Compound Diclofenac Sodium Injection (复方双氯芬酸钠注射液)复方双氯芬酸钠注射液
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
- 广州白云山明兴制药有限公司Chinese legal name: 广州白云山明兴制药有限公司
主要成分Active Ingredients
- 含对乙酰氨基酚Handui Yixian Anji Fen
药物知识说明
含对乙酰氨基酚是一种在国家药监局注册认定的药品。标注生产企业为广州白云山明兴制药有限公司。
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：广州白云山明兴制药有限公司Chinese legal name: 广州白云山明兴制药有限公司、广州白云山明兴制药有限公司Chinese legal name: 广州白云山明兴制药有限公司、广州白云山明兴制药有限公司Chinese legal name: 广州白云山明兴制药有限公司。
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: 复方双氯芬酸钠注射液) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 广州白云山明兴制药有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 广州白云山明兴制药有限公司Chinese legal name: 广州白云山明兴制药有限公司, 广州白云山明兴制药有限公司Chinese legal name: 广州白云山明兴制药有限公司, 广州白云山明兴制药有限公司Chinese legal name: 广州白云山明兴制药有限公司.
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: 复方双氯芬酸钠注射液Compound Diclofenac Sodium Injection (复方双氯芬酸钠注射液)
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 2ml:双氯芬酸钠25mg,对乙酰氨基酚0.15gRecorded Chinese specification: 2ml:双氯芬酸钠25mg,对乙酰氨基酚0.15g
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
- 广州白云山明兴制药有限公司Chinese legal name: 广州白云山明兴制药有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H19990253
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H19990253
Manufacturer
Chinese legal name: 广州白云山明兴制药有限公司 (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H19990253
生产企业
广州白云山明兴制药有限公司(国产)
适应症
适用于：|1.缓解类风湿关节炎、骨关节炎。脊柱关节病、痛风性关节炎、风湿性关节炎等各种慢性关节炎的急性发作期或持续性的关节肿痛症状。|2.各种软组织风湿性疼痛，如肩痛、腱鞘炎、滑囊炎、肌痛及运动后损伤性疼痛等。|3.急性的轻、中度疼痛如：手术、创伤、劳损后等的疼痛，原发性痛经，牙痛，头痛等。
用法用量
深部肌肉注射，每日1次，每次1～2ml，必要时每天2次，于两侧臀部分别注射。疗程不超过2天。年老、体弱的高热患者酌情减量，或遵医嘱。
不良反应
1.胃肠道反应：为最常见的不良反应，主要为胃不适、腹痛、烧灼感、反酸、纳差、便泌恶心等，其中少数患者可出现溃疡、出血、穿孔。|2.神经系统表现有头痛、眩晕、嗜睡、兴奋等。|3.可引起浮肿、少尿，电解质紊乱等严重不良反应。|4.其他少见的有血清氨基转移酶一过性升高，极个别患者出现黄疸、皮疹、心律失常、粒细胞减少、血小板减少等。
禁忌
1.活动性胃肠道溃疡或出血患者禁用。|2.对本品、乙酰水杨酸或其他非甾体抗炎药过敏者禁用。
注意事项
1.胃肠道系统溃疡病史者慎用。 |2.心、肝、肾功能损害患者慎用。 |3.可以抑制血小板凝集，延长出血时间，故有出血时间延长疾患的患者慎用。 |4.使用期间出现眩晕或其他中枢神经系统紊乱时应避免驾驶车辆或操作机器。 |5.参阅双氯芬酸钠与对乙酰氨基酚项下的注意事项。
贮藏
密封，置阴凉处。
规格
2ml:双氯芬酸钠25mg,对乙酰氨基酚0.15g
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.