Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Menotrophin
Ferring Pharmaceuticals Ltd
G03GA02
Menotrophin
75unit
Powder and solvent for solution for injection
Intramuscular; Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 06050100; GTIN: 5015919649238 05015919648613
Patient Information READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, nurse or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. IN THIS LEAFLET: 1. What Menopur is and what it is used for 2. Before you use Menopur 3. How to use Menopur 4. Possible side effects 5. How to store Menopur 6. Further information 1. WHAT MENOPUR IS AND WHAT IT IS USED FOR WHAT MENOPUR IS Menopur contains a medicine called menotrophin. This is a mixture of hormones obtained from the urine of women who have passed the menopause. • The dose of these hormones is given in International Units (IU). • Each bottle (vial) contains the equivalent of 75 IU of FSH (follicle stimulating hormone) and 75 IU of LH (luteinising hormone). Menopur helps reproductive organs to work normally in both women and men. A fertility specialist should supervise your treatment. WHAT MENOPUR IS USED FOR IN WOMEN, Menopur is used for: • Infertility caused by eggs not being produced properly in the ovaries (anovulatory infertility). It works by helping follicles (which contain eggs) to mature in the ovaries. • IVF (in vitro fertilisation) and other types of ‘assisted conception’. It works by helping multiple follicles and eggs to develop. The eggs are then harvested and fertilised outside the body. IN MEN, Menopur is used for: • Low sperm count (oligospermia). ALSO, IF YOU ARE A WOMAN DO NOT USE MENOPUR IF: • You have tumours of your womb (uterus), ovaries or breasts. • You have cysts on your ovaries or enlarged ovaries that are not due to polycystic ovary syndrome (a condition that prevents eggs from being released from the ovaries). • You have bleeding from your v Citiți documentul complet
OBJECT 1 MENOPUR 75IU Summary of Product Characteristics Updated 03-Jun-2016 | Ferring Pharmaceuticals Ltd 1. Name of the medicinal product MENOPUR ® 2. Qualitative and quantitative composition _Active ingredient_ Each vial with dry substance contains highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to 75 IU human follicle stimulating hormone (FSH) and 75 IU human luteinising hormone (LH). 3. Pharmaceutical form Powder for injection; and solvent for parenteral use. 4. Clinical particulars 4.1 Therapeutic indications Treatment of female and male infertility in the following groups of patients: - Anovulatory women: MENOPUR can be used to stimulate follicle development in amenorrhoeic patients. Clomiphene (or a similar ovulation inducing agent which influences steroid feed-back mechanisms) is the preferred treatment for women with a variety of menstrual cycle disturbances, including luteal phase insufficiency with anovulatory cycles and with normal prolactin, and also amenorrhoeic patients with evidence of endogenous oestrogen production but normal prolactin and normal gonadotrophin levels. Non-responders may then be selected for menotrophin therapy. - Women undergoing superovulation within a medically assisted fertilisation programme: MENOPUR can be used to induce multiple follicular development in patients undergoing an assisted conception technique such as in-vitro fertilisation (IVF). - Hypogonadotrophic hypogonadism in men: MENOPUR may be given in combination with human chorionic gonadotrophin (e.g. Choragon) for the stimulation of spermatogenesis. Patients with primary testicular failure are usually unresponsive. 4.2 Posology and method of administration Anovulatory infertility: Menotrophin is administered to induce follicular maturation and is followed by treatment with chorionic gonadotrophin to stimulate ovulation and corpus luteum formation. The dosage and schedule of treatment must be determined according to the needs of each patient. Response is monitored by studying the p Citiți documentul complet