देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MENOTROPHIN, HIGHLY PURIFIED
Ferring Sdn. Bhd.
MENOTROPHIN, HIGHLY PURIFIED
1 Units
FERRING GMBH
Consumer Medication Information Leaflet (RiMUP) MENOPUR ® MULTIDOSE 600IU MENOPUR ® MULTIDOSE 1200IU Powder and solvent for solution for injection Menotrophin HP 600IU and 1200IU 1 READ THE ENTIRE LEAFLET CAREFULLY BEFORE 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 nurse. - 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 nurse. This includes any possible side effects not listed in the leaflet 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. Content of the pack and other information 1. WHAT MENOPUR ® IS AND WHAT IT IS USED FOR MENOPUR ® is provided as a powder which must be mixed with liquid (solvent) before it is used. It is given as an injection under the skin. MENOPUR ® contains two hormones called follicle stimulating hormone (FSH) and luteinizing hormone (LH). FSH and LH are natural hormones produced in both males and females. They help the reproductive organs to work normally. The FSH and LH in MENOPUR ® are obtained from the urine of postmenopausal women. The active ingredient is highly purified, and is known as menotrophin. MENOPUR ® is used to treat female infertility in the following situations: i. Anovulation, including polycystic ovarian disease (PCOD), in women who have been unresponsive to treatment with clomiphene citrate. ii. Women in Assisted Reproductive Technology, (ART) programmes (including in vitro fertilization / embryo transfer [IVF/ET], gamete intra-fallopian transfer [GIFT] and intracytoplasmic sperm injection [ICSI]). MENOPUR ® helps the ovaries to develop many egg sacs (follicles) where an egg might develop (multiple follicular developments). 2 पूरा दस्तावेज़ पढ़ें
Proposed packaging material Code (61,62) -I-MY -06.01 Size Submission ☐NDA ☐Renewal ☒Variation change detail no.: 125375 remove of alcohol swab Code of p revious version (61,62) -I-MY -05.01 Change s 125375 Remove of alcohol swab ☐CCDS version: ☐Core PIL version: ☐SPC country/version/date: ☐LAC no.: Name & Date JIW O, 18-MAY -2017 MENOPUR ® multidose 600 IU and 1200 IU Powder and Solvent for Solution for Injection COMPOSITION MENOPUR ® multidose 600 IU: Each vial with powder contains highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to follicle stimulating hormone activity FSH 600 IU and luteinizing hormone activity LH 600 IU. MENOPUR ® multidose 1200 IU: Each vial with powder contains highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to follicle stimulating hormone activity FSH 1200 IU and luteinizing hormone activity 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. List of excipients: Powder: lactose monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate , phosphoric acid (concentrated) Solvent: m etacresol, water for injection PHARMACEUTICAL DOSAGE FORM Powder and solvent for solution for injection INDICATIONS MENOPUR ® is indicated for the treatment of infertility in the following clinical situation s: 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 int racytoplasmic sperm injection (ICSI). DOSAGE AND ADMINISTRATION Treatment with MENOPUR ® should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Method of administration MENOPUR ® 600IU AN पूरा दस्तावेज़ पढ़ें