Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
follitropin beta (recombinant)
Organon (Ireland) Ltd.
follitropin beta (recombinant)
300IU/0,36ml
solution for s/c injection
Prescription
S-CCDS-MK8328-SOI-082013A 1 SUMMARY OF PRODUCT CHARACTERISTICS FOR ARMENIA PUREGON ® 1. NAME OF THE MEDICINAL PRODUCT PUREGON 150 IU/0.18 mL, 300 IU/0.36 mL, 600 IU/0.72 mL or 900 IU/1.08 mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One cartridge contains a net total dose of 150 IU, 300 IU, 600 IU or 900 IU recombinant follicle-stimulating hormone (FSH) activity in 0.18, 0.36, 0.72 or 1.08 mL aqueous solution. The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 833 IU/mL aqueous solution. This strength corresponds to 83.3 microgram of protein/mL (specific in vivo bioactivity equal to approximately 10 000 IU FSH/mg protein). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colorless solution. In cartridges, designed to be used in conjunction with a pen injector. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _In the female _ Puregon is indicated for the treatment of female infertility in the following clinical situations • Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate. • Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. _in vitro_ fertilization/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. _In the male _ S-CCDS-MK8328-SOI-082013A 2 • Deficient spermatogenesis due to hypogonadotrophic hypogonadism. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems. The first injection of Puregon should be performed under direct medical supervision. _Posology _ When using the pen injector, it should be realized that the pen is a precision device that accurately delivers the Прочитать полный документ