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  药店国别: 芬兰药房
产地国家: 芬兰
所属类别: 心血管系统药物->治疗心衰药物
处方药:处方药
包装规格: 2.5毫克/毫升 5毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
Orion
生产厂家英文名:
Orion
该药品相关信息网址1:
http://www.simdax.com/
原产地英文商品名:
SIMDAX INJECTION 2.5mg/ml 5ml/vial
原产地英文药品名:
LEVOSIMENDAN
中文参考商品译名:
SIMDAX注射剂 2.5毫克/毫升 5毫升/瓶
中文参考药品译名:
左西孟旦
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Heart failure
临床试验期:
完成
中文适应病症参考翻译1:
心力衰竭
药品信息:

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 详细处方信息以本药内容附件PDF文件(201261500113716.pdf,201261500113311.PDF)的“原文Priscribing Information”为准
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 部分中文左西孟旦处方资料(仅供参考)

分类名称
一级分类:循环系统药物 二级分类:抗心功能不全药物 三级分类:其他

药品英文名
Levosimendan

药品别名
Simdax

药理作用
本品为钙离子增敏剂,通过改变钙结合信息传递而起作用。本品直接与肌钙蛋白相结合,使钙离子诱导的心肌收缩所必需的心肌纤维蛋白的空间构型得以稳定,从而使心肌收缩力增加,而心率、心肌耗氧无明显变化。同时本品具有强力的扩血管作用,通过激活三磷酸腺苷(ATP)敏感的钾通道使血管扩张,本品主要使外周静脉扩张,使心脏前负荷降低,对治疗心力衰竭有利。当大剂量使用本品时,具有一定的磷酸二酯酶抑制作用,可使心肌细胞内cAMP浓度增高,发挥额外的正性肌力作用。

药动学
本品可以很快的速度从肠道被吸收,并且具有很高的生物利用度。口服用14C标记的药物后,可以在消化道、肝、肾、尿中测得很高的放射性,说明药物及其代谢产物广泛分布于这些组织中,但在脑组织中测得的放射性很低,提示药物较难透过血-脑屏障。药物在人体内代谢完全,在尿液和粪便仅测到微量原形药物。药物在人体内的生物转化主要是在肝中与谷胱甘肽结合。结合物不稳定,很快转换为半胱氨酸和半胱氨酰的衍生物。这些物质具有生物活性,是药物出现在尿中的主要代谢产物。本品也可被肠道菌群还原,产生的氨基衍生物(OR-1855)在随粪便排出体外之前可进一步被乙酰化为OR-1896。OR-1855和OR-1896消除半衰期长,可以延长药物的血液动力学作用。药物主要通过尿和胆汁两条途径排泄,尿中出现的药物代谢物为半胱氨酸及半胱氨酸甘氨酸与药物的结合物,在尿中仅发现微量的原形药物。

适应证
本品用于心力衰竭的治疗。

禁忌证
对本品过敏者禁用。

注意事项
本品口服可被肠道菌群还原,还原产物参与肠肝循环并且具有与左西孟旦相似的生物活性,使头痛、眩晕等副作用的发生率增高。

不良反应
不良反应较少,偶见头痛、眩晕、心悸等。

用法用量
1.口服:每次1~4mg,每日2~4次。2.静滴:以5%葡萄糖液稀释,起始以12~24μg/kg负荷剂量静注10min,而后以0.1μg/(kg·min)的速度滴注。用药30~60min后,观察药物的疗效,滴注速度可调整为0.2~0.5μg/(kg·min)。建议进行6~24h的输注。

药物相应作用
本品可与多巴酚丁胺或氨力农、二磷酸腺苷(ADP)合用,具有协同作用。   

规格:左西孟旦片剂:1mg/片。左西孟旦注射液:12.5mg/5ml,25mg/10ml。冷藏。

Simdax® (levosimendan)
Simdax (levosimendan) is a calcium sensitiser developed for intravenous use in hospitalised patients with acutely decompensated heart failure (ADHF).

Simdax® is indicated for the short-term treatment of acutely decompensated severe chronic heartfailure (ADHF) in situations where conventional therapy is not sufficient, and in cases where inotropic support is considered appropriate.

Important safety information
•Simdax is contraindicated in patients with:
- A known hypersensitivity to levosimendan or to any of the excipients
- Severe hypotension and tachycardia
- Significant mechanical obstructions affecting ventricular filling or outflow or both
- Severe renal impairment (creatinine clearance <30 ml/min) and severe hepatic impairment
- A history of torsades de pointes

•Caution is advised in patients with low baseline systolic or diastolic blood pressure or those at risk for a hypotensive episode. More conservative dosing regimens are recommended for these patients.
Physicians should tailor the dose and duration of therapy to the condition and response of the patient.

•Severe hypovolaemia should be corrected prior to levosimendan infusion. If excessive changes in blood pressure or heart rate are observed, the rate of infusion should be reduced or the infusion discontinued.

•Non-invasive monitoring for at least 4-5 days after the end of infusion is recommended. Monitoring is recommended to continue until the blood pressure reduction has reached its maximum and the blood pressure starts to increase again, and may need to be longer than 5 days if there are any signs of continuing blood pressure decrease, but can be shorter than 5 days if the patient is clinically stable. In patients with mild to moderate renal or mild to moderate hepatic impairment an extended period of monitoring may be needed.

•Simdax should be used cautiously in patients with mild to moderate hepatic impairment. Impaired hepatic function may lead to prolonged exposure to the active metabolites, which may result in a more pronounced and prolonged haemodynamic effect.

•Simdax infusion may cause a decrease in serum potassium concentration. Thus, low serum potassium concentrations should be corrected prior to the administration of Simdax and serum potassium should be monitored during treatment. As with other medicinal products for heart failure, infusions of Simdax may be accompanied by decreases in haemoglobin and haematocrit and caution should be exercised in patients with ischaemic cardiovascular disease and concurrent anaemia.

•Simdax infusion should be used cautiously in patients with tachycardia, atrial fibrillation with rapid ventricular response or potentially life-threatening arrhythmias.

•Experience with repeated administration of Simdax is limited.

•Experience with concomitant use of vaso-active agents, including inotropic agents (except digoxin), is limited. Benefit and risk should be assessed for the individual patient.

•Simdax should be used cautiously and underclose ECG monitoring in patients with ongoing coronary ischaemia, long QTc interval regardless of aetiology, or when given concomitantly with medicinal products that prolong the QTc interval.

•The use of levosimendan in cardiogenic shocknhas not been studied. No information is available on the use of Simdax in the following disorders: restrictive cardiomyopathy, hypertrophic cardiomyopathy, severe mitral valve insufficiency, myocardial rupture, cardiac tamponade, and right ventricular infarction.

•Simdax should not be administered to children as there is very limited experience of use in children and adolescents under 18 years of age.

•Limited experience is available on the use of Simdax in patients with heart failure after surgery, and in severe heart failure in patients awaiting heart transplantation.

•The most frequent adverse events with Simdax are ventricular tachycardia, atrial fibrillation, hypotension, ventricular extrasystoles, tachycardia and headache.

•Other common (< 1/10, > 1/100) adverse events include hypokalaemia, insomnia, dizziness, cardiac failure, myocardial ischaemia, extrasystoles, nausea, constipation, diarrhoea, vomiting and haemoglobin decreased.
 
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 详细处方信息以本药内容附件PDF文件(201261500113716.pdf,201261500113311.PDF)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2014-06-29
附件:


201261500113716.pdf    

201261500113311.PDF    

 
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