He Ri (和日)和日
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
- 海南中和药业有限公司Chinese legal name: 海南中和药业有限公司
主要成分Active Ingredients
- 胸腺法新Xiongxian Faxin
药物知识说明
胸腺法新是一种在国家药监局注册认定的药品。标注生产企业为海南中和药业有限公司。
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：海南中和药业有限公司Chinese legal name: 海南中和药业有限公司、海南中和药业有限公司Chinese legal name: 海南中和药业有限公司、海南中和药业有限公司Chinese legal name: 海南中和药业有限公司。
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: 和日) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 海南中和药业有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 海南中和药业有限公司Chinese legal name: 海南中和药业有限公司, 海南中和药业有限公司Chinese legal name: 海南中和药业有限公司, 海南中和药业有限公司Chinese legal name: 海南中和药业有限公司.
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: 和日Recorded Chinese name: 和日
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 1.6mg1.6 mg
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
- 海南中和药业有限公司Chinese legal name: 海南中和药业有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20051916
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H20051916
Manufacturer
Chinese legal name: 海南中和药业有限公司 (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H20051916
生产企业
海南中和药业有限公司(国产)
适应症
1.慢性乙型肝炎。 2.作为免疫损害病者的疫苗免疫应答增强剂。免疫系统功能受到抑制者，包括接受慢性血液透析和老年病患，本品可增强病者对病毒性疫苗，例如流感疫苗或乙肝疫苗的免疫应答。
用法用量
用前每瓶胸腺法新(1.6mg)以1ml注射用水溶解后立即皮下注射(不应作肌注或静注)。治疗慢性乙型肝炎的推荐剂量：每次1.6mg，每周2次，两次相隔3-4天，连续给药6个月(共52针)，其间不应间断。作为免疫损害病者的疫苗免疫应答增强剂：每次1.6mg，每周2次，两次相隔3-4天，连续4周(共8针)，第一针应在给疫苗后立即皮下注射。
不良反应
胸腺法新的耐受性良好。部分患者可能有注射部位不适。慢性乙肝患者接受本品治疗时，可能出现ALT水平暂时波动至基础值两倍以上,此时通常应继续使用,除非有肝衰竭的症状和预兆出现。
禁忌
对本品成份过敏者禁用；正在接受免疫抑制治疗的患者如器官移植者禁用。
注意事项
1、当用来治疗慢性乙肝时，肝功能试验，包括血清ALT、白蛋白和胆红素应在治疗期间作定期评估，治疗完毕后应检测乙肝e抗原（HBeAg）、表面抗原(HBsAg)、HBV-DNA和ALT酶，亦应在治疗完毕后2、4和6个月检测，因为病人可能在治疗完毕后随访期内出现应答。2、本品应在医师指导下应用。如患者自行在医院外使用，应注意注射器具的消毒和处理。
贮藏
遮光、密封，2-8°C保存。
规格
1.6mg
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.