Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
ganirelix
N.V. Organon
H01CC01
ganirelix
Pituitary and hypothalamic hormones and analogues
Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques.In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.
Revision: 24
Authorised
2000-05-16
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ORGALUTRAN 0.25 MG/0.5 ML SOLUTION FOR INJECTION 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 Orgalutran is and what it is used for 2. What you need to know before you use Orgalutran 3. How to use Orgalutran 4. Possible side effects 5. How to store Orgalutran 6. Contents of the pack and other information 1. WHAT ORGALUTRAN IS AND WHAT IT IS USED FOR Orgalutran contains the active substance ganirelix and belongs to a group of medicines called “anti- gonadotrophin-releasing hormones” which act against the actions of the natural gonadotrophin releasing hormone (GnRH). GnRH regulates the release of gonadotrophins (luteinising hormone (LH) and follicle stimulating hormone (FSH)). Gonadotrophins 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). Orgalutran inhibits the action of GnRH, resulting in suppression of the release of especially LH. Orgalutran is used for _ _ In women undergoing assisted reproduction techniques, including _in vitro_ fertilisation (IVF) and other methods, occasionally ovulation may occur too early causing a significant reduction in the chance of getting pregnant. Orgalutran is used to prevent the premature LH surge that might cause such Przeczytaj cały dokument
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. Excipient with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium-free’. For the 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 Orgalutran 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 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 Przeczytaj cały dokument