Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
corifollitropin alfa
N.V. Organon
G03GA09
corifollitropin alfa
Sex hormones and modulators of the genital system,
Reproductive Techniques, Assisted; Ovulation Induction; Investigative Techniques
Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program.Elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG).
Revision: 23
Authorised
2010-01-25
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE USER ELONVA 100 MICROGRAMS SOLUTION FOR INJECTION ELONVA 150 MICROGRAMS SOLUTION FOR INJECTION corifollitropin 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 Elonva is and what it is used for 2. What you need to know before you use Elonva 3. How to use Elonva 4. Possible side effects 5. How to store Elonva 6. Contents of the pack and other information 1. WHAT ELONVA IS AND WHAT IT IS USED FOR Elonva contains the active ingredient corifollitropin alfa and belongs to the group of medicines called gonadotropic hormones. Gonadotropic hormones play an important role in human fertility and reproduction. One of these gonadotropic hormones is Follicle Stimulating Hormone (FSH), which is needed in women for the growth and development of follicles (small round sacs in your ovaries that contain the eggs) and in adolescent males (14 years and older) for treatment of delayed puberty due to hypogonadotropic hypogonadism (HH), in combination with a medicine called human Chorionic Gonadotropin (hCG). In women Elonva is used to help achieve pregnancy in women having infertility treatment, such as _in vitro_ fertilisation (IVF). IVF involves collecting the eggs from the ovary, fertilising them in the laboratory, and transferring the embryos into the uterus a few days later. Elonva causes the growth and development of several follicles at the same time by a controlled stimulation of the ovaries. In adolescent males (14 years Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Elonva 100 micrograms solution for injection Elonva 150 micrograms solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Elonva 100 micrograms solution for injection Each pre-filled syringe contains 100 micrograms of corifollitropin alfa* in 0.5 mL solution for injection. Elonva 150 micrograms solution for injection Each pre-filled syringe contains 150 micrograms of corifollitropin alfa* in 0.5 mL solution for injection. *corifollitropin alfa is a glycoprotein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Excipient(s) with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear and colourless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Elonva is indicated for Controlled Ovarian Stimulation (COS) in combination with a Gonadotropin Releasing Hormone (GnRH) antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. Elonva is indicated for the treatment of adolescent males (14 years and older) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Elonva for COS should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Treatment with Elonva for hypogonadotropic hypogonadism should be initiated and supervised by a physician experienced in the treatment of hypogonadotropic hypogonadism. Posology In the treatment of women of reproductive age, the dose of Elonva is based on weight and age. 3 _-_ _ _ A single 100-microgram dose is recommended in women who weigh less than or equal to 60 kilograms and who are 36 years of age or younger. _-_ _ _ A single 150-microgram dose Perskaitykite visą dokumentą