Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
follitropin alfa
Theramex Ireland Limited
G03GA05
follitropin alfa
Sex hormones and modulators of the genital system,
Anovulation
In adult womenAnovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate;Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer;Ovaleap in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L.In adult menOvaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
Revision: 10
Authorised
2013-09-27
32 B. PACKAGE LEAFLET 33 Package leaflet: Information for the user Ovaleap 300 IU/0.5 mL solution for injection Ovaleap 450 IU/0.75 mL solution for injection Ovaleap 900 IU/1.5 mL solution for injection follitropin alfa 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. What is in this leaflet 1. What Ovaleap is and what it is used for 2. What you need to know before you use Ovaleap 3. How to use Ovaleap 4. Possible side effects 5. How to store Ovaleap 6. Contents of the pack and other information 1. What Ovaleap is and what it is used for What Ovaleap is This medicine contains the active substance follitropin alfa, which is almost identical to a natural hormone produced by your body called “follicle-stimulating hormone” (FSH). FSH is a gonadotropin, a type of hormone that plays an important role in human fertility and reproduction. In women, FSH is needed for the growth and development of the sacs (follicles) in the ovaries that contain the egg cells. In men, FSH is needed for the production of sperm. What Ovaleap is used for In adult women, Ovaleap is used: • to help ovulation (release of a mature egg cell from the follicle) in women that cannot ovulate and that have not responded to treatment with a medicine called “clomifene citrate”. • to help follicles develop in women undergoing assisted reproductive technology procedures (procedures that may help you to become pregnant) such as “in vitro fertilisation”, “gamete intra-fallopian transfer” or “zygote intra-fallopian transfer”. • in combination with a Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ovaleap 300 IU/0.5 mL solution for injection Ovaleap 450 IU/0.75 mL solution for injection Ovaleap 900 IU/1.5 mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa*. Ovaleap 300 IU/0.5 mL solution for injection Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution for injection. Ovaleap 450 IU/0.75 mL solution for injection Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution for injection. Ovaleap 900 IU/1.5 mL solution for injection Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution for injection. *Follitropin alfa (recombinant human follicle-stimulating hormone [r-hFSH]) is produced in Chinese Hamster Ovary Cells (CHO DHFR - ) by recombinant DNA technology. Excipient(s) with known effect: Ovaleap contains 0.02 mg per mL of benzalkonium chloride Ovaleap contains 10.0 mg per mL of benzyl alcohol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution. The pH of the solution is 6.8 to 7.2. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications In adult women • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate. • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer. • Ovaleap in association with a luteinising hormone (LH) preparation is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. 3 In adult men • Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonad Lesen Sie das vollständige Dokument