Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
follitropin beta (recombinant)
N.V. Organon
G03GA06
follitropin beta (recombinant)
300IU/0,36ml
solution for s/c injection
cartridge 0,42ml, (6/2x3/) needles
Prescription
Registered
2015-05-15
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Puregon 50 IU/0.5 ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 50 IU recombinant follicle-stimulating hormone (FSH) in 0.5 ml aqueous solution. This corresponds to a strength of 100 IU/ml. One vial contains 5 microgram of protein (specific _in _ _vivo _ bioactivity equal to approximately 10 000 IU FSH / mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _In adult females:_ 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 _ fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. _In adult males:_ • 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 with Puregon should be performed under direct medical supervision. Posology _Dosage in the female_ There are great inter- and intra-individual 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. This requires ultrasound assessment of follicular development. The concurrent determination o Прочитать полный документ