Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
follitropin alfa, lutropin alfa
Merck Europe B.V.
G03GA30
follitropin alfa, lutropin alfa
Sex hormones and modulators of the genital system,
Infertility, Female
Pergoveris is indicated for the stimulation of follicular development in women with severe luteinising-hormone (LH) and follicle-stimulating-hormone deficiency.In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/l.
Revision: 15
Authorised
2007-06-25
60 B. PACKAGE LEAFLET 61 PACKAGE LEAFLET: INFORMATION FOR THE USER PERGOVERIS 150 IU/75 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION follitropin alfa/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 Pergoveris is and what it is used for 2. What you need to know before you use Pergoveris 3. How to use Pergoveris 4. Possible side effects 5. How to store Pergoveris 6. Contents of the pack and other information 1. WHAT PERGOVERIS IS AND WHAT IT IS USED FOR WHAT PERGOVERIS IS Pergoveris contains two different active substances called “follitropin alfa” and “lutropin alfa”. Both belong to the family of hormones called “gonadotropins”, which are involved in reproduction and fertility. WHAT PERGOVERIS IS USED FOR This medicine is used to stimulate the development of follicles (each containing an egg) in your ovaries. This is to help you get pregnant. It is for use in adult women (18 years old or above) who have low levels (severe deficiency) of “follicle stimulating hormone” (FSH) and “luteinising hormone” (LH). These women are usually infertile. HOW PERGOVERIS WORKS The active substances in Pergoveris are copies of the natural hormones FSH and LH. In your body: • FSH stimulates the production of eggs • LH stimulates the release of the eggs. By replacing the missing hormones, Pergoveris allows women with low levels of FSH and LH to develop a follicle. This will then release an egg, after an injection of the hormone “human chorionic gonadotropin (hC Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pergoveris 150 IU/75 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa* (r-hFSH) and 75 IU (equivalent to 3 micrograms) of lutropin alfa* (r-hLH). After reconstitution, each mL of the solution contains 150 IU r-hFSH and 75 IU r-hLH per milliliter. _ _ * produced in genetically engineered Chinese hamster ovary (CHO) cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder: white to off-white lyophilised pellet. Solvent: clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Pergoveris 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 Pergoveris therapy is to promote follicular development followed by final maturation after the administration of human chorionic gonadotropin (hCG). Pergoveris should be given as a course of daily injections. If the patient is amenorrhoeic and has low endogenous oestrogen secretion, treatment can commence at any time. A recommended regimen commences with one vial of Pergoveris daily. If less than one vial daily is used, the follicular response may be unsatisfactory because the amount of lutropin alfa may be insufficient (see section 5.1). Treatment should be tailored to the individual patient’s response as assessed by measuring follicle size by ultrasound and oestrogen response. If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7 to 14 day intervals and preferably by 37.5 to 75 IU increments using a licensed follitropin alfa preparation. It may be acceptable to Lesen Sie das vollständige Dokument