英文名：Follitrope

　　通用名：重组人促卵泡激素注射液

　　医疗保险：否

　　产品类别：生物制品

　　主要成份：基因重组人促卵泡激素

　　产品性状：预填充注射液无色或微黄色液体

　　适应症：在下列临床情况中适用于治疗不孕的女性：在医学辅助生殖技术（例如：体外受精（IVF)，输卵管内配子移植术（GIFT)，受精卵输卵管内转移（GIFT)以及精子卵浆内注射技术（ICSI））中用于控制性超排卵以诱导多个卵泡发育

　　【规格】75IU，150IU，225IU，300IU预填充注射器包装

　　【贮藏】2~8°C密闭容器避光保存和运输，避免冷冻

　　【有效期】24个月

　　【生产企业】企业名称：LG Life Sciences, Ltd.

　　Product Name

　　Follitrope

　　Composition

　　Follitrope Inj.

　　75 or 150 IU recombinant follicle stimulating hormone (FSH) lyophilized powder

　　Follitrope Pre-filled Syringe

　　75, 150, 225 or 300 IU recombinant follicle stimulating hormone (FSH) liquid

　　Indication

　　Treatment of female infertility in the following clinical situations:

　　Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction program (e.g. in vitro fertilization/embry transfer; IVF/ET, gamete intra-fallopian transfer; GIFT, zygote intra-fallopian transfer; ZIFT, intracytoplasmic sperm injection; ICSI)

　　Anuvulation in clomiphene-resistant anovulatory infertility women (WHO Group II, including polycystic ovarian disease (PCOD))

　　Dosage and Administration

　　Treatment with Follitrope should be initiated under the supervision of a physician experienced in the treatment of fertility problems.

　　Follitrope is intended for subcutaneous and intramuscular administration. The powder should be reconstituted prior to the first use with the solvent provided. 3 vials of Follitrope Inj. 75 IU or 150 IU can be reconstituted with 1 mL solvent.

　　Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilization or other assisted reproductive technologies:

　　Various stimulation protocols are applied in order to suppress the endogenous LH surge and to control tonic levels of LH. A Commonly used regimen for hyperovulation involves the administration of 150~300 IU of Follitrope daily, commencing on days 2 to 5 of the cycle. Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum estrogen levels and/or ultrasound examination), with the dose adjusted according to the patients response, to usually not higher than 450 IU daily. In general, adequate follicular development was achieved on average by the tenth day of treatment. A single injection up to 10,000 IU hCG (human Chorionic Gonadotropin) is administered 48 hours after the last Follitrope injection.

　　How Supplied

　　Follitrope Inj.

　　75 IU 1 vial with solvent vial / pack

　　150 IU 1 or 5 vials with solvent vial / pack

　　Follitrope Pre-filled Syringe

　　75, 150, 225 or 300 IU 1 pre-filled syringe / pack

　　Storage Condition

　　Follitrope Inj.

　　Store below 25 ℃ in a hermetic container protected from light.

　　Follitrope Pre-filled Syringe

　　Store at 2 ~ 8 ℃ in a hermetic container.

　　Shelf Life

　　36 months