国: ニュージーランド
言語: 英語
ソース: Medsafe (Medicines Safety Authority)
Menotrophin 600 [iU]
Pharmaco (NZ) Ltd
600 IU
Powder for injection with diluent
Active: Menotrophin 600 [iU] Excipient: Dibasic sodium phosphate heptahydrate Lactose monohydrate Phosphoric acid Polysorbate 20 Metacresol Nitrogen Water for injection
Prescription
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) (eg, in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)).
Package - Contents - Shelf Life: Combination pack, Type I vial, prefilled solvent syringe, reconstitution needle - 600 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days reconstituted stored at or below 25°C - Syringe, glass, Type I prefilled solvent syringe - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type I vial containing powder for injection - 600 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
2017-07-27
MENOPUR ® 1 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 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/EF (in vitro fertilisation/embryo transfer) 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 The active ingredient in this preparation is extracted from human urine. Th 完全なドキュメントを読む
NEW ZEALAND DATA SHEET MENOPUR 600IU and 1200IU Version 04 August 2022 Page 1 of 12 MENOPUR 600IU and 1200IU powder and solvent for solution for injection Menotrophin HP 1 PRODUCT NAME MENOPUR 600IU and 1200IU powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MENOPUR 600 IU (600 IU/mL after reconstitution): Each vial with powder contains highly purified menotrophin (human menopausal gonadotrophin, hMG) corresponding to follicle stimulating hormone (FSH) activity 600 IU and luteinising hormone (LH) activity 600 IU. MENOPUR 1200 IU (600 IU/mL after reconstitution): Each vial with powder contains highly purified menotrophin (human menopausal gonadotrophin, hMG) corresponding to follicle stimulating hormone (FSH) FSH 1200 IU and luteinising hormone (LH) LH 1200 IU. Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in postmenopausal urine, is present in MENOPUR and is the main contributor of the LH activity. For full list of excipients, see section 6.1 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)). 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. _DOSAGE _ There are great inter-individual variations in the response of the ovaries to exogenous gonadotrophins. This mak 完全なドキュメントを読む