Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Urofollitropin
IBSA Farmaceutici Italia S.r.l
G03GA; G03GA04
Urofollitropin
225 international unit(s)
Powder and solvent for solution for injection
Product subject to prescription which may not be renewed (A)
Gonadotropins; urofollitropin
Not marketed
2013-02-22
PACKAGE LEAFLET: INFORMATION FOR THE USER FOSTIMONKIT 225 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION FOSTIMONKIT 300 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION UROFOLLITROPIN 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, please 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 illeness 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 Fostimonkit is and what it is used for 2. What you need to know before you use Fostimonkit 3. How to take Fostimonkit 4. Possible side-effects 5. How to store Fostimonkit 6. Content of the pack and other information 1. WHAT FOSTIMONKIT IS AND WHAT IT IS USED FOR • FOSTIMONKIT is used to promote ovulation in women who are not ovulating and who have not responded to other treatment (clomifene citrate). • It is used to bring about the development of several follicles (and therefore several eggs) in women receiving fertility treatment. Urofollitropin is a highly purified human follicle stimulating hormone, belonging to a group of medicines called gonadotropins. This medicinal product must be used under the supervision of your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FOSTIMONKIT You and your partner’s fertility will be evaluated before your treatment is started. DO NOT USE FOSTIMONKIT IF YOU HAVE ANY OF THE FOLLOWING: a. Enlarged ovaries or cysts not caused by a hormonal disorder (polycystic ovarian disease). b. Bleeding of unknown cause. c. Cancer of the ovaries, uterus or breast. d. Abnormal swelling (tumour) of the pituitary gland or hypothalamus (brain). e. Hypersensitivity (allergy) to Urofollitropin or any of the ingredients in Fostimo Lestu allt skjalið
Health Products Regulatory Authority 11 December 2019 CRN008HGV Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fostimon PFS 225 IU Powder and Solvent for Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 225 IU of urofollitropin (follicle-stimulating hormone FSH): 1 ml of reconstituted solution contains either 225 IU or 450 IU of urofollitropin when respectively 1 or 2 vials are reconstituted in 1 ml of solvent. The specific _in vivo_ activity is equal or superior to 5000 IU of FSH per mg of protein. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white to off-white and the solvent is clear and colourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sterility in women: - Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate. Controlled ovarian hyperstimulation to induce the development of multiple follicles in Assisted Reproductive Technologies (ART) such as _in vitro_ fertilisation (IVF), Gamete Intra-fallopian Transfer (GIFT) and Zygotes Intra-fallopian Transfer (ZIFT). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment with Fostimon PFSshould be initiated under the supervision of a physician experienced in the treatment of infertility problems. There are great inter- and intra-individual variations in the response of the ovaries to exogenous gonadotropins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. This requires ultrasonography and may also include monitoring of oestradiol levels. - Anovulation (including PCOS): The objective of a treatment with Fostimon PFS is to develop a single mature de Graaf follicle from which the ovum will be released after the administration of human chorionic gonadotropins (hCG). Fostimon PFS can be administered by daily injection. In menstruati Lestu allt skjalið