Recorded Chinese product: 氟罗沙星注射液氟罗沙星注射液
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
- 山西普德药业股份有限公司Chinese legal name: 山西普德药业股份有限公司
主要成分Active Ingredients
- 辅料为注射用水Recorded Chinese composition: 辅料为注射用水
- 用适量溶液调节pH值Yongshi Liangrong Yetiao Jiezhi
药物知识说明
辅料为注射用水是一种在国家药监局注册认定的药品。该药品含有用适量溶液调节ph值-aefc94d3等成分。
该药品关联的活性成分包括：用适量溶液调节ph值。这些成分信息来自国家药监局数据库。
该药品标注的生产企业为：山西普德药业股份有限公司Chinese legal name: 山西普德药业股份有限公司。
您可以探索含有相同成分的其他药品：用适量溶液调节ph值-aefc94d3成分药品。
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: 氟罗沙星注射液) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Manufacturers recorded for this product: 山西普德药业股份有限公司Chinese legal name: 山西普德药业股份有限公司.
Explore other medicines containing the same ingredient: 用适量溶液调节ph值 productsProducts containing this recorded ingredient.
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: 氟罗沙星注射液Recorded Chinese product: 氟罗沙星注射液
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 2ml:0.1g2 mL:0.1 g
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
- 山西普德药业股份有限公司Chinese legal name: 山西普德药业股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20059506
关联实体Relationships
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H20059506
Manufacturer
Chinese legal name: 山西普德药业股份有限公司 (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H20059506
生产企业
山西普德药业股份有限公司(国产)
适应症
可用于对本品敏感细菌引起的：急性支气管炎，慢性支气管炎急性发作及肺炎等呼吸系统感染；膀胱炎、肾盂肾炎、前列腺炎，附睾炎，淋病奈瑟菌性尿道炎等泌尿生殖系统感染；伤寒沙门菌感染，细菌性痢疾等消化系统感染；皮肤软组织感染、骨感染，腹腔感染及盆腔感染等。
用法用量
避光缓慢静脉滴注，一次0.2-0.4g，一日1次，稀释于5%葡萄糖250-500ml注射液中。
不良反应
1.胃肠道反应较为常见，可表现为腹部不适或疼痛、腹泻、恶心呕吐、食欲不振。 |2.中枢神经系统反应可有头昏、头痛、兴奋、嗜睡或失眠。 |3.过敏反应有皮疹、皮肤瘙痒，偶可发生渗出性多形红斑及血管神经性水肿。少数患者有光敏反应。 |4.少数患者可发生血氨基转移酶、血尿素氮增高及周围血象白细胞降低，多属轻度，并呈一过性。 |5.偶可发生： |(1)癫痫发作、精神异常、烦躁不安，意识混乱、幻觉、震颤。 |(2)血尿、发热、皮疹等间质性肾炎表现。 |(3)结晶尿，多见于高剂量应用时。 |(4)关节疼痛。 |(5)静脉炎。
禁忌
1.对本品或喹诺酮类药物过敏者禁用。 |2.孕妇、哺乳期妇女及18岁以下患者禁用。
注意事项
1.本品忌与生理盐水或葡萄糖盐水并用。|2.明显肝肾功能损害者慎用。|3.本品不宜与其他药物混合使用。|4.本品静脉滴注速度不宜过快，45-60分钟内不超过0.2g。|5.在治疗过程中以及治疗结束后三天内，避免阳光浴和人工紫外线照射。
贮藏
避光，密闭保存。
规格
2ml:0.1g
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.