Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
Ferring Ireland Limited United Drug House, Magna Drive Magna Business Park, Citywest Road Dublin 24 , Ireland
G03GA02
MENOTROPHIN 600 IU
SOLUTION FOR INJECTION IN A PRE-FILLED PEN
MENOTROPHIN 600 IU
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-02-24
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER MENOPUR 600 IU SOLUTION FOR INJECTION IN PRE-FILLED PEN MENOPUR 1200 IU SOLUTION FOR INJECTION IN PRE-FILLED PEN menotrophin 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 MENOPUR is and what it is used for 2. What you need to know before you use MENOPUR 3. How to use MENOPUR 4. Possible side effects 5. How to store MENOPUR 6. Contents of the pack and other information 1. WHAT MENOPUR IS AND WHAT IT IS USED FOR MENOPUR comes as a solution for injection in a pre‑filled pen. The injection is given under your skin (‘sub-cutaneous’ injection) – usually in the tummy. MENOPUR contains ‘menotrophin’, which is a mixture of two natural hormones called: • follicle stimulating hormone (FSH) and • luteinizing hormone (LH). These hormones help reproductive organs to work normally. The FSH and LH hormones in menotrophin are obtained from the urine of women who have passed the menopause. WHAT MENOPUR IS USED FOR MENOPUR is used to treat women who cannot become pregnant. It is used for: • women whose ovaries do not produce eggs. This includes women with ‘polycystic ovarian disease’ (‘PCOD’). MENOPUR is used when women have already had a medicine called ‘clomiphene citrate’, but this medicine has not helped. • women in ‘assisted reproductive technology’ programmes. This includes: o ‘In vitro fertilisation’ (IVF) or ‘embryo transfer’ (ET) o ‘Gamete intra-fallopian transfer’ (GIFT) o ‘Intracytoplasmic sperm Prečítajte si celý dokument
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Menopur 600 IU solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled multidose pen delivers highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to follicle stimulating hormone activity FSH 600 IU and luteinizing hormone activity LH 600 IU in 0.96 mL solution. One mL of solution contains 625 IU FSH activity and 625 IU LH activity. Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in postmenopausal urine, is present in Menopur and is the main contributor of the LH activity. The active ingredient in Menopur is obtained from the urine of postmenopausal women. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled pen (injection). Clear solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Menopur is indicated for the treatment of infertility in the following clinical situations: Anovulation, including polycystic ovarian disease (PCOD), in women who have been unresponsive to treatment with clomiphene citrate. Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART) (e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra- fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Menopur should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Posology There are great inter-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. Menopur can be given alone or in combination with a gonadotrophin-releasing hormone (GnRH) agonist or antagonist. Recommendations about dosage and duration of treatment may change depending Prečítajte si celý dokument