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
2022-02-02
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One cartridge contains 300 IU or 600 IU (concentration of 833 IU/mL) of follitropin beta (recombinant). This strength corresponds to 83.3 microgram of protein/mL (specific _in vivo_ bioactivity equal to approximately 10 000 IU FSH/mg protein). Total dose meant for 6 injections. When more injections are given the net total may be lowered, because each injection has to be preceded by an air shot. Excipient(s) with known effect: This medicinal product contains 10 mg of benzyl alcohol per mL. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for subcutaneous injection Clear and colourless aqueous solution. In cartridges, designed to be used in conjunction with a pen injector. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _In 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_ fertilization/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. _In 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 of Puregon® should be performed under direct medical supervision. _Method of administration _ Puregon® solution for injection in cartridges has been developed for use in the Puregon Pen and should be administered subcutaneously. The injection site should Прочитать полный документ