País: Armenia
Idioma: inglés
Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
menotropin
Ferring GmbH
menotropin
75IU
powder lyophilized for solution for injection
Prescription
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MENOPUR 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: 1 injection bottle with powder contains highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to FSH 75 IU and LH 75 IU. 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 lyophilisation cake. Appearance of solvent: clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MENOPUR is indicated for the treatment of female infertility in the following clinical situations: • 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-Follopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)] 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 immediately prior to use. Up to 3 injection bottles of MENOPUR may be dissolved in 1 ml of the solvent provided. The solution should not be used if it contains particles or if it is not clear. DOSAGE Dosage regimens described below are identical for subcutaneous and intramuscular administration. There are great inter- and intraindividual 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 depending on the ovarian response. MENOPUR can be given alone or in combination with a gonadotrophin- SPC MENOPUR Germany 2008 English (Menogon HP for AM).doc 1/8 releasing hormone (GnRH) agonist or antagonist. Recommendati Leer el documento completo