מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
ganirelix acetate
Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)
H01CC01
ganirelix
Pituitary and hypothalamic hormones and analogues
Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
Prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
Authorised
2022-07-15
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: INFORMATION FOR THE USER GANIRELIX GEDEON RICHTER 0.25 MG/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE ganirelix READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ganirelix Gedeon Richter is and what it is used for 2. What you need to know before you use Ganirelix Gedeon Richter 3. How to use Ganirelix Gedeon Richter 4. Possible side effects 5. How to store Ganirelix Gedeon Richter 6. Contents of the pack and other information 1. WHAT GANIRELIX GEDEON RICHTER IS AND WHAT IT IS USED FOR Ganirelix Gedeon Richter contains the active substance ganirelix and belongs to a group of medicines called “antigonadotropin-releasing hormones” which act against the actions of the natural gonadotropin-releasing hormone (GnRH). GnRH regulates the release of gonadotropins (luteinising hormone (LH) and follicle stimulating hormone (FSH)). Gonadotropins play an important role in human fertility and reproduction. In women, FSH is needed for the growth and development of follicles in the ovaries. Follicles are small round sacs that contain the egg cells. LH is needed to release the mature egg cells from the follicles and ovaries (i.e. ovulation). Ganirelix Gedeon Richter inhibits the action of GnRH, resulting in suppression of the release of especially LH. _Ganirelix Gedeon Richter is used for _ In women undergoing assisted reproduction techniques, including _in vitro _ fertilisation (IVF) and other methods, occasionally ovulation may occur too early cau קרא את המסמך השלם
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ganirelix Gedeon Richter 0.25 mg/0.5 mL solution for injection in pre-filled syringe 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 gonadotropin 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 the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear and colourless solution, with a pH of 4.8–5.2 and an osmolality of 260-300 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ganirelix Gedeon Richter is indicated for the prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART). In clinical studies ganirelix was used with recombinant human follicle stimulating hormone (FSH) or corifollitropin alfa, the sustained follicle stimulant. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ganirelix Gedeon Richter should only be prescribed by a specialist experienced in the treatment of infertility. Posology Ganirelix 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. Ganirelix Gedeon Richter (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 ganirelix 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 ganirelix may קרא את המסמך השלם