ACTILYSE
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Package:
VIALS: 1 + 1 vials of 50 ml water for injection.
Dosage:
Myocardial infarction: 90 minutes accelerated dose regimen for patients with M.I. in whom treatment can be started within 6 hours of the onset of symptoms; up to the maximal dose of 100 mg (see lit.)
3 hour dosage regimen for patients in whom treatment can be started between 6 and 12 hours of the onset of symptoms, up to maximal dose of 100 mg (see lit.).
For patients below 65 kg, the total dose should not exceed 1.5 mg/kg.
Adjunctive therapy: Acetylsalicylic acid should be initiated as soon as possible of the onset of symptoms and continued for the first months after M.I. See lit.
Pulmonary embolism:Total dose of 100 mg is to be administered in 2 hours (see lit.). Total dose not to exceed 1.5 mg/kg in patients below 65 kg.
Adjunctive therapy: Initiate heparin therapy (see lit.).
Acute ischemic stroke: Treatment must be performed by a physicain specialized in neurological care. Recommended dose is 0.9 mg/kg body weight infused I.V. over 60 minutes with 10% of the total dose administered as an initial I.V. bolus. Treatment must be started within 3 hours of the onset of symptoms.
Adjunctive therapy: The safety and efficacy of this regimen with concomitant administration of heparin and acetylsalicylic acid within the first 24 hours of the onset of symptoms have not been sufficiently investigated (see lit.). Heparin therapy should be inititiated after treatment.
Use in children and the elderly: Not indicated for the treatment of acute stroke in children under 18 years or adults over 80 years.
Prescribing Restrictions: None
Indications:
Acute myocardiac infarction. Massive pulmonary embolism with hemodynamic deprivation. Fibrinolytic treatment of acute ischemic stroke, restricted to prescription by specialist in neurology. Treatment must be started within 3 hours of onset of the stroke symptoms and after prior exclusion of intracranial hemorrhage by means of appropriate imaging techniques.
Contra-Indications:
Patients with a high risk of hemorrhage (see lit.). C/I in acute M.I. and acute pulmonary embolism: Any history of stroke. C/I in acute ischemic stroke: See lit.
Special Precautions:
See prescribing information for full details.
Side Effects:
See prescribing information for full details.
Drug Interactions:
See prescribing information for full details.
