国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Follitropin alfa
Gedeon Richter (UK
G03GA05
Follitropin alfa
600unit/1ml
Solution for injection
Subcutaneous
No Controlled Drug Status
VMP not recommended to prescribe - patient training required
BNF: 06050100; GTIN: 7640165220283
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BEMFOLA 75 IU/0.125 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN BEMFOLA 150 IU/0.25 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN BEMFOLA 225 IU/0.375 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN BEMFOLA 300 IU/0.50 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN BEMFOLA 450 IU/0.75 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN Follitropin alfa This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 symptoms 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 Bemfola is and what it is used for 2. What you need to know before you use Bemfola 3. How to use Bemfola 4. Possible side effects 5. How to store Bemfola 6. Contents of the pack and other information 1. WHAT BEMFOLA IS AND WHAT IT IS USED FOR WHAT BEMFOLA 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 BEMFOLA IS USED FOR IN ADULT WOMEN , Bemfola is used: • to help release an egg from the ovary (ovulation) in women that cannot ovulate and that di 阅读完整的文件
OBJECT 1 BEMFOLA 225 IU/0.375 ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN Summary of Product Characteristics Updated 17-Aug-2017 | Gedeon Richter (UK) Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen 2. Qualitative and quantitative composition Each mL of the solution contains 600 IU (equivalent to 44 micrograms) of follitropin alfa*. Each pre- filled pen delivers 225 IU (equivalent to 16.5 micrograms) in 0.375 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 pre-filled pen (injection). Clear colourless solution. The pH of the solution is 6.7 - 7.3. 4. Clinical particulars 4.1 Therapeutic indications In adult women • Anovulation (including polycystic ovariansyndrome, PCOS) 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 (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 Gonadotropin (hCG) therapy. 4.2 Posology and method of administration Treatme 阅读完整的文件