prescription
Registered
2021-05-21
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: Active ingredient: ganirelix acetate 0.25 mg in 0.5 ml aqueous solution. Excipients: mannitol, glacial acetic acid 99%, sodium hydroxide and/or glacial acetic acid, water for injections. Excipient with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colorless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hypestimulation (COH) for assisted reproduction techniques (ART). In clinical trials Orgalutran was used with recombinant 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 patients 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 in general on day 5 or day 6 of FSH administration or on day 5 or day 6 following the administration of corifollitropin alfa. In high responders an early LH rise may be prevented by starting Orgalutran treatment on day 5. The start of Orgalutran may be delayed in absence of follicular growth. Orgalutran and FSH should be administered approximately at the same time. However, the preparations should not be mixed and different injection sites are to be used. FSH dose adjustments should be based on the number and size of growing follicles, rather than on the amount of circulating oestradiol. (see S 阅读完整的文件