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The type of bleeds associated with thrombolytic therapy can be divided into two broad categories: superficial bleeding, normally from punctures or damaged blood vessels; internal bleeding at any site or body cavity.
With intracranial haemorrhage neurological symptoms such as somnolence, aphasia, hemiparesis, convulsion may be associated.
Adverse reactions listed as follows are classified according to frequency and system organ class. Frequency groupings are defined according to the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
The number of patients treated in clinical trials in the indications acute massive pulmonary embolism and acute ischaemic stroke (within the 0 - 4.5 hours time window) was very small in comparison to the number in the trial for acute myocardial infarction. Therefore, small numerical differences observed in comparison with the number in acute myocardial infarction were presumably attributable to the small sample size. Except for intracranial haemorrhage as side effect in the indication acute ischaemic stroke as well as for reperfusion arrhythmias in the indication acute myocardial infarction there is no medical reason to assume that the qualitative and quantitative side effect profile of ACTILYSE in the indications acute massive pulmonary embolism and acute ischaemic stroke is different from the profile in the indication acute myocardial infarction. (See Tables 3, 4, 5 and 6.)
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