藥碼
ACT05
藥名
rTPA 50 mg/Vial
英文商品名
Actilyse 針 50 mg/Vial
中文商品名
栓體舒注射液
螢幕名
Actilyse 針 50 mg/Vial
劑型
Inj
規格
Inj 50mg/Vial.
成分
藥理分類
Thrombolytic Agents
健保碼
KC00743248
ATC碼
藥品圖片
外觀圖片
適應症
【藥品性質提示】
★必確認適應症:缺血性腦中風(ischemic stroke)、肺栓塞(PE)

#建議持續輸注 (IV pump) 之高警訊藥品

栓塞
Acute ischemic stroke: Treatment of acute ischemic stroke as soon as possible but within 3 hours of symptom onset
Pulmonary embolism: Management of acute massive pulmonary embolism
ST-elevation myocardial infarction: Management of STEMI for the lysis of thrombi in coronary arteries. Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy. Thrombolytic therapy is an option in centers without PCI capability, followed by transfer to a PCI-capable center.
藥理
Tissue plasminogen activator (TPA) manufactured by DNA technology. It enhances the conversion of plasminogen to plasmin by binding to fibrin, initiating fibrinolysis with limited systemic proteolysis.
藥動學
禁忌症
1. Patients with active internal bleeding
2. History of cerebrovascular accident, intracranial neoplasm, aneurysm, or recent (within 2 months) intracranial or intraspinal surgery or trama
懷孕分類
C
哺乳分類
Infant risk can not be ruled out. Breastfeeding women should stop breastfeeding within 24 hours after taking Actilyse.<20230914>
副作用
1. Bleeding complications, reperfusion arrhythmias and reinfarction are the primary concerns of therapy
2. Systemic fibrinolysis is less than that seen with streptokinase
劑量和給藥方法
ST-elevation myocardial infarction(STEMI):
1. Symptoms onset <6 hours: 15 mg as a bolus, followed by 0.75 mg/kg (up to 50 mg) over 30 min, then 0.5 mg/kg (up to 35 mg) over the next 60 min immediately.
2. Symptoms onset 6-12 hours: 10 mg as a bolus, followed by 50 mg over 60 min, then 40 mg over the next 120 min immediately; for patients <65 kg, Intravenous infusion for 3 hours, do not exceed 1.5mg/kg dosage.<20230914>
Pulmonary embolism(PE):
10 mg as a bolus in 1-2 min, followed by 90 mg over 120 min (up to 100 mg); for patients <65 kg, Intravenous infusion for 2 hours, do not exceed 1.5mg/kg dosage.
Acute ischemic stroke:
0.9 mg/kg (maximum total dose: 90 mg); 10% as an IV bolus over 1 minute, followed by 90% as a continuous infusion over 60 minutes
小兒調整劑量
腎功能調整劑量
1. There are no dosage adjustments provided in the manufacturer's labeling.
2. Hemostatic defects due to severe renal disease may increase the risk for bleeding.
肝功能調整劑量
1. There are no dosage adjustments provided in the manufacturer's labeling.
2. Significant hepatic impairment and hemostatic defects due to severe hepatic disease may increase the risk for bleeding.
安定性
Reconstitute to a concentration of 1 mg/mL with provided sterile water for injection. Do not shake; gently swirl or slowly invert to mix.
注射給藥指引
給藥途徑
IV pump (持續靜脈輸注)
靜脈輸注液
再生溶液:所附溶劑 SWFI(仿單);稀釋溶液:NS(仿單)
每瓶稀釋液體積
再生溶液:所附溶劑 50mL SWFI(仿單)
注射濃度
以所附溶劑 SWFI 調配後 1mg/mL,可再以 NS 稀釋至不低於 0.2mg/mL(仿單)
給藥速率
詳見「劑量與給藥方法」
安定性
Reconstitute to a concentration of 1 mg/mL with provided sterile water for injection. Do not shake; gently swirl or slowly invert to mix.
注意事項
1. 不應與其他藥物混合於同一輸注液瓶中或同一靜脈輸注管中使用 (即使是 heparin 也不可以)。
2. 不相容:dobutamine、dopamine、heparin、nitroglycerin
* NS:0.9%生理食鹽水; D5W:5%葡萄糖水; LR:乳酸林格氏液; 1/2NS:0.45%生理食鹽水; SWFI:注射用水
藥袋資訊
臨床用途
缺血性中風
主要副作用
出血傾向
泡製方法
儲存方式
請置於 15-30℃ 乾燥處儲存
注意事項
其他說明
【必確認缺血性腦中風或肺栓塞】| 急首 e2 | 藥庫 注B22 |
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
17815
自費價
20487.25
仿單
資料庫
健保給付規定