Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chorionic gonadotrophin human
Organon Pharma (UK) Ltd
G03GA01
Chorionic gonadotrophin human
5000unit
Powder and solvent for solution for injection
Subcutaneous; Intramuscular
Schedule 4 (CD Anab)
Valid as a prescribable product
BNF: 06050100; GTIN: 5013257000780 5013257000797
PACKAGE LEAFLET: INFORMATION FOR USER Pregnyl® 5000 I.U.powder for solution for injection (Human Chorionic Gonadotrophin) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or nurse. • This medicine has been prescribed for you. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What is Pregnyl and what is it used for? 2. When should you not use this medicine or when should you be extra careful with this medicine? 3. How to use this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT IS PREGNYL AND WHAT IS IT USED FOR? Pregnyl belongs to a group of medicines called gonadotrophins (sex hormones). It controls the release of eggs from the ovary in women, and controls production of the male hormone, testosterone in men. WOMEN In female infertility it can be used to cause women to ovulate (OVULATION INDUCTION) . Pregnyl is also used along with other fertility drugs, to help produce eggs in medically assisted reproduction programmes (IVF TREATMENT) . MEN In men it is used to help treat DELAYED PUBERTY , UNDESCENDED TESTES or oligospermia (LOW SPERM COUNT) . ASK YOUR DOCTOR if you are unsure why you have been given Pregnyl. 2. WHEN SHOULD YOU NOT USE THIS MEDICINE OR WHEN SHOULD YOU BE EXTRA CAREFUL WITH THIS MEDICINE? WHEN SHOULD YOU NOT USE THIS MEDICINE? • If you are ALLERGIC (hypersensitive) to human chorionic gonadotrophin (hCG) or any of the other ingredients of this medicine (listed in section 6). • If you have a THYROID , ADRENAL or PITUITARY illness which is not being treated. • If you have CANCER , (especially a horm Leggi il documento completo
OBJECT 1 PREGNYL 5000IU Summary of Product Characteristics Updated 18-May-2018 | Merck Sharp & Dohme Limited 1. Name of the medicinal product Pregnyl ® 5000 I.U. powder for solution for injection. 2. Qualitative and quantitative composition Pregnyl consists of a freeze-dried powder for injection. The active ingredient [human chorionic gonadotrophin (hCG)] which is obtained from the urine of pregnant women, has luteinizing hormone (LH) activity. An ampoule contains 5000 I.U. hCG. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for injection. The powder is a white, dry powder or cake. 4. Clinical particulars 4.1 Therapeutic indications In the female Sterility due to the absence of follicle-ripening or ovulation. In combination with FSH or HMG, promotion of controlled superovulation in medically assisted reproduction programmes. In the male Hypogonadotrophic hypogonadism. Delayed puberty associated with insufficient gonadotrophic pituitary function. Sterility in selected cases of deficient spermatogenesis. 4.2 Posology and method of administration Posology _In the female_ _Sterility due to the absence of follicle-ripening or ovulation._ 5,000–10,000 IU hCG to induce ovulation, following treatment with an FSH (Follicle Stimulating Hormone) or HMG (Human Menopausal Gonadotrophins) preparation. _In combination with FSH or HMG, promotion of controlled superovulation in medically assisted _ _reproduction programmes._ 5,000–10,000 IU hCG 30 - 40 hours after the last FSH or HMG injection. Pregnyl should not be administered if the following criteria have not been met: at least 3 follicles greater than 17mm in diameter are present with 17ß estradiol levels of at least 3500 pmol/L (920 picogram/ml). Oocyte collection is carried out 32 - 36 hours after the hCG injection. _As luteal phase support_, two to three injections of 1,000 to 3,000 IU hCG each may be given within nine days of ovulation or embryo transfer, for example on day 3, 6 and 9 after ovulation induction or embryo t Leggi il documento completo