Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
human menopausal gonadotrophin, Quantity: 1200 IU
Ferring Pharmaceuticals Pty Ltd
human menopausal gonadotrophin
Injection, solvent for
Excipient Ingredients: water for injections; metacresol
Subcutaneous
1 (1 vial, 2 prefilled syringes with solvent for reconstitution, 1 needle for reconstitution)
(S4) Prescription Only Medicine
MENOPUR is indicated for the treatment of infertility in the following clinical situations:,Anovulatory infertility, 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)).
Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2011-09-13
MENOPUR ® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION _Human menopausal gonadotrophin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Menopur. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Menopur against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT MENOPUR IS USED FOR Menopur contains highly purified human menopausal gonadotrophin (hMG), also known as menotrophin, as the active ingredient. It is obtained from the urine of post-menopausal women. hMG is a mixture of three hormones with follicle stimulating hormone (FSH) activity and luteinising hormone (LH) activity found naturally in humans. Menopur belongs to a class of medicines called gonadotrophins. Menopur is used to treat infertility (reproduction related conditions) in women. Menopur is used in women who are not ovulating (not producing eggs). It helps women become pregnant by stimulating the ovarian follicles to release an egg. Menopur is also used to stimulate the ovarian follicles in women undergoing Assisted Reproductive Technology (ART) such as IVF/ET (in vitro fertilisation/embryo transfer), GIFT (gamete intra- fallopian transfer) and ICSI (intracytoplasmic sperm injection) to help them become pregnant. Your doctor will be able to talk to you about your specific fertility problem. Menopur is given only by or under the supervision of your doctor. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU USE MENOPUR Lire le document complet
Page 1 of 14 #24207-v16C AUSTRALIAN PI - MENOPUR ® (HUMAN MENOPAUSAL GONADOTROPHIN) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Human menopausal gonadotrophin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MENOPUR 600 IU (600 IU/mL after reconstitution) MENOPUR 1200 IU (600 IU/mL after reconstitution) MENOPUR 600 IU: each vial with powder contains highly purified menotrophin (human menopausal gonadotrophin, hMG) corresponding to follicle stimulating hormone activity FSH 600 IU and luteinising hormone activity LH 600 IU. MENOPUR 1200 IU: each vial with powder contains highly purified menotrophin (human menopausal gonadotrophin, hMG) corresponding to follicle stimulating hormone activity FSH 1200 IU and luteinising hormone activity LH 1200 IU. Excipient with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Appearance of powder: white to off-white lyophilisation cake. Appearance of solvent: clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MENOPUR is indicated for the treatment of infertility in the following clinical situations: Anovulatory infertility, 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)). Page 2 of 14 #24207-v16C 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with MENOPUR should be initiated under the supervision of a physician experienced in the treatment of fertility problems. 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 dependi Lire le document complet