Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
lutropin alfa
Merck Europe B.V.
G03GA07
lutropin alfa
Sex hormones and modulators of the genital system,
Ovulation Induction; Infertility, Female
Luveris in association with a follicle-stimulating-hormone (FSH) preparation is recommended for the stimulation of follicular development in women with severe luteinising-hormone (LH) and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level
Revision: 21
Authorised
2000-11-29
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER Solvent in ampoules LUVERIS 75 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION lutropin alfa 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, pharmacist 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Luveris is and what it is used for 2. What you need to know before you use Luveris 3. How to use Luveris 4. Possible side effects 5. How to store Luveris 6. Contents of the pack and other information 1. WHAT LUVERIS IS AND WHAT IT IS USED FOR WHAT LUVERIS IS Luveris is a medicine containing lutropin alfa, a recombinant Luteinising Hormone (LH) which is essentially similar to the hormone found naturally in humans, but is made by means of biotechnology. It belongs to the family of hormones called gonadotropins, which are involved in the normal control of reproduction. WHAT LUVERIS IS USED FOR Luveris is recommended for the treatment of adult women who have been shown to produce very low levels of some of the hormones involved in the natural reproductive cycle. The medicine is used together with another hormone called Follicle Stimulating Hormone, (FSH), to bring about the development of follicles, which are in the ovary, the structures maturing the eggs (ova). It is followed by treatment with a single dose of human Chorionic Gonadotropin (hCG), which leads to the release of an egg from the follicle (ovulation). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LUVERIS DO NOT USE LUVERIS • if you are allergic to gonadotropins (such as luteinising hormone, follicle stimulating hormone or h Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Luveris 75 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 75 IU of lutropin alfa*. * recombinant human luteinising hormone (r-hLH) produced in genetically engineered Chinese hamster ovary (CHO) cells by recombinant DNA technology For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection (powder for injection). Appearance of the powder: white lyophilised pellet Appearance of the solvent: clear colourless solution The pH of the reconstituted solution is 7.5 to 8.5. Presentations other than ampoules should be considered for self-administration by patients. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Luveris in association with a follicle stimulating hormone (FSH) preparation is indicated for the stimulation of follicular development in adult women with severe luteinising hormone (LH) and FSH deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Luveris should be initiated under the supervision of a physician experienced in the treatment of fertility disorders. Posology In LH and FSH deficient women, the objective of Luveris therapy in association with FSH is to promote follicular development followed by final maturation after the administration of human chorionic gonadotropin (hCG). Luveris should be given as a course of daily injections simultaneously with FSH. If the patient is amenorrhoeic and has low endogenous estrogen secretion, treatment can commence at any time. Luveris should be administered concomitantly with follitropin alfa. A recommended regimen commences at 75 IU of lutropin alfa (i.e. one vial of Luveris) daily with 75 to 150 IU FSH. Treatment should be tailored to the individual patient’s response as assessed by measuring follicle size by ultrasound and estrogen response. 3 In clinical trials, Luveris has been shown to increase the ovarian sensitivity to follitropin alfa. If Pročitajte cijeli dokument