Miejun Qianlie Xiansu Rongye (灭菌前列腺素E2溶液)灭菌前列腺素E2溶液
This is a medicine registration record from NMPA data.本页为国家药监局药品注册记录。
Labeled sections from the recorded Chinese source are included below. English wording is a reference translation when one is on file, not an official English label.本记录未接入产品级适应症/安全性标注字段。
生产企业Manufacturer
- 开封康诺药业有限公司Chinese legal name: 开封康诺药业有限公司
主要成分Active Ingredients
- 地诺前列酮Dinuo Qianlie Tong
药物知识说明
地诺前列酮是一种在国家药监局注册认定的药品。标注生产企业为开封康诺药业有限公司。
该药品暂无关联的活性成分信息。
该药品标注的生产企业为：开封康诺药业有限公司Chinese legal name: 开封康诺药业有限公司、开封康诺药业有限公司Chinese legal name: 开封康诺药业有限公司、开封康诺药业有限公司Chinese legal name: 开封康诺药业有限公司。
本页面内容来自国家药监局数据库，MedicineGraph在此基础上提供关系图谱和知识导航。
Medicine Knowledge
This medicine (original name: 灭菌前列腺素E2溶液) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 开封康诺药业有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 开封康诺药业有限公司Chinese legal name: 开封康诺药业有限公司, 开封康诺药业有限公司Chinese legal name: 开封康诺药业有限公司, 开封康诺药业有限公司Chinese legal name: 开封康诺药业有限公司.
Source: MedicineGraph authoritative database. Relationships derived from registered product information.
这是什么What is this
- 通用名/品名Recorded product name: 灭菌前列腺素E2溶液Recorded Chinese name: 灭菌前列腺素E2溶液
- 剂型Dosage form: 溶液剂Solution
- 规格Specification: 1ml:2mg1 mL:2 mg
本段仅展示注册/说明书已记录的身份属性，不含适应症或用法建议。Identity attributes from registration/leaflet records only; no indications or usage advice.
生产企业Manufacturer
- 开封康诺药业有限公司Chinese legal name: 开封康诺药业有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H41025219
信息来源Source and scope
国家药品监督管理局（中国）药品注册数据及已接入说明书字段。National Medical Products Administration (China) medicine-registration data and linked leaflet fields.
- 品名来源Name source: 10多万条药品说明书数据库 (HIGH)Package-insert database (more than 100,000 records) (HIGH)
- 生产企业来源Manufacturer source: 10多万条药品说明书数据库Package-insert database (more than 100,000 records)
- 剂型来源Dosage-form source: 10多万条药品说明书数据库Package-insert database (more than 100,000 records)
范围：当前 MedicineGraph 注册记录及已记录的精确关系；非完整目录，亦不构成疗效等同主张，也不支持换用判断。不含适应症/安全性推断。Scope: current MedicineGraph registration records and exact recorded relationships; not a complete catalog and not a claim of therapeutic equivalence. No inferred indications/safety.
本段为已核准说明书原文摘录（非改写、非AI摘要），非正式英文标签，亦不构成用药建议。 Not an official English label and not medical advice. English wording, when shown, is a reference translation of the Chinese source label.
English translation for reference. Translated from the Chinese source label. Not an official English label and not medical advice.
NMPA approval number
国药准字H41025219
Manufacturer
Chinese legal name: 开封康诺药业有限公司 (domestically manufactured)
Indications
English translation unavailable. The original Chinese source label remains available below.
Dosage and administration
English translation unavailable. The original Chinese source label remains available below.
Adverse reactions
English translation unavailable. The original Chinese source label remains available below.
Contraindications
English translation unavailable. The original Chinese source label remains available below.
Precautions
English translation unavailable. The original Chinese source label remains available below.
Storage
English translation unavailable. The original Chinese source label remains available below.
Specification
English translation unavailable. The original Chinese source label remains available below.
中文说明书原文Original Chinese source label
批准文号
国药准字H41025219
生产企业
开封康诺药业有限公司(国产)
适应症
可用于中期妊娠引产、足月妊娠引产和治疗性流产，对妊娠毒血症（先兆子痫、高血压）、妊娠合并心肾疾患者、过期妊娠、死胎不下、水泡状胎块、羊膜早破、高龄初产妇等均可应用。
用法用量
应用前，将前列腺素E2和碳酸钠溶液各1支加入10ml等渗盐水中，摇匀使成稀释液，供宫腔给药或静脉滴注给药。
1.静滴：将上述含2mg前列腺素E2的稀释液加入5%葡萄糖液500ml中静脉滴注，一般滴速：中期妊娠引产每分钟4-8μg（每分钟15-30滴左右）；足月妊娠引产每分钟1μg。
2.宫腔内羊膜腔外给药：每次给药200μg，2小时给药1次。给药3小时后，亦可酌情加用适量缩宫素，以加速产程进展。
不良反应
1.常见的不良反应有恶心、呕吐、腹泻、发热(常在用药后15-45分钟出现，停药后2-6小时恢复正常)等；少数患者有畏寒、头痛及出现胎心率改变、胎儿窘迫等。
2.本药用量过大或同时合用其它宫缩药，可使子宫痉挛及肌张力过高，甚至挛缩，因而导致宫颈撕裂、宫颈后方穿孔、子宫破裂和大出血。
3.约10%的妇女在用药后舒张压降低。
4.静滴时，少数出现类似静脉炎症状，停药后自动消失。
禁忌
1.对本品过敏者禁用。
2.胎膜已破者禁用。
3.多胎经产妇(6胎或以上)或有难产史者禁用。
4.有头盆不称、胎位异常、子宫收缩过强或胎儿窘迫者禁用。
注意事项
1.当药品性状发生改变时禁用。
2.有贫血史、活动性心脏病、高血压史等心血管疾病者慎用。
3.有糖尿病史，肝、肾病史、癫痫病史者慎用。
4.有宫颈硬化、子宫纤维瘤、子宫手术史、宫颈炎、阴道炎慎用。
5.有青光眼、哮喘、活动性肺病者慎用。
贮藏
密闭，在-8℃左右可存放3个月；在-20℃可存放半年
规格
1ml:2mg
信息来源Source and scope
国家药品监督管理局（中国）药品注册数据。National Medical Products Administration (China) medicine-registration data.
范围：当前 MedicineGraph 注册记录及已记录的精确关系；非完整目录，亦不构成疗效等同主张，也不支持换用判断。Scope: current MedicineGraph registration records and exact recorded relationships; not a complete catalog and not a claim of therapeutic equivalence.