Gutai Ning (固泰宁)固泰宁
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
- 银谷制药有限责任公司Yingu Zhiyao Youxian Zeren Gongsi
主要成分Active Ingredients
- 鲑降钙素 辅料为冰醋酸Recorded Chinese composition: 鲑降钙素 辅料为冰醋酸
- 醋酸钠Cusuan Na
- 注射用水Water for Injection (注射用水)
- 鲑降钙素Guijiang Gaisu
- 辅料为冰醋酸Recorded Chinese composition: 辅料为冰醋酸
药物知识说明
鲑降钙素 辅料为冰醋酸是一种在国家药监局注册认定的药品。该药品含有相关活性成分。
该药品关联的活性成分包括：注射用水、醋酸钠Cusuan Na、鲑降钙素Guijiang Gaisu、鲑降钙素Guijiang Gaisu。这些成分信息来自国家药监局数据库。
您可以探索含有相同成分的其他药品：注射用水-4ef6f8fd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: 固泰宁) is a medicine registered with the national drug regulatory authority. It contains active ingredient(s) as recorded.
Active ingredients associated with this product: 醋酸钠Cusuan Na, 鲑降钙素Guijiang Gaisu, 鲑降钙素Guijiang Gaisu.
Explore other medicines containing the same ingredient: products 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: 固泰宁Recorded Chinese name: 固泰宁
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 1ml：8.3ug(50IU)。1 mL:8.3 μg(50 IU)
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
- 银谷制药有限责任公司Yingu Zhiyao Youxian Zeren Gongsi
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20040495
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H20040495
Manufacturer
Chinese legal name: 银谷制药有限责任公司 (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H20040495
生产企业
银谷制药有限责任公司(国产)
适应症
1．禁用或不能使用常规雌激素与钙制剂联合治疗的早期和晚期绝经后骨质疏松症以及老年性骨质疏松症。 2．继发于乳腺癌、肺癌或肾癌、骨髓瘤和其他恶性肿瘤骨转移所致的高钙血症。 3．变形性骨炎。
用法用量
皮下或肌肉注射，在医生指导下用药。老年骨质疏松症：采用肌肉或皮下注射，十二周为一疗程。第一周：每日一次，每次50-100IU；第二周：隔日一次，每次50-100IU；第三周至第十二周：每周一次，每次50-100IU。治疗期间根据病情，每日服钙元素0.5-1.0克，维生素D400单位；痉挛性低钙症会在钙离子降低时发生，若有此反应可补充钙制剂。
不良反应
1.可以出现恶心、呕吐、头晕、轻度的面部潮红伴发热感。这些不良反应与剂量有关，静脉注射比肌内注射或皮下注射给药更常见。
2.罕见的多尿和寒战已有报告。在罕见的病例中，给予本品可导致过敏反应，包括注射部位的局部反应或全身性皮肤反应。据报道个别的过敏反应可导致心动过速、低血压和虚脱。
禁忌
1.对降钙素过敏者禁用。
2.孕妇及哺乳期妇女禁用。
注意事项
1．本品临床使用前必须进行皮肤试验。皮肤试验方法如下：(1ml：50IU)用T.B针筒取0.2ml，用生理盐水稀释至1ml，皮下注射0.1ml(约1IU)，观察15分钟，注射部位不超过中度红色为阴性，超过中度红色为阳性。
2．长期卧床治疗的患者，每日需检查血液生化指标和肾功能。
3．治疗过程中如出现耳鸣、肱晕、哮喘应停用。
4．变形性骨炎及有骨折史的慢性疾病患者，应根据血清碱性磷酸酶及尿羟脯氨酸排出量决定停药或继续治疗。
贮藏
遮光，密闭，在2～8℃保存。
规格
1ml：8.3ug(50IU)。
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.