دواعي استعمال بيوريجون 50 وحدة/0.5مل فيال

Recombinant FSH (follitropin beta) 50 IU/0.5 ml solution for injection, 1 vial (Organon; Multipharma, Egypt).

• Anovulation (including PCOS) in women unresponsive to clomifene citrateالفئة: Adult femalesEuropean Medicines Agency (EMA)
• Controlled ovarian hyperstimulation for multiple follicle development in medically assisted reproduction (IVF/ET, GIFT, ICSI)الفئة: Adult femalesEuropean Medicines Agency (EMA)
• Deficient spermatogenesis due to hypogonadotrophic hypogonadismالفئة: Adult malesEuropean Medicines Agency (EMA)

• Women: common - headache, abdominal pain/distension, OHSS, pelvic pain, injection-site reactions; uncommon - breast complaints, ovarian cysts/enlargement, nausea, diarrhoea, constipation, generalised hypersensitivity. Anaphylactic reactions reported post-marketing.نشرة دولية لتركيبة مكافئة · European Medicines Agency (EMA)
• Men: common - headache, acne, rash, epididymal cyst, gynaecomastia, injection-site reactions.نشرة دولية لتركيبة مكافئة · European Medicines Agency (EMA)

• Hypersensitivity to follitropin beta or excipients; tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus; primary gonadal failure.نشرة دولية لتركيبة مكافئة · European Medicines Agency (EMA)
• Additionally in women: undiagnosed vaginal bleeding; ovarian cysts or enlarged ovaries not related to PCOS; reproductive-organ malformations or uterine fibroids incompatible with pregnancy.نشرة دولية لتركيبة مكافئة · European Medicines Agency (EMA)

• Risk of ovarian hyperstimulation syndrome (OHSS), which may be severe; monitor follicular development by ultrasound (and oestradiol) and observe for at least two weeks after hCG.نشرة دولية لتركيبة مكافئة · European Medicines Agency (EMA)
• Multiple pregnancy, ectopic pregnancy, miscarriage, ovarian torsion and thromboembolic events have been reported with gonadotropin treatment.نشرة دولية لتركيبة مكافئة · European Medicines Agency (EMA)
• May contain traces of streptomycin and/or neomycin, which can cause hypersensitivity in susceptible persons. Treatment should be started under supervision of a physician experienced in fertility treatment.نشرة دولية لتركيبة مكافئة · European Medicines Agency (EMA)

• Clomifene citrateConcomitant use may enhance the follicular response.European Medicines Agency (EMA)
• GnRH agonistsAfter pituitary desensitisation a higher follitropin beta dose may be needed.European Medicines Agency (EMA)

• Use during pregnancy is not indicated; data are insufficient to exclude a teratogenic effect after inadvertent exposure, though no particular malformative effect has been reported.نشرة دولية لتركيبة مكافئة · European Medicines Agency (EMA)
• No data on excretion in milk; excretion is unlikely given the high molecular weight. Follitropin beta may affect milk production.نشرة دولية لتركيبة مكافئة · European Medicines Agency (EMA)

• Ultrasound assessment of follicular development, with optional serum oestradiol, to individualise dosing and reduce OHSS/multiple-pregnancy risk.نشرة دولية لتركيبة مكافئة · European Medicines Agency (EMA)

• Recombinant FSH with amino-acid sequence identical to human FSH; drives follicular recruitment and development (EU SmPC).