中文通用名称:尿促性素 英文通用名称: Menotropins 产 品 分 类: 西药\女性生殖系统用药\其它女性生殖系统药 药 物 功 效 1.主要与绒促性素合用，用于促性腺激素分泌不足(下丘脑-垂体功能低下或不协调)所致的无排卵性不孕症,一般主张用于氯米芬(CC)或溴隐停等诱发排卵无效的病例。 … 用法用量: 成人 ·常规剂量 ·肌内注射 1.用于助孕技术中，刺激超排卵周期：对正常排卵妇女，希望刺激更多卵泡发育。从月经的第3-5日开始使用本药，一次75-150U，一日1次，连用7日。同时用B超监测卵泡变化，当卵泡直径达16-17mm、尿雌激素24小时水平达100-200μg时，即注射绒促性素5000-10000U以诱导排卵，并在其后32-36小时取卵或指导同房。未能妊娠者可重复治疗2个周期。如单纯用本药，则初量为150U，一日1次给药。 2.用于治疗下丘脑-垂体无排卵性不育或闭经：多在氯米芬或溴隐亭等诱导排卵无效时使用本药及绒促性素，方法同上。 3.男性促性腺激素低下的少精症：在用绒促性素使睾丸体积增至8ml左右后，可一周用本药1次，一次75-150U，约用12个月。 注射用尿促性素(以FSH效价计)(1)75U。(2)150U。 贮法：遮光，密闭，在干燥处保存。 (1)对本药过敏者。(2)孕妇。(3)绝经妇女。(4)原因不明的阴道出血者。(5)子宫肌瘤患者。(6)卵巢功能低下或缺如者(女性先天性性腺或卵巢发育不全综合征(Turner综合征)、单纯性腺发育不良、卵巢早衰)。(7)多囊泡性卵巢、卵巢囊肿或肿瘤及其它卵巢增大者。(8)甲状腺或肾上腺皮质功能减退者。(9)颅内病变(包括垂体肿瘤)者。(10)血栓栓塞性疾病患者。(11)男性前列腺癌或其它雄激素依赖性疾病患者。 规格: 75 U/瓶 5瓶/盒 生产厂家：辉凌制药有限公司（Ferring Pharmaceuticals） Menopur® (menotropins for injection, USP) is a preparation of gonadotropins, extracted from the urine of postmenopausal women, which has undergone additional steps for purification. Each vial of Menopur® contains 75 International Units (IU) of follicle-stimulating hormone (FSH) activity and 75 IU of luteinizing hormone (LH) activity, plus 21 mg lactose monohydrate and 0.005 mg Polysorbate 20 and Sodium Phosphate Buffer (Sodium Phosphate Dibasic, Heptahydrate and Phosphoric Acid) in a sterile, lyophilized form intended for reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Menopur® is administered by subcutaneous (SC) injection. The biological activity of Menopur® is determined using the USP bioassays for FSH (ovarian weight gain assay in female rats) and LH (seminal vesicle weight gain assay in male rats), modified to increase the accuracy and reproducibility of these assays. The FSH and LH activity assays are standardized using the Fourth International Standard for Urinary FSH and Urinary LH, November 2000, by the Expert Committee on Biological Standardization of the World Health Organization (WHO ECBS). Human Chorionic Gonadotropin (hCG) is detected in Menopur®. Both FSH and LH are glycoproteins that are acidic and water soluble. Therapeutic class: Infertility. INDICATIONS Menopur® administered subcutaneously is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART program. Dosage Assisted Reproductive Technologies The recommended initial dose of Menopur® for patients who have received a GnRH agonist for pituitary suppression is 225 IU. Based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results) subsequent dosing should be adjusted according to individual patient response. Adjustments in dose should not be made more frequently than once every two days and should not exceed 150 IU per adjustment. The maximum daily dose of Menopur® given should not exceed 450 IU and dosing beyond 20 days is not recommended. Once adequate follicular development is evident, hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. The administration of hCG must be withheld in cases where the ovaries are abnormally enlarged on the last day of therapy. This should reduce the chance of developing OHSS. Administration Dissolve the contents of one to six vials of Menopur® in one mL of sterile saline and ADMINISTER SUBCUTANEOUSLY immediately. Any unused reconstituted material should be discarded. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. The lower abdomen (alternating sides) should be used for subcutaneous administration. HOW SUPPLIED Menopur® (menotropins for injection, USP) is supplied in sterile vials as a lyophilized, white to off-white powder or pellet. Each vial of Menopur® is accompanied by a vial of sterile diluent containing 2 mL of 0.9 % Sodium Chloride Injection, USP: 75 IU FSH and 75 IU of LH activity, supplied as: NDC 55566-7501-1 : Box of 5 vials + 5 vials diluent. NDC 55566-7501-2 : Box of 5 vials + 5 vials diluent + 5 Q•Cap™ vial adapters. Storage Lyophilized powder may be stored refrigerated or at room temperature (3° to 25°C/37° to 77°F). Protect from light. Use immediately after reconstitution. Discard unused material. DIRECTIONS FOR USING MENOPUR® Wash hands thoroughly with soap and water. Before injections, the septum tops of the vials should be wiped with an aseptic solution to prevent contamination of the contents. To prepare the Menopur® solution, inject 1 mL of Sterile Saline for Injection, USP into the vial of Menopur®. DO NOT SHAKE, but gently swirl until the solution is clear. Generally, the Menopur® dissolves immediately. Check the liquid in the container. If it is not clear or has particles in it, DO NOT USE IT. For patients requiring a single injection from multiple vials of Menopur®, up to 6 vials can be reconstituted with 1 mL of Sterile Saline for Injection, USP. This can be accomplished by reconstituting a single vial as described above (see step 3). Then draw the entire contents of the first vial into a syringe, and inject the contents into a second vial of lyophilized Menopur®. Gently swirl the second vial, as described above, once again checking to make sure the solution is clear and free of particles. This step can be repeated with 4 additional vials for a total of up to 6 vials of lyophilized Menopur® into 1 mL of diluent. Draw the reconstituted Menopur® into an empty, sterile syringe. Hold the syringe pointing upwards and gently tap the side to force any air bubbles to the top; then squeeze the plunger gently until all the air has been expelled and only Menopur® solution is left in the syringe. Menopur® works if it is injected SC . The recommended sites for SC injection are either side of the lower abdomen alternating between left and right sides of the lower abdomen below the naval. SC injection of Menopur® into the thigh is not recommended unless the lower abdomen is not useable because of scarring, surgical deformity or other medical conditions. The injection site should be swabbed with alcohol. Clean about two inches around the point where the needle will go in and let the alcohol dry for at least one minute before proceeding. For SC injection, the needle should be inserted at a 90° angle to the skin surface.