Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
MENOTROPHIN
FERRING PHARMACEUTICALS LTD
G03GA02
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
MENOTROPHIN 1200 IU
S.C, I.M
Required
FERRING GmbH ,GERMANY
HUMAN MENOPAUSAL GONADOTROPHIN
HUMAN MENOPAUSAL GONADOTROPHIN
Sterility in females with hypo or normogonadotropic ovarian insufficiency: stimulation of follicle growth. Sterility in males with hypo or normogonadotropic hypogonadism: In combination with HCG to spermatogenesis
2017-02-28
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1. NAME OF THE MEDICINAL PRODUCT MENOPUR multidose 600 IU MENOPUR multidose 1200 IU 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MENOPUR 600 IU: Each vial of powder contains highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to 600 IU human follicle stimulating hormone (FSH) and 600 IU human luteinizing hormone (LH) activity. MENOPUR 1200 IU: Each vial of powder contains highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to 1200 IU follicle stimulating hormone (FSH) and 1200 IU human luteinizing hormone (LH) activity. Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in postmenopausal urine, is present in MENOPUR and contributes to the overall luteinizing hormone activity. Menotrophin is produced from human urine. For a 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 lyophilised cake. Appearance of solvent: clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of Sterility in females with hypo or normogonadotropic ovarian insufficiency: stimulation of follicle growth. Sterility in males with hypo or normogonadotropic hypogonadism: In combination with HCG to spermatogenesis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with MENOPUR should be initiated under the supervision of a physician experienced in the treatment of fertility problems. METHOD OF ADMINISTRATION MENOPUR is intended for subcutaneous (S.C.) or intramuscular (I.M.) injection after reconstitution with the solvent provided. The powder should be reconstituted prior to use. The reconstituted solution is for multiple injections and can be used for up to 28 days. Vigorous shaking should be avoided. The solution should not be used if it contains particles or if it is not clear. DOSAGE Dosage regimens described below are identical for S.C. and I.M. administration. There are great inter-individual variations in the response of the ov Przeczytaj cały dokument