Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
follitropin delta
Ferring Pharmaceuticals A/S
G03GA10
follitropin delta
Sex hormones and modulators of the genital system,
Anovulation
Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Revision: 6
Authorised
2016-12-12
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE USER REKOVELLE 12 MICROGRAMS/0.36 ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN follitropin delta 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 REKOVELLE is and what it is used for 2. What you need to know before you use REKOVELLE 3. How to use REKOVELLE 4. Possible side effects 5. How to store REKOVELLE 6. Contents of the pack and other information 1. WHAT REKOVELLE IS AND WHAT IT IS USED FOR REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility. REKOVELLE is used in the treatment of female infertility and in women undergoing assisted reproduction programmes such as _in vitro_ fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from which eggs are collected and fertilised in the laboratory. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE REKOVELLE _ _ Before starting treatment with this medicine, a doctor should check you and your partner for possible causes of your fertility problems. DO NOT USE REKOVELLE • if you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine (listed in section 6) • if you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus • if you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION REKOVELLE 12 micrograms/0.36 mL solution for injection One pre-filled multidose pen delivers 12 micrograms follitropin delta* in 0.36 mL solution. REKOVELLE 36 micrograms/1.08 mL solution for injection One pre-filled multidose pen delivers 36 micrograms follitropin delta* in 1.08 mL solution. REKOVELLE 72 micrograms/2.16 mL solution for injection One pre-filled multidose pen delivers 72 micrograms follitropin delta* in 2.16 mL solution. One mL of solution contains 33.3 micrograms of follitropin delta* *recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6) by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in a pre-filled pen (injection). Clear and colourless solution with a pH of 6.0-7.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an _in vitro f_ ertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Posology The posology of REKOVELLE is individualised for each patient and aims to obtain an ovarian response which is associated with a favourable safety/efficacy profile, i.e. aims to achieve an adequate number of oocytes retrieved and reduce the interventions to prevent ovarian hyperstimulation syndrome (OHSS). REKOVELLE is dosed in micrograms (see section 5.1). The dosing regimen is specific for REKOVELLE and the microgram dose cannot be ap Pročitajte cijeli dokument