দেশ: সিঙ্গাপুর
ভাষা: ইংরেজি
সূত্র: HSA (Health Sciences Authority)
GANIRELIX
ORGANON SINGAPORE PTE. LTD.
H01CC01
0.25 mg/0.5 ml
INJECTION
GANIRELIX 0.25 mg/0.5 ml
SUBCUTANEOUS
Prescription Only
VETTER PHARMA-FERTIGUNG GMBH & CO KG
ACTIVE
2003-01-07
CCDS-MK-8761-INJ-052012_SIN 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 (INN) in 0.5 ml aqueous solution. The active substance ganirelix 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 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 hyperstimulation (COH) for assisted reproduction techniques (ART). In clinical trials Orgalutran was used with recombinant follicle stimulating hormone (FSH). 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 may start at day 2 or 3 of menses. Orgalutran (0.25 mg) should be injected subcutaneously once daily, starting in general on day 6 of FSH administration. In high responders an CCDS-MK-8761-INJ-052012_SIN 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 সম্পূর্ণ নথি পড়ুন
CCDS-MK-8761-INJ-082020_SIN 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 (INN) in 0.5 ml aqueous solution. The active substance ganirelix 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 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 hyperstimulation (COH) for assisted reproduction techniques (ART). In clinical trials Orgalutran was used with recombinant follicle stimulating hormone (FSH). 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 may start at day 2 or 3 of menses. Orgalutran (0.25 mg) should be injected subcutaneously once daily, starting in general on day 6 of FSH administration. 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 section 5.1 Pharmacodynamic properties). Daily treatment with Orgalut সম্পূর্ণ নথি পড়ুন