Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
FOLLITROPIN ALFA; LUTROPIN ALFA
MERCK SERONO LTD
G03GA05
SOLUTION FOR INJECTION
LUTROPIN ALFA 150 IU / 0.48 ML; FOLLITROPIN ALFA 300 IU / 0.48 ML
S.C
Required
MERCK EUROPE B.V., THE NETHERLANDS
FOLLITROPIN ALFA
Pergoveris is indicated for the stimulation of follicular development in adult women with sever LH and FSH deficiency.In clinical trials, these patients were defined by an endogenous serum LH level < 1.2IU/l
2023-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only PERGOVERIS ® Pre-filled pen Solution for Subcutaneous Injection Active ingredients: Follitropin Alfa (r-hFSH) Lutropin Alfa (r-hLH) Provided in three volumes: Pergoveris (300 IU* r-hFSH + 150 IU r-hLH)/0.48 mL Pergoveris (450 IU r-hFSH + 225 IU r-hLH)/0.72 mL Pergoveris (900 IU r-hFSH + 450 IU r-hLH)/1.44 mL (*IU – international units) Inactive and allergenic ingredients in the preparation – see section 6. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Keep this leaflet; you may need to read it again. 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. The medicine is not intended for girls and adolescent girls below the age of 18. 1. WHAT IS THE MEDICINE INTENDED FOR The medicine is intended for stimulation of follicles and their maturation in the ovaries in adult women with severe gonadotropin hormone deficiency (FSH and LH). In clinical trials, patients were defined by levels of LH (the luteinizing hormone) in the blood, below 1.2 international units per liter. Therapeutic group: Gonadotropin hormones that are involved in regulating the reproductive system. The medicine contains 2 active ingredients called Follitropin Alfa and Lutropin Alfa. Both ingredients belong to a group of hormones called gonadotropins that are involved in regulation of the reproductive system. The active ingredients in the medicine are copies of the natural hormones, FSH and LH in the body: FSH, follicle stimulating hormone - stimulates maturation of eggs. LH, luteinizing hormone - stimulates release of the eggs. The medicine allows women with low levels of FSH and LH to develop a follicle. The injection of another hormone - hu Belgenin tamamını okuyun
1 PRESCRIBING INFORMATION PERGOVERIS ® PRE-FILLED PEN 1. NAME OF THE MEDICINAL PRODUCT Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PERGOVERIS (300 IU + 150 IU)/0.48 ML: Each multidose pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa* (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa* (r-hLH) in 0.48 mL solution. PERGOVERIS (450 IU + 225 IU)/0.72 ML: Each multidose pre-filled pen contains 450 IU (equivalent to 33 micrograms) of follitropin alfa* (r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa* (r-hLH) in 0.72 mL solution. PERGOVERIS (900 IU + 450 IU)/1.44 ML: Each multidose pre-filled pen contains 900 IU (equivalent to 66 micrograms) of follitropin alfa* (r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa* (r-hLH) in 1.44 mL solution. *recombinant human follitropin alfa and recombinant human lutropin alfa are produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless to slightly yellow solution. The pH of the solution is 6.5 to 7.5, its osmolality is 250 to 400 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/L. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Pergoveris should be initiated under the supervision of a physician experienced in the treatment of fertility disorders. Posology In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of Pergoveris therapy is to develop a single mature Graafian follicle from Belgenin tamamını okuyun