Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
FOLLITROPIN ALFA
MERCK SERONO LTD
G03GA05
SOLUTION FOR INJECTION
FOLLITROPIN ALFA 600 IU/ML
S.C
Required
MERCK EUROPE B.V., THE NETHERLANDS
FOLLITROPIN ALFA
FOLLITROPIN ALFA
In adult women:• 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).• Follitropin alfa 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 men:• Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.
2014-08-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only Solution for injection in a pre-filled pen For subcutaneous injection Active ingredient: Follitropin Alfa 600 IU*/1 mL (44 mcg/1 mL) Available in the following doses: GONAL-f ® 300 IU/0.5 mL GONAL-f ® 450 IU/0.75 mL GONAL-f ® 900 IU/1.5 mL (*IU – international units) Inactive ingredients and allergens in this medicine – see section 6. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Keep this leaflet at hand; you may need to read it again. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems that their medical condition is similar. 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. 1. WHAT IS THE MEDICINE INTENDED FOR GONAL-f is a medicine that contains follitropin alfa. This is a type of Follicle Stimulating Hormone (FSH) which belongs to the family of hormones called “gonadotropins” that are involved in reproduction and fertility. Follitropin alfa is generated using genetic engineering technology. GONAL-f is used for the following situations: In women: • To help in release of an egg from the ovary (ovulation) in women who cannot ovulate and who have not responded to treatment with a medicine called “clomiphene citrate”. • In combination with another medicine called “lutropin alfa” (luteinizing hormone or LH) - to help release an egg from the ovary (ovulation) in women who do not ovulate because their bodies produce very little gonadotropins (FSH and LH). • To help in the development of several follicles (which contain eggs) in women undergoing fertility treatments (a procedure that helps you to become pregnant), such as in vitro fertiliz Прочитайте повний документ
PRESCRIBING INFORMATION GONAL ® F 1. NAME OF THE MEDICINAL PRODUCT GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in a pre-filled pen. GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in a pre-filled pen. GONAL-f 900 IU/1.5 mL (66 micrograms/1.5 mL) solution for injection in a pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 600 IU of follitropin alfa*, (equivalent to 44 micrograms). Each pre-filled multidose pen delivers 300 IU (equivalent to 22 micrograms) in 0.5 mL. Each pre-filled multidose pen delivers 450 IU (equivalent to 33 micrograms) in 0.75 mL. Each pre-filled multidose pen delivers 900 IU (equivalent to 66 micrograms) in 1.5 mL. * 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 Solution for injection in a pre-filled pen. Clear colourless solution. The pH of the solution is 6.7 to 7.3. 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 patients undergoing superovulation for assisted reproductive technologies (ART) such as _in vitro_ fertilization (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 < 1.2 IU/L 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 gonadotrophin (hCG) therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with GONAL-f sho Прочитайте повний документ