Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
UROFOLLITROPIN
Ferring Ireland Ltd
G03GA04
UROFOLLITROPIN
75 International Unit
Pdr+Solv for Soln for Inj
Product subject to prescription which may not be renewed (A)
urofollitropin
Not Marketed
2006-01-09
Package leaflet: InformatIon for the user BRAVELLE 75 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, 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 symptoms are the same as yours. • If you get any side effects, talk to your doctur or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What BRAVELLE is and what it is used for 2. What you need to know before you use BRAVELLE 3. How to use BRAVELLE 4. Possible side effects 5. How to store BRAVELLE 6. Contents of the pack and other information 1. WHAT BRAVELLE IS AND WHAT IT IS USED FOR BRAVELLE 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. BRAVELLE contains a hormone called follicle stimulating hormone (FSH). FSH is a natural hormone produced in both males and females. It helps the reproductive organs to work normally. The FSH in this medicine is obtained from the urine of postmenopausal women. It is highly purified, and is then known as urofollitropin. BRAVELLE 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). BRAVELLE 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 reproduction programmes (including in vitro fertilisation/embryo transfer [IVF/ET], gamete intra-fallopian transfer [GIFT] and intracytoplasmic sperm injection [ICSI]). BRAVELLE helps the ovaries develop many egg sacs (follicles) where an egg might develop (multiple follicular develo Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BRAVELLE 75 IU powder and solvent for solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 82.5 IU of highly purified urinary follicle stimulating hormone (FSH), urofollitropin. When reconstituted with the solvent provided, each vial delivers 75 IU of FSH. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Appearance of powder: Lyophilised, white to off-white caked mass. Appearance of solvent: Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BRAVELLE is indicated for the treatment of female 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 BRAVELLE should be initiated under the supervision of a physician experienced in the treatment of fertility problems. POSOLOGY 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 monitoring of ovarian response by ultrasonography alone or preferably in combination with measurement of oestradiol levels. BRAVELLE can be given alone or in combination with a gonadotropin-releasing hormone (GnRH) agonist or antagonist for controlled ovarian hyperstimulation. There is no clinical trial experience with the use of BRAVELLE in combination with GnRH antagonists in this indication. Recommendations about dosage and du Прочитайте повний документ