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全民健康保險藥品給付規定 / 健保碼及健保價 |
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See related Actilyse inj "Boehringer Ingelheim"[栓體舒 注射劑] information |
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製造商 |
Boehringer Ingelheim |
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代理/經銷商 |
Boehringer Ingelheim |
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成份 |
Alteplase (recombinant human tissue-type plasminogen activator) |
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適應症 |
Thrombolytic treatment in acute MI, acute massive pulmonary embolism with hemodynamic instability & acute ischemic stroke. |
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用量 |
MI: 90 mins (accelerated) dose regimen started within 6 hr after symptom onset 15 mg as IV bolus, 50 mg infused over the 1st 30 mins, followed by 35 mg infused over 60 mins until the max dose of 100 mg. Patients < 65 kg 15 mg as IV bolus & 0.75 mg/kg over 30 mins (max 50 mg), followed by 0.5 mg/kg infused over 60 mins (max 35 mg). MI: 3 hr dose regimen for patients in whom treatment can be started between 6 & 12 hr after symptom onset 10 mg as IV bolus, 50 mg infused over 1st hr, followed by 10 mg infused over 30 mins, until the max dose of 100 mg over 3 hr. Patient < 65 kg Max total dose: 1.5 mg/kg. Pulmonary embolism 10 mg as IV bolus over 1-2 mins, followed by 90 mg infused over 2 hr. Max total dose: 1.5 mg/kg in patients < 65 kg. Acute ischemic stroke 0.9 mg/kg (max 90 mg) infused over 60 mins with 10% of the total dose administered as an initial IV bolus over 1 min. Therapy should be initiated within 3 hr after onset of symptoms. |
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過量 |
View Actilyse[栓體舒] overdosage for action to be taken in the event of an overdose. |
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美國食品藥物管理局之懷孕等級 |
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. |
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禁忌 |
High risk of hemorrhage eg. significant bleeding disorder at present or within the past 6 months, known hemorrhagic diathesis; patients receiving oral anticoagulants; a history of CNS damage; history or evidence or suspected intracranial hemorrhage including sub-arachnoid hemorrhage; severe uncontrolled arterial HTN; major surgery or significant trauma in the past 10 days, recent trauma to head or cranium; prolonged or traumatic cardiopulmonary resuscitation (> 2 mins), obstetrical delivery within the past 10 days, recent puncture of a non-compressible blood-vessel; severe hepatic dysfunction including hepatic failure, cirrhosis, portal HTN, active hepatitis; bacterial endocarditis, pericarditis; acute pancreatitis; history of ulcerative GI disease during the last 3 months; arterial aneurysms, arterial/venous malformations; neoplasm with increased bleeding risk. In the treatment of acute MI & pulmonary embolism: Hemorrhagic stroke or stroke of unknown origin at any time, ischemic stroke or transient ischemic attack (TIA) in the preceding 6 month, except current acute ischemic stroke within 3 hr. Treatment of acute ischemic stroke: symptoms of ischemic attack began > 3 hr prior to infusion start or when time of symptom onset is unknown; symptoms of acute ischemic stroke that were either rapidly improving or only minor before start of infusion; severe stroke as assessed clinically &/or by appropriate imaging techniques; seizure at the onset of stroke; history of previous stroke or serious head-trauma within 3 months; a combination of previous stroke & DM; administration of heparin within 48 hr preceding the onset of stroke with an elevated activated partial thromboplastin time at presentation; platelet count < 100,000/mm3; active internal bleeding; intracranial neoplasm, arteriovenous malformation, or aneurysm; systolic BP > 185 or diastolic BP > 110 mmHg, or aggressive management necessary to reduce BP to these limits; blood glucose < 50 or > 400 mg/dL. |
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注意事項 |
Monitor in patients receiving ACE inhibitors concomitantly. Recent IM inj or small recent traumas, conditions with an increased risk of hemorrhage. Treatment of acute MI & pulmonary embolism: also includes systolic BP > 160 mmHg; elderly. Treatment of acute MI: also includes Coronary thrombolysis may result in arrhythmia associated with reperfusion, thromboembolic risk may be increased in patients with left heart thrombus eg mitral stenosis or atrial fibrillation. Concomitant use of GPIIb/IIIa antagonists increases risk of bleeding. |
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不良反應 |
Bleeding, intracranial hemorrhagic neurological symptoms eg somnolence, aphasia, hemiparesis, convulsion. Cholesterol crystal embolisation, reperfusion arrhythmias, nausea, vomiting, drop in BP, increased temp, epistaxis, ecchymosis.
View ADR Monitoring Website[參閱藥物不良反應監測表格] |
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交互作用 |
Risk of haemorrhage may be increased with use of coumarin derivatives, platelet aggregation inhibitors, heparin & other agents influencing coagulation. Concomitant treatment with ACE inhibitors may enhance the risk of anaphylactoid reactions.
View more drug interactions with Actilyse[栓體舒] |
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使用上注意 |
For caution against possible variation of physical aspect of medicine... click to view Actilyse[栓體舒] detailed prescribing infomation |
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儲存 |
View Actilyse[栓體舒] storage conditions for details to ensure optimal shelf-life. |
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描述 |
View Actilyse[栓體舒] description for details of the chemical structure and excipients (inactive components). |
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作用 |
View Actilyse[栓體舒] mechanism of action for pharmacodynamics and pharmacokinetics details. |
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本商品之市售規格 |
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劑型 |
包裝 |
圖片 |
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Actilyse 注射劑 |
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Actilyse 20 mg x 1's |
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Actilyse 50 mg x 1's |
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Manufacturer: |
Boehringer Ingelheim |
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Distributor: |
Boehringer Ingelheim |
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