Recorded Chinese product: 甲磺酸培氟沙星片甲磺酸培氟沙星片
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
- 内蒙古通辽制药股份有限公司Chinese legal name: 内蒙古通辽制药股份有限公司
主要成分Active Ingredients
- 培氟沙星Peifu Shaxing
药物知识说明
培氟沙星是一种在国家药监局注册认定的药品。该药品含有培氟沙星-f75408b5等成分。
该药品关联的活性成分包括：培氟沙星Peifu Shaxing。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：内蒙古通辽制药股份有限公司Chinese legal name: 内蒙古通辽制药股份有限公司。
您可以探索含有相同成分的其他药品：培氟沙星-f75408b5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: 甲磺酸培氟沙星片) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 培氟沙星Peifu Shaxing.
Manufacturers recorded for this product: 内蒙古通辽制药股份有限公司Chinese legal name: 内蒙古通辽制药股份有限公司.
Explore other medicines containing the same ingredient: 培氟沙星 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: 甲磺酸培氟沙星片Recorded Chinese product: 甲磺酸培氟沙星片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 0.1g(按C17H20FN3O3计算)Recorded Chinese specification
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.
主要成分Ingredients
生产企业Manufacturer
- 内蒙古通辽制药股份有限公司Chinese legal name: 内蒙古通辽制药股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H10950194
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H10950194
Manufacturer
Chinese legal name: 内蒙古通辽制药股份有限公司 (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H10950194
生产企业
内蒙古通辽制药股份有限公司(国产)
适应症
本品适用于由培氟沙星敏感菌所致的各种感染：泌尿感染;呼吸道感染;耳、鼻、喉感染;妇科：生殖系统感染;腹部和肝、胆系统感染;骨和关节感染;皮肤感染、败血症和心内膜炎、脑膜炎。
用法用量
口服。成人一日0.4～0.8g,分2次服用。
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、恶心或呕吐。|2.中枢神经系统反应可有头昏、头痛、嗜睡或失眠。|3.过敏反应: 皮疹、皮肤瘙痒,偶可发生渗出性、多形性红斑及血管神经性水肿。少数患者有光敏反应。|4.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.少数患者可发生血清氨基转移酶升高、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。
禁忌
对本品及氟喹诺酮类药过敏患者禁用。
注意事项
1.由于目前大肠埃希菌对氟喹诺酮类药物耐药者多见,应在给药前留取尿培养标本,参考细菌药敏结果调整用药。|2.本品大剂量应用或尿pH值在7以上时可发生结晶尿。为避免结晶尿的发生,宜多饮水,保持24小时排尿量在1200ml以上。|3.肾功能减退者,需根据肾功能调整给药剂量。|4.应用氟喹诺酮类药物可发生中、重度光敏反应。应用本品时应避免过度暴露于阳光,如发生光敏反应需停药。|5.肝功能减退时,如属重度(肝硬化腹水)可减少药物消除,血药浓度增高,肝、肾功能均减退者尤为明显,均需权衡利弊后应用,并调整剂量。|6.原有中枢神经系统疾患者,例如癫痫及癫痫病史者均应避免应用,有指征时需仔细权衡利弊后应用。
贮藏
密封，置阴凉处。
规格
0.1g(按C17H20FN3O3计算)
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.