Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
choriogonadotropin alfa
Merck Europe B.V.
G03GA08
choriogonadotropin alfa
Sex hormones and modulators of the genital system,
Anovulation; Reproductive Techniques, Assisted; Infertility, Female
Ovitrelle is indicated in the treatment of:women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth;anovulatory or oligo-ovulatory women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.
Revision: 22
Authorised
2001-02-02
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE USER OVITRELLE 250 MICROGRAMS/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE choriogonadotropin 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 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 illness 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 Ovitrelle is and what it is used for 2. What do you need to know before you use Ovitrelle 3. How to use Ovitrelle 4. Possible side effects 5. How to store Ovitrelle 6. Contents of the pack and other information 1. WHAT OVITRELLE IS AND WHAT IT IS USED FOR WHAT OVITRELLE IS Ovitrelle contains a medicine called ‘choriogonadotropin alfa’, made in a laboratory by a special recombinant DNA technique. Choriogonadotropin alfa is similar to a hormone found naturally in your body called ‘chorionic gonadotropin’, which is involved in reproduction and fertility. WHAT OVITRELLE IS USED FOR Ovitrelle is used together with other medicines: • To help develop and ripen several follicles (each containing an egg) in women undergoing assisted reproductive technologies (procedure that may help you to become pregnant) such as ‘ _in vitro_ fertilisation’. Other medicines will be given first to bring about the growth of several follicles. • To help release an egg from the ovary (ovulation induction) in women who cannot produce eggs (‘anovulation’), or women who produce too few eggs (‘oligo-ovulation’). Other medicines will be given first to develop and ripen the follicles. 2. WHAT DO YOU NEED TO KNOW BEFORE YOU USE OVITRELLE DO NOT USE OVITRELLE • if you are allergic to choriogonad Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 250 micrograms choriogonadotropin alfa* (equivalent to approximately 6,500 IU) in 0.5 mL solution. * recombinant human chorionic gonadotropin, r-hCG produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. Clear, colourless to slightly yellow solution. The pH of the solution is 7.0 ± 0.3, its osmolality 250-400 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ovitrelle is indicated in the treatment of • Adult women undergoing superovulation prior to assisted reproductive technologies (ART) such as in _ vitro_ fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth, • Anovulatory or oligo-ovulatory adult women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory women after stimulation of follicular growth. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Ovitrelle should be performed under the supervision of a physician experienced in the treatment of fertility problems. Posology The maximum dose is 250 micrograms. The following dose regimen should be used: • Women undergoing superovulation prior to assisted reproductive technologies (ART) such as _in vitro_ fertilisation (IVF): One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after the last administration of a follicle stimulating hormone (FSH) or human menopausal gonadotropin (hMG) preparation, i.e. when optimal stimulation of follicular growth is achieved. 3 • Anovulatory or oligo-ovulatory women: One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after optimal stimula Lire le document complet