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英文药名: Menopur(Menotrophin)
中文药名: 美诺孕, 注射用高纯度尿促性素
生产品牌药厂家: Ferring Pharmaceuticals Inc
药品说明
中文通用名称：尿促性素
英文通用名称：Menotropins
中文其他名称：喜美康, 休米根, 高孕乐, 注射用尿促性素, 护玫贡, 普格纳, 注射用高纯度尿促性素, 贺美奇, 美能康
英文其他名称： Pergonal, Menotrophin, HMG, Humegon, Menotrophins, Ganadotrophin, Gonadotrophin, Pergogreen, Menotrophin for Injection, Highly Purified Menotrophin for Injection, Menopur
产品所属分类：女性生殖系统用药\其它女性生殖系统药
适应症：
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。
2.与绒促性素合用，用于原发性或继发性闭经的治疗以及卵巢功能试验等。
3.用于多囊卵巢综合征(PCOS)，特别是用氯米芬无效者。
4.助孕技术中对正常排卵妇女刺激促超排卵，常与氯米芬及绒促性素配合使用，一次可获得多个卵细胞。
5.与绒促性素合用治疗男性促性腺激素低下及不育，刺激生精功能。
注意事项：
1.禁忌症
(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。
2.慎用
(1)哮喘患者。
(2)心脏病患者。
(3)癫痫患者。
(4)偏头痛患者。
(5)肾功能不全患者。
3.药物对妊娠的影响
(1)用本药刺激排卵，常出现多个卵泡同时发育，多胎妊娠率高，早产也较多见。
(2)有报道，使用本药与绒促性素合并治疗后的妊娠出现死胎和先天性畸形，但未证明与本药有直接关系。
(3)对已妊娠者禁用。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为X级。
4.药物对哺乳的影响: 尚不明确。
5.用药前后及用药时应当检查或监测
(1)用药期间应进行全面的盆腔检查，可用B超对卵巢进行严密监护，观察卵巢大小及卵泡发育数目。尤其是从雌激素浓度开始上升后，应每日进行盆腔检查，直至加用绒促性素后至少2周。
(2)治疗过程中应每日测量基础体温，有助于了解卵巢排卵。
(3)通过宫颈粘液、阴道脱落细胞检查，可了解体内雌激素水平；用药1周后，应监测尿或血中的雌激素水平。
(4)宫颈粘液检查也有助于了解卵泡成熟程度或有否排卵。
(5)用β人绒毛膜促性腺激素(β-HCG)免疫试验检测早孕。
不良反应：
1.常见卵巢过度刺激综合征(OHSS)，轻者出现恶心、呕吐、胃部与下腹部的不适或胀感及疼痛、卵巢轻度增大(可在7-10日内消除)；中度与重度者可致卵巢直径增大至10cm、胸闷、气急、尿量减少、胸水、腹水、卵泡囊肿破裂出血、电解质紊乱、血容量降低、肾衰竭甚至死亡。
2.用药后常可增加动脉栓塞的危险性。
3.男性在尿促性素-绒促性素治疗中，偶见女性化乳房发育，但目前认为是绒促性素的作用。
给药说明：
1.由于本药在体内的药代动力学和降解速度因人而异，卵巢血供也受过去盆腔手术或疾病的影响，并且卵巢贮备能力还因年龄而不同，因此，促排卵药物必须强调个体化方案。应根据卵巢的反应，选择适当的用药时间及剂量，以提高受孕率及防止OHSS的发生。
2.若24小时尿雌激素高于200μg，血雌激素不低于3660Pmol/L，B超检查卵巢直径大于5cm(或直径不小于16mm的卵泡数目超过3个以上)，则应停用本药，以免发生OHSS。
3.如24小时尿雌激素高于200μg，则不宜用大量绒促性素，以免引起对卵巢的过度刺激。
4.OHSS常在注射绒促性素后3-7日发生，对中度与重度的OHSS，应住院治疗，以免发生不可逆的电解质紊乱，甚至死亡；对重度OHSS，应立即停药。
5.用药期间在进行妇科检查时应小心操作，并嘱患者避免性生活。应从用绒促性素和排卵前1日开始每日同房。如卵巢明显增大，应避免同房，以减少卵巢囊肿破裂的发生率。
6.本药为粉针剂，应在临用时溶于1-2ml灭菌注射用水中。注意液体应沿瓶壁缓慢流下，以免产生大量泡沫。
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。
制剂与规格：
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。
【原产地英文商品名】Menopur 75U/vial 5vials/box
【原产地英文药品名】menotropins
【中文参考商品译名】Menopur 75 U/瓶 5瓶/盒
【中文参考药品译名】menotropins
【生产厂家中文参考译名】辉凌制药有限公司
【生产厂家英文名】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. |
