국가: 아르메니아
언어: 영어
출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ganirelix (ganirelix acetate)
Organon (Ireland) Ltd.
ganirelix (ganirelix acetate)
0,25mg/0,5ml
solution for s/c injection
Prescription
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. For a 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 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 start of Orgalutran may be delayed in absence of follicular growth, although clinical experience is based on starting Orgalutran on day 5 or day 6 of stimulation. Orgalutran and FSH should be ad 전체 문서 읽기