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  药店国别: 美国药房
产地国家: 美国
所属类别: 心血管系统药物->抗心绞痛药物
处方药:处方药
包装规格: 2500单位/0.2毫升 10X0.2毫升
计价单位:
  点击放大  
生产厂家英文名:
Pfizer Laboratories Div Pfizer Inc
该药品相关信息网址1:
https://www.rxlist.com/fragmin-drug.htm
该药品相关信息网址2:
https://www.pfizer.com/products/product-detail/fragmin
原产地英文商品名:
Fragmin For Injection 2500UNIT/0.2mL 10X0.2mL
原产地英文药品名:
Dalteparin Sodium
中文参考商品译名:
注射用达肝素 2500单位/0.2毫升 10X0.2毫升
中文参考药品译名:
达肝素钠
原产地国家批准上市年份:
2015/04/01
英文适应病症1:
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
英文适应病症2:
Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer.
临床试验期:
完成
中文适应病症参考翻译1:
预防不稳定型心绞痛和非Q波心肌梗死的缺血性并发症
中文适应病症参考翻译2:
延长治疗症状性静脉血栓栓塞(VTE),以减少成人癌症患者的复发
药品信息:

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详细处方信息以本药内容附件PDF文件(201953023421437.pdf)的“原文Priscribing Information”为准
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部分中文注射用达肝素处方资料(仅供参考)

【英文名称】Fragmin

【适用证】

FRAGMIN是一种低分子量肝素(LMWH)

- 预防不稳定型心绞痛和非Q波心肌梗死的缺血性并发症(1.1)

- 在急性疾病期间腹部手术,髋关节置换手术或行动严重受限的医疗患者中预防深静脉血栓形成(DVT)(1.2)

- 延长治疗症状性静脉血栓栓塞(VTE),以减少成人癌症患者的复发。 在这些患者中,FRAGMIN治疗从最初的VTE治疗开始,持续6个月(1.3)

- 治疗症状性静脉血栓栓塞(VTE)以减少1个月及以上儿科患者的复发(1.4)

- 使用限制:

FRAGMIN不适用于急性VTE治疗(1.5)

【用法用量】

---不稳定的心绞痛和非Q波MI:

每12小时皮下注射120 IU / kg(含阿司匹林)(2.1)

---腹部手术中的DVT预防:

每天皮下注射2,500 IU或每日皮下注射5,000 IU或皮下注射2,500 IU,12小时后皮下注射2,500 IU,然后每日皮下注射5,000 IU(2.2)

---髋关节置换手术中的DVT预防:

术后开始 - 手术后4至8小时皮下注射2,500 IU,然后每天皮下注射5,000 IU,或术前开始 - 术前2,500小时皮下注射2小时,术后4至8小时皮下注射2,500 IU,然后每天一次5,000 IU皮下注射(2.2)术前开始 - 手术前晚上5,000 IU皮下注射,术后4至8小时皮下注射5,000 IU(2.2)

---医疗患者的DVT预防:

5,000 IU皮下每日一次(2.2)

---成人癌症患者的VTE延长治疗:

第1个月:每天皮下注射200 IU / kg(2.3)

每月2 - 6:150 IU / kg皮下每日一次(2.3)

【禁忌】

活动性大出血(4)

肝素诱导的血小板减少症或肝素诱导的血小板减少症伴血栓形成史(4)

对达肝素钠过敏(4,6.1)

在接受硬膜外/椎管内麻醉的患者中,不要给予FRAGMIN(5.1)

----治疗不稳定性心绞痛和非Q波MI

----长期VTE预防(4)

对肝素或猪肉产品过敏(4)

【使用注意】

•出血:在出血风险增加的情况下要小心(5.1)

•血小板减少症:密切监测任何程度的血小板减少症(5.2)

•苯甲醇防腐剂:不要在新生儿和婴儿中使用多剂量配方,因为它们含有苯甲醇(5.3)

•实验室检查:推荐定期血细胞计数(5.4)

【INDICATIONS AND USAGE】

FRAGMIN is a low molecular weight heparin (LMWH) indicated for

--Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (1.1)

--Prophylaxis of deep vein thrombosis (DVT) in abdominalsurgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness (1.2)

--Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months (1.3)

--Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month of age and older (1.4)

--Limitations of Use:

FRAGMIN is not indicated for the acute treatment of VTE (1.5)

【CONTRAINDICATIONS】

Active major bleeding (4)

History of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis (4)

Hypersensitivity to dalteparin sodium (4, 6.1)

In patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN (5.1)

----As a treatment for unstable angina and non-Q-wave MI

----For prolonged VTE prophylaxis (4)

Hypersensitivity to heparin or pork products (4)

【WARNINGS AND PRECAUTIONS】

•Hemorrhage: Use caution in conditions with increased risk of hemorrhage (5.1)

•Thrombocytopenia: Monitor thrombocytopenia of any degree closely (5.2)

•Benzyl Alcohol Preservative: Do not use multiple-dose formulations in neonates and infants as they contain benzyl alcohol (5.3)

•Laboratory Tests: Periodic blood counts recommended (5.4)

【DOSAGE AND ADMINISTRATION】

---Unstable angina and non-Q-wave MI:

120 IU/kg subcutaneous every 12 hours (with aspirin) (2.1)

---DVT prophylaxis in abdominal surgery:

2,500 IU subcutaneous once daily or 5,000 IU subcutaneous once daily or 2,500 IU subcutaneous followed by 2,500 IU subcutaneous 12 hours later and then 5,000 IU subcutaneous once daily (2.2)

---DVT prophylaxis in hip replacement surgery :

Postoperative start – 2,500 IU subcutaneous 4 to 8 hours after surgery, then 5,000 IU subcutaneous once daily, or Preoperative start – day of surgery 2,500 IU subcutaneous 2 hours before surgery followed by 2,500 IU subcutaneous 4 to 8 hours after surgery, then 5,000 IU subcutaneous once daily (2.2) Preoperative start – Evening Before Surgery 5,000 IU subcutaneous followed by 5,000 IU subcutaneous 4 to 8 hours after surgery (2.2)

---DVT prophylaxis in medical patients:

5,000 IU subcutaneous once daily (2.2)

---Extended treatment of VTE in adult patients with cancer:

Month 1: 200 IU/kg subcutaneous once daily (2.3)

Months 2 – 6: 150 IU/kg subcutaneous once daily (2.3)

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详细处方信息以本药内容附件PDF文件(201953023421437.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2019-5-30
附件:
201953023421437.pdf    

 
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