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See related Actilyse powd for inj information |
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Manufacturer |
Boehringer Ingelheim |
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Distributor |
Hong Kong: Zuellig/Macau: Agencia Lei Va Hong |
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Contents |
Alteplase |
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Indications |
Thrombolytic treatment in acute MI & acute massive pulmonary embolism with haemodynamic instability. Fibrinolytic treatment of acute ischaemic stroke. Treatment must be started w/in 3 hr of onset of the stroke symptoms and after prior exclusion of intracranial hemorrhage.
Click to view Actilyse detailed prescribing infomation |
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Dosage |
MI: 90 min (accelerated) dose regimen started w/in 6 hr after symptom onset 15 mg IV bolus, 50 mg infusion over 30 min, followed by 35 mg infusion over 60 min until the max dose of 100 mg. Patient <65 kg 15 mg IV bolus & 0.75 mg/kg over 30 min (max 50 mg), followed by 0.5 mg/kg infusion over 60 min (max 35 mg). MI: 3 hr dose regimen started between 6 & 12 hr after symptom onset 10 mg IV bolus, 50 mg IV infusion over 1st hr, followed by 10 mg infusion over 30 min until the max dose of 100 mg over 3 hr. Patient <65 kg Max total dose: 1.5 mg/kg. Max dose of alteplase: 100 mg. Pulmonary embolism 10 mg IV bolus over 1-2 min, followed by 90 mg IV infusion over 2 hr. Patient <65 kg Max total dose: 1.5 mg/kg. Acute ischaemic stroke 0.9 mg/kg (max 90 mg) IV infusion over 60 min w/ 10% of the total dose administered as an initial IV bolus.
Click to view Actilyse detailed prescribing infomation |
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Overdosage |
View Actilyse overdosage for action to be taken in the event of an overdose. |
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Contraindications |
Known haemorrhagic diathesis; significant bleeding disorder at present or w/in the past 6 mth; patients receiving oral anticoagulants; manifest or recent severe or dangerous bleeding; history of or suspected intracranial haemorrhage, CNS damage; subarachnoid haemorrhage; recent (<10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a noncompressible blood vessel; severe uncontrolled arterial HTN; bacterial endocarditis, pericarditis; acute pancreatitis; ulcerative GI disease during the last 3 mth, oesophageal varices, arterial aneurysms, arterial/venous malformations; neoplasm; severe liver disease; major surgery or significant trauma in the past 3 mth; haemorrhagic stroke; ischaemic stroke; transient ischaemic attack in past 6 mth, except w/in 3 hr; minor neurological deficit; administration of heparin w/in 48 hr; history of prior stroke & concomitant diabetes; platelet count <100,000/mm3; systolic BP >185 or diastolic BP >110 mmHg; blood glucose <50 or >400 mg/dL.
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Warnings |
For additional cautionary notes to warn of the potential risk of using the medicine... click to view Actilyse detailed prescribing infomation |
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Special Precautions |
Small, recent traumas; conditions w/ an increased risk of haemorrhage; systolic BP >160 mmHg. Elderly & childn. Pregnancy & lactation.
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Adverse Drug Reactions |
Bleeding, recurrent ischaemia/angina, hypotension and heart failure/pulmonary oedema, reperfusion arrhythmias; decreased BP, increased body temp. Cardiac arrest, cardiogenic shock, reinfarction.
View ADR Monitoring Form |
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Drug Interactions |
Coumarin derivatives, oral anticoagulants, platelet aggregation inhibitors, heparin & other agents inhibiting coagulation. GPIIb/IIIa antagonists. ACE inhibitors.
View more drug interactions with Actilyse |
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Pregnancy Category (US FDA) |
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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Caution For Usage |
For caution against possible variation of physical aspect of medicine... click to view Actilyse detailed prescribing infomation |
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Storage |
View Actilyse storage conditions for details to ensure optimal shelf-life. |
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Description |
View Actilyse description for details of the chemical structure and excipients (inactive components). |
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Mechanism of Action |
View Actilyse mechanism of action for pharmacodynamics and pharmacokinetics details. |
