Recorded Chinese product: 单硝酸异山梨酯氯化钠注射液单硝酸异山梨酯氯化钠注射液
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
- 天津华津制药有限公司Chinese legal name: 天津华津制药有限公司
主要成分Active Ingredients
- 单硝酸异山梨酯Danxiao Suanyi Shanli Zhi
药物知识说明
单硝酸异山梨酯是一种在国家药监局注册认定的药品。该药品含有单硝酸异山梨酯-78b15725等成分。
该药品关联的活性成分包括：单硝酸异山梨酯Danxiao Suanyi Shanli Zhi。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：天津华津制药有限公司Chinese legal name: 天津华津制药有限公司。
您可以探索含有相同成分的其他药品：单硝酸异山梨酯-78b15725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: 单硝酸异山梨酯氯化钠注射液) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 单硝酸异山梨酯Danxiao Suanyi Shanli Zhi.
Manufacturers recorded for this product: 天津华津制药有限公司Chinese legal name: 天津华津制药有限公司.
Explore other medicines containing the same ingredient: 单硝酸异山梨酯 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: 单硝酸异山梨酯氯化钠注射液Recorded Chinese product: 单硝酸异山梨酯氯化钠注射液
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 250ml:单硝酸异山梨酯20mg与氯化钠2.25gRecorded Chinese specification: 250ml:单硝酸异山梨酯20mg与氯化钠2.25g
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
- 天津华津制药有限公司Chinese legal name: 天津华津制药有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20040135
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H20040135
Manufacturer
Chinese legal name: 天津华津制药有限公司 (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H20040135
生产企业
天津华津制药有限公司(国产)
适应症
预防和治疗心绞痛；与洋地黄及(或)利尿剂合用治疗慢性心力衰竭。
用法用量
静脉滴注。药物剂量可根据病人的反应调整，一般有效剂量为每小时2~7mg。开始给药速度为60μg/分，一般速度为60~120μg/分，每日一次，10天为一疗程。
不良反应
用药初期可能会出现硝酸酯引起的血管扩张性头痛，通常连续使用数日后，症状可消失。还可能出现面部潮红、眩晕、直立性低血压和反射性心动过速。偶见血压明显降低、心动过缓、心绞痛加重和晕厥。
禁忌
1.急性循环衰竭（休克、循环性虚脱）；
2.严重低血压（收缩压<90 mmHg）；
3.急性心肌梗死伴低充盈压（除非在有持续血流动力学监测的条件下）；
4.肥厚梗阻型心肌病；缩窄性心包炎或心包填塞；严重贫血；青光眼；颅内压增高；对硝基化合物过敏者。
注意事项
1.给不明原因的肺循环高压（原发性肺动脉高压）的病人服用本品，由于对肺通气不足部分血液供应相对增加的结果，可以导致动脉血氧含量的暂时降低（低氧血症），这种情况特别见于心脏冠状血管循环紊乱（冠心病）的病人。
2.因本品可增高眼内压，青光眼患者慎用。
3.在下列情况下需要特别小心的医疗监护：―主动脉瓣狭窄和/或二尖瓣狭窄―有循环调节紊乱倾向（体位性低血压）的病人―伴有颅内压升高的疾病（到目前为止进一步压力增加只见于静脉输入高剂量硝酸甘油后）―严重肾功能损害的病人―甲状腺功能减退、营养不良及体重过低患者
4.因本品为含0.9%氯化钠的溶液，对需要限制钠盐的患者慎用。
贮藏
遮光，密闭保存
规格
250ml:单硝酸异山梨酯20mg与氯化钠2.25g
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.