Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
follitropin alfa
Merck Europe B.V.
G03GA05
follitropin alfa
Sex hormones and modulators of the genital system,
Anovulation; Reproductive Techniques, Assisted; Infertility, Female; Hypogonadism
Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate.Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in-vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).GONAL-f 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
Revision: 26
Authorised
1995-10-20
124 B. PACKAGE LEAFLET 125 PACKAGE LEAFLET: INFORMATION FOR THE USER GONAL-F 75 IU POWDER AND SOLVENT FOR 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 or pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What GONAL-f is and what it is used for 2. What you need to know before you use GONAL-f 3. How to use GONAL-f 4. Possible side effects 5. How to store GONAL-f 6. Contents of the pack and other information How to prepare and use the GONAL-f powder and solvent 1. WHAT GONAL-F IS AND WHAT IT IS USED FOR WHAT GONAL-F IS GONAL-f contains a medicine called “follitropin alfa”. Follitropin alfa is a type of “follicle stimulating hormone” (FSH) which belongs to the family of hormones called “gonadotropins”. Gonadotropins are involved in reproduction and fertility. WHAT GONAL-F IS USED FOR IN ADULT WOMEN, GONAL-f is used: • to help release an egg from the ovary (ovulation) in women that cannot ovulate and that did not respond to treatment with a medicine called “clomiphene citrate”. • together with another medicine called “lutropin alfa” (“luteinising hormone” or LH) to help release egg from the ovary (ovulation) in women whose body is producing very little gonadotropins (FSH and LH). • to help develop several follicles (each containing an egg) 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 ADULT Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT GONAL-f 75 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 5.5 micrograms of follitropin alfa* equivalent to 75 IU. Each mL of the reconstituted solution contains 75 IU. * recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Appearance of the powder: white lyophilised pellet. Appearance of the solvent: clear colourless solution. The pH of the reconstituted solution is 6.5 to 7.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adult women • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene 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. • GONAL-f in association with a luteinising hormone (LH) preparation is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. In adult men _ _ • GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with GONAL-f should be initiated under the supervision of a physician experienced in the treatment of fertility disorders. Posology The dose recommendations given for GONAL-f are those in use for urinary FSH. Clinical assessment of GONAL-f indicates that its daily doses, regimens of administration, and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products. It is advised to a Прочетете целия документ