Recorded Chinese product: 氯膦酸二钠注射液氯膦酸二钠注射液

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

主要成分Active Ingredients

药物知识说明

氯屈膦酸二钠是一种在国家药监局注册认定的药品。该药品含有氯屈膦酸二钠-1e568249等成分。

该药品关联的活性成分包括:氯屈膦酸二钠Lvqu Linsuan Erna。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:金陵药业股份有限公司南京金陵制药厂Chinese legal name: 金陵药业股份有限公司南京金陵制药厂。

您可以探索含有相同成分的其他药品:氯屈膦酸二钠-1e568249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: 氯膦酸二钠注射液) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: 氯屈膦酸二钠Lvqu Linsuan Erna.

Manufacturers recorded for this product: 金陵药业股份有限公司南京金陵制药厂Chinese legal name: 金陵药业股份有限公司南京金陵制药厂.

Explore other medicines containing the same ingredient: 氯屈膦酸二钠 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: 氯膦酸二钠注射液Recorded Chinese product: 氯膦酸二钠注射液
  • 剂型Dosage form: 注射剂Injection
  • 规格Specification: 5ml:0.3g(按CH2Cl2Na2O6P2计)Recorded Chinese specification: 5ml:0.3g(按CH2Cl2Na2O6P2计)

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

  • 金陵药业股份有限公司南京金陵制药厂Chinese legal name: 金陵药业股份有限公司南京金陵制药厂

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H19980183

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H19980183

Manufacturer

Chinese legal name: 金陵药业股份有限公司南京金陵制药厂 (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

Protect from light and keep tightly closed.

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H19980183

生产企业

金陵药业股份有限公司南京金陵制药厂(国产)

适应症

1.恶性肿瘤并发的高钙血症。|2.溶骨性癌转移引起的骨痛。|3.可避免或延迟恶性肿瘤溶骨性骨转移。|4.各种类型骨质疏松。

用法用量

1.Paget病:300mg/日,静脉滴注3小时以上,共5日,以后改口服。|2.高钙血症:300mg/日,静脉滴注3~5日或一次给予1.5g静脉滴注,血钙正常后改口服。

不良反应

1.最常报告的与氯膦酸盐有关的不良反应为胃肠道反应,如恶心、呕吐和腹泻。有至多10%的患者发生。|2.但这些反应通常很轻微,且多发生于大剂量时。|3.氯磷酸二钠治疗曾偶尔引起甲状旁腺素和转氨酶血清浓度升高。|4.这些变化通常是一过性的且极少超过实验室参考范围的二倍。|5.亦曾报告有碱性磷酸酶血清浓度的改变及无症状的低钙血症。|6.此外,有报告个别病例还发生了类似于过敏反应的呼吸功能损害或已有阿司匹林过敏哮喘的患者的呼吸功能损害,以及皮肤反应。|7.曾有可逆性蛋白尿、血清肌酐升高和肾功能障碍的报告。|但是,因为大多数患者都已到了疾病晚期,所以尚不能确定氯膦酸盐治疗导致肾功能障碍的作用。

禁忌

氯膦酸二钠不应与其它双膦酸盐同时使用,或用于已知对双膦酸盐过敏的患者。

注意事项

1.在氯膦酸二钠治疗期间,必须保持足量的液体摄入。静脉内输注氯膦酸二钠,或高钙血症患者或肾衰患者采用氯膦酸二钠治疗时,这一点尤其重要。|2.氯膦酸盐主要经肾消除。因此,肾功能衰竭患者应慎用氯膦酸二钠(参见【用法用量】)。 |3.氯膦酸盐静脉给药可能会引起肾功能障碍,尤其当输注速度太快或所用剂量明显高于推荐剂量时。

贮藏

遮光,密封保存。

规格

5ml:0.3g(按CH2Cl2Na2O6P2计)

证据Evidence

  • 批准文号: 国药准字H19980183
  • rights: 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。

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.