Fufang Tongsuan Pian (复方α-酮酸片)复方α-酮酸片
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
- 南京白敬宇制药有限责任公司Chinese legal name: 南京白敬宇制药有限责任公司
主要成分Active Ingredients
- 种羟氨基酸钙Zhongqiang Anji Suangai
- 种氨基酸Zhongan Jisuan
- 含种酮氨基酸钙Hanzhong Tongan Jisuan Gai
药物知识说明
种羟氨基酸钙是一种在国家药监局注册认定的药品。标注生产企业为南京白敬宇制药有限责任公司。
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：南京白敬宇制药有限责任公司Chinese legal name: 南京白敬宇制药有限责任公司、南京白敬宇制药有限责任公司Chinese legal name: 南京白敬宇制药有限责任公司、南京白敬宇制药有限责任公司Chinese legal name: 南京白敬宇制药有限责任公司。
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α-酮酸片) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 南京白敬宇制药有限责任公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 南京白敬宇制药有限责任公司Chinese legal name: 南京白敬宇制药有限责任公司, 南京白敬宇制药有限责任公司Chinese legal name: 南京白敬宇制药有限责任公司, 南京白敬宇制药有限责任公司Chinese legal name: 南京白敬宇制药有限责任公司.
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α-酮酸片Recorded Chinese name: 复方α-酮酸片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 0.63g0.63 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
- 南京白敬宇制药有限责任公司Chinese legal name: 南京白敬宇制药有限责任公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20103286
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H20103286
Manufacturer
Chinese legal name: 南京白敬宇制药有限责任公司 (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H20103286
生产企业
南京白敬宇制药有限责任公司(国产)
适应症
本品配合低蛋白饮食，预防和治疗因慢性肾功能不全而造成蛋白质代谢失调引起的损害。通常用于肾小球滤过率低于每分钟25毫升的患者。低蛋白饮食要求成人每日蛋白摄入量为40克或40克以下。
用法用量
口服。 1.一日3次，一次4~8片，用餐期间整片吞服。必要时遵医嘱。此剂量是按70kg成人体重计算的。 2.对于肾小球滤过率低于每分钟25毫升的患者，本品配合不超过每日40克（成人）的低蛋白饮食，可长期服用。
不良反应
可能发生高钙血症。如出现高钙血症，建议减少维生素D的摄入量。如高钙血症持续发生，将本品减量并减少其他含钙物质的摄入。
禁忌
1. 高钙血症和氨基酸代谢紊乱。
2. 遗传性苯丙酮尿患者使用本品时，须注意本品含有苯丙氨酸。
注意事项
1. 本品宜在用餐时服用，使其充分吸收并转化为相应的氨基酸。应定期监测血钙水平，并保证摄入足够的热卡。
2. 不要把药品存放在儿童接触得到的地方。
3. 请勿服用超过有效期的产品。
贮藏
25℃以下，干燥保存。
规格
0.63g
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.