ประเทศ: อิสราเอล
ภาษา: อังกฤษ
แหล่งที่มา: Ministry of Health
FOLLICLE STIMULATING HORMONE (FSH); LUTEINIZING HORMONE
FERRING PHARMACEUTICALS LTD
G03GA
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
FOLLICLE STIMULATING HORMONE (FSH) 75 IU/VIAL; LUTEINIZING HORMONE 75 IU/VIAL
I.M, S.C
Required
FERRING GmbH ,GERMANY
GONADOTROPINS
Sterility in females with hypo or normogonadotropic ovarian insufficiency: stimulation of follicle growth. Sterility in males with hypo or normogonadotropic hypogonadism.
2021-07-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only MENOGON POWDER FOR RECONSTITUTING A SOLUTION FOR INJECTION ACTIVE INGREDIENT: Each ampule with powder contains menotropin (HMG): 75 IU FSH (follicle-stimulating hormone) and 75 IU LH (luteinizing hormone). Inactive ingredients and allergens: See the section ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? WOMEN: infertility that is caused by ovary failure, promoting follicle growth in fertility treatments. Infertility in women with ovarian failure and normal secretion of gonadotropins: stimulating follicle growth. MEN: Infertility caused by testicular failure. Infertility in men with hypogonadism who have low or normal secretion of gonadotropins. THERAPEUTIC GROUP: gonadotropins. MENOGON contains human menopausal gonadotropin (HMG), a substance secreted in the urine of post-menopausal women that is used to treat infertility in women and men. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE: • if you are sensitive (allergic) to menotropin or any of the other ingredients in this medicine. WOMEN • if you are pregnant or breastfeeding • if you have been diagnosed with enlarged ovaries or cysts that are not caused by polycystic ovary syndrome (a disorder associated with formation of ovarian cysts and hormonal disorders) • if you have vaginal bleeding for an unknown reason • if you have cancer of the womb, ovaries, or breasts. In addition, do not use MENOGON with conditions that make normal pre อ่านเอกสารฉบับเต็ม
1. NAME OF THE MEDICINAL PRODUCT Menogon 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ampoule with powder contains Menotropin (human menopausal gonadotropin, HMG) corresponding to 75 IU FSH and 75 IU LH. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Sterility in females with hypo- or normogonadotropic ovarian insufficiency: Stimulation of follicle growth. • Sterility in males with hypo- or normogonadotropic hypogonadism. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Sterility in females: The dosage of HMG for the induction of follicle growth in normo- or hypogonadotropic women varies according to the individual. The amount depends on ovarian response and should be checked by ultrasound examinations of the ovaries and measuring estradiol levels. If the HMG dosage is too high for the treated individual, multiple uni- and bilateral follicle growth can occur. HMG is administered intramuscularly or subcutaneously and in general, the therapy is begun with a daily dosage corresponding to 75–150 IU FSH. If the ovaries do not respond, the dosage can slowly be increased until a rise in estradiol secretion and follicle growth is evident. Treatment with the same dosage of HMG continues until the desired pre-ovulatory estradiol serum level is attained. If the level rises too quickly, the dosage should be reduced. To induce ovulation, 5000 or 10000 IU HCG are injected i.m. 1 to 2 days after the last HMG administration. Note: After a HMG dosage too high for the corresponding individual has been administered the following HCG administration can cause an unintentional hyperstimulation of the ovaries. Sterility in males: Initially, 3 X 1000 to 3000 IU HCG a week are administered until a normal testosterone serum level is reached. Then, an additional dose of HMG (3 X 75–150 IU FSH + 75–150 IU LH) per week is administered IM for a few months. METHOD OF ADMINISTRATION Menogon is administered อ่านเอกสารฉบับเต็ม