Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Menotrophin
Ferring Ireland Ltd
G03GA02
Menotrophin
Powder and solvent for solution for injection
human menopausal gonadotrophin
Not marketed
2022-10-21
1 _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER MENOTROPHIN FERRING 75 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Menotrophin 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 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What MENOTROPHIN FERRING is and what it is used for 2. What you need to know before you use MENOTROPHIN FERRING 3. How to use MENOTROPHIN FERRING 4. Possible side effects 5. How to store MENOTROPHIN FERRING 6. Content of the pack and other information 1. WHAT MENOTROPHIN FERRING IS AND WHAT IT IS USED FOR MENOTROPHIN FERRING is provided as a powder which must be mixed with liquid (solvent) before it is used. It is given as an injection under the skin or in the muscle. MENOTROPHIN FERRING contains two hormones called follicle stimulating hormone (FSH) and luteinizing hormone (LH). FSH and LH are natural hormones produced in both males and females. They help the reproductive organs to work normally. The FSH and LH in MENOTROPHIN FERRING are obtained from the urine of postmenopausal women. The active ingredient is highly purified, and is known as menotrophin. MENOTROPHIN FERRING is used to treat female infertility in the following two situations: i. Women who cannot become pregnant because their ovaries do not produce eggs (including polycystic ovarian disease). MENOTROPHIN FERRING is used in women who have already been given a medicine called clomiphene citrate to treat their infertility, but this medicine has not helped. ii. Women in assisted reproductive technology programmes (ART) (including _in vitro_ fertilisation/embryo transfer Lue koko asiakirja
Health Products Regulatory Authority 25 October 2022 CRN00CSJR Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Menotrophin Ferring 75 IU powder and solvent for solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial with powder contains highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to follicle stimulating hormone activity FSH 75 IU and luteinizing hormone activity LH 75 IU. Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in postmenopausal urine, is present in Menotrophin Ferring and contributes to the overall luteinizing hormone activity. The active ingredient in Menotrophin Ferring is obtained from the urine of postmenopausal women. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Appearance of powder: white to off-white lyophilisation cake Appearance of solvent: clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Menotrophin Ferring is indicated for the treatment of infertility in the following clinical situations: Anovulation, including polycystic ovarian disease (PCOD), in women who have been unresponsive to treatment with clomiphene citrate. Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART) (e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Menotrophin Ferring should be initiated under the supervision of a physician experienced in the treatment of fertility problems. POSOLOGY Dosage regimens described below are identical for S.C. and I.M. administration. There are great inter-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian Lue koko asiakirja