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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->抗血栓药物
处方药:处方药
包装规格: 1000U/毫升 1毫升/小瓶 25小瓶/盒
计价单位:
  点击放大  
生产厂家英文名:
Fresenius Kabi USA, LLC
该药品相关信息网址1:
https://www.rxlist.com/heparin-drug.htm
原产地英文商品名:
Heparin Sodium Injection 1000U/ML 1ML/vial 25vial/box
原产地英文药品名:
Heparin Sodium
中文参考商品译名:
肝素钠 1000U/毫升 1毫升/小瓶 25小瓶/盒
中文参考药品译名:
肝素钠
原产地国家批准上市年份:
2010/06/18
英文适应病症1:
Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension
英文适应病症2:
Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease
英文适应病症3:
Prophylaxis and treatment of pulmonary embolism
英文适应病症4:
Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)
英文适应病症5:
Prevention of clotting in arterial and cardiac surgery
临床试验期:
完成
中文适应病症参考翻译1:
抗凝治疗预防和治疗静脉血栓形成及其扩展
中文适应病症参考翻译2:
预防术后深静脉血栓形成和肺栓塞的低剂量方案,用于接受胸腹外科手术的患者或因其他原因有发生血栓栓塞性疾病的风险
中文适应病症参考翻译3:
预防和治疗肺栓塞
中文适应病症参考翻译4:
栓塞治疗心房颤动
中文适应病症参考翻译5:
急性和慢性消耗性凝血病的治疗
药品信息:

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详细处方信息以本药内容附件PDF文件(201931023284111.pdf)的“原文Priscribing Information”为准
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部分中文肝素钠处方资料(仅供参考)


【英文名称】
Heparin Sodium

【适用证】

肝素钠注射液适用于:

抗凝治疗预防和治疗静脉血栓形成及其扩展;

预防术后深静脉血栓形成和肺栓塞的低剂量方案,用于接受胸腹外科手术的患者或因其他原因有发生血栓栓塞性疾病的风险(见剂量和用法);

预防和治疗肺栓塞;

栓塞治疗心房颤动;

急性和慢性消耗性凝血病的治疗(弥散性血管内凝血);

预防动脉和心脏手术中的凝血;

预防和治疗周围动脉栓塞。

肝素也可用作输血,体外循环和透析过程中的抗凝血剂。

【用法用量】

当溶液和容器允许时,应在给药前肉眼检查肠外药物产品的颗粒物和变色。

确认药物的给药之前正确肝素钠注射液小瓶的选择给患者(一个或多个EE警告,致命用药错误)。不得将1 mL样品瓶与“导管锁定冲洗”样品瓶或其他1 mL不合适浓度的样品瓶混淆。确认您在服用药物之前选择了正确的药物和强度。

当肝素加入到用于连续静脉给药输注液,容器应该被反转至少六次以确保充分混合,并防止在溶液中的肝素的池。

肝素钠不通过口服给药有效,应由间断静脉内注射,静脉内输注,或深皮下(intrafat,即,髂嵴或腹部脂肪层上方)注射给药。应避免肌内注射给药途径,因为注射部位经常发生血肿。

肝素钠的剂量应根据患者的凝血试验结果进行调整。当通过连续静脉输注给予肝素时,凝血时间应在治疗的早期阶段大约每四小时确定一次。当通过静脉内注射间歇给药时,应在治疗的早期阶段每次注射前进行凝血试验,之后以适当的间隔进行凝血试验。剂量被认为是足够的,当活化部分凝血酶时间(APTT)是1.5〜2倍或正常时全血凝血时间是大约升高控制值的2.5至3倍。在深度皮下(脂肪内)注射后,对注射后4-6小时抽取的样品最好进行剂量充分性测试。

周期性血小板计数,血细胞比容和大便隐血试验肝素治疗的整个过程中被推荐,而不管给药途径的。

【注意事项】

肝素钠不应用于有下列情况的患者:

严重血小板减少症;

当适当的血液凝固试验,例如全血凝固时间,部分促凝血酶原激酶时间等不能以适当的间隔进行时(这种禁忌症是指全剂量肝素;通常不需要监测凝血参数) 接受低剂量肝素的患者);

无法控制的活动性出血状态(见警告),除非是由于弥漫性血管内凝血引起的。

【INDICATIONS AND USAGE】

Heparin Sodium Injection is indicated for:

Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension;

Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease (see DOSAGE AND ADMINISTRATION);

Prophylaxis and treatment of pulmonary embolism;

Atrial fibrillation with embolization;

Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);

Prevention of clotting in arterial and cardiac surgery;

Prophylaxis and treatment of peripheral arterial embolism.

Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures.

【CONTRAINDICATIONS】

Heparin sodium should NOT be used in patients with the following conditions:

Severe thrombocytopenia;

When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin);

An uncontrollable active bleeding state (see WARNINGS), except when this is due to disseminated intravascular coagulation.

【WARNINGS】

Heparin is not intended for intramuscular use.

【DOSAGE AND ADMINISTRATION】

Parenteral drug products should be inspected visually for particulate matter and dis coloration prior to administration, whenever solution and container permit.

Confirm the choice of the correct Heparin Sodium Injection vial prior to administration of the drug to a patient (s ee WARNINGS, Fatal Medication Errors). The 1 mL vial must not be confused with a “catheter lock flush” vial or other 1 mL vial of inappropriate strength. Confirm that you have selected the correct medication and strength prior to administration of the drug.

When heparin is added to an infusion solution for continuous intravenous administration, the container should be inverted at least six times to ensure adequate mixing and prevent pooling of the heparin in the solution.

Heparin sodium is not effective by oral administration and should be given by intermittent intravenous injection, intravenous infusion, or deep subcutaneous (intrafat, i.e., above the iliac crest or abdominal fat layer) injection. The intramus cular route of administration should be avoided becaus e of the frequent occurrence of hematoma at the injection site.

The dosage of heparin sodium should be adjusted according to the patient’s coagulation test results. When heparin is given by continuous intravenous infusion, the coagulation time should be determined approximately every four hours in the early stages of treatment. When the drug is administered intermittently by intravenous injection, coagulation tests should be performed before each injection during the early stages of treatment and at appropriate intervals thereafter. Dosage is considered adequate when the activated partial thromboplastin time (APTT) is 1.5 to 2 times normal or when the whole blood clotting time is elevated approximately 2.5 to 3 times the control value. After deep subcutaneous (intrafat) injections, tests for adequacy of dosage are best performed on samples drawn four to six hours after the injection.

Periodic platelet counts, hematocrits and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration.

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详细处方信息以本药内容附件PDF文件(201931023284111.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2019-3-10
附件:
201931023284111.pdf    

 
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